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This is the reason why the work at Accelerated Cure Project is so important! It is so annoying that researchers don't share their results! Although this article is about cancer the same applies to other diseases, including MS




January 22, 2008
Essay
Cancer Data? Sorry, Can’t Have It

By ANDREW VICKERS
Not long ago, I asked a respected cancer researcher if he could send me raw data from a trial he had recently published. He refused. Sharing data would make the study team members “uncomfortable,” he said, as I might use this to “cast doubt” on their results.

I’d heard this before: as a statistician who designs and analyzes cancer studies, I regularly ask other researchers to provide additional information or raw data. Sometimes I want to use the data to test out a new idea or method of statistical analysis. And knowing exactly what happened in past studies can help me design better research for the future. Occasionally, however, there are statistical analyses I could run that might make an immediate and important impact on the lives of cancer patients.

A few years back, a study was published showing that a certain drug could prevent one type of cancer. The problem was that the drug didn’t work very well and had some side effects, so almost no one used it. At the same time, a colleague showed that a protein found in the blood could predict which patients were at high risk for cancer. We put two and two together and realized that we could use the protein test to work out which patients would benefit from the drug.

To make things even easier for us, it turned out that the researchers who had conducted the trial had actually measured this protein in all their patients. So we wrote to them and asked whether they would share their data. They refused on the grounds that they might consider a similar analysis at some point in the future. But years have passed, no such analyses have been forthcoming and few patients are benefiting from what could be a very effective drug.

Given the enormous physical, emotional and financial toll of cancer, one might expect researchers to promote the free and open exchange of information. The patients who volunteer for cancer trials often suffer through painful procedures and harsh experimental treatments in the hope of hastening a cure. The data they provide ought to belong to all of us. Yet cancer researchers typically treat it as their personal property.

I’m sometimes told that sharing data would violate patient privacy — though changing names to codes is easy enough. Other requests are killed by red tape. When a colleague and I wanted to analyze the data from a completed breast cancer trial, merely getting permission to speak to the study’s organizing committee required a one-hour phone call with the scientist in charge of the agenda. Only after another one-hour call with the committee itself were we allowed to submit a formal proposal — to which we received no response.

Most refusals are more blunt. “I am not prepared to release the data at this point,” one researcher wrote me, even though he was a government employee and his trial, which had been published several years earlier, was federally financed.

Dr John Kirwan, a rheumatologist from the University of Bristol in England, has studied researchers’ attitudes on sharing data from clinical trials. He found that three-quarters of researchers he surveyed, as well as a major industry group, opposed making original trial data available. It is worth restating this finding: most scientists doing research on how best to help those in pain, or at risk of death, want to keep their data a secret.

Dr. Kirwan went on to ask his subjects why. Their reasons were entirely trivial: one cited the difficult of putting together a data set (wouldn’t this have to be done anyway in order to publish a paper?); another was concerned that the data might be analyzed using invalid methods (surely a judgment for the scientific community as a whole). This is something of a clue that the real issue here has more to do with status and career than with any loftier considerations. Scientists don’t want to be scooped by their own data, or have someone else challenge their conclusions with a new analysis.

Yet this is exactly what cancer patients need. They want new results to be published as quickly as possible and to encourage a robust debate on the merits of key research findings.

An acquaintance of mine was recently diagnosed with breast cancer, and it gives me some comfort to know that there are drugs she can take that will improve her chance of cure. We know that these drugs are of benefit because more than 20 years ago, a group of Oxford statisticians persuaded researchers around the world to pool data from their breast-cancer trials.

With the rise of the Internet, sharing data has become a simple matter. Geneticists, for example, publish their raw data on a central Web site. The data from medical trials are given freely by patients. They should insist that these belong to science as a whole.

Andrew Vickers is a biostatistician at Memorial Sloan-Kettering Cancer Center in New York.


Copyright 2008 The New York Times Company
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Okay, now I'm REALLY angry.

Unless a prearranged data sharing agreement is made prior to any data collection, such as with the Accelerated Cure Project, it is not surprising that researchers are not willing to share their raw data. When propositioned with such a request, most researchers, in my opinion, would be correct to assume that such requests would lead to the data being stolen and published independently of the original researchers. In today's research environment where career promotion and research funding are directly linked to publication, raw data winds up being a closely guarded treasure. Moreover, most university researchers do not actually own the rights to their own data. It is owned by the university and the university likely has the final word on what can be shared and what cannot. For example, when I was in graduate school, I had to sign an agreement that anything I did in the lab was owned by the university. Moreover, my lab manager explained to me that if I had what I thought was a patentable idea, I should not work on that idea while in the university lab and I should also be able to provide clear documentation that work on such a project was never conducted in the university lab or with any university lab resources. Otherwise, the university would be able to legally claim ownership of the patent should such work lead to those ends.

NHE

Okay, I understand, but don't you think the proprietary way things are handled leads to the chronic duplication in research that we continue to see? I understand that someone wants to protect their research for their own publication but certainly there should be some way to do that and yet use the information gleaned from that research to further the study of the subject. Does that make sense or am I just being naive?

From the first post:

"Their reasons were entirely trivial: one cited the difficult of putting together a data set (wouldn’t this have to be done anyway in order to publish a paper?); another was concerned that the data might be analyzed using invalid methods (surely a judgment for the scientific community as a whole)."
In whose opinion are their reasons trivial? This Andrew Vickers seems to have an awfully high opinion of himself to claim that the original researchers concerns were trivial. It would seem that a cancer statistician (as he claims to be) of any ability should already be involved in collaborations established through his/her own institution and would have enough of a professional reputation and connections to have become involved with the projects when the projects were first being designed. If his ideas are so great, why doesn't he organize his own team of clinicians and design a study and get it funded. Science is an extremely competitive arena. You can't sit back and expect others to do the heavy lifting for you. If someone asked for data from me and they were not an established researcher in some way, I would be suspicious of their motives. Perhaps they are just trying to give their snake oil infomercial on late night TV some validity by tying themselves to my study and my institution. Many scientists can probably tell a story of how they feel their ideas were stolen. It is not a trivial concern with regards to one's future in a career and earning a livelyhood.

Most institutions have IRBs (Internal Review Boards). In order to initiate a study and try for grant funding, the researcher needs to get approval from the IRB by defining exactly how the study will be conducted and the use of the data. Protocols must be explained in detail with many checks and controls. This is to insure ethical standards are adhered to, patients rights are protected, and data collected is valid. To have someone outside of the original plan start using the data could already be prohibited by the IRB or funding agency, and would most likely require some indepth review, request to the IRB for amendments and explaining. Why should the original investigators put themselves through that time and effort and risk their original approval just to give their data to someone who hadn't established his credentials with them before? Grants are usually predefined projects, objectives, and teams, not pickup games in sandlot football for some Johnny-come-lately.

"This is something of a clue that the real issue here has more to do with status and career than with any loftier considerations."
And what are those loftier considerations? Andrew Vickers' status and career?

As far as organizations being overly protective of ideas and owning the employees' ideas, it can be a bit frustrating because the organization may not see the full value and may not be as diligent in bringing the idea to fruition through the legal/technology development department(s). On the outside it requires an entrapreneur to champion one's own ideas and develop them. It is often the same inside an organization, ie. one needs to be an intrapreneur. Some organizations even incorporate this into their operating style. They will hire managers, put them on a project, and they have to be an intrapreneur and champion that project within the organization, competing for the resources they need for their project.

I had an idea for a software application for use in drug discovery a couple of years ago. I submitted it to our legal/tech devo department and they put in for a provisional patent. In the meantime I developed a prototype that we are using in our group. My boss and I even got involved with a new company (former employee) in India to take on the full development. Our organization and the new company continually discussed the licensing conditions for the idea for most of a year but the conditions were too constrictive and demanding (time-lines for payments and royalties) for the new company to accept. So that feel through. Now my organization has decided not to go for the full patent since that costs a lot. My boss and I have a meeting coming up to get the rights turned over to us since our organization does not appear to have any further interest. So, when we get the rights, we are interested in getting a grant to develop the idea. This would make me an intrapreneur since I would be spending about half my time working on it and hiring people into the organization to work on it, while keeping my day job. As far as the idea being lucrative for us, perhaps in the future we can get with the company in India to develop a big glossy version that can be sold to big pharma. We are primarily interested in simply developing the idea into an available tool for researchers to use. We just want to get our little Kitty Hawk contraption to fly. We'll think about charging for flights and how to lose people's baggage later, if ever.

I think the attitude about ideas should be, if you have an idea and you think your organization knows its value and can do a better job in developing it than you, then it's an idea. On the other hand, if you don't think the organization is going to be an effective route for developing the idea, then... you have to decide what to do. An organization needs to convince its employees that their ideas will be taken seriously.

Wesley

How would it cast doubts on their results? If they showed the data that would back up their results. The only reason I can think of for them to do this is if their results are false and they still want to make the money.

TwistedHelix wrote:Okay, now I'm REALLY angry.

Dom,

As you can see by some of the responses, the issues can be quite complex.

Having said that, you can imagine how guarded the "big four" MS drug producers are when it comes to their medications for MS. Bottom line....our very society has created an atmosphere within the world of MS medicine to ensure that advance knowledge and scientific development will progress as slowly as possible!

Is it any wonder that after some 6 decades of MS research, we still don't even know what causes MS?

Harry

to ensure that advance knowledge and scientific development will progress as slowly as possible!

It's all about marketing, gotta milk the dollars out of everything that already exists before anything new comes along.

robbie wrote:

to ensure that advance knowledge and scientific development will progress as slowly as possible!

It's all about marketing, gotta milk the dollars out of everything that already exists before anything new comes along.

Robbie,

I'll second that opinion! 3 of the 4 CRABs have been out there since the early '90s and have actually gone up in price in the past couple of years. That despite the millions and millions of dollars of profit made AFTER their development costs have long since been paid.

Harry

Yes, it's about marketing – which goes hand in hand with competition – and those two things drive our markets, economies and the explosion in technology. The trouble is, they also foster an atmosphere of great secrecy and jealous guarding of discoveries which put the brakes on development. It probably happens in the world of consumer goods: there must have been some fantastic ideas which never saw the light of day because they got lost in the quagmire of commercial interest, but there's a world of difference between a better microwave and medical progress… Us!

I wish I could see a way to separate market forces from the development of new therapies, but I can't: everything I can think of either involves a huge dose of altruism, high levels of trust, or some totally independent, ultra-ethical governing body with worldwide authority which could oversee and coordinate all research and absolutely, honestly, promise never to use its power for gain. I think the Accelerated Cure Project is the closest we're going to come to that one,

I wish there was a way for us to make our own database of information to share. Like our pediatric immunizations and illnesses in childhood and adulthood that we've had plus blood work information and MRI information about lesions, age of onset of symptoms, EDSS scores, etc. It sounds like a huge task to undertake but we would have a good data repository to extrapolate information and to SHARE with anyone who could and would use it to help us.

Marcia

Marcia
Accelerated Cure Project has a repository - as of the end of the year there were 891 subjects at 6 sites. It will continue to grow this year. Is this what you were talking about?
Lor

Personally, I can't agree with anyone claiming the issues are "complex." It is really straightforward. The purpose of the work of disease research (at least that funded by taxes or charitable contributions) is to ultimately benefit the people with the disease.

If you agree the data should not be shared, are you not stating that it is more important that a specific researcher have the chance of a publication than to have the information made more quickly available to help people with cancer?

The researchers fear is that someone else will find out something important about cancer sooner than they would. Explain to me how that is something we should be fearing.

I'm sorry that researchers have created a system for themselves (yes, they created it) that would "punish" them for being slower, but the solution is not to hide data! If they *had* to share the data, the reward system would change very quickly.

E.g. The human genome project (and many of its offshoots) require data to be made public as soon as it is *generated*. They have an agreement that you are honor bound to not publish a result without consulting the generator of the data, and it has worked well to date.

In matters of disease research I believe we should be ethically bound to do what results in the most benefit to the patients in the shortest amount of time. Any argument that does not lead to that end is seriously broken.

Now, if the researchers want to spend their own personal money on their research (which basically is what happens in pharma companies) rather than the tax-payers' or charitable donations, then they can be free to hide their data all they want. Not that that would make it OK ethically, but I feel they would be within their rights.

Loriyas,

I think the ms project is a pretty good idea but i'd like to see more data out there that we (the lay people) can look at. I would love to go out to a database and query it to get statistical info on ... say... the number of people who had mononucleosis prior to their diagnosis, and the number of women who took fertility drugs prior to being dx'd, the number of people on rebif who don't have side effects, the number of people who don't test positive for mrtc's and what kind of ms they've been dx'd with. This is the type of information that I'd like to be able to make queries to get a grasp on this awful illness. I get so frustrated that the only number I hear is that 400,000 in the US have ms. I would like to know if this number should really be 1million today versus 400,000 20 years ago. It seems that more people are being dx'd with ms. Is this because we have more advanced dx procedures or are more people getting this disease and why. I want data to massage to extrapolate information. No one can tell me anything about how this disease will progress in me but it sure would be nice to see what the chances are that if I do nothing how will I be in 10 years instead of taking a CRAB for 10 years and not getting any worse but acquiring the need for a liver transplant since the CRABs destroyed it.

Has anyone seen any information like what I listed above from the MS project data collection or is it another black hole where we put info in but never see anything from itexcept for extremely generic info. I looked at what is out there but it was difficult to read and I never saw any of the information I wanted to see. I want to be able to go somewhere and get real information, real numbers, and to extrapolate stats on the breakdown of how ms acts on us.

I apologize if I have rambled. I'm half delirious from taking tamiflu, codeine cough syrup, and the first day of a z-pack antibiotic. I got the flu shot but low and behold there is a strain that has made it's way to central Kentucky and wasn't included in the vaccine. One of my 5 year olds got it last week and she's given it to me. (She had the vaccine too.) Apparently it's going around her kindergarten classroom. My ms symptoms are starting to all come to the surface and I'm feeling pretty yucky.

Anyhow, I'm sorry I digressed. I have a stats degree and would love to hack into some data to feel like I'm gaining some control over this disease.

Marcia

The researchers fear is that someone else will find out something important about cancer sooner than they would. Explain to me how that is something we should be fearing.

Art,

In a perfect world this would be great but even in the grass roots research world, research data is guarded. Being able to publish results first and having a better opportunity to obtain the limited research money that results from that is what the "game" is all about. I don't like it any more than you do but that is unfortunately the reality. My cousin's son is a PhD micro-biology cardiac system researcher and it's all about being first and getting that almighty grant money.

I'm sorry that researchers have created a system for themselves (yes, they created it) that would "punish" them for being slower, but the solution is not to hide data! If they *had* to share the data, the reward system would change very quickly.

That would be nice but I doubt we will ever see that happen in our lifetime.

In matters of disease research I believe we should be ethically bound to do what results in the most benefit to the patients in the shortest amount of time. Any argument that does not lead to that end is seriously broken.

I'm sure that if this happened in the past with MS research, we would be a lot closer today to a cure if not already have one. But unfortunately ethics always seems to take a second position behind the almighty dollar. How sad!

Harry