October 26

Protecting Editorial Integrity – Dr. Stefan Kreuszewski BMJ

Protecting Editorial Integrity – Dr. Stefan Kreuszewski BMJ

Sun, 6 Feb 2005

In his BMJ editorial, “A tough nut to crack,” Kamran Abassi writes: “The drug industry considers the BMJ a tough nut to crack,” an insider recently told us. Publishing a “favourable” research paper is far trickier in the BMJ than other journals, he said, but when a paper is published it’s worth £200m to the company. Some of that revenue inevitably finds its way into the “swimming pool” funds of highly paid doctors who trot the globe’s conference venues putting a positive spin on company products. “You’re just anti-industry,” complains one of our marketing team, pointing an accusing finger at the BMJ’s editors. We’re not anti-industry, of course, we just like to think we’re a tough nut to crack – and that’s official.”

AHRP board member, Dr. Stefan Kruszewski, commends the BMJ for its resolve, noting that life and death decisions depend upon the integrity of medical research. Thus, it is imperative that everyone involved in every facet of the process upholds the highest standards of integrity. “The reasons are simple and timeless. The products, treatments, therapies and pharmaceuticals derived from research and its applications are only as safe and effective as their honest and responsible scientific discipline.”

Contact: Vera Hassner Sharav

Protecting Editorial Integrity through Responsibility and Resolve
5 February 2005
Stefan P. Kruszewski,
Harrisburg, Pennsylvania USA

The BMJ must be steadfast in its resolve as a Œtough nut to crack.'(1) The reasons are simple and timeless. The products, treatments, therapies and pharmaceuticals derived from research and its applications are only as safe and effective as their honest and reproducible scientific discipline.

Research science can be corrupted at any step of the research process. It is the very reason behind the passion that drives the arguments for full disclosure and transparency. Since this is not a theoretical exercise, but one from which human lives are held in the balance, the stages of the process are worth reiterating: If basic science is corrupted, clinical protocols can not accurately proceed. If the results of an early clinical trial are misreported, the basis for larger trials is skewed. If negative data or adverse effects are hidden, the risk -benefit questions cannot be addressed. If the positive conclusions are embellished, the marketing and advertisement are at risk. If the regulatory bodies do not perform their tasks in an independent and unbiased manner, the approval process is corrupted. (2) If any facet of the pharmaceutical Œdiamond’ is not etched carefully or any person who chooses to make decisions about the process is not scrupulously clear about the reasons and responsibilities that they have undertaken, the entire process suffers as a result. The consequences for that interruption of the scientific process violate the Hippocratic Oath, our common welfare and can harm an uninformed public.

That said, kudos to Kamran Abbasi for having the courage and opportunity to assert and defend his positions, as he writes in his recent Editor’s Choice remarks. (1) What he does must be the mainstay of responsible editing, not the exception.

He and his editorial staff must expose published studies whose conclusions are not corroborated by the research results; where statistical analysis is simply a means to achieve a positive result rather than a meaningful analysis of benefit and reward; and when sloppy and uncontrolled clinical research designs merit neither statistical analysis nor publication.

The freedom and responsibility to speak out are the cornerstones of obligatory medical reporting since it that duty that protects the integrity of scientific debate. Editor Abbasi must not only remain impervious to retreat from those essential endeavors, but must continue to safeguard his editorial and investigative reporters: Susan Mayor, Ray Moynihan, Lynn Eaton, Owen Dyer, Tony Sheldon and Jeanne Lenzer, and so many others—-who brilliantly share that burden and exemplify that responsibility. (3, 4, 5, 6)

I’m going to be corny, but I believe what I’m saying to my soul. The current day courageous medical editors and writers are not unlike other freedom fighters who fought for lofty ideals: Lech Walesa’s pro-democratic Solidarity efforts in the Gdansk shipyards prior to the collapse of the Soviet Union; Nelson Mandela’s struggles and sacrifice against apartheid in South Africa; and, Rosa Park’s refusal to sit at the back of the bus in a segregated 1955 Montgomery, Alabama. Like them, freedom fighters for ethical and honest medical reporting must be protected and nurtured. The search for scientific truth can be precarious, but the goal is keen.

1. Abbasi, K. A Tough Nut to Crack. BMJ 2005; 330: 7485.O-h (29 January)

2. Spiers, Alexander. Save the FDA.BMJ 2005; 330:308 (5 February), doi:10.1136/bmj.330.7486.308

3. Mayor, S. Rofecoxib caused excess heart disease. BMJ 2005; 330: 212 (29 January)

4. Dyer, O. Surgeon is struck off for failing to mention disciplinary action. BMJ 2005;330:274 (5 February), doi:10.1136/bmj.330.7486.274-a

5. Sheldon, T. Pfizer found guilty of breaching code. BMJ.2005;330:162 (22 January), doi:10.1136/bmj.330.7484.162-b

6. Lenzer, J. Public interest group accuses FDA of trying to discredit whistleblower. BMJ 2004; 329: 1255( 27 November)

Competing interests: None declared

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