Update on Litigation in Looney v. Moore (SUPPORT Trial Class Action)

By Michelle Meyer

For those closely following the litigation over this clinical trial, a few updates. On January 22, the district court ruled on defendants’ motions to dismiss plaintiffs’ third amended complaint. That complaint named as defendants the director of the IRB, the chair of the IRB, the other members of the IRB (“the IRB defendants”)—all in their individual capacities; the PI of the trial, in his individual capacity; Masimo Corporation, the manufacturer of the oximeter used in the trial; and fictitious defendants (ABC Health Care Providers #1-100; ABC Individuals #1-100; and XYZ Entities #1-100). The complaint stated seven counts: products liability and negligence against Masimo; negligence, negligence per se, lack of informed consent, and breach of fiduciary duty against the IRB defendants and the PI; and wrongful death against all defendants.

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Progress is Possible in the Institutional Corruption of Healthcare

By Christopher Robertson

Today, there are two big stories that relate to the “institutional corruption” of medicine (aka conflicts of interests).  For those who have been working long and hard on these issues, they are cause for hope.  The needle does move.

First, one of the biggest pharmaceutical companies, GlaxoSmithKline, has decided that it will stop paying doctors to promote their drugs.   My prior work has shown that such payments are quite common (e.g., 61% of urologists and 57% of gastroenterologists taking money), and that they likely influence the prescribing decisions of the doctors who take such money.  In recent months, Glaxo has made several such moves towards greater transparency and integrity, often as a result of threatened or actual criminal prosecutions.  (See their newfound commitment to opening up their clinical trial data too.)

The NYT story quotes an industry consultant suggesting that the move to stop paying physicians is a result of the Affordable Care Act’s “sunshine” requirement that such payments will be disclosed, and that several other drugmakers are considering similar moves. I am a bit skeptical that the disclosure mandate had such an effect, since the disclosures were already required by Massachusetts and other states, and as part of the “corporate integrity agreements” that came of several federal prosecutions.  My sense is that such disclosures are not likely to reach patients in a useable way, so its hard to understand how the transparency could really impose much of a disincentive on the companies.  Yet, something has caused Glaxo to change course.

Second, the National Football League has decided to give the National Institute of Health $30 million to study brain injuries.  The counterfactual is that the NFL could have kept the money, of course.  But the more interesting alternative is that the NFL could have just spent the money itself, hand-picking the researchers and carefully specifying how the research should be performed, in order to buy the scientific conclusions that it preferred. This has been the classic strategy of industries facing litigation risk, from tobacco, to asbestos, and now the paper industry, whose law firm actually commissions scientific studies on its behalf.  The NFL’s move instead proves that it is possible for a self-interested party to nonetheless fund independent, credible, gold-standard research, by using an intermediary, such as the NIH.

This is exactly the sort of reform that I have called for, as an alternative to the false dichotomy between public funding and private interest. For companies that have a bona fide interest in discovering and publicizing the scientific truth, a credible intermediary like the NIH can reassure consumers of scientific information that it is valid.  Now, if only we can get big pharmaceutical companies to make the same move for their clinical trials and other scientific research studies.  Perhaps the first-movers will be the most innovative companies who have bona fide products and are tired of them being lost in the cheap talk?  If physicians making prescribing decisions continue to give greater credence towards NIH-funded research, such integrity could be rewarded.

 EDIT:  Corrected link to NFL story on NYT, and corrected amount from $100M to $30M.  Also, disclaimer: I am not involved in this Petrie Flom Center collaboration with the NFL, and the views expressed here are entirely my own.

Skype co-founder Jaan Tallinn highlights X-risk

By Nir Eyal

Young people often assume that their life expectancies will remain what life expectancy is today—although life expectancy will grow by the time they are old. When all of us imagine our futures, we often neglect to take account of radical technologies which were not foreseeable prior to their invention, just as the internet wasn’t, and instead imagine something closer to present realities. We do not appreciate how different the future could be.

Among other things, the future might be dangerous to humankind in ways that we fail currently to appreciate. We got lucky, and nuclear energy seems hard for individuals to develop at home, but will that last, and will new WMDs be impossible to replicate with 3D printers or other future technologies? Can anyone guarantee that viruses manufactured for scientific research will not be spread by error or terror? Can we guarantee that robots designed for contained military purposes would not go out of control? Or that once artificial intelligence is advanced enough to design other artificial intelligence, humans will remain safe for long? Some of the greatest dangers to our species are unknown, simply because the technologies that create them have not been invented yet—just as many technologies that exist and threaten us today were not invented 100 years ago.

In a multimedia presentation that drew a prolonged applause from a crowd of Harvard undergraduates, Estonian programmer Jaan Tallin wove together three stories: the story of Kazaa and Skype, which he helped start; his personal journey into studying and promoting the study of existential risk; and a “sermon” (as he put it, tongue in cheek) on the ethical responsibilities of technology developers.

Tallin proposed taking active steps in anticipation of our future errors, both to make businesses robust and to keep our species safe in an opaque future: incorporating safety margins, and continually questioning one’s assumptions. He concluded by arguing, provocatively, that indispensable to both goals is having fun.

The talk was organized by the student organization Harvard High Impact Philanthropy (HHIP).

HHIP: Jaan Tallinn, co-founder of Skype, talks on responsible technology development

So You Want to be a Technology Developer…

The roots of Skype go back to one email. If that email hadn’t been sent, the world today might be different. In general, technology development is not something that “just happens” — instead, it’s a result of particular actions by individual people. Moreover, the responsibility of technology developers must increase proportionally to the power of their creations. The talk sketches out a vision of what it means to be a responsible technology developer, using behind the scenes stories and videos from the early days of Skype development.

 Jaan Tallinn, co-founder of Skype

Wednesday, October 30th

5:30 – 6:30 PM

Science Center A

RSVP to this event

The event is organized by Harvard HIP (High Impact Philanthropy).

Unreliable Biomedical Science, and a Solution?

By Christopher Robertson

The Economist has a long, detailed, and readable piece about the difficulties of inferring anything from the published findings of biomedical science.  There are all sorts of problems that fall short of scientific fraud, including the the biases caused by industry-funding of biomedical science, the biases of unblinded raters who see what they want to see, and the biases of journal editors towards only publishing “positive” findings.  (I am particularly enamored with this graphic, which shows the fundamental problem of inference.)  It is rare for researchers to even bother to attempt to replicate prior findings, but when replications are attempted, they often fail.  

The Economist piece can be read as something close to an outright assault on empiricism, at least as we now know it.  In practical terms, it is prudent for physicians, patients, and payors to be wary of the findings presented in even the top journals.

One of the beauties of our scientific system is that it is wildly decentralized.  Scientists (and their funders) can test any hypothesis that they find interesting, and they can use whatever methods they prefer.  Likewise, journal editors can publish whatever they want.  While such academic and market freedom is attractive, it results in quite a hodgepodge of science, with replication studies and publication of null results being afterthoughts.  The NIH and NSF have in the past functioned to set an agenda and demand rigor, but as their funding wanes, the chaos waxes.

The problems are scientific, but any solution will be institutional (and thus legal).  I have argued for a partial solution to industry bias in my short article, called “The Money Blind:  How to Stop Industry Influence in Biomedical Science Without Violating the First Amendment.”  Independent scientific testing could be conducted by a neutral intermediary, which would pool funds.  In a similar vein, there is also a new project of the Science Exchange, called “The Reproducibility Initiative.”  This program offers to be the independent scientific agency, which attempts to validate known results.   But there is not yet a large-scale funding model in place.  If biomedical journal editors would at least put disclosures in their structured abstracts (an intervention we have tested), over the long run that may also nudge industry to use such gold-standard independent testing, when they have something that is truly provable.  And, at least in the domain of the products regulated by the FDA, the agency should consider using its current statutory authority to push companies towards independent, robust, and replicated science.

Symposium on Institutional Corruption and Pharmaceutical Policy

The Edmond J. Safra Center for Ethics at Harvard University has organized a symposium on Institutional Corruption and Pharmaceutical Policy that will be published in the forthcoming issue of the Journal of Law, Medicine & Ethics, 2013: Vol. 14 (3).  It will be published at the begining of September.

The goals of pharmaceutical policy and medical practice are often undermined due to institutional corruption — that is, widespread or systemic practices, usually legal, that undermine an institution’s objectives or integrity. The pharmaceutical industry’s own purposes are often undermined.  In addition, pharmaceutical industry funding of election campaigns and lobbying skews the legislative process that sets pharmaceutical policy. Moreover, certain practices have corrupted medical research, the production of medical knowledge, the practice of medicine, drug safety, and the Food and Drug Administration’s oversight of pharmaceutical marketing.

Marc Rodwin invited a group of scholars to analyze these issues, with each author taking a different look at the sources of corruption, how it occurs and what is corrupted. The articles address five topics: (1) systemic problems, (2) medical research, (3) medical knowledge and practice, (4) marketing, and (5) patient advocacy organizations.

For more information on the symposium, including a full list of the articles, please visit the Safra Center’s website. You can also access advanced copies of the 16 symposium articles through SSRN online.

For a summary of each article and the key themes in the symposium see, Marc Rodwin, Institutional Corruption and Pharmaceutical Policy.