The Pain Drug Fraud Scandal: Implications for Clinicians, Investigators, and Journals

Early this year we began to hear rumors, and early in the Spring pain clinicians and investigators learned that a well-known and widely published anesthesiologist and pain drug investigator, Scott Reuben, MD, was responsible for over 20 studies based on fraudulent data. A listing of those studies appears below. The resulting scandal has been described as the most egregious example of academic misconduct and research fraud in modern memory. Most of Dr. Reuben's papers benefited the pharmaceutical manufacturers that funded his research. Exposure of the fraud was first formally reported last February and was publicized in Anesthesiology News¹ and Scientific American² the following month.

Scott Rueben was well known to many of us in the pain community, including this editor. Just prior to this coming to light, he and I were discussing writing a chapter together for a major pain textbook. Early in those discussions he stated he had to withdraw for reasons he was not at liberty to reveal. Nine months later the truth came out. Apparently he had been advised by legal counsel to cancel all pending professional obligations because his fraud was about to be revealed.

I, like many colleagues, was shocked when the truth came to light. Scott was an articulate spokesman for good care of pain patients. He frequently presented study data, some from what he described as his own work and some from that of others. He made compelling arguments for what seemed to be intuitively good pharmacotherapy and he often presented data from his own studies to support those positions.

We should now ask what we have learned from this. …. Obviously Scott Reuben's publications have been discredited. One of the first formal statements issued about it was from Steven L. Shafer, MD, editor-in-chief of Anesthesia and Analgesia, which retracted 10 of Dr. Reuben's articles. In his retraction statement, Dr. Shafer said: “We are left with a large hole in our understanding of this field. There are substantial tendrils from this body of work that reach throughout the discipline of postoperative pain management.” The “outing” of Dr. Reuben's actions resulted from an internal investigation by his home institution, Baystate Medical Center in Springfield, Massachusetts. He apparently had failed to file a study with the hospital Institutional Review Board (IRB) that he had allegedly conducted there and had discussed publicly. The resulting inquiry revealed other studies he had published for which there was no IRB record, including papers published in respected journals.

It would be easy to simply reject what Scott Reuben supported and to condemn sponsorship of drug studies by the pharmaceutical industry. This Journal believes those are not wise conclusions. Scott was perhaps the most effective advocate for multimodal analgesia and specifically for using more than one pharmacological approach concurrently, e.g., an opioid and a nonsteroidal anti-inflammatory agent (NSAID). Although work he published supporting this approach is now known to be fraudulent, there is other supporting evidence for this approach and there is no evidence that it is not beneficial. Clearly, confirmatory work will be needed to fully support this position. But pharmacological principles and clinical observation do support this approach.

Congress and federal agencies are increasingly sensitive to real and perceived conflicts of interest among investigators. Recently strengthened federal conflict of interest rules have prevented many of the most knowledgeable researchers and clinicians from serving on FDA advisory committees. As a result, consultation to the agency has increasingly come from persons who are not truly expert in the topics under consideration. Most reasonable persons recognize that transparency is essential, but totally eliminating consultants who have had any relationships with industry is counterproductive. Some critics have used the Reuben issue to decry pharmaceutical manufacturer–supported drug studies. In a capitalistic system such as ours, the business that invests the capital to bring a product to market will benefit from it. That approach has given the United States the most effective pharmaceutical industry in the world. No federal or state agency routinely sponsors studies of commercializable pharmaceuticals. If the industry were not permitted to sponsor studies, the government would have to do so. Yet many of the loudest critics of industry-sponsored research also oppose an increased role of the government in private business. Even in single payer health systems with fully socialized medicine, drug studies are typically industry sponsored.

Financial relationships between industry and clinical investigators are not inherently flawed. Oversight and regulation are essential and in some cases may deserve review and strengthening. But most such relationships are done with adequate oversight and transparency. Explicit statements of study sponsorship and full disclosure of relationships between the investigators and sponsors are essential. In the case of Dr. Reuben, such disclosures were not always made.

The vast majority of investigators do their work with integrity and the best possible outcomes for patients as their goal. In the Reuben case, there is no evidence that any study sponsors coerced him in any way. The fault and guilt were his alone.

It is important for every Journal to review its disclosure and transparency policy. This Journal is doing that now. Concurrently, it is important that we not disassemble a research system that has served society well for the most part.