Princess Health and What Revolving Door? - An Unprecedented Endorsement of a Political Appointment by the "Gold Standard" Medical Journal. Princessiccia

Princess Health and What Revolving Door? - An Unprecedented Endorsement of a Political Appointment by the "Gold Standard" Medical Journal. Princessiccia

conflicts of interest FDA medical journals NEJM New England Journal of Medicine revolving doors

Gusty 09:02 Add Comment

An Unprecedented Endorsement 

It's deja vu all over again.  In the spring of 2015, the New England Journal, the most prestigious US medical journal, published a remarkable series of opinion pieces extrolling physician-industry collaborations, and minimizing the significance of resulting conflicts of interest.  More remarkable was the extent that the articles' argument were bolstered by logical fallacies (look here).

Doubling down, the New England Journal of Medicine appeared to make its first ever endorsement of a nominee for federal office.  On October 28, 2015, the NEJM published an editorial with the almost campaign slogan like title, "Califf for the FDA," which enthusiastically endorsed the current presidential nominee to be Commissioner of the US Food and Drug Administration (FDA). (1)   It began, [with italics added for emphasis]

Robert M. Califf, M.D., has been nominated to be the next head of the Food and Drug Administration (FDA); he currently serves as Deputy Commissioner for the Office of Medical Products and Tobacco. We think his confirmation as commissioner should proceed as quickly as possible. Because the FDA oversees the safety and, in some spheres, the efficacy of products that constitute about 25% of our economy, the country needs a strong and experienced leader who can keep the FDA focused on its mission.

And the editorial concluded,

Califf's experience, his proven leadership abilities, his record of robust research to guide clinical practice, and his unwavering dedication to improving patient outcomes are unsurpased qualifications for the post of commissioner of the FDA; we strongly endorse his nomination and urge the Senate to act favorably on it. 

I have never seen this journal, known primarily for publishing research and scholarly opinion on medicine and health care, publicly render an opinion about a nomination for a federal position, let alone such an enthusiastic one.  A quick search of the journal revealed that it had taken no position and made no comment about the nominations of the last three US FDA Commissioners, (Dr Margaret Hamburg, Dr Andrew von Eschenbach, Dr Lester Crawford, and Dr Mark McClellan, look here) who were nominated by one Democratic and one Republican President.

Dismissing Concerns about Conflicts of Interest

This fervid endorsement came in the face of some controversy about the nomination, particularly about Dr Califf's previous ties to industry (see this post ).  He has participated in many industry sponsored clinical research projects.  For example, a 2013 JAMA disclosure statement included 13 commercial research sponsors of his work.  It also noted his consultative relationships with 32 commercial firms.  We discovered he also had a "board level" conflict of interest, having been a director of Portola Pharmaceuticals, for which he received over $250,000 in 2014 (see this proxy statement).  He also had been paid for "educational activities" in previous years, possibly including "drug talks," at least per one blogger.  So in my humble opinion, the nomination of Dr Califf could potentially become one of the most significant health care revolving door cases to affect US government.


Such consideration may have influenced Senator Bernie Sanders (I - Vermont), who is currently running for President.  In early October he announced he would oppose the Califf nomination.

Furthermore, since our post but before the publication of the NEJM editorial, there have been new revelations.   Dr Califf twithdrew as authors from several papers that had been accepted for publication, seemingly violating norms for declaring authorship of scholarly works, (see the Boston Globe here).   Dr Califf was revealed to have been a board member of and consultant to Faculty Connection LLC, which advises academic researchers "who want to work with industry" about regulatory submissions (see Intercept.com here)

Yet the Editor of the New England Journal of Medicine dismissed concerns about Dr Califf's industry relationships,

a few concerns have been expressed about his associations with industry, and these concerns may have caused some to withhold support for his nomination.

Like Califf, we believe that our actions should be driven by data, not innuendo. Since 2005, Califf has reported, as an investigator, the outcomes of seven clinical trials sponsored solely by industry in primary publications in major general medical journals. Of these trials, four had a negative outcome (i.e., not favoring the intervention), two favored the intervention, and one, with a factorial design, had a mixed outcome. Given this performance, it is impossible to argue that Califf has a pro-industry bias.

This opinion may yet carry the day.  The New York Times reported that

Dr Robert M Califf ... coasted through a confirmation hearing on Tuesday, with  most members of a Senate committee - including some who have been skeptical about his ties to the pharmaceutical industry - seeming set to support his candidacy.

This occurred despite one more major revelation that appeared since the editorial was published, but before the hearing.  A large pharmaceutical company clinical trial which Dr Califf ran had been criticized as biased in favor of the company's drug by the FDA's own staff and consultants. (see POGO here).  And it occurred despite calls by various organizations for the nomination to be turned down, including by Public Citizen and the AIDS Healthcare Foundation (see Medscape here).

Missing the Main Point

However, the NEJM editorial seemed to miss the main point.  It revolved around the claim that

It is impossible to argue that Califf has a pro-industry bias.

This was based apparently on an informal evaluation by Dr Drazen of seven of Dr Califf's 1200 publications.  So at best this was about the question of pro-industry bias in research publications. 

However, the controversy is about Dr Califf's nomination as the head of the US government agency that oversees the pharmaceutical, device and biotechnology industries, among others, and tries to assure the safety and effectiveness of drugs, biologics and medical devices, among other responsibilities.  The overriding issue is about the risk that his decision making in these capacities could be biased.  The real issue is the revolving door, not bias in research.

As we have repeated very recently, the revolving door can be veiwed as a species of conflict of interest.   Government officials who can look forward to extremely lucrative employment in health care industry may be much more inclined to seem friendly to the industry while in office.  Government officials who were previously paid by industry, and who benefited from financial interactions with industry, are likely to maintain their industry mindset and be mindful of their industry friends.  But the concern here is not that this risks biasing future research.  The risk is that a person who previously enjoyed close ties, including close financial ties to industry is at risk of putting the interests of industry over those of citizens and patients while running a US government agency charged with regulating that industry and protecting the health and safety of those citizens and patients.

Worse, some experts have suggested that the revolving door is in fact corruption.  As we noted here, the experts from the distinguished European anti-corruption group U4 wrote,

The literature makes clear that the revolving door process is a source of valuable political connections for private firms. But it generates corruption risks and has strong distortionary effects on the economy, especially when this power is concentrated within a few firms.

  Dr Drazen's editorial never directly addressed that issue.  It is one that should still be a concern.

Mission-Hostile Management?

Finally, the effect of the Califf nomination on the FDA has generated considerable public comment.  The effect of the New England Journal of Medicine's unprecendented editorial endorsement of the nomination has generated almost no discussion.  Only on the 1BoringOldMan blog was there note of the past industry ties of the current NEJM editor inspired their own controversies, and asked "since when is the editorship of the NEJM a position from which to weigh in on such matters?" (look here).

Using the editorship to so weigh in could not only obfuscate the debate about the nomination.  It could threaten the mission of a proud medical institution. The NEJM claims a

reputation as the 'gold standard' for quality biomedical research and for the best practices in clinical medicine.

It claims its editorials are

thoughtful, carefully reasoned analyses and interpretations [which] help you crystallize your own opinions on current topics and findings

Yet the blanket and unprecedented endorsement of the current FDA nominee appears otherwise.  We have previously argued that the earlier NEJM opinion pieces on conflicts of interest were based on logical fallacies more than "thoughtful, carefully reasoned analyses and interpretation."  In the Editor's apparent haste to defend industry-physician relationships, he risks the reputation and mission of once what was really a gold standard.

 Reference

1.  Drazen JM. Califf for the FDA.  N Engl J Med 2015;  DOI: 10.1056/NEJMe1513828 (link here)  

Princess Health and The Real Dark Side of Health Care: Health Care Corruption. Princessiccia

Princess Health and The Real Dark Side of Health Care: Health Care Corruption. Princessiccia

anechoic effect Annals of Internal Medicine health care corruption medical journals professionalism

Gusty 14:35 Add Comment

The editors of the prestigious Annals of Internal Medicine just stated they they were shocked, shocked to find out that physicians occasionally express disrespect for patients when the patients cannot hear or see them.  The occasion was an editorial signed by three editors whose title included the phrase, "shining a light on the dark side of health care."(1)  The editorial referred to an anonymous narrative that recounted two incidents from the past.(2)

Two Alleged Incidents of Physicians' Expression of Disrespect for Patients

The first incident, discussed second hand, was of a obstetrician who made a sexist comment about a patient, who was under anesthesia, presumably unconscious, and being prepared for surgery.  The second incident, presumably less recent, was of an obstetric/gynceology resident who, after performing an emergency procedure that saved a woman from potentially fatal acute hemmorhage, performed an impromptu dance routine that appeared to disrespect the patient's ethnicity, until stopped by the anesthesiologist who issued a profance rebuke.

The names of the people involved, the hospitals in which these incidents occurred, and even the years when they happened are unknown.  The Annals did not publish anything suggested their veracity was corroborated.

There was no apparent harm to or direct effect on any patient as a result of either incident.  Of course, both alleged incidents suggested very disrespectful expression by the two physicians.  Their actions appeared unprofessional.

The Editorial Reaction

As noted above, the editorial called the incidents examples of medicine's "dark side."  It further said they may make "readers' stomachs churn," referred to "medicine's dark underbelly," and "repugnant behavior," and characterized the narrative as "disgusting and scandalous," and having the potential to "damage the profession's reputation."  The editorial characterized the the behavior of the obstetrician in the first incident as "highly disrespectful," and said it "reeked of misogyny and disrespect," while the second "reeked of all that plus heavy overtones of sexual assault and racism." 

That is certainly extreme language.  The editors appeared shocked, shocked that any physician could ever express disrespect for a patient, even when the patient could not possible be aware of that.  Nonetheless, of course, the behavior alleged to have occurred was certainly inappropriate and unprofesional, and cannot be condoned.

The Media Reaction

The two articles got considerable publicity, and media coverage also made the incidents out to be extremely sordid, using words like,"disturbing," "astonishing," "unsavory," (albeit also "boorish,") (LA Times); "criminal," "vulgarity," (MedPage Today); "appalling," "troubling," (NY Times); and  "misogynistic," "abhorrent," (US News and World Report).  I must note that some of the news coverage did reflect doubts that the two Annals of Internal Medicine articles represented some horrendous catastrophe, raising issues such as the humanness of doctors, so that some may be "prone to sociopathy and criminality;" the stress of some medical emergencies leading to letting off steam, or poor attempts at humor; and doubts about the representativeness and validity of the two alleged anecdotes.

Nonetheless, it seemed to me that the Annals articles and the media coverage did suggest an impending crisis due to the sordid behavior of perhaps numerous doctors, and at least the tone of the media coverage they provoked suggested the need for immediate action.

Was the Outrage Justified?

However, first keep in mind that these two incidents involved two individual doctors, one a trainee.  There are approximately 800,000 physicians in the US.  They are human.  Is it any surprise that some are "bad apples," and that others occasionally behave badly?  There is nothing in the two articles to suggest that these incidents reflected more organized, systemic actions.

Furthermore, the articles seemed to ignore the fact that mechanisms, perhaps not flawless, are already in place to address unprofessional behavior by physicians, even if no one involved in the published narrative may have used them.  In the US, physicians are subject to discipline from state licensing boards.  They may be reported to those boards for unprofessional behavior.  The boards can sanction physicians in a variety of ways, up to and including permanent loss of license.  Both alleged incidents apparently occurred in teaching hospitals.  Attendings and residents at teaching hospital must answer to department chairs, medical school deans and hospital staffs.  So mechanisms for policing such behavior exist, even if they may have not been used in this case.  A look at state medical board websites reveals that that physicians are often sanctioned for bad behavior that disrespects or even endangers patients. 

Finally, the Annals of Internal Medicine used very strong language, involving churning stomachs, reeks of misogyny, sexual assault, and racism, dark underbellies, etc.  Was this a proportionate response to two anonymous cases that did not involve allegations of direct patient harm?

The Real Dark Side

Readers of Health Care Renewal know that we often discuss systemic problems in health care, often involving the leadership of large health care organizations, that may produce real harms to patients' and the public's health, but for which no good policing mechanisms seem to exist.  Worse, these problems seem to be a taboo topic in health care policy discussions, and in medical journals, like the Annals of Internal Medicine.

In my humble opinion, the Annals' editorial outrage would ring less hollowly if it was accompanied by even greater outrage at such more extreme problems. 

Let me start with a recent example.

Example: the Anechoic AllTrials US Launch

Very recently we discussed how the launch of new US AllTrials initiative got almost no notice.  Specifically, even though a sponsor of the initiative is the American College of Physicians, that organization's publication, the Annals of Internal Medicine, did not comment on it.  (A search of the journal using the term AllTrials produced no results.)

However, the AllTrials initiative means to tackle the problem of suppressed clinical research.  We have long discussed how research may be systematically suppressed when its results do not please its commercial sponsors.  Particularly, trials of drugs or devices that do not produce favorable results may be suppressed by their sponsors, usually the companies that make the drugs or devices.  Such suppression breaks trust with and therefore hugely disrespects the patients who volunteered to participate in the trials, who believed they were contributing to science and public health.  Suppressing data that drugs and devices may be ineffective and harmful may endanger patients by letting them be treated by such drugs and devices in the illusory belief that they are safe.  Yet where is the outrage about such dishonest behavior by large and powerful health care organizations that disrespects, and more importantly, endangers patients?

Health Care Corruption

When a pharmaceutical, biotechnology, or device company withholds results of a clinical trial to makes its product look better and enhance its revenue, that is an example of health care corruption.

Transparency International defines corruption as

Abuse of entrusted power for private gain

When health care corporations run clinical trials, we entrust them to do honest research and be worthy of the trust of their research subjects.  Withholding the results to enhance revenue is therefore abuse of that entrusted power for private gain.

Health Care Corruption as a Taboo Topic

This blog focuses on the US, and we  now have in our archives some amazing stories that document various forms of health care corruption in the US, including numerous allegations of misbehavior by large health care organizations ending in legal settlements, and examples of outright fraud, bribery, kickbacks and other crimes.  Some large and profitable health care corporations have made numerous such settlements over recent years.  (For example, see the track record to date of Pfizer Inc here and that of Johnson and Johnson here.)

Much of this bad behavior was meant to sell drugs, devices, or clinical services, often in situations in which their benefits did not outweigh their harms.  For example, we just discussed the latest settlement by Amgen of allegations that it promoted an epoetin (Aranesp) "off-label" for cancer patients not on chemotherapy.  Such "misbranding" was not merely a technical violation, since it has been shown that use of the drug in this situation increases mortality.   Such bad behavior thus likely harmed numerous patients.

Furthermore, efforts to police these kinds of corruption have been weak and scattered.  Most cases have ended with legal settlements that at most involve fines to corporations, yet the fines are rarely big enough to significantly affect their overall revenues.  While the corporations themselves may be thus punished, the people who actually authorized, directed or implemented the bad behavior are usually unscathed.  So as we have discussed frequently, such attempts at justice are unlikely to deter future bad behavior.

In fact, people more distinguished than yours truly have been warning about health care corruption for years. In particular, in 2006, the Transparency International Global Corruption Report focused on health care corruption, and asserted in its executive summary, " the scale of corruption is vast in both rich and poor countries."  It also noted how diverse is health care corruption:

In the health sphere corruption encompasses bribery of regulators and medical professionals, manipulation of information on drug trials, the diversion of medicines and supplies, corruption in procurement, and overbilling of insurance companies. It is not limited to abuse by public officials, because society frequently entrusts private actors in health care with important public roles. When hospital administrators, insurers, physicians or pharmaceutical company executives dishonestly enrich themselves, they are not formally abusing a public office, but they are abusing entrusted power and stealing precious resources needed to improve health.

It further stated how serious the consequences of corruption may be for patients and public health:

Corruption deprives people of access to health care and can lead to the wrong treatments being administered. Corruption in the pharmaceutical chain can prove deadly....

The poor are disproportionately affected by corruption in the health sector, as they are less able to afford small bribes for health services that are supposed to be free, or to pay for private alternatives where corruption has depleted public health services.

Corruption affects health policy and spending priorities.

Occasionally, something is published about health care corruption in the US in the medical literature.

- In 2009, qualitative interviews by Pololi et al in the Journal of General Internal Medicine produced many striking anecdotes suggesting corruption in US academic medicine. Four of the interviews were with faculty whose leaders allegedly used deception for personal and professional gain (i.e., �a situation of major unethical use of funding,� �fraudulently creating data for a research project,� �we�re lying to the people who are doing our school evaluations, we�re putting things on paper that we do that we don�t do,� �that�s what I think he felt he had to do�hide money, lie about money, or at least cook the books a little bit.�)(4)  These results produced few echoes, particularly not any strident editorials about the need to address corruption.
- In 2011, an article in the Lancet suggested that "there is more corruption in the G8 countries than in the whole of Africa," but for any health care professional to acknowledge that would be "professional suicide" (see this post).(3)
- Finally, in 2013, a Transparency International survey showed that 43% of Americans believe their health care system is corrupt.  Yet this received no media attention, and to my knowledge has never been mentioned in a major US medical journal.  (Look here.)

So health care corruption remains a largely taboo topic.  (On Health Care Renewal, we call corruption "anechoic," since evidence of health care corruption produces few echoes.) 

The Annals of Internal Medicine, like most major medical journals, has long avoided discussion of health care corruption, and how systemic corruption harms patients' and the public's health.

Of course, the unwillingness to discuss global health care corruption, health care corruption in the US, and the relationship of health care corruption in the US to corruption in other sectors may arise from the fear, as stated by one person interviewed in Charles Ferguson's documentary Inside Job, that discussion could lead to investigation, and investigation could "find the culprits".

Summary

It is perfectly fitting and proper for the Annals of Internal Medicine to call attention to various kinds of unprofessional behavior by physicians and health care professionals, such as sexist, disrespectful expression, even if such behavior is already subject to sanctions by medical boards, accrediting organizations, etc. In my humble opinion, however, if such disrespectful comments by physicians should generate outrage, corrupt behavior by large health care organizations that may harm patients and the public health, and which often goes largely unchallenged by civil authorities, should deserve more outrage.

Of course, it is one thing to criticize individual physicians, and ask physicians to "call out our colleagues" who behave unacceptably.

It is another to call out large, powerful, wealthy organizations and the executives who have become rich running them.  Such executives command well funded marketing and public relations departments, and corps of attorneys ready to take on perceived critics.

But if we really want better health care and public health, we all have to step up.  In particular, I urge the editors of the Annals of Internal Medicine, and other major health and medical journals to take on health care corruption as vigorously as they would take on physicians' expressions of "misogyny and disrespect."

ADDENDUM (26 August, 2015) - This post was republished on the Naked Capitalism blog. 

References
1.  Laine C, Taichman DB, LaCombe MA. On being a doctor: shining a light on the dark side.  Ann Intern Med 2015; 163: 320.  Link here.
2.  Anonymous.  Our family secrets.  Ann Intern Med 2015; 163: 321.  Link here.
3. Horton R. Offline: ten commandments, G8 corruption, and OBL. Lancet 2011; 377: 1638. Link here.
4. Pololi L, Kern DE, Carr P, Conrad P, Knight S. The culture of academic medicine: faculty perceptions of the lack of alignment between individual and institutional values. J Gen Intern Med. 2009;24:1289�95. Link here.

Princess Health and Guest Post: Scholarly Mad Libs and Peer-less Reviews. Princessiccia

Princess Health and Guest Post: Scholarly Mad Libs and Peer-less Reviews. Princessiccia

China deception medical journals

Gusty 13:28 Add Comment

Health Care Renewal presents a guest post by Marjorie Lazoff, MD, a Board certified internist with a clinical background in academic emergency medicine.  She is currently a full time freelance editor and independent consultant specializing in evidence-based clinical content and medical informatics.

On December 17, 2014, Scientific American published an investigative report by journalist Charles Seife documenting a new and curious form of scholarly publication fraud, For Sale: �Your Name Here� in a Prestigious Science Journal. As an editor and supporter of evidence-based medicine I am both appalled by, and sympathetic to, how such widespread fraud could take place unnoticed.

Seife describes how he discovered the doctored writings:

The dubious papers aren't easy to spot. Taken individually each research article seems legitimate. But in an investigation by Scientific American that analyzed the language used in more than 100 scientific articles we found evidence of some worrisome patterns�signs of what appears to be an attempt to game the peer-review system on an industrial scale�

�This is not a simple case of plagiarism. Many seemingly independent research teams have been plagiarizing the same passage. An article in PLOS ONE may eventually lead to 'our better, comprehensive understanding' of the association between mutations in the XRCC1 gene and thyroid cancer risk. Another in the International Journal of Cancer (published by Wiley) might eventually lead to 'our better, comprehensive understanding' of the association between mutations in the XPA gene and cancer risk�and so on. Sometimes there are minor variations in the wording but in more than a dozen articles we found almost identical language with different genes and diseases seemingly plunked into the paragraph, like an esoteric version of Mad Libs, the parlor game in which participants fill in missing words in a passage.

Another example virtually eliminates the likelihood of coincidence:

There is no such thing as a 'Beggers funnel plot'�the proliferation of 'Begger's' tests [were discovered] by accident. While looking for trends in medical journal articles, papers [were found] that had almost identical titles, similar choices in graphics and the same quirky errors, such as 'Begger's funnel plot.'

Seife�s investigative reporting revealed that China was the source of most of his �fill-in-the-blanks� research. Further,

Much of the funding for these suspect papers comes from the Chinese government. Of the first 100 papers identified by Scientific American [and listed at the close of his article], 24 had received funding from the National Natural Science Foundation of China (NSFC), a governmental funding agency roughly equivalent to the U.S.'s National Science Foundation. Another 17 acknowledged grants from other government sources.

Seife suspects that most research probably began as legitimate work without intent to deceive, but somewhere an author or service was added to help ensure publication through the necessarily arduous manuscript review process.

The culprit?

A quick Internet search uncovers outfits that offer to arrange, for a fee, authorship of papers to be published in peer-reviewed outlets. They seem to cater to researchers looking for a quick and dirty way of getting a publication in a prestigious international scientific journal.

Seife�s investigation goes undercover, 60 Minutes style:

In November Scientific American asked a Chinese-speaking reporter to contact MedChina, which offers dozens of scientific 'topics for sale' and scientific journal 'article transfer' agreements. Posing as a person shopping for a scientific authorship, the reporter spoke with a MedChina representative who explained that the papers were already more or less accepted to peer-reviewed journals; apparently, all that was needed was a little editing and revising. The price depends, in part, on the impact factor of the target journal and whether the paper is experimental or meta-analytic. In this case, the MedChina rep offered authorship of a meta-analysis linking a protein to papillary thyroid cancer slated to be published in a journal with an impact factor of 3.353. The cost: 93,000 RMB�about $15,000.

Finally, the corrosive effect of this particular fraud on scientific and medical publication is real:

Publishers at the moment are fighting an uphill battle. 'Without insider information it's very difficult to police this,' Clinical Endocrinology's Bevan says. CE and its publisher, Wiley, are trying to close loopholes in the editorial process to flag suspicious late changes in authorship and other irregularities. 'You have to accept that people are submitting things in good faith and honesty,' Bevan says.

That is the essential threat. Now that a number of companies have figured out how to make money off of scientific misconduct, that presumption of honesty is in danger of becoming an anachronism.

Were this the only threat currently facing research journals today! Last month, Retraction Watch published an article describing a known and partially-related problem: fake peer reviews, in this case involving 50 BioMed Central papers. In the above-described article, Seife referred to this BioMed Central discovery; he was able to examine 6 of these titles and found that all were from Chinese authors, and shared style and subject matter to other �paper mill-written� meta-analyses.

Retraction Watch agrees:

It would seem that a third party, perhaps marketing services helping authors have papers accepted, was involved.

Problems with peer review are longstanding editorial fodder. For a description of another recent peer review scam, this one involving authors hijacking researchers� identities, see the article also written by Retraction Watch editors and published last month in Nature.

On Friday, in response to requests by several publishers, The Committee on Publication Ethics (COPE) posted a statement on inappropriate manipulation of peer review processes 

While there are a number of well-established reputable agencies offering manuscript-preparation services to authors, investigations at several journals suggests that some agencies are selling services, ranging from authorship of pre-written manuscripts to providing fabricated contact details for peer reviewers during the submission process and then supplying reviews from these fabricated addresses. Some of these peer reviewer accounts have the names of seemingly real researchers but with email addresses that differ from those from their institutions or associated with their previous publications, others appear to be completely fictitious.

COPE recommends, among other things, the retraction of articles based solely on fraudulent reviews. Retraction Watch�s announcement earlier today of a MacArthur Foundation grant to help fund a comprehensive and freely available database of retractions could not have come at a better time!

Seife and Retraction Watch have documented new forms of published research fraud among third world researchers. Certainly the solution is not for editors and readers to suspect all papers from specific countries; there are ample instances of research fraud emanating from English-speaking researchers and top U.S. institutions. Research from around the world is critically important, particularly although not exclusively in the basic sciences, emerging infectious disease, and public health/epidemiology. Now that it has been identified, a common screening procedure for manuscripts at a journal can be adjusted to filter out this new form of plagiarism.

Sadly, it seems to me that fraudulent research of all types can flourish within a perfect storm of circumstances and factors: the globalization of science and medicine encourages non-or-limited English-speaking researchers to publish (or perish) in the highest impact English language journals; the proliferation of open-access wannabes, hybrids of every color and degree of sincerity, and other money-over-science journals and companies that rip off desperate and na�ve researchers; a complicated, time-consuming and often author-unfriendly manuscript submission process; and journal editors who struggle with limited staffing and resources, necessarily arduous editorial processes, and the pressure of increasing numbers of worthy manuscripts deserving to reach the scientific and medical communities in near-real time. Research fraud is particularly destructive given traditional publishing�s ongoing struggle to survive the transformational Electronic Age; the pervasive if not perverse marketing of pharma, medical device companies, and self-promoting individuals and institutions using �unbiased� research; and today�s bizarrely anti-science culture.

Health Care Renewal is wonderful at calling out intentionally perpetrated health care events whose importance and implications can be debated, depending on one�s perspective and personal values. Here, I think, we have the reverse: there is near unanimity over the need to prevent fraudulent papers of any type from contaminating our research databases, as best as is humanly and technologically possible. There is also near unanimity among quality medical journals throughout the world, and internationally respected editor and publisher groups, to confront and solve these problems. The enemy identified by HCR is not always unrestrained greed or maliciousness. Sometimes, as in this case, the enemy is a cacophony of small circumstances and extraneous factors that could, if left unattended, invisibly erode something we all hold dear.

Without ongoing attention and support from the entire medical and science communities, we risk the progressive erosion of our essential, venerable research database, until it finally becomes too contaminated for even our most talented editors to heal.

Dr Marjorie Lazoff

ADDENDUM (30 December, 2014) - This post was reposted on the Naked Capitalism blog on 24 December, 2014.

ADDENDUM (7 January, 2015) - See also comments on DSHR's Blog.  

ADDENDUM (19 January, 2015) - This post was reposted by TruthOut on 10 January, 2015.