Healthy Skepticism Library item: 9068

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Publication type: news

Yeoman B.
Putting Science in the Dock
The Nation 2007 Mar 26
http://www.thenation.com/docprem.mhtml?i=20070326&s=yeoman

Full text:

EXCERPT On a chilly morning in November 2001, David Healy stood in a witness
box in Kansas City, Kansas, and received a sobering lesson on the US legal
system. A professor of psychological medicine at Cardiff University in
Wales, Healy was an expert on serotonin, depression and the brain. He had
served as secretary of the British Association for Psychopharmacology. Drug
companies sought his advice. He was widely published in scientific journals.

Healy had crossed the Atlantic to testify in a lawsuit filed against
the pharmaceutical firm Pfizer by the parents of a teenager who had hanged
himself in his bedroom closet. Thirteen-year-old Matthew Miller had just
started taking Zoloft, a drug that can ease depression by boosting serotonin
levels in the brain. But the medication seemed to backfire. During his week
on Zoloft, Matthew grew “more agitated than I had ever seen him,” his
mother, Cheryl Miller, later recalled. She and her husband, Mark, believed
their son’s suicide was a direct and gruesome side effect of the drug.

The Millers knew that psychiatrists had seen violent suicidal
behavior in a handful of patients taking selective serotonin reuptake
inhibitors (SSRIs) like Zoloft. They invited Healy to testify about this
rare phenomenon. Though he routinely prescribed SSRIs in his own practice,
Healy had become increasingly outspoken about the dangers of these
antidepressants. He believed the evidence showed that the drug could be
largely blamed for Matthew’s suicide.

Before the trial could begin, though, Pfizer used a tactic that has
grown increasingly common in lawsuits involving scientific testimony: It
filed a thirty-six-page challenge to block Healy from even appearing before
a jury. “Dr. Healy’s reports consist of personal beliefs, speculation,
innuendo, unscientific claims and theories, and mere musings,” Pfizer’s
lawyers argued. “He has avoided, rather than followed, scientific methods in
this case…. He knew what he was hired to say and, without bothering to
explore the facts, said it.”

Pfizer’s challenge triggered a “Daubert hearing,” a procedure judges
use to evaluate the credentials of scientific witnesses and the quality of
their work. Now, in the half-empty courtroom, Healy found his research
ripped apart.

Pfizer attorney Malcolm Wheeler read a statement by Healy that
antidepressants can produce side effects tormenting enough to drive suicidal
patients over the edge. Then, unexpectedly, Wheeler changed the subject to
pizza. “[What] if a person who is depressed eats a piece of pizza and gets a
stomachache because it’s greasy,” Wheeler asked, “and he just said, ‘That’s
the last straw; I’m going to commit suicide?’ Could the pizza be held
responsible?”

Healy was taken aback by the question. “I think, Mr. Wheeler, you’re
playing with the actual example slightly,” he said in his understated way. “I am indeed,” Wheeler shot back. It was a particularly stark unmeeting of the minds. But the
encounter illustrates what often happens when science is called upon to
settle questions of law.

People are exposed to risks all the time: They take medications,
work around toxic chemicals, undergo risky surgeries, smoke cigarettes, use
electronic devices that emit radiation. Sometimes they get sick or injured,
either as a result of the exposure or simply by coincidence. It’s the role
of science to determine what caused the harm, and the role of law to
determine who must take the blame.

In the past the courts asked scientists to play gatekeeper by
deciding what was good science—permissible in the courtroom—and what
wasn’t. But 1993 brought a dramatic shift. The Supreme Court ruled in
Daubert v. Merrell Dow Pharmaceuticals that scientists should not be the
ultimate arbiters of the quality of science. That power should be reserved
for judges.

The decision brought the two disciplines into ugly conflict. Since
Daubert , respected researchers have seen their legitimacy questioned, even
rejected, by judges who may never have taken a college biology course.
Cutting-edge science has been banished from courthouses. And juries, a
fundamental element of the justice system, have been stripped of much of
their power. “Daubert lets judges have much too much leeway to follow their
personal inclinations,” says Stanley Feldman, retired chief justice of the
Arizona Supreme Court. “It’s an interference in the jury process and wholly
unneeded.” Feldman says the 1993 ruling was written to address legitimate
concerns about how science is used in courtrooms. But “the remedy,” he says,
“is worse than the problem.”

As a result of Daubert, plaintiffs find it harder to collect damages
for injuries and illnesses they might have suffered because of others’
negligence. The result, say legal experts as well as scientists, is a system
that has tilted further to the benefit of large corporations.

For most of the past century, judges had little direction about what
type of science to admit into their courtrooms. They relied primarily on a
terse 1923 federal court decision, called Frye v. United States , which
allowed scientific testimony if the underlying principles had gained
“general acceptance” within the field. If most researchers backed a theory,
that meant it was permissible in court.

Then, in the 1980s and ’90s, two developments shook US courtrooms.
The first was a rise in “toxic torts”—lawsuits claiming that particular
drugs or other chemicals had caused injuries. The science behind these cases
was often complex, giving rise to concerns that jurors could be confused or
even misled. “You had experts dueling over novel theories of causation,”
says Ed Imwinkelried, a law professor at the University of California,
Davis. The other development was the emerging movement to ban “junk
science” from courtrooms, led by Peter Huber, a scholar with the
conservative Manhattan Institute. “The legal establishment has adjusted
rules of evidence,” Huber wrote in his controversial 1991 book Galileo’s
Revenge , “so that almost any self-styled scientist, no matter how strange
or iconoclastic his views, will be welcome to testify in court.”

Galileo’s Revenge was firmly in the legal zeitgeist when the Supreme
Court took up the Daubert case, which involved the drug Bendectin and birth
defects. In his ruling, Justice Harry Blackmun essentially overturned Frye
and instructed judges to act as strict gatekeepers, favoring evidence that
had undergone rigorous testing, carried acceptable error rates, survived
peer review and won “widespread acceptance” in professional circles.

Blackmun acknowledged that these new criteria could exclude
cutting-edge research, favoring instead a “stifling and repressive
scientific orthodoxy.” This, he said, was unavoidable. “Scientific
conclusions are subject to perpetual revision,” he wrote. “Law, on the other
hand, must resolve disputes finally and quickly.”

Daubert’s tougher standard had an immediate impact, both in federal
courts and in states that adopted the federal standard. “The Supreme Court
said to judges, You have to look. You have to ask, Does this thing even pass
the laugh test?” says David Venderbush, a New York attorney who has
represented defendants in silicone-breast-implant litigation. At first,
Daubert did weed out sloppy and unscientific claims. In one Florida case, a
woman who gave birth to a daughter with several deformities sued the
manufacturers of an acne cream she used while pregnant. Her only expert
witness was a gynecologist with no expertise in embryology who could not
cite a single study linking the medicine to birth defects.

But now rigorous science also gets thrown out. “There have been
numerous examples where highly qualified scientists, sterling scientists,
have been Dauberted out,” says David Ozonoff, chair emeritus of Boston
University’s department of environmental health. That’s because
controversial lawsuits often turn on groundbreaking science—the type that
attracts the best researchers and the type Daubert discourages.

The impact has been lopsided. “In retrospect, it’s pretty clear that
Daubert strengthened the role of defendants,” says Joe Cecil, a senior
researcher with the Federal Judicial Center in Washington, DC. Chemical and
pharmaceutical firms often use Daubert to challenge scientific evidence
provided by injured and sickened plaintiffs, who carry the burden of proof
in a legal action. The defendant gets the first shot at mounting a Daubert
challenge—and if it wins, the case is often dismissed through a process
called summary judgment.

In March 2006, for example, Dow Chemical persuaded a federal judge
to exclude the opinions of three scientists including renowned North
Carolina toxicologist Ken Rudo, who had concluded that groundwater
contamination at a Louisiana trailer park increased residents’ risk of
cancer. The case was then dismissed. This wasn’t unusual: The RAND Institute
for Civil Justice, in a 2002 analysis of 400 lawsuits, found a marked
upswing in summary judgments following Daubert. In 96 percent of those
judgments, the defense prevailed.

These odds have scared away some plaintiffs’ attorneys from even
filing lawsuits. “Daubert is now part of the gamesmanship of litigation,
which makes things more expensive and has a great impact in terms of ‘Is
this case worth litigating?’” says Margaret Berger, a professor at Brooklyn
Law School and the nation’s leading Daubert scholar. “Undoubtedly,
plaintiffs just do not go ahead with these cases because they can’t afford
the Daubert challenge.” Berger fears that by insulating corporations,
Daubert emboldens them to take risks with consumer safety and health. “If
you put in too strict a standard, you take away the deterrent effect of tort
law,” she says.

Nineteen ninety-seven was a rough year for Matt Miller. The family
had moved, and the boy had a big new middle school to adjust to. His grades
had fallen and his teachers complained that he was acting out—head-butting
his locker and urinating on the bathroom floor. That spring he told a
teacher, “If my parents send me away to camp, I’ll kill them and myself.”

Many depressed people are suicidal. But Matt’s parents were
convinced that it was the medicine itself, not Matt’s troubles, that pushed
him over the edge. Few psychiatrists at the time believed that
antidepressants triggered suicidal thoughts and acts, but even then there
was evidence that the Millers might be right. For most of a decade,
psychiatrists had observed uncharacteristic suicidal behavior among some
SSRI users. “It’s sudden and obsessive,” says E. Jane Garland, a professor
of psychiatry at the University of British Columbia. “It’s not like someone
was severely depressed and was thinking about killing themselves.” In 1991,
a year after the first case reports appeared in medical journals, Harvard
psychiatrist Anthony Rothschild conducted a dramatic study: Three patients
who had made serious suicide attempts while taking the SSRI Prozac were put
back on the drug, under controlled conditions to guarantee their safety.
Each of them again felt suicidal urges, accompanied by akathisia, a
tormenting agitation described by Harvard psychiatrist Joseph Glenmullen as
“living twenty-four hours a day with the sensation of nails scratching up
and down a blackboard.”

Why would a drug prevent suicide in some depressed people and
potentiate it in others? One hypothesis holds that SSRIs restore a person’s
vigor before wiping away the depression. Perhaps patients regain the energy
to kill themselves before the medicine eases their intense sadness. What’s
more, SSRIs upset the overall balance of chemicals in the brain, says
Harvard’s Glenmullen. To compensate for the serotonin boost, the level of
dopamine—serotonin’s chemical partner—plummets. “Whenever the drugs step
on the chemical gas pedal, the brain tries to slam on the brakes,”
Glenmullen writes in his book Prozac Backlash . “The result is jerking,
stop-and-go oscillations in brain activity that can go out of control.”
Dopamine suppression is associated with loss of motor control—hence the
akathisia, which many researchers link directly to suicide.

The Millers knew that to win their lawsuit, a credible scientist
would have to testify that SSRIs could have caused their son’s death. Their
attorney, Andy Vickery, approached Dr. Healy. The professor had already
survived scrutiny in the American legal system: A federal judge in Hawaii
had described Healy as “an experienced and well-qualified
psychopharmacologist” whose opinions were admissible by Daubert standards.

As an expert witness, Healy used his access to Pfizer’s
clinical-trial data to reanalyze the company’s results. He found that
volunteers on Zoloft had twice the risk of suicide as those taking placebos.

The most alarming evidence, though, came from his own research. In
an attempt to understand the varying effects of different antidepressants,
Healy recruited twenty healthy, nondepressed volunteers, giving half of them
Zoloft and the other half reboxetine, a drug that works on the brain
chemical norepinephrine. After two weeks on the drug, and a two-week
cleansing period, the volunteers switched medications. Healy asked the
volunteers to keep diaries of their emotions, and interviewed them in detail
afterward.

The first half of the study produced few surprises. But after the
crossover, the experiment took a chilling turn: Two of the volunteers taking
Zoloft suddenly became suicidal, though neither had suffered from
depression. “I had this sudden feeling that the walls were turning green and
pressing in,” one of them, whom Healy calls Joanna to protect her privacy,
remembers. “My mind had emptied out, and there was this tiny thought that
grew until it filled my head: I had to go out and throw myself under a
lorry. And I had to do it right now.” Joanna was halfway out the door before
a ringing telephone snapped her out of the delusion. Another woman, also on
Zoloft, had recurring nighttime thoughts of hanging herself from a ceiling
beam.

“We had veered away from the brink of disaster,” Healy says.
“Goodness only knows how we’d have handled it if anything had actually
happened.”

Not everyone was impressed with the findings, which were published
in the peer-reviewed journal Primary Care Psychiatry . Pfizer called the
study “rife with design flaws and methodological flaws,” noting that many of
the participants knew Healy personally and might have been biased by his
opinions. Others, though, found the experiment compelling.
“Healthy-volunteer studies take depression out of the equation,” says
University of Nevada professor of psychiatry and behavioral sciences David
Antonuccio. “They make it impossible to blame the disease.” Although Healy’s
study was small, his exit interviews elicited far more information about the
drugs’ side effects than most studies provide. “Science starts with careful
observation,” Glenmullen says. “And David’s study provided rich
observation.”

Pfizer’s attorneys never offered a definitive explanation for Matt
Miller’s death.
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