Reporter, Position at the time of successful or attempted communication (relevant drug or device) Statement
Drug or device withdrawn (n=10)
Irene Frachon MD, pulmonologist, Universite Europeene de Bretagne, Breast France (anorexin drug (benfluorex)) “The [court] trial [against Servier] comes as a huge relief. Finally, we are able to see the end of an intolerable scandal.”[@129229]
Georges Cliché MD, cardiologist, Marseilles, France (anorexin drug (benfluorex)) “[Servier’s drug safety expert] comes to tell me that my [adverse event] observation] is null and that it must be withdrawn…. She gave me a biology lesson and explained to me that I was talking nonsense.”
Lucien Abenheim MD PhD MS. Professor, Epidemiology/ Biostatistics, McGill University, Canada (anorexin drug (phenfluramine-fentermine) “Serious questions need to be asked about a drug approval process that gives more weight to drug company lobbyists than independent medical researchers.”[@129270]
Stuart Rich MD, Director, Rush Hospital Heart Institute, Associate Professor, Division of Cardiology, Rush College of Medicine, Illinois (anorexin-drug (phenfluramine-fentermine) When I got back to my office at the medical center earlier that morning, he [the company vice-president] called me directly. He told me he saw my interview on the Today show, and warned me that it was very dangerous for me to talk to the press about that; that if I had any issues regarding their product that I wanted to publish in a scientific journal, so be it. But if I spoke to the media about their drug, bad things would happen.”[@129143]
Dennis Mangano MD PhD 2006, Professor of Medicine, Vice-Chair, Department of Anesthesia, University of California/San Francisco (cox-2-inhibitor (valdecoxib) “They [Pfizer] did not want to deal with me because my mandate has always been, whatever I find, I publish, good, bad, indifferent.”[@129164]
Eric Topol MD, Professor, Chairman, Cardiovascular Medicine Department, Cleveland Clinic Medical Center, Chief Scientific Officer, Cleveland Clinic Medical College, Ohio (cox-2-inhibitor (rofecoxib) “I am bothered by continued outrageous lies of Merck with the full-page multiple ads that 'they published everything' and that they never had a trial which showed any harm of Vioxx before September 2004.”[@129185]
David Graham MD, Associate Director for Science and Medicine, Office of Drug Safety, FDA, Silver Spring, Maryland. (cox-2-inhibitor (rofecoxib) “The [FDA] response from senior management in my Office, the Office of Drug Safety, was equally stressful. I was pressured to change my conclusions and recommendations, and basically threatened that if I did not change them, I would not be permitted to present the paper at the conference.”[@129140]
Gurkipal Singh MD. Adjunct Clinical Professor, Medicine, Division of Gastroenterology and Hepatology, Department of Medicine, Stanford University School of Medicine, California. (cox-2-inhibitor (cox-2-inhibitors (rofecoxib) “I persisted in my enquiries [about rofecoxib safety]– I was warned that if I continued in this fashion, there would be serious consequences for me. I was told that Dr. Louis Sherwood, a Merck senior vice-president, and a former Chief of Medicine at a medical school, had extensive contacts within the academia.. Dr. Sherwood called several of my superiors at Stanford to complain.”[@129139]
Stephen Graves MD, Professor of Surgery, University of Melbourne/the Australian Orthopedic Association’s National Joint Registry, Australia (Articular Surface Replacement Hip Prostheses) “It is a complete untruth that DePuy did not have reason to withdraw the ASR [hip prostheses] before now; we have been telling them since 2007, but they allowed it to be used on thousands of people…. There’s a natural tendency for companies [to think] it’s probably factors other than a device, because they have invested a lot of time in it.”[@129228]
Antoni Nargol MD, Consultant Surgeon, University Hospital of North Tees, England (Articular Surface Replacement Hip Prostheses) “They [DePuy] put the blame on myself and colleagues.”[@129232]
Hooman Narchasm MD PhD, Instructor, Harvard Medical School and cardiothoracic surgeon, Brigham and Women’s Hospital, Mass (morcellator) “Congress must ask how it is that a surgical error becomes standard of practice.”[@129171]
Lawrence Brass MD, Professor of Neurology and Epidemiology and Public Health, Yale University School of Medicine (phenylpropanolamine) “Supposed experts in the field are willing to say we somehow put the public at risk by publishing the results. They’re willing to do that in the courtroom while paid tens of thousands of dollars, but they are not willing to write a letter to be judged in a peer-reviewed forum — that’s the worst kind of professional. That’s despicable.”[@129177]
Victoria Hampshire DVM, Safety Officer, FDA Center for Veterinary Medicine, Commissioned Officer at the FDA, Silver Spring, Maryland. “To take this much stress home [after reporting tumors among ivermectin/pyrantel-treated dogs] and not to sleep for weeks is not worth it.”[@129144]
Tyrone Hayes PhD, Professor, University of California/Berkeley, California (atrazine) “Ultimately they [Syngenta] told me I could not publish the data outside their closed panel…. Tim Pastoor [a Syngenta vice-president] threatened him and his family”[@129148; @129188]
Peter Wilmshurst MB ChB BScD, cardiologist and cardiology research registrar, Saint Thomas’ Hospital, London, England (amrinone) “Company employees asked us to exclude some patients from the analysis. These were ones where there was a downward trend in contractility. The effect of excluding them would have been to produce an apparent but spurious increase in contractility in the remainder. We refused. My supervisor and I were then threatened with litigation. …When you are threatened by a multinational with infinite amounts of money, some people might find that a good reason not to go ahead.[@129165; @129173]
Black box warning added (N=5)
Henrik Thompsen MD, Professor and Chairman of Radiology Department at Copenhagen University Hospital, Denmark (gadodiamide) “I believe that the lawsuit [filed by General Electric] is an attempt to silence me.”[@129268]
John Buse MD PhD, Professor of Medicine, Chief, Division of Endocrinology, University of North Carolina School of Medicine, Chapel Hill, North Carolina (rosiglitazone) “There was a high-ranking member of the company that had a longstanding professional relationship before he joined the company with my chairman… [The conversation between the two men] was characterized to me as being disturbing. The phrases that I remember…involved that number, $4 billion [sought by the company via a lawsuit]. The second was that I was characterized as a liar. And the third was that I was characterized as being for sale.”[@129195]
Charles Bennett MD PhD MPP. Buehler Professor of Medicine and Economics, Northwestern University Schools of Medicine and Management, Hematologist/Oncologist, Northwestern University, Illinois “We have a safety signal [for ESAs] on deep vein thrombosis, and we now have a safety signal that we see on survival…. How much more do we need to show you to stop overuse of these drugs? How many safety signals do we need before we get to the idea that we have to reconsider what we are doing here?”[@129224]
Michael Henke MD PhD, Associate Professor, Head of Clinical Research Section, and Vice-Chairman of the Department for Radiation Oncology, University of Freiburg, Freiburg, Germany. “Everyone claims to want to protect cancer patients, and if there is agreement on this, it should be easy to come to a conclusion. Nevertheless, the doctor is making a little money prescribing erythropoietin, the scientist is making money, the manufacturer is making money.”[@129269]
David Healy MD, Director of the North Wales Department of Psychological Medicines, Professor of Psychiatry, University of Wales College of Medicine, Walse, United Kingdom “The guest lecturer gave the opinion that I had no right to present data like this [on SSRI-associated suicides]. Even when it was pointed out that these data were consistent with other data in pharmaceutical company files, he still insisted I had no right to present the data. He said it would ruin my career. Both a witness and I found the conversation disturbing.”[@129162]
Product application not submitted to FDA for consideration of regulatory approval (n=1)
Peter Wilmshurst MB ChB BScD, consultant cardiologist at the Royal Shrewsbury Hospital and Senior Lecturer in Medicine at Keele University in Keele, England (related to the patent foramen ovale closure device). “My experience suggests that corporations can use the English defamation laws to misrepresent the results of clinical research, A corporation can propagate a misleading version and can use the defamation laws to bully those who object to remaining silent.…Truths should not be decided by those with the greatest wealth using bullying and threats to make a scientist retract what he or she knows is true.”[@129193]
Delayed FDA approval (n=1)
Nancy Olivieri MD, Professor of Paediatrics and Medicine, University of Toronto. Director, Thalassemia Program, Hospital for Sick Children and University Health Network (deferiprone) “The company [Apotex] was very much against informing the patients [about lack of efficacy and serious toxicities].”[@129150]
No regulatory action (n=4)
Aubrey Blumsohn MD, Senior Lecturer/Laboratory Head, Bone Metabolism Research, Sheffield University, England “The company failed to allow investigators access to randomization and event codes from the study. They continued to refuse access to this information to authors even after ghost-authoring work in the names of myself and Dr. Eastell, and after substantial and increasing information emerged to suggest that the company data analysis could not be trusted.”[@129135; @129190; @129218]
Igancio Chapela PhD, Assistant Professor, University of California/Berkeley, California (maize) "I don't want to be a martyr by any means, but I cannot avoid now realising that this is a very, very well concerted, and coordinated and paid for campaign [by Monsanto] against me."[@129146; @129181]
David Kern MD, Associate Professor, Brown University; Director, General Internal Medicine/Occupational and Environmental Health Service; Memorial Hospital; Director, Occupational Medicine, Brown University, Rhode Island. “There were many courageous folks who stood up for me, but most looked the other way. I’m mightily discouraged by the failure of the community to do more.”[@129152; @129182]
Betty Dong Pharm D, Associate Professor, University of California, San Francisco School of Pharmacy, San Francisco, California “They [the pharmaceutical corporation] accused me of falsifying data. They sent private investigators after me to investigate my personal and professional life…The part of that is very difficult is that none of it is true and you can’t always get your reputation back in place.”[@129150]
Guiring Jiang MD, Research Radiologist, Sheffield University. No statement could be identified.