Integrity of Scientific Findings Marred

ALLIANCE FOR HUMAN RESEARCH PROTECTION   (AHRP)
http://www.ahrp.org
Contact: Vera Hassner Sharav
Tel: 212-595-8974
e-mail: [EMAIL PROTECTED]

FYI

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&posit
ion=

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.

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