The HerniaSurge-International Guidelines for Adult Hernias: A Willful and Deceitful Document

The HerniaSurge-International Guidelines for Adult Hernias: A Willful and Deceitful Document.

The virtues, which transcend any document, particularly International Guidelines, must include ethics, integrity and transparency. There cannot be a whiff of favouritism, collusion, cronyism, lobbyism, conspiracy or complicity. With such demanding criteria, the HerniaSurge International Guidelines sponsored and supported financially by Ethicon, Bard and the European Hernia Society (EHS) have failed dismally! The AHS on the other hand, never really had a significant role other than to acquiesce. The same objections applied to those “sister societies” which are not hernia societies at all but endoscopic societies and whose influence in recommendations in hernia surgery can only be spurious at best and contentious.

I have good reasons for wearing the mantle of paternalism. While I had an important role in the creation of the AHS, I was just as instrumental in the preparation and creation of the journal HERNIA in 1996-1997. I knew JP Chevrel in the days of GREPA when neither the AHS nor the EHS existed. He and I, unbeknownst to the other, lived in the 11th arrondissement in Paris France, as neighbours. We probably attended the same Lycée Voltaire, which incorporated our geographical arrondissement. We subsequently found ourselves interested in medicine and eventually, hernias. In those days, Chevrel who became the general secretary for GREPA, was not fluent in English. He had, unsuccessfully, attempted to create a hernia Journal with Springer-Verlag, France, where his wife Anne was an executive. The potential subscribers made up too small a membership for GREPA (200 or so in those days). When I suggested to Chevrel that it was time to import the newly created AHS (whose board I was on) with its 900 members … Springer listened, cooperated and the deal was endorsed.

The foremost flaw of the “International Guidelines” was its acceptance for publication in HERNIA without the hallowed, time-honoured practice of submitting them to blind, peer review. I, unlike the other three editors, objected vehemently. Agneta Montgomery saw it fit to state, while Marc Miserez and Robert Fitzgibbons agreed, that “the committee members were the finest authorities in the world” and acted as their own “peer reviewers” so that in a sense, the “Guidelines” were automatically peer reviewed and ratified!

Joseph Addison, the English essayist and poet (1672-1719) must have lived this situation when he stated that:” A man must be excessively stupid, as well as uncharitable, who believes there is no virtue but on his own side”!

Further and significantly: who decided what a “world authority is”? Who lays down the criteria and what are those criteria? Who decided that out of one billion people in the Western Hemisphere, only four US surgeons qualified as experts? How does a surgeon from Niger, one from Senegal, another from Thailand as well as Singapore achieve such a lofty status, which is denied to most surgeons of the New World, especially Argentina whose glorious historical contributions are constantly being rediscovered?! How does the Netherlands, with a population of 17 million souls rate 12 world experts with a 13th one as an external, non-blinded reviewer? If that is not nepotism and cronyism, I would like someone from HerniaSurge to explain it to the world audience, which has been targeted.

Saddest of all is Maarten Simons who hammers away at the fact that he does not believe the statistics of Bassini. Fortunately, Bassini simply described his version of an operation for hernias and kept a log of all consecutive 262 operations much as did other scientists such as Koch, Pasteur, Ehrlich, Lister in their laboratories … should these medical giants also be disowned of their research?

Drs Miserez, Montgomery and Fitzgibbons threatened to pull rank and therefore majority vote by going ahead and publishing the “International Guidelines” despite my objections. My principles would have been shattered if I allowed such abuse of trust by editors thought to be squeaky-clean. The readership would never know our world colleagues would be led down the garden path. Lawyers, judges, surgeons would be misled for the guidelines do nothing but promote mesh for all hernia repairs. Even pure tissue repairs would be eliminated for ever at a time when chronic pain, with the lowest incidence acknowledged by the guidelines, would mean over 120 000 chronic pain patients a year in the US alone and 2.4 million worldwide!

A nefarious projection by the industry would be to declare that they have no involvement with decision making, that surgeons demand a mesh of such specification and they provide it. An ideal defence in court to absolve the industry at the expense of some patients whose lives have been robbed from them. But also to shift the blame of chronic Post-Herniorrhaphy Pain on surgeons who are not familiar with the use of mesh, devices, or who may have been improperly trained. Was it not Ira Rutkow who claimed, “with a plug, you do not need to know your anatomy”! I heard him more than once state this sophism.

To proceed with the ethics, integrity, transparency of the “International Guidelines”, I called for an input by the publishers of the journal HERNIA: Springer Verlag in New York. Their administration agreed that the editors were in a quandary, that the situation was highly unusual, controversial and never met before and called for Solomonic wisdom. If not internal then, external! This came in the form of a “Guest Editor-in-Chief”, a well-known editor for his excellence as a leader of his own journal for many years. This quality was confirmed by his decision: “The International Guidelines could be published but … Dr Bendavid, as a dissenting editor, must be given the right to a rebuttal to be published in the same edition as will carry the International Guidelines”!

This intercession was an unequivocal vindication of my protest. I drafted a text for this rebuttal, which reflected all the reasons for my objections. The response by Dr Miserez’ was that the rebuttal was too long (2500 words and must be no longer than 900) and will be considered a “Letter to the Editor” subject to an editorial decision. After a year of back and forth arguments, the editors simply decided to publish the “International Guidelines” without due process of blind peer review, consideration of the Springer Publishing recommendation, with utter disregard of the “Guest Editor” and by the simple, forthwith elimination of my rebuttal without due process.

Subsequent communications with Springer Publishing revealed that, indeed the journal HERNIA belongs to Springer Publishing but according to the original agreement of 1997, the EHS-AHS have complete control of contents and editorial comments! A loophole which would be unabashedly exploited without a hint of restraint and which the editors hoped would not be questioned and eventually overlooked. A perfect loophole for abuse of privilege by an opinionated, dogmatic editorial board or biased hernia society.

The next step for the societies to eliminate any risk of a whimper on my part was to ask for my resignation from the editorial board of the journal. This was duly carried out by AHS President Alfredo Carbonell who is not known for a lack of bombast or bravado in getting things done. His connection, as well as that of many others, with the industry will be examined in the next issue, which will deal with conflicts of interest. I was suddenly reminded of the words of Edmund Burke: “the greater the power, the more dangerous the abuse” but then, we are living in strange times where editors are people and readers are not.

What better example of blunt cronyism and “occult” lobbyism since, by the industry’s presence on society boards, in every funded activity, direction of research, sponsorship, lunch and learn may be at their entire discretion. Charles Koch has reminded us “cronyism is nothing more than welfare for the rich and powerful and should be abolished”. A form of nefarious parasitism.

Dr. Peter Gotzsche, the Director of the Nordic Cochrane Center in Copenhagen, has stated “Much of what the drug industry does, fulfills the criteria for organized crime in US law...” Watch Dr. Peter Gotzsche here.

Perhaps the most deleterious, occult aspect of the International Guidelines (IG) is the delicate issue of financial Conflict of Interest (COI). That section has been cryptically modified to create trust and is a facet that needs our closest examination and focus. There is no obligation to report COI in Europe, except for drug products whereas in the US and Canada, it is a requirement at conferences and in publications. One has relied on an honour system in North America, which has not been strictly adhered to. Unfortunately, there are neither consequences nor penalties for transgressors. Would “dyscoism” be an adequate neologism to describe this egregious situation with COI?

The Journal of the American College of Surgeons has seen fit within the last year to offer two seminal publications on “Investigation of Financial Conflict of Interest among Published Ventral Hernia Research” with 21 references (1) and “Comparison of Conflict of Interest among Published Hernia Researchers Self-reported with the Centers for Medicare and Medicaid Services Open Payment Database” with 23 references, each dealing with COI (2). In the former, in their conclusion … “Within the ventral hernia literature, 70% of articles have a COI. Self-reporting of COI is discordant in 63% of the articles”. In the latter publication, again in conclusion … “There is substantial discordance between self-reported COI in published articles compared with those in the Centers for Medicare and Medicaid Services Open Payments Database”

Where would one find articles on hernias more frequently than in HERNIA, the World Journal of Hernia and Abdominal Wall Surgery?

Despite a year long stand-off, emboldened by the fact that they could ignore the publishers’ wise and sensible recommendation, the editors of HERNIA (Marc Miserez, Robert Fitzgibbons and Agneta Montgomery) proceeded to publish the “International Guidelines” as if they had been properly vetted through the time hallowed blind peer review. And without the proposed rebuttal suggested by the guest editor. To flout convention, to disregard what is tantamount to a rule of law in the publishing industry is an abuse of editorial authority which I had never witnessed before. And while no such blind peer review was ever sought by the editors, the end result was a travesty because they sought the opinion of three “external reviewers”: Dr B. Ramshaw (Knoxville, TN), Doctor J. Jeekel (Rotterdam) and A. Sharma (New Delhi, India) who were not blinded, for whom we have no declared COI but with a hint of substantial connection to the industry. At last count, B. Ramshaw was connected to 14 companies, J. Jeekel is another surgeon from the Netherlands connected to and supported by BARD. I see no information on COI from A. Sharma. Payments by the industry to US surgeons can be checked here.

The editors were careful to add a “Disclaimer”: … “Since both editors-in-Chief and one Associate Editor are coauthor (sic) of this manuscript, an independent review was conducted”. Who were these reviewers and under what conditions are they referring to the three surgeons named above? I believe they are referring to Ramshaw, Jeekel and Sharma. Ramshaw and Jeekel are connected to industry, Sharma’a association cannot be determined.

A delicate question which remains unanswered is whether the various “Guidelines” for Wound Closure, Colostomy site Herniation, Abdominal Wall Reconstruction etc. emanating from members of the EHS and published in HERNIA have been subjected to the same lack of peer reviews, handling and vetting.

I, for one, have lost complete trust in this editorial team because of their gross and inappropriate abuse of editorial privilege, for unethical practices but above all, for a glaring lack of integrity. Editorial boards were never intended to be autocratic. These same editors were careful to point out that “The guidelines were financed by BARD as well as by Johnson and Johnson. The EHS is also acknowledged to have contributed “generously”. The “sponsor (sic) had no direct or indirect influence on methodology or the content of the guidelines”. Is this a credible statement in view of the ill-intended gambits, which have been perpetrated? Who is the ultimate recipient and beneficiary of such a generous cabal?

Curiously, several authors who had “no COI connected to the Guidelines” did disclose receiving moneys from Bard, Johnson and Johnson, B. Braun, Cook Medical, FEG Dynamesh, Gore, Medtronic for projects “not connected to the guidelines”(sic). It would seem that some researchers and “collaborative surgeons” have acquired the dissimulating quality of a chameleon.

The addition of endoscopic surgeons and their societies in lending their weight and influence through cross-pollination and grafting with true hernia surgeons, smacks of ethical interference resulting in an unfortunate imbroglio.

Ironically, suspicions of a strong conflicts of interest were raised by the “Guidelines” which promoted laparoscopic mesh for ALL female patients and ALL male patients over the age of 18. No serious practitioner can accept such recommendations.

The solicitation of encomiums from the leaders of the different societies, described as “endorsements” by those societies betrays a real insecurity. The worth of an opus is decided by the quality of the work not by the recommendation of shills. There were eight such recommendations, comments, endorsements, a most unusual number when one is the rule. Ironically, those encomiums were obviously political in nature as several members of the EHS and AHS supported my objections but insisted that their name not be used for obvious reasons … two such people wrote endorsements(!!), Carbonell’s statement (and that of many others) will be better understood in view of the conflicts of interest as will be discussed in the next issue.

I was particularly struck by the underlying mealy-mouthed, unsubstantiated, bromidic tenor of those endorsements.

In summary, HerniaSurge’s International Guidelines for adult hernia is an affront to all sensible and rational surgeons who have seriously studied hernias. Not only for the dubious choice of the experts, their moot geographical origins, their methodology, but for bypassing the time honed and honored principle of blind peer review and objectivity. All the members of the steering, working committees to the external reviewers chosen by the editors have been so chosen arbitrarily in the light of a strong hint of cronyism, coziness and collaboration with the industry.

For those reasons, HerniaSurge’s “Guidelines” are an intended deceitful document, which should, on principle and in fact, be rejected and ignored.

Perhaps it is time to recall that “Honesty is the fastest way to prevent a mistake from turning into a failure”!

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