Integrity of Scientific Findings Marred

Integrity of Scientific Findings Marred

Tue, 2 Dec 2003

Two cases shed light on a cultural malaise and the price we pay when scientists fail to adhere to scrupulous scientific methods: Dr. Thomas Butler, chief of infectious diseases division of Texas Tech University, ran afoul of the law; Dr. George Ricaurte, neurologist, Johns Hopkins University, ran afoul of his competitive colleagues. Both cases provide a glimpse into the culture of opportunism and “sloppy” science.

The cases illustrate how a cadre of scientists are more concerned with hustling for grants and enhancing their careers than they are with scientific methodology or rules for safe handling hazardous compounds. In some cases their negligence pose a threat to the community. Yet, no matter how egregious the breach, scientists tend to rally around one of their own, referring to the mishandling of toxic–even lethal– compounds as “sloppy.” However, “sloppy” methodology undermines the integrity of the research.

Dr. Butler testified in court that he didn’t know the whereabouts of 30 vials containing deadly plague specimens which he had transported to the US from Tanzania. He said he either “lost” or “destroyed” them but didn’t remember. Butler’s report of the missing plague vials was scary, bringing 60 FBI agents to scour the Texas community, and leading to his arrest. Scientists around the country rallied to his defense, claiming a scientist should not be treated to such indignity.

During his trial, Butler’s questionable financial dealings took center stage. The trial revealed his lucrative “shadow contracts” with pharmaceutical companies. SCIENCE reported:

“In a diabetes study for Pharmacia, Texas Tech received $325 for every subject Butler enrolled, while it netted $650 for every patient enlisted by a colleague who also partook in the study. Thinking that Butler had cut a lousy deal for his institute, Stacey Pugh of the Office of Clinical Trials admonished Butler to renegotiate the contract. Butler refused– but what he did not tell Pugh, Webster said, was that he also received $325 per patient himself. Butler did not deny this. Taken together, the “companion consultancies” were worth $1,038,000, Webster said– a figure that Butler did not contest either.”

See: Martin Enserink, “Difficult day for the defense …A money-losing business … Was Butler ill?” SCIENCE, Friday, 21 November at: http://sciencenow.sciencemag.org/feature/data/butlertrial.shtml

Prosecutors argued that the plague scare was a deliberate hoax to divert attention from fraudulent financial deals. A Texas jury convicted Butler yesterday on 44 counts of fraud relating to the diversion of funds from Texas Tech.

See: Kenneth Chang, “Split Verdicts in Texas Trial of Professor and the Plague, The New York Times, Dec 2, 2003, p. A-22 at: http://www.nytimes.com/aponline/national/AP-Plague-Professor-Trial.html

Dr. George Ricaurte’s published reports claiming to have evidence that the recreational use of mind altering drugs caused permanent brain damage, were highly publicized.

Since 1988, Ecstasy, the so-called “date drug” was a particular focus of his research. Dr. Ricaurte’s findings supported government restrictions on the use of Ecstasy which had been outlawed since 1985. Dr. Ricaurte’s findings have been a source of contentiousness among competing neurologists and psychiatrists who have been stymied from gaining approval to conduct Ecstasy experiments in patients who are not drug abusers. But those who propose to expose psychiatric patients to destabilizing, psychoactive drugs, such as Ecstasy, are irresponsible. The outcome of such drug experiments in patients is unpredictable.

Most disturbing about Dr. Ricaurte’s research methods is the revelation in today’s New York Times that two of Dr. Ricaurte’s human subjects in a 1996 Ecstasy experiment have come forth to report that the experiment was tainted. They told the Times that they “and other Ecstasy users flown in from the West Coast took memory tests while still jet-lagged” and sedated.

They said that their sleep patterns were recorded under abnormal conditions, when they were in pain and not rested after a lumbar puncture. They said that PET scans were taken “after shots of morphine and a drug, mCPP, that causes the same eyeball twitching and teeth- grinding as Ecstasy, but none of the euphoria.”

They also indicated that, contrary to protocol requirements, one of them had used heroin within 5 days of the experiment without being detected. “Although the two used many drugs, the research assistant who interviewed them by phone told them what not to admit to her if they wanted to be in the study, Greg said. They were instructed to avoid all drugs for three weeks to avoid tainting the study; Greg says he had used heroin five days earlier.”

Dr. Ricaurte acknowledged that hair tests exist that can accurately detect many drugs, even those taken months earlier. The Times reports that “Greg’s friend reiterated that he had been badly treated and said he felt the research was skewed to prove he was brain-damaged.”

Dr. Ricaurte garnered $10 million in taxpayer funds for his research. Hopkins stands by him.

~~~~~~~

http://www.nytimes.com/2003/12/02/science/02ECST.html?pagewanted=print&position=

THE NEW YORK TIMES
December 2, 2003, p. F1
Research on Ecstasy Is Clouded by Errors
By DONALD G. McNEIL Jr.

EXCERPT:

In September, the journal Science issued a startling retraction.

A primate study it published in 2002, with heavy publicity, warned that the amount of the drug Ecstasy that a typical user consumes in a single night might cause permanent brain damage.

It turned out that the $1.3 million study, led by Dr. George A. Ricaurte of Johns Hopkins University, had not used Ecstasy at all. His 10 squirrel monkeys and baboons had instead been injected with overdoses of methamphetamine, and two of them had died. The labels on two vials he bought in 2000, he said, were somehow switched.

The problem corrupted four other studies in his lab, forcing him to withdraw four other papers.

It was not the first time Dr. Ricaurte’s lab was accused of using flawed studies to suggest that recreational drugs are highly dangerous. In previous years he was accused of publicizing doubtful results without checking them, and was criticized for research that contributed to a government campaign suggesting that Ecstasy made “holes in the brain.”

Dr. Ricaurte, a 50-year-old neurologist at Hopkins since 1988, is probably the best-known Ecstasy expert in the war on drugs. He has received $10 million from the National Institute on Drug Abuse, more than any other investigator of the amphetamine analogs known as designer drugs, club drugs or diet drugs, including MDMA, better known as Ecstasy, and its close relative MDA.

He vigorously defends his work, saying much of it has been confirmed by other researchers, and arguing that he is often unfairly attacked by scientists who minimize the dangers of designer drugs because they want to use them in research.

Johns Hopkins stands behind him. “The institution has every confidence in his ability,” said Gary Stevenson, a spokesman. Of the primate study, he said Dr. Ricaurte “made an honest mistake, then discovered it and revealed it.”

But other scientists, and two human research subjects of Dr. Ricaurte’s who came forward after the retraction, say they see a pattern of shaky research supporting alarmist press releases.

xxx cut xxx

COMPLETE ARTICLE SEE: http://www.nytimes.com/2003/12/02/science/02ECST.html?pagewanted=print&position=