By Dr. Sherri Tenpenny
The press has led us to believe that the recall of a medical research paper represents a rare, media-worthy event. Case in point: the week-long blitz announcing the retraction of a single, disputed paper, published in The Lancet in 1998. By comparison, the retraction of more than 100 papers by two medical researchers didn’t even make the evening news. The enormity of that recall rattled the entire subspecialty of anesthesiology and pain management. The identification of many more recalled papers exposes the extent of scientific misconduct and the failure of peer review across the entire medical industry.
During the week of March 3, the editors of 16 international medical journals announced the retraction of “unethical” research carried out by German doctor, Joachim Boldt, a leading specialist on intravenous fluid management. Boldt has published more than 200 studies, many on a colloid product called hydroxyethyl starch, or HES.
Anesthesiologists rely on colloids to deliver nutrients to cells and to keep a patient’s blood volume high during surgery, thus avoiding the risks that can come with blood transfusions. Boldt is under investigation for allegedly forging up to 90 of his studies, thought to contain bogus, fraudulent, manipulated and/or distorted data. However, an even more serious infraction is that it appears Boldt did not have the approval of an Institutional Review Board (IRB), an ethics body required by law for all clinical research. Investigations done without the oversight of an IRB is a criminal offense.
This was not Boldt’s first violation. On October 28, 2010, the editor of Anesthesia & Analgesia withdrew an article entitled, “Cardiopulmonary Bypass Priming Using a High Dose of a Balanced Hydroxyethyl Starch (HES) vs. an Albumin-Based Priming Strategy” under suspicion of scientific misconduct. An investigation concluded that there was no convincing evidence that the study had ever been done.
Scientific Misconduct All Around the World
Breached ethical research standards are not isolated occurrences. A search of online journals for “retracted” papers and reviewing the relatively new, important blog, Retraction Watch, reveals an alarming number of papers retracted for data manipulation and other malfeasances. For example, The American Society for Microbiology (ASM), publisher of Infection and Immunity, recently retracted five papers by researcher Naoki Mori, published between 2000 and 2009. ASM also banned Mori from publishing in any of its journals for 10 years. To date, 16 papers of his have been revoked, including studies published in Journal of Virology, Retrovirology, and Blood.
Last month, The Korean Journal of Otolaryngology-Head and Neck Surgery retracted 17 papers published between 1993 and 2006, with the common theme of ‘overlap’. According to Retraction Watch, this is “almost always a euphemism for plagiarism, whether self or otherwise.”
Britain has long been plagued by researcher misconduct. In 1996, the British General Medical Council (GMC) took action against Dr. Geoffrey Fairhurst for forging consent forms of patients involved in drug company sponsored research. Fairhurst became the 16th physician to be found guilty of serious professional misconduct by the GMC and to be struck from the medical roster. Ironically, Fairhurst had been the vice chairman of his local medical ethics committee. At the time of his dismissal, The British Medical Journal (BMJ) joined forces with The Lancet, calling on the medical profession to get a grip on research misconduct. “Otherwise,” said Richards Smith M.D., then-editor of the BMJ, “government will have to do it, and the doctors’ ability to regulate themselves will be thrown further into doubt.”