Why Opening Up Clinical Trials Data Is Good For Pharma Companies Too

from the everybody-wins dept

Earlier this year we wrote about how AbbVie, the pharma company spun out of Abbott Laboratories, had gone to court to stop the European Medicines Agency (EMA) from releasing clinical trials information about one of its drugs. Despite what AbbVie claimed, this was not commercially sensitive in any way, but simply basic data about safety and efficacy.

It's often overlooked that this data is mostly obtained by testing new drugs on volunteer members of the public who take the medicines in order to establish their safety. By definition, these volunteers are putting themselves at risk. They selflessly offer to do that in order to advance medicine and confer benefits on society as a whole. That means the clinical data obtained from such tests belongs to the public that made them possible, at least from a moral viewpoint.

If a company seeks to prevent the free dissemination of that safety data, as AbbVie is doing in Europe, it is breaking the implicit compact it made with the people who agreed to try out its drugs. Those invited to take part in future trials of AbbVie's drugs might then begin to ask why they should endanger their health and even lives purely to boost one company's profits.

But even if AbbVie is resistant to the argument that it has a moral obligation to allow the clinical trials data to be released, and is not concerned that the public might think that it has something to hide, perhaps it will be won over by a recent article in The New England Journal of Medicine (NEJM), written by four people from the EMA. This puts forward a quite different argument, that releasing test data will directly benefit pharma companies themselves, and offers a number of reasons why.

First, access to the full data sets of completed studies will lead to improvements in the design and analysis of subsequent trials.

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Filed Under: clinical trials, data, innovation, openness, pharma
Companies: abbvie

DRM In HTML5: What Is Tim Berners-Lee Thinking?

from the what-about-the-users? dept

Back in January, we reported on a truly stupid idea: making DRM an official aspect of HTML5. Things then went quiet, until a couple of weeks ago a post on a W3C mailing announced that the work was "in scope". An excellent post on the EFF's blog explains:

This means the controversial Encrypted Media Extensions (EME) proposal will continue to be part of that group's work product, and may be included in the W3C's HTML5.1 standard. If EME goes through to become part of a W3C recommendation, you can expect to hear DRM vendors, DRM-locked content providers like Netflix, and browser makers like Microsoft, Opera, and Google stating that they can now offer W3C standards compliant "content protection" for Web video.

Perhaps the W3C should worry less about its own position and more about the users it claims to put first. After all, the net effect of creating an official standard for interoperable DRM will be to make it easier for copyright companies to adopt it -- there won't even be the present barriers and friction caused by incompatible ad-hoc systems that might make them think twice about adding it. Instead, it is likely to become the default on most online products, placing more obstacles in the way of fair-use rights of users, particularly those who are visually-impaired, who will find it harder to access these materials at all if such DRM becomes commonplace.

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Filed Under: drm, html5, open, openness, tim berners-lee
Companies: w3c

The NSA Has No Solution For The Real 'Snowden Problem' And It's Only Going To Get Worse

from the it's-called-reaping-what-you've-sewed,-mofos dept

The NSA still has no idea what Snowden took or what leak is going to be revealed next. It also seemingly has no contingency plan for the sort of situation any forward-thinking intelligence agency should realize is a distinct possibility.

It has made some moves, all mostly involving the closing of system barn doors, including end-to-end audits and the constantly hovering threat to eliminate 90% of its sysadmin staff. But no matter what methods and safeguards it implements, it's not going to eliminate the problem. As much as the revelations to date are only the "tip of the iceberg," Snowden himself is only the leading edge of a generational shift in thinking -- one that doesn't bode well for government entities that value their secrecy.

Charlie Stross provides some background on a generational shift in attitude towards loyalty and the long-held "company man" ideal, one that was fostered by previous generations and their "one job for life" outlook.

Generation X's parents expected a job for life, but with few exceptions Gen Xers never had that — they're used to nomadic employment, hire-and-fire, right-to-work laws, the whole nine yards of organized-labour deracination. Gen Y's parents are Gen X. Gen Y has never thought of jobs as permanent things. Gen Y will stare at you blankly if you talk about loyalty to their employer; the old feudal arrangement ("we'll give you a job for life and look after you as long as you look out for the Organization") is something their grandparents maybe ranted about, but it's about as real as the divine right of kings. Employers are alien hive-mind colony intelligences who will fuck you over for the bottom line on the quarterly balance sheet. They'll give you a laptop and tell you to hot-desk or work at home so that they can save money on office floorspace and furniture. They'll dangle the offer of a permanent job over your head but keep you on a zero-hours contract for as long as is convenient. This is the world they grew up in: this is the world that defines their expectations.

Sure, it is possible to build a career in the classified world of government contracting, but there are no guarantees. Younger people grew up knowing this: there are no employment guarantees anywhere. They see it in their friends. They see it all around them.

Many will also believe in openness, especially the hacker types the NSA needs to recruit. They believe that information wants to be free, and that security comes from public knowledge and debate. Yes, there are important reasons why some intelligence secrets need to be secret, and the NSA culture reinforces secrecy daily. But this is a crowd that is used to radical openness. They have been writing about themselves on the internet for years. They have said very personal things on Twitter; they have had embarrassing photographs of themselves posted on Facebook. They have been dumped by a lover in public. They have overshared in the most compromising ways -- and they have got through it. It is a tougher sell convincing this crowd that government secrecy trumps the public's right to know.

In broad terms, commentators in the mainstream and corporate media have tended to assume that all of these actors needed to be brought to justice, while independent players on the Internet and elsewhere have been much more supportive. Tellingly, a recent Time magazine cover story has pointed out a marked generational difference in how people view these matters: 70 percent of those age 18 to 34 sampled in a poll said they believed that Snowden “did a good thing” in leaking the news of the National Security Agency’s surveillance program.

(1) You never go around your boss. (2) You tell your boss what he wants to hear, even when your boss claims that he wants dissenting views. (3) If your boss wants something dropped, you drop it. (4) You are sensitive to your boss’s wishes so that you anticipate what he wants; you don’t force him, in other words, to act as a boss. (5) Your job is not to report something that your boss does not want reported, but rather to cover it up. You do your job and you keep your mouth shut.

The former United States ambassador to the United Nations, John Bolton, argued that Snowden “thinks he’s smarter and has a higher morality than the rest of us … that he can see clearer than other 299, 999, 999 of us, and therefore he can do what he wants. I say that is the worst form of treason.”

For the leaker and whistleblower the answer to Bolton is that there can be no expectation that the system will act morally of its own accord. Systems are optimized for their own survival and preventing the system from doing evil may well require breaking with organizational niceties, protocols or laws. It requires stepping outside of one’s assigned organizational role. The chief executive is not in a better position to recognize systemic evil than is a middle level manager or, for that matter, an IT contractor. Recognizing systemic evil does not require rank or intelligence, just honesty of vision.

[S]lighted or bruised employees who lack instinctive loyalty because the culture they come from has spent generations systematically destroying social hierarchies and undermining their sense of belonging are much more likely to start thinking the unthinkable.

Filed Under: chelsea manning, ed snowden, internet freedom, loyalty, openness, sharing, surveillance, whistleblowing

Extending The Spectrum Of Openness To Include The Moral Right To Share

from the now-there's-a-thought dept

Eaves's post examines some of the details of Abraham's map:

Particularly interesting is Sunil's decision to include non-legal "permissions" such as ignoring the property holders rights in his spectrum of openness. He sees this as the position of the Pirate Party, which he suggests advocates that people should have the right to do what they want with intellectual property even if they don't have permission, with the exception, interestingly, of ignoring attribution.

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Filed Under: attribution, copyright, culture, developing world, openness, sharing, sunil abraham

The Result Of Stupid Protectionism: Microsoft Kinect Can't Be Used On Microsoft Windows PCs

from the really,-really-stupid dept

With all the recent coverage of how Microsoft handled the Xbox One release, in which it had originally planned on limiting used games use and requiring an internet connection to function, before subsequently walking all that back amid the understandable outcry, you may have been under the impression that Microsoft learned its lesson. Perhaps you thought that they would no longer go about product releases in a locked-up, protectionist fashion.

Well, you'd be wrong, of course. Recent reports indicate that Microsoft is reversing the way they handled tinkering capabilities on their Kinect device for their new console, locking the device up this go around.

Ars Technica reports that "the new generation Kinect that comes packaged with every Xbox One console has a proprietary connector that cannot be plugged directly into a PC and that Microsoft is not planning to release an adapter to allow such cross-platform use."

Even if developers want to hack the sensor and use it, Microsoft won't like it. The company told Ars that Kinect for Xbox One "is not licensed for commercial use, supported, or under warranty when used on any other platform, including Windows."

Filed Under: kinect, openness, pcs, xbox
Companies: microsoft

Yes, Journalists Should Be Advocates For Shedding Light On Secret Government Powers

from the say-that-again dept

Maybe it's just me, but I don't think anyone can read that without wondering whether Bart Gellman has slipped from journalist to advocate. And from there it's a short step to wondering whether he suppressed the guidelines in his earlier story because they didn't fit his preferred narrative. Somehow they were not worth disclosing when they might have blunted privacy concerns but they had to be disclosed once "they seem[ed] to demonstrate that the president’s words are untrue." Put another way, it seemed better to hold the truth back until it could be used to sandbag the adversary.

What @stewartbaker overlooks is that my advocacy is for open debate of secret powers. That's what journalists do

Filed Under: advocacy, bart gellman, glenn greenwald, government, journalism, openness, reporting, stewart baker, transparency

Congress Planning To Debate CISPA Behind Closed Doors; No Public Scrutiny Allowed

from the shameful dept

Filed Under: cispa, congress, house intelligence committee, markup, openness, privacy, scrutiny

Disappointing: Tim Berners-Lee Defends DRM In HTML 5

from the he-should-know-better dept

During a post-talk Q&A, he defended proposals to add support for "digital rights management" usage restrictions to HTML5 as necessary to get more content on the open Web: "If we don't put the hooks for the use of DRM in, people will just go back to using Flash," he claimed.

What's more, DRM is wholly ineffective at preventing copying. I suspect Berners-Lee knows this. When geeks downplay fears over DRM, they often say things like: "Well, I can get around it, and anyway, they'll come to their senses soon enough, since it doesn't work, right?" Whenever Berners-Lee tells the story of the Web's inception, he stresses that he was able to invent the Web without getting any permission. He uses this as a parable to explain the importance of an open and neutral Internet. But what he fails to understand is that DRM's entire purpose is to require permission to innovate.

For limiting copying is only the superficial reason for adding DRM to a technology. DRM fails completely at preventing copying, but it is brilliant at preventing innovation. That's because DRM is backstopped by anti-circumvention laws like the notorious US Digital Millennium Copyright Act of 1998 (DMCA) and the EU Copyright Directive of 2002 (EUCD), both of which make it a crime to compromise DRM, even if you're not breaking any other laws. Effectively, this means that you have to get permission from a DRM licensing authority to add any features, since all new features require removing DRM, and the DRM license terms prohibit adding any features not in the original agreement, and omitting any of the mandatory restrictions featured in that agreement.

As the leading standards-setting body for the Web, the W3C has an enormous, sacred and significant trust. The future of the Web is the future of the world, because everything we do today involves the net and everything we'll do tomorrow will require it. Now it proposes to sell out that trust, on the grounds that Big Content will lock up its "content" in Flash if it doesn't get a veto over Web-innovation. That threat is a familiar one: the big studios promised to boycott US digital TV unless it got mandatory DRM. The US courts denied them this boon, and yet, digital TV continues (if only Ofcom and the BBC had heeded this example before they sold Britain out to the US studios on our own high-def digital TV standards).

Flash is already an also-ran. As Berners-Lee himself will tell you, the presence of open platforms where innovation requires no permission is the best way to entice the world to your door. The open Web creates and supplies so much value that everyone has come to it – leaving behind the controlled, Flash-like environs of AOL and other failed systems. The big studios need the Web more than the Web needs big studios.

Filed Under: cory doctorow, drm, html5, internet, openness, permission, tim berners-lee

EU VP On Aaron Swartz: If Our Laws Hold Back Benefits From Openness, We Should Change Those Laws

from the still-waiting-for-the-others dept

As Techdirt has reported over the last ten days, the death of Aaron Swartz has provoked an outpouring of grief from friends and colleagues, who understandably wish to express their shock and anger at what happened. You'd expect that. What you might not expect is for a Vice-President of the European Commission to add her voice, but that's exactly what Neelie Kroes did this week. Her post is short, and worth reading in its entirety:

You've probably seen the terrible news about the death of Aaron Swartz. It's always horrifying when someone so young and so clearly talented feels they have no option but to take their own life. I know that this is something that shook the internet community deeply. And my thoughts are with his family, and what they must be going through right now.

This was a man who saw that greater openness can be good for citizens, and good for society. Hugely disruptive -- but hugely beneficial.

For me, the case is particularly clear when there aren't copyright issues, when information was already paid for by taxpayers, and when more openness can help new innovations and scientific discoveries.

I would never condone unlawful activity. But in my view, if our laws, frameworks and practices stand in the way of us getting all those benefits, then maybe they need to be changed.

Agree or disagree with his methods, Aaron could see the open direction we’re heading in, and its benefits. In the meantime, those scientists who are paying tribute by making their own work legally, openly available aren't just showing their respects -- they are also benefiting scientific progress.

The other notable phrase is that "if our laws, frameworks and practices stand in the way of us getting all those benefits [of openness], then maybe they need to be changed". That's of a piece with her earlier frank comments about copyright being "a tool to punish and withhold, not a tool to recognise and reward," and her call for "flexibility in the system, not the straitjacket of a single model."

Given the stony silence from just about everyone in positions of power regarding Aaron Swartz's suicide, it's good that at least one politician had the decency to offer her condolences and admit that there's something seriously wrong with today's approach to sharing knowledge. It would be even better if more of her colleagues came to a similar realization and expressed it with equal honesty.

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Filed Under: aaron swartz, benefits, eu, laws, neelie kroes, openness, rules, scientific progress