HHS says researcher fabricated, falsified data on sleep apnea in severely obese patients

In the Wall Street Journal (4/10/09) Health Blog, Sarah Rubenstein wrote that, according to the Office of Research Integrity at the Health and Human Services Department, "Robert Fogel, a former assistant professor at Harvard Medical School, fabricated and falsified data in a study of sleep apnea in severely obese patients." The office said that Fogel "changed or falsified nearly half of the sleep data "so that those data would better conform to his hypothesis." He is also accused of fabricating "about 20 percent of anatomic data that supposedly came from CT scans."

The study, titled "Anatomic and Physiologic Predictors of Apnea Severity in Morbidly Obese Subjects," has since been retracted from the journal Sleep. Commenting on the false data, Fogel said "What I did was obviously horrendously wrong," but that "this was the only paper on which he'd done this." Fogel’s fabrications don’t appear as widespread as those of a Massachusetts doctor who allegedly faked data in 21 published studies. Specifically, PHS found that for the data reported in the Sleep paper, the Respondent:

• Changed/falsified roughly half of the physiologic data
• Fabricated roughly 20% of the anatomic data that were supposedly obtained from Computed Tomography (CT) images
• Changed/falsified 50 to 80 percent of the other anatomic data
• Changed/falsified roughly 40 to 50 percent of the sleep data so that those data would better conform to his hypothesis.

A New Low in Drug Research: 21 Fabricated Studies

We’ve written about plenty of controversies around drug trials, from ghostwriting to keeping quiet about unflattering results.

But the latest news is particularly eye-popping: A prominent Massachusetts anesthesiologist allegedly fabricated 21 medical studies involving major drugs. Baystate Medical Center in Springfield, Mass., has asked several anesthesiology journals to retract the studies, which appeared between 1996 and 2008. The hospital says its former chief of acute pain, Scott S. Reuben, faked data used in the studies.

Some of the studies reported favorable results from use of Pfizer’s Bextra and Merck’s Vioxx, both painkillers that have since been pulled from the market. Others offered good news about Pfizer’s pain drugs Lyrica and Celebrex and Wyeth’s antidepressant Effexor XR. Doctors said Reuben’s work was particularly influential in pain treatment and that they were shocked by the news.

“We are left with a large hole in our understanding of this field,” said the editor-in-chief of Anesthesia and Analgesia, which first reported on the retractions. “There are substantial tendrils from this body of work that reach throughout the discipline of postoperative pain management.”Pfizer had funded some of Reuben’s research and had also paid him to speak on behalf of its medicines.

And another horror story:

A medical device company and four of its executives have been indicted on charges of conducting unapproved clinical trials in which three patients died, according to the U.S. Department of Justice.

The company, Norian Corporation, of Cupertino, Calif., faces 52 felony counts, including conspiracy to impede the lawful functions of the FDA, seven counts of making false statements, and 44 counts of shipping an adulterated product. Its parent company, Synthes, of Switzerland and West Chester, Pa., faces 44 misdemeanor counts of shipping an adulterated product

The indictment charges that, from May 2002 to fall 2004, Norian conspired with parent company Synthes and four top executives to use Norian XR and Norian SRS to surgically treat vertebral compression fractures of the spine Norian SRS, in vertebral compression fracture procedures as part of a test market, according to the Department of Justice. Ultimately, 52 surgeons were trained on use of the product in such procedures.

The surgeries were performed despite a warning on the FDA approved label for Norian XR against such use -- preliminary studies had found that the cement reacted chemically with human blood, resulting in clotting. Animal studies had shown that the blood clots became lodged in the lungs, according to the Department of Justice.

Norian conducted three of the training sessions, canceling others after three patients in whom Norian XR was used died on the operating table. The company did not recall the product from the market -- doing so would have required a disclosure about the deaths to the FDA.

Instead, the Department of Justice charges that the company carried out a cover-up in which they lied to the FDA during inspections in May and June 2004.

* Tune in tomorrow for In defense of Defensive medicine.

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