Richard Smith: Rethinking the publication of surgical innovations

richard_smith_2014A scandal in cardiothoracic research has led Martin Elliott, a cardiothoracic surgeon at Great Ormond Street, to conclude that current methods of publishing surgical innovations are not only inadequate but also shameful. In a Gresham lecture in London recently he presented proposals for improving the sharing of surgical innovations.

The scandal

The scandal, which is now known across the globe, concerns Paolo Macchiarini, a brilliant and charismatic but ultimately flawed cardiothoracic surgeon. Macchiarini has replaced diseased tracheas in a series of patients with plastic tracheas that are supposedly covered in the patients’ stem cells. Most of the patients have died, and a Belgian cardiothoracic surgeon has said that he’d rather face a firing squad than undergo Macchiarini’s operation—because it would be a quicker and less painful form of execution.

Macchiarini has published many papers that are now under a cloud. As often happens with charismatic mavericks, at least some of the hierarchy at the Karolinska Hospital in Sweden were seduced by Macchiarini and have paid with their positions. Anybody who’d like to know more about the allegations might watch three chilling documentaries that were recently broadcast by the BBC. Macchiarini has recently hit back, stating that the BBC film “grossly misrepresents” him and tells a story “that simply wasn’t what happened.” Whilst he admits that mistakes have been made in the preparation of published articles he says there was no intention to deceive.

Elliott directs the National Service for Severe Tracheal Disease in the UK and worked with Macchiarini and others to “grow” tracheas in the laboratory. Together they performed the world’s first stem-cell-supported tracheal transplant in a child, and the child is alive and well seven years later. But the scandal surrounding Macchiarini has cast a pall over stem-cell-supported transplants, disrupting work that could prove important.

The present system of publishing surgical innovations

Imagine, argued Elliott to illustrate faults in the present system of publishing, that he had developed a new operation, the Elliott Operation. He would do a few operations, and the outcome would be good. “I want to publish it. If I don’t, I am sure that someone will copy my idea and get there first, and that would be no good would it? My vanity (I will enjoy the press conference) and the CV pressure again.” By the “CV pressure” he means that he needs a long CV in order to be appointed and promoted and then to win grants, fame, and airmiles. (One definition of a successful scientist is turning data into airmiles.)

After listening to Elliott’s lecture I watched in the documentary Macchiarini displaying his patients at press conferences as artists might display a new sculpture. The journalists were adoring, and the patients hugely grateful—ironically as not long afterwards some of them died terrible deaths. Macchiarini was in heaven, revelling in the adoration, fame, and gratitude. He must have felt all powerful.

Elliott sends his paper to a journal “as early as I think I can get away with it”; and the more prestigious the better. What he sends is a story wrapped up in the form of a scientific paper “with a positive bias.” He sends no raw data but a “précis, written by me, the self-interested one.”

The journal loves innovative ideas and wants to be first, hoping the exciting paper will be “good for readership, advertising, and subscription figures.” The editor too may be imaging the press conference, with the world’s television cameras on him and his journal. After perfunctory peer review, the journal publishes “my brilliant paper.”

A second wave of surgeons now tries the operation for fear of being “judged old-fashioned by their peers.” New procedures, confesses Elliott, are how surgeons “weight our cojones.” Usually the second wave of surgeons gets poorer results, and there is little incentive for them to publish. They may look poor, and anyway the journals are unlikely to be interested. As a result “the data associated with these second operations are lost forever…consider how many unreported deaths and complications there must have been in centres trying the procedure.”

A better system

At the heart of Elliott’s thinking is that the raw data derived from operations is more valuable than what is usually published—the story written by the protagonist with selected and sketchy data.

The data should not be “owned” by the surgeon who did the operation. “It is in my best interests,” says Elliott, “to show my operation in the best light, or bin the results if everything looks as though it is going pear shaped. It is also in my best interest to retain those data under my ownership to retain my eponym and perhaps associated IP deals that may be negotiable.”

Elliott’s thinking has led him to five proposals.

Firstly, datasets must be well designed in advance, secure, and publicly accessible.

Secondly, the data should be complete, including all outcomes, adverse effects, and costs.

Thirdly, the data should be held by an “honest broker,” which might be a professional body or other trusted institution.

Fourthly, “no unit or surgeon should be allowed to perform the innovative procedure without agreeing to submit complete and validated data to the dataset held by the ‘honest broker’.” Not a single patient’s data should be lost.

Fifthly, no patient should be allowed to have the innovative procedure unless he or she agrees to the use of their data in this way. Elliott said that this sounded “Stalinist” but added that he had “yet to meet a patient or family unwilling to share their data in a research study.

Elliott made passing references in his talk to randomised trials and how ideally new surgical procedures should be tested in randomised trials, although there are many more problems with testing surgical procedures compared with drugs in trials—not least that the surgical procedure depends on the skill of the operator and is often a moving target. But sharing data is just as important with trials as with series of patients.

“The current methods of publishing surgical results are outdated, inefficient, incomplete and in most cases little more than stamp collecting,” concluded Elliott. We need to do better, and Elliott’s clarion call joins a growing chorus recognising that our present system of sharing research and awarding academics is broken and needs changing.

Richard Smith was the editor of The BMJ until 2004.

See alsoClara Hellner Gumpert: The Karolinska Institute after the Macchiarini scandal