Medical Researchers Want Up To Five Years Exclusivity For Clinical Trial Data Derived From Volunteers

from the papers-before-patients dept

A year ago, we wrote about how TPP's requirement for "data exclusivity" risked undermining one of science's fundamental principles: that facts cannot be owned. Data exclusivity is just the latest attempt by Big Pharma to extend its monopoly over drugs, whether using patents or other means. To a certain extent, you might expect that: after all, companies are designed to maximize profits, and if it means more people suffer or die along the way, well, that's regrettable but sort of beside the point. However, it's surprising to see a group of medical researchers writing in the prestigious New England Journal of Medicine (NEJM) calling for just the same kind of data exclusivity. The post is in response to an earlier NEJM article by the International Committee of Medical Journal Editors (ICMJE), entitled "Sharing Clinical Trial Data":

As a condition of consideration for publication of a clinical trial report in our member journals, the ICMJE proposes to require authors to share with others the deidentified individual-patient data (IPD) underlying the results presented in the article (including tables, figures, and appendices or supplementary material) no later than 6 months after publication.

Reasonable enough, you might think. But in the new commentary from the International Consortium of Investigators for Fairness in Trial Data Sharing -- which doesn't seem to have any online presence currently -- a group of "282 investigators in 33 countries" (pdf) beg to differ:

Although we believe there are potential benefits to sharing data (e.g., occasional new discoveries), we believe there are also risks (e.g., misleading or inaccurate analyses and analyses aimed at unfairly discrediting or undermining the original publication) and opportunity costs (e.g., the ICMJE proposal would have enormous direct costs and would probably divert resources, both financial and human, from the actual conduct of trials).

It's rather telling that the new discoveries that arise from research are dismissed as "occasional," while the rather weird concern about "discrediting or undermining the original publication" is put forward as if it were a major problem in the field. The International Consortium of Investigators for Fairness in Trial Data Sharing has a few suggestions for what should be done instead of the ICMJE proposal:

The timeline for providing deidentified individual patient data should allow a minimum of 2 years after the first publication of the results and an additional 6 months for every year required to complete the study, up to a maximum of 5 years.

Five years' data exclusivity takes us into TPP territory. And then there's this:

Persons who were not involved in an investigator-initiated trial but want access to the data should financially compensate the original investigators for their efforts and investments in the trial and the costs of making the data available.

You may have thought research was about winning new knowledge and willingly sharing it with your peers, but in fact it's about money. Actually, what is most shocking about the International Consortium of Investigators for Fairness in Trial Data Sharing's opinion piece is not what it says, but what it doesn't say. The whole thrust of the piece is what a tough life researchers have:

To complete an RCT [randomized, controlled trial], investigators must develop a protocol, obtain funding, overcome regulatory and bureaucratic challenges, recruit and follow participants, undertake analyses, and publish the results. This process takes several years, and for large clinical trials it can sometimes take a decade or longer. Adequate incentives for researchers to invest the substantial time and effort required to conduct RCTs and to publish the results in a timely fashion are important.

But at least it's a noble struggle, you might think, since this is all done for the patients' benefit. Or maybe not:

A key motivation for investigators to conduct RCTs is the ability to publish not only the primary trial report, but also major secondary articles based on the trial data.

It's all about those career-enhancing publications, apparently. But it's not just the patients who are missing from the International Consortium of Investigators for Fairness in Trial Data Sharing's worldview. They are also ignoring an absolutely indispensable aspect of clinical trials. It's so important that the ICMJE's article begins by acknowledging it in the first sentence:

The International Committee of Medical Journal Editors (ICMJE) believes that there is an ethical obligation to responsibly share data generated by interventional clinical trials because participants have put themselves at risk.

This is why the data that results from those clinical trials must be shared as soon as possible: because members of the public who volunteer to take part in them have literally risked their lives in order to benefit others. The idea that this data should be hoarded by the researchers for up to five years just so that they can squeeze out a few more articles that look good on their CV is profoundly insulting to the participants and their unsung selflessness.

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Filed Under: clinical trials, data, data exclusivity, medical research

Sweden Considers Making DNA Donated Purely For Medical Research Available To Police And Insurance Companies

from the so-what-if-we-promised-we-wouldn't? dept

When it comes to biometrics, you really can't beat DNA. You can always erase your fingerprints, or wear contact lenses to fool iris scanners, but there's no way of changing all your DNA enough to make it unrecognizable (even with the new CRISPR technique). Couple that with the fact that we are shedding DNA everywhere we go -- leaving tell-tale markers on everything we touch -- and you have the perfect surveillance mechanism. That's why earlier UK plans to give police access to medical databases are problematic, to say nothing of Kuwait's mandatory DNA database for all citizens, residents and visitors. Now Rick Falkvinge has written a post about troubling moves in Sweden:

Since 1975, Sweden has taken a DNA sample from all newborns for medical research purposes, and asked parents’ consent to do so for this research purpose. This means that over time, Sweden has built the world's most comprehensive DNA database over everybody under 43 years of age. But now, politicians are considering opening up this research-only DNA database to law enforcement and private insurance companies.

As Falkvinge points out, this is not just a betrayal of a trust, it is totally counterproductive:

This is, of course, an outrageous and audacious breach of contract with the parents who were promised the sample would be used only for the good of humanity in terms of medical research. The instant there's a mere suspicion that this will be used against the sampled newborn in the future -- as is the case now -- instead of being used for the good of humanity as a whole, people won't provide the DNA database with more samples, or at least not enough samples to provide researchable coverage.

The risk that Sweden might proceed down this road is also a reminder that once such huge databases are created, it is almost inevitable that one day someone will come along and say: "since we have this information, surely nobody could object to it being used to catch terrorists/pedophiles/rapists etc. etc." And as the news from Sweden shows, initial promises that such sensitive data will only be used for research are worthless, since they can always be revoked later on, and there is no easy way of removing the data once it is on the database.

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Filed Under: dna, information, insurance, law enforcement, medical research, police, privacy, sharing, sweden

The CISPA Circus Goes To Baltimore With Another Misleading 'Local Pride' Editorial

from the maryland-versus-china dept

Recently, I responded to an editorial by CISPA author Mike Rogers in the Detroit News, wherein he took some blatant China fearmongering and targeted it at Michigan's specific industry concerns to rouse the local rabble in CISPA's favor. Now Rep. Ruppersberger—the other driving force behind the bill—is applying the same tactic in Maryland, with an editorial in the Baltimore Sun that focuses on the supposed cyber-threat to the life sciences industry:

Here in Maryland, for example, our growing life sciences sector has generated one-third of all job gains over the last 10 years. It's now supporting more than $9.6 billion in salaries for Maryland families and contributes nearly $500 million to incomes and sales tax revenues each year.

The 500 bioscience companies in Maryland are developing ground-breaking therapies for diseases like muscular dystrophy, inventing state-of-the-art medical devices and testing cutting-edge vaccines. These innovations are valuable and worth protecting. Indeed, just like designer handbags or secret family recipes, many want to imitate — and even duplicate — such successes.

For decades, countries like China have been using every means possible to steal the ideas of American corporations. Today, thousands of highly trained Chinese, Russian and Iranian hackers are pilfering our trade secrets by breaking into the computer networks of U.S. corporations. And we're leaving the door unlocked for them.

Something seems off about comparing the desire to copy new disease therapies with the desire to make knockoff handbags, but I guess that was just meant to clarify things for anyone who didn't understand why ground-breaking medical research is valuable. Of more concern is his statement that the door is left "unlocked"—a blatant exaggeration that makes it sound like CISPA's data-sharing provisions are the difference between airtight security and no security at all, even though security experts question whether CISPA would have any real impact. He then goes on to do exactly what I criticized Rogers for doing, by focusing in on the one (supposedly) useful and genuine cybersecurity aspect of the bill while ignoring the rest:

Currently, the U.S government can identify malicious computer code that could be an incoming cyber attack on a government or corporate network. But the law won't allow us to share this information with private companies so that they can protect themselves.

That's why House Intelligence Committee Chairman Mike Rogers, a Michigan Republican, and I have crafted the Cyber Intelligence and Sharing Protection Act (H.R. 3523), which the House overwhelmingly passed this month in a bipartisan vote. This common-sense bill will simply allow the federal government and American companies to share suspicious computer code. Despite recent media reports, the bill does not authorize the government to monitor your computer use or read your email, Tweets or Facebook posts. Nor does it authorize the government to shut down websites or require companies to turn over personal information.

This is just a bunch of half-truths, semantics and disingenuous statements. Firstly, while there may be some data sharing the government wants to do that is currently blocked by the law, there are also existing mechanisms that allow some sharing to happen. Rather than carve out specific exceptions to the specific laws that are getting in the way, CISPA creates broad immunity provisions that wipe out all existing privacy concerns.

Secondly, the bill does not "simply" allow what Ruppersberger says it allows. CISPA's definition of the information that can be shared allows for much more than just "suspicious computer code," instead potentially including all sorts of tangential data related to a network attack—which, yes, could include lots of personal information. CISPA also does not limit the government to using this information for merely technical purposes related to cybersecurity—it permits them to dig through whatever data they collect for evidence of certain types of crime. You'll notice that investigating violent crime and child exploitation (both specifically listed in the text of CISPA) are not mentioned anywhere in this editorial.

Thirdly, while both of Ruppersberger's assertions about what the bill "does not authorize" the government to do are technically accurate, only the latter is giving the full story. It's true that CISPA does not permit the government to shut down websites or require information from companies—but as for monitoring people and reading their communications, as I just described, it's a bit more complicated. No, CISPA does not allow the government to go out and monitor whoever they wish, but it does allow them to thoroughly mine whatever data is given to them—data that will undoubtedly include private information.

For good measure, Ruppersberger throws in some more fearmongering about terrorist hackers taking down power grids (even though CISPA doesn't include anything that would let the government put a common sense regulation in place, like, say, don't connect power grids to the internet) before circling back to the talking-point of Maryland's valuable medical research. Like Rogers, he plays up the imminence of the threat, claiming "it wouldn't take years from China to steal it all from us" and in fact "it could happen in mere keystrokes"—as if at any moment someone could just select "U.S. Economy" and press delete.

I have a feeling this won't be the last of these locally-focused editorials from the pro-CISPA camp. I'm rooting for a Las Vegas feature on the need to protect casino secrets, because while it would surely still be inaccurate and misleading, it might at least be interesting.

Filed Under: baltimore, cispa, dutch ruppersberger, maryland, medical research, mike rogers

Medical Researchers Resort To File Sharing To Get Access To Journal Research

from the those-filthy-pirates dept

When you hear about file sharing and unauthorized access to information online, the view pushed by many copyright maximalists is that it's just a bunch of morally corrupt kids who don't want to pay for stuff gleefully "stealing" music and movies from those hard working entertainment industry employees. Of course, the real picture is a lot more complex. For example, apparently there's a growing community of medical researchers using file sharing to exchange information and research reports that they have trouble accessing otherwise. In the past, we've talked about the growing effort to get scientific research published in open access journals, rather than locked up in ridiculously expensive (especially given that they don't have to pay writers or even the peer reviewers) old school research journals.

While open access journals are certainly becoming a lot more popular and useful, there's still plenty of useful research that's very difficult for many to access. At least in the medical field, it looks like some researchers took a page from various private file sharing communities. Christian Zimmerman points us to a report looking at one such community that had over 100,000 registered users sharing scans and uploads of medical research reports from non-open journals via some basic forum-type software (so not really peer-to-peer... yet). The community that was looked at contained nearly 300,000 postings, with people requesting certain reports, and others delivering them.

Apparently, the system was quite effective, with nearly 83% of requests for certain articles resulting in delivery of the requested article. The analysis notes that the 83% is probably low, as there would likely have been a higher success rate if people making the requests followed the stated rules for making a request (some did not). The analysis also noted that people weren't doing this to get back at the journal publishers, but just to help each other out:

From the participants' comments made in the forums, however, there does not appear to be any vindictiveness on the part of the participants against the journals or holders of copyright, but a mood of togetherness, of openness and sharing, and communal assistance. Most remarkable, is that the activity described in this paper did not occur within closed, secure, password- and firewall-protected environments, but within open environments, easily publicly accessible, and easily searchable and referenced by general search engines such as Google.

Though, it should be noted that this particular forum apparently later did go behind a private wall. Still, it's interesting to see the parallel between this and other types of file sharing -- showing, again, that people of all types are recognizing that access to information that's out there should be a given.

Filed Under: file sharing, medical research, open access journals

Another Example Of How Patents Skew Medical Research

from the why-bother? dept

When it comes to patents, the argument for pharmaceutical patents is a lot more compelling than for many other areas. However, as you start to dig into the details, the argument for pharma patents becomes a lot more troublesome in that it creates incentives that have little to do with improving healthcare, and quite a lot to do with what can be patented. The monopoly power granted by patents pushes all research money into only things that can be patented, ignoring other possible cures, even if they can be both profitable and quite helpful. A recent GAO study found this to be a worrisome trend, noting that fewer new innovative drugs are being created -- with pharma firms instead focusing on ways to extend the patent protection on existing products by pulling a few tricks (such as "reinventing" Claritan as Clarinex just to get more patent coverage).

William Stepp points us to an example of how this focus on patents has helped to hold back one doctor's promising research on a way to help heal brain injuries. The doctor in question had come across some interesting findings back in the 1960s, but one of the problems in getting support for the research was that the findings wouldn't produce a patentable pharmaceutical product. Instead, it just showed that progesterone, a natural female hormone, could help heal brain injuries. Since it's just a natural hormone, there's nothing that can be patented, and the doctor had a very difficult time finding anyone to back the research. After decades of working on it -- often completely on the side, it seems that he's finally been able to build up some support -- and it turns out that his early findings did make sense and that the results appear to work equally well in humans as in rats (his initial test subjects). This is a clearly a big discovery -- and it was delayed decades because the focus on patents obscured the bigger issue.

This is the exact same thing that is seen repeatedly in Andy Kessler's book, The End of Medicine about the healthcare system. Time and time again, it's the pharmaceutical industry and their focus on what can they patent (rather than what can be done to improve healthcare) that gets in the way of real improvements that could save lives. The focus on what can be patented, and the games played to extend patents (at great costs) means that money that should be going towards much more useful areas of healthcare get diverted into less useful, but artificially profitable, endeavors. That's what happens when you set up artificial monopolies.

Filed Under: medical research, patents