5/15/2000 – Doctor lashes out in Prozac battle

The Boston Globe has wasted no time in doing a story based on
the Vickery & Waldner press release sent previously. Mark
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Doctor lashes out in Prozac battle

By Richard A. Knox, Globe Staff, 5/15/2000

Dr. Jonathan O. Cole, a Harvard psychiatrist who was one of the
first to suggest that Prozac and similar antidepressants could
precipitate suicide, is now criticizing drug companies and the US
Food and Drug Administration, saying they are failing to take the
problem seriously.

Cole made his complaint in support of a federal court lawsuit
that claims the drug Zoloft, a chemical cousin of Prozac, caused
a 13-year-old Kansas City youth to kill himself.

”I still believe our 1990 article was correct and it does happen,”
Cole said of the alleged suicide-antidepressant link that he and
other McLean Hospital researchers first suggested a decade
ago.

Although Cole had remained silent amid manufacturers’ efforts
to discredit his research, the Boston psychiatrist said he was
angered by the actions of Zoloft’s maker, Pfizer Inc., in fighting
the lawsuit brought by the family of Matthew Miller, the Missouri
teenager.

The youth had been taking Zoloft for only a week when he
hanged himself in his bedroom closet on July 28, 1997. His
parents insist he had never displayed suicidal tendencies and
had never been treated for behavioral problems. They say the
boy had been unusually restless and jumpy in the days before
his death – symptoms that Cole and other researchers say are
warning signs of alleged antidepressant-related suicides.

”Against this background … There is a clear prima facie case that
Zoloft caused Matthew Miller to commit suicide,” said Dr. David
Healy, a British researcher who is the family’s chief expert
witness.

Pfizer lawyers, calling Healy a practitioner of ”junk science,” are
asking Kansas City Federal District Court Judge Katheryn Vratil
to disallow Healy as an expert witness. Cole was recruited by the
Houston law firm representing the Miller family to vouch for
Healy’s scientific rigor.

Pfizer representatives say there is no credible scientific evidence
that Zoloft and related drugs precipitate suicide. Company
officials did not return telephone calls Friday seeking comment.

In the decade since Cole and Harvard colleagues first reported
on early cases of extreme agitation among people taking Prozac
and related antidepressants, use of these drugs – called
selective serotonin reuptake inhibitors, or SSRIs – has reached
84 million prescriptions a year.

The wholesale cost of SSRI prescriptions last year was $7
billion, a 15 percent jump from 1998, according to IMS Health, a
Pennsylvania research firm.

Moreover, US physicians are prescribing Prozac, Zoloft, and a
related drug called Paxil for ever-younger patients and for a
broadening list of disorders.

A University of Michigan researcher reported Friday in Boston
that nearly 2 percent of North Carolina children ages 6 to 14
received SSRI drugs in 1998. A growing number of physicians
are giving children prescriptions for SSRIs along with stimulants
such as Ritalin, the researcher said, despite the absence of any
studies supporting such use.

Dr. Jerry Rushton and his colleagues found that Prozac, Zoloft,
and Paxil are being used widely by children not only for
depression, but for school phobia, anxiety disorders,
bed-wetting, eating disorders, and attention deficit-hyperactivity
disorder. Their study was presented at the annual meeting of the
American Academy of Pediatrics and the Pediatric Academic
Societies.

While manufacturers have been successful so far in deflecting
criticism, opponents say the tide may be turning, due to lawsuits,
media reports, books, and statements from prominent scientists
such as Cole.

The Globe reported a week ago that Eli Lilly and Co., the maker
of Prozac, was aware more than a decade ago that suicidal
thoughts occurred in as many as 1 percent of patients who were
given the drug in early trials. Furthermore, the patent for a new
form of Prozac, invented by physicians at McLean Hospital in
Belmont and scientists at Marlborough-based Sepracor Inc.,
specifically mentions suicide as a possible side effect of the
original Prozac. Lily has embraced the new Prozac and plans to
market it within two years.

”I have seen patients and reviewed cases where an SSRI
unmistakably precipitated a driven preoccupation with suicide,”
said Cole, 74.

Such responses are unusual, Cole said, but they should be
taken more seriously by manufacturers and federal regulators.
”It’s a relatively small problem, but it exists,” he said in an
interview.

The problem, critics say, is that infrequent adverse effects are
magnified when millions of people take a drug every day. ”I
sense the scientific community is beginning to understand they
made a mistake in concluding that they could rule out suicide as
an adverse effect” from SSRI drugs, said Thomas J. Moore, a
drug industry critic at George Washington University in
Washington, D.C.

Nobody knows how many suicides have occurred among the
millions of people who have taken SSRI antidepressants.
Richard Ewing, a lawyer in a firm representing the Miller family,
said the FDA had recorded about 2,000 suicides between 1988
and 1997 that may have been related to the drugs, but says the
agency acknowledges that this is a small fraction of the probable
cases.

Healy, the British researcher, has estimated that as many as
50,000 suicides worldwide may be related to the drugs’ use.

Cole cited two studies by Texas researchers in 1993 and 1995
suggesting that about 1 in 200 patients reported having new
suicidal thoughts while on Prozac, while none did while taking
an older non-SSRI drug.

This rate ”sounds about right to me,” Cole said. It’s ”rare enough
to make most physicians not notice the effect, but common
enough to cause serious adverse effects, such as death by
suicide, in a few patients,” he said.

But Cole said no one has done the large-scale studies
necessary to pin down the frequency of SSRI-related suicides.
Such studies are not easy to do, since suicides are uncommon
events even among clinically depressed people and
researchers must distinguish those related to the underlying
depression from those preceded by the extreme agitation, called
akathisia.

”Although the manufacturers of SSRI drugs could and should
have done these studies, to my knowledge no manufacturer of
an SSRI drug has ever done a study where the primary outcome
of interest was to measure … suicidality” that emerged during
treatment, Cole said in a document filed with the federal court
Friday.

Cole also said an FDA advisory panel convened in 1991 to
consider the alleged SSRI-suicide link ”never came to grips with
the reality or non-reality of the phenomenon.”

But other researchers defend drug manufacturers and federal
officials for the way they have responded to studies suggesting a
suicide link. These include Dr. Anthony J. Rothschild of the
University of Massachusetts Medical School, who coauthored a
1991 study that the SSRI critics cite as evidence of a suicide
problem.

Rothschild and his colleagues administered Prozac to three
patients who had attempted suicide and found they developed
severe agitation and suicidal thoughts once again. Those
symptoms subsided when Prozac was withdrawn or when the
drug was countered by one with calming effects, according to the
study.

But Rothschild said he thinks Eli Lilly and Co., Prozac’s
manufacturer, and the FDA ”adequately addressed” the
concerns.

”The thing that disturbs me” about current SSRI critics,
Rothschild said, ”is the tone that suggests there’s almost a
conspiracy to cover up information and not do the right studies.”

This story ran on page A01 of the Boston Globe on 5/15/2000.
© Copyright 2000 Globe Newspaper Company.

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