Scott Reuben

Last updated
Scott S. Reuben
Born1958 (age 6465)
Occupation Anesthesiologist
Criminal statusReleased in 2010
Conviction(s) Pleaded guilty February 24, 2010
Criminal charge Health care fraud
PenaltySix months in federal prison, three years' supervised release, $5,000 fine, forfeiture of $50,000, $360,000 restitution

Scott S. Reuben (born 1958) is an American anesthesiologist who falsified data heralding the benefits of the Pfizer pain medication Celebrex while downplaying its negative side effects. [1]

Contents

He was Professor of Anesthesiology and Pain Medicine at Tufts University in Boston, Massachusetts and chief of acute pain at Baystate Medical Center in Springfield, Massachusetts from February 1991 [2] until 2009 when he was sentenced to prison for healthcare fraud. Reuben was considered to be a prolific and influential researcher in pain management, and his purported findings altered the way millions of patients are treated for pain during and after orthopedic surgeries. [1] Reuben has now admitted that he never conducted any of the clinical trials on which his conclusions were based "in what may be considered the longest-running and widest-ranging cases of academic fraud." [3] Scientific American has called Reuben the medical equivalent of Bernie Madoff, the former NASDAQ chairman who was convicted of orchestrating a $65-billion Ponzi scheme. [1]

Background

Reuben was educated at Columbia University. [4] He graduated from medical school at the State University of New York at Buffalo in 1985 and undertook his anesthesiology residency at Mount Sinai Medical Center in New York City.

Reuben fell under suspicion when Baystate conducted a routine audit in May 2008 which revealed that Reuben had not been given approval for two studies that he intended to present during the hospital's research week. On March 10, 2009 a Baystate spokeswoman announced that Reuben admitted to fabricating many of the data underlying his research. Reuben never conducted the clinical trials that he wrote about in 21 journal articles dating from at least 1996. [1] [3] In some cases, he even invented the patients. [5] Although Reuben often co-wrote papers with other researchers, Baystate found that the other researchers did not know about or participate in Reuben's studies, [5] and their names were forged on documents. [1] [4] The hospital asked the journals to retract the studies, which reported favorable results from painkillers including Pfizer Inc.'s Bextra, Celebrex and Lyrica and Merck & Co. Inc.'s Vioxx. His studies also claimed Wyeth's antidepressant Effexor could be used as a painkiller. Pfizer gave Reuben five research grants between 2002 and 2007. He was a paid member of the company's speakers bureau, giving talks about Pfizer drugs to colleagues. [6] [7] Reuben also wrote to the Food and Drug Administration, urging the agency not to restrict the use of many of the painkillers he studied, citing his own data on their safety and effectiveness. [7]

"Doctors have been using (his) findings very widely," said Steven Shafer, editor of Anesthesia and Analgesia , a scientific journal that published ten articles identified as containing fraudulent data. [8] "His findings had a huge impact on the field." [6] He also described Reuben's actions as the biggest case of fraud in the history of anesthesiology. [5] Fellow editor Paul White believed that Reuben's fraudulent studies may have actually harmed patients due to the sale of "billions of dollars' worth of drugs" that caused slower recovery times. [1]

Reuben's work had actually come under scrutiny as early as 2007, when several anesthesiologists noticed his studies never showed negative results. [4] Greg Koski, former director of the Office for Human Research Protections, said the fraud was unusual because Reuben was able to carry it on for almost 13 years without being caught by the peer review process. [5]

All of Reuben's 21 fraudulent articles, as well as the article abstracts, are documented in the magazine Healthcare Ledger.

Tufts has since cut ties with Reuben, [7] and his Massachusetts medical license was permanently revoked after a period in which he voluntarily agreed not to practice.

Sentencing

On January 7, 2010 Reuben agreed to plead guilty to one count of health care fraud. Prosecutors alleged that Reuben obtained thousands of dollars in grants for research that he never performed. [9] He formally pleaded guilty on February 21, 2010 before Judge Michael Ponsor. On May 24, Ponsor sentenced him to six months in prison, followed by three years of supervised release. He was ordered to pay a $5,000 fine, forfeit $50,000 to the government and make $360,000 in restitution to pharmaceutical companies. [10] [11] The plea deal effectively ended his career as a doctor; most states will not grant medical licenses to convicted felons.

On November 16, 2011 the U.S. Food and Drug Administration (FDA) issued an order permanently debarring Reuben from assisting in drug applications. [12]

Impact

A 2009 review of systematic review articles used in evidence-based medicine found that while some reviews were no longer valid when the Reuben studies were removed, the conclusions in the majority of them remained unchanged. [13] The review found that the key Reuben claims that needed to be re-examined were "the absence of detrimental effects of coxibs on bone healing after spine surgery, the beneficial long-term outcome after preemptive administration of coxibs including an allegedly decreased incidence of chronic pain after surgery, and the analgesic efficacy of ketorolac or clonidine when added to local anesthetics for intravenous regional anesthesia." [13]

In 2010 the editorial in Anaesthesia argued that, [14]

Reuben's fabricated data may have had impact beyond systematic review conclusions because they addressed topical questions for which anaesthetists, surgeons, and patients seek answers, such as the utility of multimodal anaesthesia, or whether non-steroidal anti-inflammatory drugs (NSAIDs) influence bone healing ... Millions of people have had NSAIDs after fractures, trauma or orthopaedic surgery without problems of bone healing. The plausibility of a sizeable negative effect of NSAIDs on bone healing has to be questioned.

See also

Related Research Articles

<span class="mw-page-title-main">Anesthesia</span> State of medically-controlled temporary loss of sensation or awareness

Anesthesia is a physiological state of controlled, temporary loss of sensation or awareness that is induced for medical or veterinary purposes. It may include some or all of analgesia, paralysis, amnesia, and unconsciousness. An individual under the effects of anesthetic drugs is referred to as being anesthetized.

<span class="mw-page-title-main">Anesthesiology</span> Medical specialty concerned with anesthesia and perioperative care

Anesthesiology, anaesthesiology, or anaesthesia is the medical specialty concerned with the total perioperative care of patients before, during and after surgery. It encompasses anesthesia, intensive care medicine, critical emergency medicine, and pain medicine. A physician specialized in anesthesiology is called an anesthesiologist, anaesthesiologist, or anaesthetist, depending on the country. In some countries, the terms are synonymous, while in other countries they refer to different positions, and anesthetist is only used for non-physicians, such as nurse anesthetists.

<span class="mw-page-title-main">Spinal anaesthesia</span> Form of neuraxial regional anaesthesia

Spinal anaesthesia, also called spinal block, subarachnoid block, intradural block and intrathecal block, is a form of neuraxial regional anaesthesia involving the injection of a local anaesthetic or opioid into the subarachnoid space, generally through a fine needle, usually 9 cm (3.5 in) long. It is a safe and effective form of anesthesia usually performed by anesthesiologists that can be used as an alternative to general anesthesia commonly in surgeries involving the lower extremities and surgeries below the umbilicus. The local anesthetic with or without an opioid injected into the cerebrospinal fluid provides locoregional anaesthesia: true analgesia, motor, sensory and autonomic (sympathetic) blockade. Administering analgesics in the cerebrospinal fluid without a local anaesthetic produces locoregional analgesia: markedly reduced pain sensation, some autonomic blockade, but no sensory or motor block. Locoregional analgesia, due to mainly the absence of motor and sympathetic block may be preferred over locoregional anaesthesia in some postoperative care settings. The tip of the spinal needle has a point or small bevel. Recently, pencil point needles have been made available.

<span class="mw-page-title-main">Rofecoxib</span> Nonsteroidal anti-inflammatory drug

Rofecoxib is a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID). It was marketed by Merck & Co. to treat osteoarthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, acute pain conditions, migraine, and dysmenorrhea. Rofecoxib was approved in the US by the US Food and Drug Administration (FDA) in May 1999, and was marketed under the brand names Vioxx, Ceoxx, and Ceeoxx. Rofecoxib was available by prescription in both tablet-form and as an oral suspension.

<span class="mw-page-title-main">Celecoxib</span> Nonsteroidal anti-inflammatory drug

Celecoxib, sold under the brand name Celebrex among others, is a COX-2 inhibitor and nonsteroidal anti-inflammatory drug (NSAID). It is used to treat the pain and inflammation in osteoarthritis, acute pain in adults, rheumatoid arthritis, ankylosing spondylitis, painful menstruation, and juvenile rheumatoid arthritis. It may also be used to decrease the risk of colorectal adenomas in people with familial adenomatous polyposis. It is taken by mouth. Benefits are typically seen within an hour.

Awareness under anesthesia, also referred to as intraoperative awareness or accidental awareness during general anesthesia (AAGA), is a rare complication of general anesthesia where patients regain varying levels of consciousness during their surgical procedures. While anesthesia awareness is possible without resulting in any long-term memory, it is also possible for the victim to have awareness with explicit recall, where victims can remember the events related to their surgery.

COX-2 inhibitors (coxibs) are a type of nonsteroidal anti-inflammatory drug (NSAID) that directly targets cyclooxygenase-2, COX-2, an enzyme responsible for inflammation and pain. Targeting selectivity for COX-2 reduces the risk of peptic ulceration and is the main feature of celecoxib, rofecoxib, and other members of this drug class.

The American Society of Anesthesiologists (ASA) is an educational, research and scientific association of physicians organized to raise the standards of the medical practice of anesthesiology and to improve patient care.

Harold Randall Griffith was a Canadian anesthesiologist and a leader in the fields of anesthesiology.

Cardiothoracic anesthesiology is a subspeciality of the medical practice of anesthesiology, devoted to the preoperative, intraoperative, and postoperative care of adult and pediatric patients undergoing cardiothoracic surgery and related invasive procedures.

Geriatric anesthesia is the branch of medicine that studies anesthesia approach in elderly.

The International Anesthesia Research Society (IARS) is an international, professional medical society dedicated to improving clinical care, education and research in anesthesia, pain management, and perioperative medicine. It was founded in 1922 by Francis Hoeffer McMechan.

Neurosurgical anesthesiology, neuroanesthesiology, or neurological anesthesiology is a subspecialty of anesthesiology devoted to the total perioperative care of patients before, during, and after neurological surgeries, including surgeries of the central (CNS) and peripheral nervous systems (PNS). The field has undergone extensive development since the 1960s correlating with the ability to measure intracranial pressure (ICP), cerebral blood flow (CBF), and cerebral metabolic rate (CMR).

Joachim Boldt is a German anesthesiologist who fabricated or falsified data, including those reporting clinical trial results. Boldt was previously considered to be a leading researcher of medicinal colloids. He was an advocate for the use of colloidal hydroxyethyl starch (HES) to boost blood pressure during surgery. However, a meta-analysis of trials that excluded Boldt's fabricated data found that the intravenous use of hydroxyethyl starch is associated with a significant increased risk of death and acute kidney injury compared with other resuscitation solutions. He has been stripped of his professorship and is under criminal investigation for possible forgery of up to 90 research studies.

Certified anesthesiologist assistants(CAAs) are highly trained master’s degree level non-physician anesthesia care providers. CAAs are integral members of the anesthesia care team as described by the American Society of Anesthesiologists (ASA). All CAAs possess a baccalaureate degree, and complete an intensive didactic and clinical program at a postgraduate level. CAAs are trained in the delivery and maintenance of all types of anesthesia care as well as advanced patient monitoring techniques. The goal of CAA education is to guide the transformation of student applicants into competent clinicians.

The following outline is provided as an overview of and topical guide to anesthesia:

Yoshitaka Fujii is a Japanese researcher in anesthesiology, who in 2012 was found to have fabricated data in at least 219 scientific papers, setting what is believed to be a record for the number of papers by a single author requiring retractions.

Obstetric anesthesia or obstetric anesthesiology, also known as ob-gyn anesthesia or ob-gyn anesthesiology, is a sub-specialty of anesthesiology that provides peripartum pain relief (analgesia) for labor and anesthesia for cesarean deliveries ('C-sections').

<span class="mw-page-title-main">Alex Bekker</span> Physician, author and academic

Alex Bekker is a physician, author and academic. He is a professor and chair at the Department of Anesthesiology, Rutgers New Jersey Medical School. He is also professor at the Department of Physiology, Pharmacology & Neurosciences. He serves as the Chief of Anesthesiology Service at the University Hospital in Newark.

Alex Macario is an American anesthesiologist, academic and author. He is a vice-chair for education, a professor in the Department of Anesthesiology, Perioperative and Pain Medicine, and program director for the anesthesiology residency at Stanford University School of Medicine.

References

  1. 1 2 3 4 5 6 "A Medical Madoff: Anesthesiologist Faked Data in 21 Studies", Scientific American , March 10, 2009, retrieved December 27, 2015
  2. "Fraud Case Stuns Anesthesiologists Post-op Pain Expert Fabricated Years of Data", Anesthesiology News, vol. 35, no. 4, April 2009, retrieved 27 December 2015
  3. 1 2 Harris, Gardiner (March 11, 2009), "Doctor Admits Pain Studies Were Frauds, Hospital Says", The New York Times , retrieved December 27, 2015
  4. 1 2 3 "Fraud Case Rocks Anesthesiology Community", Anesthesiology News, March 2009
  5. 1 2 3 4 Doctor accused of faking studies; His work dealt with pain drugs, Boston Globe, March 11, 2009
  6. 1 2 Mass. doctor accused of fabricating pain studies, Associated Press, March 11, 2009
  7. 1 2 3 Top Pain Scientist Fabricated Data in Studies, Hospital Says, Wall Street Journal, March 11, 2009
  8. "Retraction Notice", Steven L. Shafer, Anesthesia and Analgesia , 20 February 2009
  9. Dr. Scott Reuben, former chief of acute pain at Baystate Medical Center in Springfield, pleads guilty to health-care fraud. The Republican, January 15, 2010
  10. Scott Reuben, a former Baystate doctor who faked research, sentenced to 6 months for health care fraud, The Republican, June 24, 2010
  11. Anesthesiologist sentenced on health care fraud charge Archived 2011-05-31 at the Wayback Machine . United States Attorney for the District of Massachusetts, June 24, 2010
  12. Scott S. Reuben: Debarment Order (FDA)
  13. 1 2 Marret; et al. (Dec 2009). "lessons from the Reuben case". Anesthesiology. 111 (6): 1279–89. doi: 10.1097/ALN.0b013e3181c14c3d . PMID   19934873.
  14. Moore, R. A.; Derry, S.; McQuay, H. J. (17 March 2010). "Fraud or flawed: adverse impact of fabricated or poor quality research". Anaesthesia. 65 (4): 327–330. doi: 10.1111/j.1365-2044.2010.06295.x . PMID   20402871.