New Discussion Draft of 21st Century Cures Act Released

By Rachel Sachs

Yesterday, a new discussion draft of the 21st Century Cures Act was released, just in time for today’s hearing on the draft before the House Energy and Commerce Committee.  At just 200 pages (although with some sections still “to be supplied”), this version is just half the size of the previous draft.  As such, it is perhaps more notable for what it took out of the original draft than for what it added in.  I haven’t had time to digest fully all of the cuts just yet, but in advance of the hearing this morning I wanted to highlight two significant deletions from the first draft and one potentially significant addition.

First, when I blogged in February about the first draft of the Act, I expressed excitement over the idea of a Medical Product Innovation Advisory Commission.  The Commission would have had the ability to oversee the way in which agencies like the NIH, FDA, and CMS all interact with each other to affect the development and dissemination of medical products.  A significant portion of my scholarship focuses on precisely these ideas, and I was hopeful that the Commission would make it into the second draft.  Alas, it did not.

Second, the first draft of the Act contained a series of very controversial exclusivity provisions.  Chief among them may have been the draft provision giving “dormant therapies” (essentially, new drugs for unmet medical needs) the option of 15 years of exclusivity.  Alexander Gaffney’s Regulatory Explainer on the first draft provides a helpful overview, for those who are interested in learning more about this provision.  But interestingly, this and other provisions relating to increased exclusivity are gone from the new draft.  Now, it is possible that some of this language will reappear later, especially as the section of the draft relating to “Repurposing Drugs for Serious and Life-Threatening Diseases and Conditions” has yet to be supplied.  But in the first draft of the document, the sections for “Repurposing Drugs” and “Dormant Therapies” were separate, so it is not clear that this is likely to happen.

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New browser app shines light on conflicts of interest

By: Christine Baugh

A new Google Chrome extension puts the spotlight on conflicts of interest. The browser app, available for free download here, was created at the Hacking iCorruption hackathon event held March 27-29 in Cambridge, MA. The event, co-sponsored by the Edmond J. Safra Center for Ethics at Harvard University and the MIT Center for Civic Media (hosted at the MIT Media Lab) brought together individuals with a variety of backgrounds and skills to work toward the common mission of fighting institutional corruption, in this case by creating practical tools. This project was one of several exciting tools created at the hackathon (information about other projects available here), and it won first prize among the projects.

The Chrome extension, called Unearth, puts funding and conflict of interest information on the abstract page of PubMed research articles. Christopher Robertson, Associate Professor of Law at the University of Arizona James E. Rodgers College of Law and Edmond J. Safra Center Fellow who was a member of the Unearth team, explains the rationale for the browser extension in this Youtube video. In short, conflict of interest and funding disclosures are often placed at the end of a research article and are generally unavailable on the abstract page. This makes it impractical for physicians and other research scientists to pay appropriate attention to this important information. Research from the Cochrane Collaboration has demonstrated that research studies funded by industry generally describe “greater benefits and fewer harmful side effects” than their non-industry funded counterparts. Thus, taking the source of research funding into account when reading a new research study is critical. Although the extension currently only works for open access articles from PubMed Central, this includes several million research articles for which funding and conflict of interest information was previously much more difficult to obtain. Additionally, the developers plan on expanding the breadth of coverage in the coming weeks. Continue reading

Bioethicist Art Caplan: Why a New Alzheimer’s Drug Isn’t A No-Brainer

A new piece by contributor Art Caplan on NBC News:

Biogen, a Cambridge, Massachusetts biotech company, announced last week that early tests of their new drug aducanumab, a monoclonal antibody, had shown impressive results in treating those with early stage Alzheimer’s disease. The drug significantly reduced the amyloid plaque buildup in the brain that is associated with Alzheimer’s.

In a very early stage safety test aducanumab slowed the cognitive decline and dementia associated with Alzheimer’s in people. On the Mini Mental Status Exam, a widely used measure of cognitive function, people at risk of Alzheimer’s who got a placebo lost around 3 points over a year. But those who got the lowest dose of aducanumab worsened by just two points and those who got a higher dose lost less than a point.

Biogen was so excited by the early results in 166 volunteers that it is going to try to go directly to a much bigger clinical trial of the drug. Wall Street was very excited too—Biogen’s stock price shot up 10 percent. […]

See the full article here.

The Medical Innovation Act: Addressing the Shrinking NIH Budget

By Rachel Sachs

Senator Elizabeth Warren (D-MA) recently introduced a new bill, the Medical Innovation Act, which would require pharmaceutical companies who settle with the government after committing certain illegal activities to reinvest additional money into the NIH.  Senator Warren views the bill as a “swear jar” for drug companies, seeking to target those who commit certain types of wrongdoing, including violating the anti-kickback statutes or defrauding Medicare and Medicaid, in order to increase government support for research at a time when the NIH’s budget has been falling.  Scholars and researchers who have lamented the shrinking of the NIH’s budget will find much to love in the bill, and they may even wish it had gone farther.

The Medical Innovation Act would be triggered under the following set of circumstances: drug companies (1) who sell at least one drug whose annual net sales exceed $1 billion, (2) where that drug can be traced at least in part to federally funded research (the Act refers to such products as “covered blockbuster drug[s]”), and (3) who enter into a settlement agreement of at least $1 million with the government after committing certain types of wrongdoing, would pay an additional penalty.  As a threshold matter, the Act will not affect companies unless they appear to have broken the law.  But even where companies have committed various forms of wrongdoing, the Act would not affect smaller drug companies, those who developed their drugs without the aid of the federal government, those who engaged in minor wrongdoing (and therefore only have small settlements), or those who take the government to trial rather than settling.

Affected companies would be required to pay an additional fine on top of the value of their settlement, paying 1% of the company’s profits multiplied by the number of covered blockbuster drugs sold by that company each year for five years.  Because the annual profits attributable to these companies are typically very high, even with the Act’s various carve-outs, Senator Warren estimates that if the Act had existed for the past five years, it would’ve provided an additional $6 billion every year to the NIH, a full 20% increase in its budget.  Going forward, this number might be smaller, if some companies respond to the Act’s incentives by committing less wrongdoing (a positive development in itself) or taking the government to trial (a relatively unlikely outcome, but possible in some cases), but the total amount is still likely to be substantial.

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Highlights from the 21st Century Cures Act

By Rachel Sachs

At the end of January, the House Energy & Commerce Committee released a discussion draft of the 21st Century Cures Act.  This document marks the beginning of the legislative phase of the 21st Century Cures Initiative, during which the Committee has held numerous roundtables and hearings and issued several white papers.  The first discussion draft of the Act, clocking in at nearly 400 pages (even with several sections “to be supplied”), is incredibly wide-ranging, including proposals that could affect every stage of the innovation process.

The discussion draft should be of interest to everyone in the health policy field.  One series of proposals is targeted at the NIH, including more support for the National Center for Advancing Translational Sciences and for the NIH’s BRAIN initiative.  Another set would act on the FDA, including one provision giving new drugs for unmet medical needs the option of 15 years of exclusivity.  This provision, based on the MODDERN Cures Act, is particularly likely to inspire a great deal of controversy and opposition.  The draft also contains a series of proposals designed to promote the development of new antibiotics, in keeping with President Obama’s recent focus on this issue.  Its attention to the use of social media by drug companies and to the FDA’s regulation of health-related software will be of interest to many, as well.

The proposed draft is much too long to catalog fully in this brief blog post, although those who are interested in a broader summary might enjoy the 13-page summary of the Act put out by the Committee, the Science summary by Kelly Servick and Jocelyn Kaiser, or Alexander Gaffney’s comprehensive Regulatory Explainer.  But I do want to highlight one section of the draft which deserves more attention than it has gotten: section 2021, which would create a national Medical Product Innovation Advisory Commission.

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The Revival of Phage Therapy to Fight Antimicrobial Resistance (AMR) – Part III: What about patent protection and alternative incentives?

By Timo Minssen

In Part II of this blog on legal issues relating to the revival of phage therapy I discussed the US Supreme Court’s decisions in Myriad and Prometheus, which might present major obstacles to the patentability of phage-related technology (a more detailed analysis of the Myriad and Prometheus decisions is available here).

Yet, all is not lost. As indicated in Part II, Myriad does not directly affect the patentability of synthetically modified biological compounds and Prometheus would still allow patents on inventive applications of natural processes and correlations that add new features to “natural laws”. Thus there still seems to be considerable leeway for patenting within the area of page therapy.

One example, mentioned in a recent Nature article, could be the skillful selection and precise combination of different phages in order to attack one specific type of bacteria. Such selections, however, would face a tough battle to overcome the “additional features that add significantly more” and “not identical” thresholds set by Prometheus and Myriad. Another example with even better prospects for patentability relates to genetically modified phages that are – due to human intervention – enabled to target only specific bacteria. This technology was recently presented by MIT researchers at the 2014 American Society for Microbiology Meeting. The researchers led by Timothy Lu had genetically engineered phages that use a DNA-editing system called CRISPR to target and kill only antibiotic-resistant bacteria while leaving other susceptible cells untouched. The significant engineering and alteration of natural products and processes involved in such inventions would most likely meet both the Myriad and Prometheus standards.

Yet, while the USPTO has recently issued new patent eligibility guidance and the CAFC has begun to directly apply Prometheus and Myriad to reject patent claims in biotech cases (e.g. In re Roslin), many questions remain unsolved. In particular, it is still not sufficiently clear exactly how much modification is required to render a molecule or method sufficiently distinct from naturally occurring product and processes. And even if the patent-eligibility threshold could be met in extraordinarily circumstances, the claimed invention would still have to fulfil other patentability requirements such as novelty, non-obviousness and the written description-requirements. The threshold for these requirements, however, have been heightened in recent years (see e.g. KSR v. Teleflex (2007) , Nautilus (2014) etc.). Considering that phage therapy is almost a century old with a substantial common general knowledge and a state of the art employing routine methods, these crucial requirements might still prevent the patentability of many useful applications.

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The Revival of Phage Therapy to Fight Antimicrobial Resistance – Part II: What about patent protection and alternative incentives?

By Timo Minssen

Three days ago I commented on a couple of legal issues raised in the recent Nature report “Phage therapy gets revitalized”  by Sara Reardon. One challenge concerns the reluctance of pharma companies to broadly invest in the development of phage therapies. As pointed out in the report, this does of course very much (but not only) relate to the question of patentability. Various aspects might present obstacles to the patentability of technology relating to phage therapy. To not complicate the discussion and considering recent developments I decided to focus on some of aspects under US patent law.

Like in Europe, the first door to patentability that phage-related technology would need to pass concerns patent eligibility. In the last years the US Supreme Court has rendered an astonishing number of fundamental patent-decisions, including not less than four (!) landmark judgments on patent eligibility, i.e. Bilski v. Kappos (2010), Mayo v. Prometheus (2012) , AMP v. Myriad (2013)  and Alice v. CLS (2014). Most relevant in this context are the decisions in Prometheus and Myriad.

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My Slate Article on the Importance of Replicating Science

By Michelle Meyer

I have a long article in Slate (with Chris Chabris) on the importance of replicating science. We use a recent (and especially bitter) dispute over the failure to replicate a social psychology experiment as an occasion for discussing several things of much broader import, including:

  • The facts that replication, despite being a cornerstone of the scientific method, is rarely practiced (and even less frequently published) not only in psychology but across science, and that when such studies are conducted, they frequently fail to replicate the original findings (let this be a warning to those of you who, like me, cite empirical literature in your scholarship);
  • Why replications are so rarely conducted and published, relative to their importance (tl;dr: it’s the incentives, stupid);
  • Why it’s critical that this aspect of the academic research culture change (because academic science doesn’t only affect academic scientists; the rest of us have a stake in science, too, including those who fund it, those who help researchers produce it (i.e., human subjects), those who consume and build on it (other scholars and policy-makers), and all of us who are subject to myriad laws and policies informed by it); and
  • Some better and worse ways of facilitating that cultural change (among other things, we disagree with Daniel Kahneman’s most recent proposal for conducting replications).

How an IRB Could Have Legitimately Approved the Facebook Experiment—and Why that May Be a Good Thing

Image courtest Flickr

Image courtesy Flickr

By Michelle Meyer

By now, most of you have probably heard—perhaps via your Facebook feed itself—that for one week in January of 2012, Facebook altered the algorithms it uses to determine which status updates appeared in the News Feed of 689,003 randomly-selected users (about 1 of every 2500 Facebook users). The results of this study—conducted by Adam Kramer of Facebook, Jamie Guillory of the University of California, San Francisco, and Jeffrey Hancock of Cornell—were just published in the Proceedings of the National Academy of Sciences (PNAS).

Although some have defended the study, most have criticized it as unethical, primarily because the closest that these 689,003 users came to giving voluntary, informed consent to participate was when they—and the rest of us—created a Facebook account and thereby agreed to Facebook’s Data Use Policy, which in its current iteration warns users that Facebook “may use the information we receive about you . . . for internal operations, including troubleshooting, data analysis, testing, research and service improvement.”

Some of the discussion has reflected quite a bit of misunderstanding about the applicability of federal research regulations and IRB review to various kinds of actors, about when informed consent is and isn’t required under those regulations, and about what the study itself entailed. In this post, after going over the details of the study, I explain (more or less in order):

  • How the federal regulations define “human subjects research” (HSR)
  • Why HSR conducted and funded solely by an entity like Facebook is not subject to the federal regulations
  • Why HSR conducted by academics at some institutions (like Cornell and UCSF) may be subject to IRB review, even when that research is not federally funded
  • Why involvement in the Facebook study by two academics nevertheless probably did not trigger Cornell’s and UCSF’s requirements of IRB review
  • Why an IRB—had one reviewed the study—might plausibly have approved the study with reduced (though not waived) informed consent requirements
  • And why we should think twice before holding academics to a higher standard than corporations

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“That’s a Lot of Marijuana”

By Nadia N. Sawicki

Earlier this month, the Drug Enforcement Administration issued notice that it would be increasing the 2014 production quota for marijuana from 21 kilograms to 650 kilograms – an almost 3000% increase. In the words of DEA spokeswoman Barbara Carreno, “That’s a lot of marijuana.” This step, according to the National Institute on Drug Abuse (NIDA), was a necessary response to a dramatic increase in current and proposed marijuana research. Continue reading

A More Transparent System for Clinical Trials Data in Europe – Mind the Gaps!

By Timo Minssen

Following the approval of the European Parliament (EP) earlier last month, the Council of the European Union (the Council) adopted on 14 April 2014 a “Regulation on clinical trials on medicinal products for human use” repealing Directive 2001/20/EC.  As described in a press-release, the new law:

“aims to remedy the shortcomings of the existing Clinical Trials Directive by setting up a uniform framework for the authorization of clinical trials by all the member states concerned with a given single assessment outcome. Simplified reporting procedures, and the possibility for the Commission to do checks, are among the law’s key innovations.”

Moreover, and very importantly, the Regulation seeks to improve transparency by requiring pharmaceutical companies and academic researchers to publish the results of all their European clinical trials in a publicly-accessible EU database. In contrast to earlier stipulations which only obliged sponsor to publish the end-results of their clinical trials, the new law requires full clinical study reports to be published after a decision on – or withdrawal of – marketing authorization applications. Sponsors who do not comply with these requirements will face fines.

These groundbreaking changes will enter into force 20 days after publication in the Official Journal of the EU. However, it will first apply six months after a new EU portal for the submission of data on clinical trials and the above mentioned EU database have become fully functional. Since this is expected to take at least two years, the Regulation will apply in 2016 at the earliest (with an opt-out choice available until 2018).

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New regulatory pathways and incentives for sustainable antibiotics: Recent European & US Initiatives

By Timo Minssen

Please find attached a ppt presentation on “New regulatory pathways and incentives for sustainable antibiotics: Recent European & US Initiatives” given on March 7, 2014 at the Broad Institute of MIT and Harvard.  The presentation was followed by a discussion moderated by US patent attorney Melissa Hunter-Ensor, Partner at Saul Ewing, Boston.

I started out by emphasizing increasing problems of antimicrobial resistance (AMR) on a global level, providing new statistics and facts. This was followed by a discussion of main reasons for these alarming developments, such as inappropriate use in agriculture and medicine, insufficient precautions, lack of education, climate change, travel behavior, insufficient collaboration and funding of R&D, scientific complexities, and the problem that incentives provided by the traditional innovation system model often fail in the case of antibiotics.

Next the presentation focused on a variety of solution models that could be discussed to fight AMR. These include both conservational and preventive approaches comprising use limitations, increased public awareness, and better hygiene, but also reactive push & pull strategies, such as increased investments, new collaborative models for R&D in antibiotics, prizes, “sui generis” IP-related incentives, regulatory responses and new pathways for approval.

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Clinical Trials of Primary Care Drugs: Could Smaller Be Better?

By Kate Greenwood

Cross-Posted at Heath Reform Watch

Lately it seems that each passing day brings another article about the cost of orphan drugs.  Earlier this week at FiercePharma, Tracy Staton reported that the United Kingdom’s National Institute for Health and Clinical Excellence (NICE) has asked Alexion Pharmaceuticals to justify the price of its drug Soliris which is, per Staton, “the most expensive drug in the world” at around $569,000 a year.  Specifically, NICE seeks “‘clarification from the company on aspects of the manufacturing, research and development costs’” of the drug.  According to Staton, this latest development in a review process characterized by “halting progress” is “a departure from NICE’s usual calculations, which typically focus on quality-of-life years and the like.”

Pushback by NICE and other payers notwithstanding, the orphan drug market is growing.  As I blogged about here, in 2013 EvaluatePharma estimated that “the worldwide orphan drug market is set to grow to $127 [billion], a compound annual growth rate of +7.4% per year between 2012 and 2018[,]” which “is double that of the overall prescription drug market, excluding generics, which is set to grow at +3.7% per year.”  In a recent article in the New England Journal of Medicine, venture-capital investors Robert Kocher and Bryan Roberts note that “more than half of the 139 drugs approved by the FDA since 2009 are for orphan diseases” and suggest that there is a risk of “systematically underinvesting in other important areas of medicine.”

Kocher and Roberts’ explain that one reason that orphan drugs attract investment is that their development costs are low.  The problem or potential problem of underinvestment in diseases like depression and diabetes could therefore be addressed, they contend, by bringing the cost of developing treatments for these common conditions in line with the cost of developing treatments for rare diseases.  And, they argue, one promising approach to doing so is to reduce clinical trial costs by reducing the size of clinical trials. Continue reading

Kevin Outterson on the Search for New Antibiotics

Kevin Outterson appeared on NPR’s “Here & Now” to discuss the growing problem of antibiotic resistance and possible ways to incentivize development of new antibiotics. From the interview:

On the misuse of antibiotics

“We should think of this as a global resource that needs to be conserved and taken care of. So antibiotics should never be used inappropriately. In the country right now, we have something on the order of 23 million people who are getting antibiotics for ear aches. Most of those situations would resolve on their own in a couple of days. We also give antibiotics many times for people just because they have some sort of a common cold — it’s estimated 18 million prescriptions a year — doesn’t help anyone who has the common cold. It’s a complete waste.”

On the rise of antibiotic-resistant bacteria

“It’s frightened people for more than a decade. You mentioned at the top the 23,000 Americans who are dying from resistant infections. The CDC said on top of that, there’s another 14,000 dying from a horrible disease, intestinal disease, called Clostridium difficile [C-diff] in the United States. Together, that’s larger than the number of people who die in this country each year from AIDS. And we’re not — as bad as things are now, the more troubling aspects, or what might happen in five or 10 years if some sort of a pathogen was resistant to everything we had got out to the population. It sounds like a Hollywood movie.”

You can listen to the full interview here.

Book Review published on SSRN

By Timo Minssen

Three weeks ago I blogged about my recent review of  “Pharmaceutical Innovation, Competition and Patent Law – a Trilateral Perspective” (Edward Elgar 2013). The full review, which is forthcoming in a spring issue of European Competition Law Review (Sweet Maxwell), is now available at SSRN:

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.

PAPER NOW AVAILABLE for 11/18 Health Law Workshop w/Aaron Kesselheim

Aaron Kesselheim is a physician and an Assistant Professor of Medicine at the Harvard Medical School. He will be speaking at the Petrie-Flom Health Law Workshop on Monday, November 18, at 5:00pm, on “Do March-In Rights Protect Public Interests in Medical Products Arising from Federally-Funded Research?”

For more details on the workshop, including information on how to obtain a copy of the paper, please visit the Petrie-Flom Center’s website.

11/7: PRIM&R Session, “Bioethics Funding at the National Institutes of Health”

Looking for a great, informative session about bioethics grants?

Bioethics Funding at the National Institutes of Health

PRIM&R 2013 Session A26

Thursday Nov. 710:30 – 11:45 a.m.

Room 305

  • Learn about NIH funding opportunities for bioethics research and scholarship
  • Receive helpful tips and tools for the grant application process
  • Provide input to NIH staff about bioethics priorities you would like to see funded
  • Meet other colleagues interested in bioethics grants
Session panelists
Liza Dawson, PhD

NIH/NIAID Division of AIDS

Joe Millum, PhD


Ann Hardy, DrPH


Sam Garner, MBE


Holly Taylor, PhD, MPH

JHU Berman Bioethics Institute


Please contact Liza Dawson,, with questions.

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.