Celecoxib: a big research fraud stands exposed

Published in The Hindu on March 19, 2009

One of the biggest research frauds in recent times has come to light. At last count, 21 of the 72 papers published in various peer-reviewed medical journals by Dr. Scott S. Reuben, of the Baystate Medical Center in Springfield, Massachusetts, U.S. have been found to contain fabricated data.

The fabricated data involved the drug celecoxib (celebrex) — a non-steroidal anti-inflammatory drug (NSAID) — manufactured by Pfizer.

The first paper containing concocted data was published in 1996 and the latest one in 2008.

While the South Korean stem cell researcher Hwang Woo Suk’s fraud of image duplication, among other things, was detected very early, it is unfathomable why Dr. Reuben’s fraud was not detected earlier. He has been submitting papers containing fabricated data for the last 13 years or so!

Internal investigations initiated by the Baystate Medical Center, and not the journals, helped expose Dr. Reuben’s fraud.

All the 21 papers are being retracted by the medical journals. According to an Editorial to be published in the May 2009 issue of the journal Anesthesiology journal, “the retracted papers have been considerably cited since 2002. …The retracted articles have been cited more than twice as often as those not retracted.”

The biggest irony is that Dr. Reuben’s “research” helped set the protocol for post-operative pain management!

Multimodal analgesia

He “pioneered” the “multimodel analgesia, where a combination of two drugs is given to manage pain. He claimed that multimodel analgesia, where celecoxib was given along with lyrica — a neuropathic agent — was preferable to giving narcotics (opioids). Lyrica is also manufactured by Pfizer.

This multimodal analgesia became the “mainstay in pain management,” notes the British Medical Journal (March 9, 2009). His “research” also claimed that celecoxib “reduces pain at six and 12 months after surgery” (British Medical Journal, March 9, 2009).

Now with the very foundation of his claim coming down like a house of cards, the best protocol to manage pain is not known.

“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.

“Those tendrils mean that almost every aspect will need to be carefully thought through,” Steven L. Shafer, Editor-in-Chief of Anesthesia and Analgesia journal was quoted as saying in Anesthology News (a medical newspaper).

Anesthesia and Analgesia is one of the journals where he published his “findings.”

The editorial in the Anesthesiology journal to be published in May 2009, notes: “Although we may not be lost in the woods, these retractions [of papers by journals] clearly raise the possibility that we might be heading in wrong directions or towards blind ends in attempts to improve pain therapy.”

Never before has a person’s cooked up data formed the basis for setting a protocol for treating people in a particular field of medicine. Multimodal therapy is an expensive option. So why did Dr. Reuben advance it as a better option to manage pain based on cooked up data?

There are many disturbing questions now being asked. Will the data fabrication fraud turn out to become a bigger scandal?

According to the Anesthology News, Dr. Reuben had received research grants from Pfizer and was a member of the drug company’s speakers’ bureau. So far Pfizer has not been accused of any wrongdoing.

“Independent clinical research advances disease treatments and improves the lives of patients,” Raymond F. Kerins Jr., a Pfizer spokesman was quoted as saying in the New York Times.

“As part of such research, we count on independent researchers to be truthful and motivated by a desire to advance care for patients. It is very disappointing to learn about Dr. Reuben’s alleged actions.”

A Pfizer spokesperson was quoted as saying in the British Medical Journal that the retraction of papers “does not change the risk-benefit profile” of the drug.