5/31/2000 – Is Academic Medicine for Sale? – New England Jour of Med

The New England Journal of Medicine
May 18, 2000 — Vol. 342, No. 20

Is Academic Medicine for Sale?

by Marcia Angell, M.D., editor,

In 1984 the Journal became the first of the major medical journals to
require authors of original research articles to disclose any financial ties
with companies that make products discussed in papers submitted to us. (1)
We were aware that such ties were becoming fairly common, and we thought it
reasonable to disclose them to readers.

Although we came to this issue early, no one could have foreseen at the time
just how ubiquitous and manifold such financial associations would become.
The article by Keller et al. (2) in this issue of the Journal provides a
striking example. The authors’ ties with companies that make antidepressant
drugs were so extensive that it would have used too much space to disclose
them fully in the Journal. We decided merely to summarize them and to
provide the details on our Web site.

Finding an editorialist to write about the article presented another
problem. Our conflict-of-interest policy for editorialists, established in
1990, (3) is stricter than that for authors of original research papers.
Since editorialists do not provide data, but instead selectively review the
literature and offer their judgments, we require that they have no important
financial ties to companies that make products related to the issues they
discuss. We do not believe disclosure is enough to deal with the problem of
possible bias. This policy is analogous to the requirement that judges recuse
themselves from hearing cases if they have financial ties to a litigant. Just
as a judge’s disclosure would not be sufficiently reassuring to the other
side in a court
case, so we believe that a policy of caveat emptor is not enough for readers
who depend on the opinion of editorialists.

But as we spoke with research psychiatrists about writing an editorial
on the treatment of depression, we found very few who did not have financial
ties to drug companies that make antidepressants. (Fortunately, Dr. Jan
Scott, who is eminently qualified to write the editorial, (4) met our
standards with respect to conflicts of interest.) The problem is by no means
unique to psychiatry. We routinely encounter similar difficulties in finding
editorialists in other specialties, particularly those that involve the
heavy use of expensive drugs and devices.

In this editorial, I wish to discuss the extent to which academic
medicine has become intertwined with the pharmaceutical and biotechnology
industries, and the benefits and risks of this state of affairs.
Bodenheimer, in his Health Policy Report elsewhere in this issue of the
Journal, (5) provides a detailed view of an overlapping issue — the
relations between clinical investigators and the pharmaceutical industry.

The ties between clinical researchers and industry include not only
grant support, but also a host of other financial arrangements.
Researchers serve as consultants to companies whose products they are
studying, join advisory boards and speakers’ bureaus, enter into patent and
royalty arrangements, agree to be the listed authors of articles
ghostwritten by interested companies, promote drugs and devices at
company-sponsored symposiums, and allow themselves to be plied with expensive
gifts and trips to luxurious settings. Many also have equity interest in the
companies.

Although most medical schools have guidelines to regulate financial
ties between their faculty members and industry, the rules are generally
quite relaxed and are likely to become even more so. For some years, Harvard
Medical School prided itself on having unusually strict guidelines. For
example, Harvard has prohibited researchers from having more than $20,000
worth of stock in companies whose products they are studying. (6) But now
the medical school is in the process of softening its guidelines. Those
reviewing the Harvard policy claim that the guidelines need to be modified
to prevent the loss of star faculty members to other schools. The executive
dean for academic programs was reported to say, “I’m not sure what will come
of the proposal. But the impetus is to make sure our faculty has reasonable
opportunities.” (7) Academic medical institutions are themselves growing
increasingly beholden to industry. How can they justify rigorous
conflict-of-interest policies for individual researchers when their own ties
are so extensive? Some academic institutions have entered into partnerships
with drug companies to set up research centers and teaching programs in which
students and faculty members essentially carry out industry research. Both
sides see great benefit in this arrangement. For financially struggling
medical centers, it means cash. For the companies that make the drugs and
devices, it means access to research talent, as well as affiliation with a
prestigious “brand.” The
time-honored custom of drug companies’ gaining entry into teaching hospitals
by bestowing small gifts on house officers has reached new levels of
munificence. Trainees now receive free meals and other substantial favors
from drug companies virtually daily, and they are often invited to opulent
dinners and other
quasi-social events to hear lectures on various medical topics. All of this
is done with the acquiescence of the teaching hospitals.

What is the justification for this large-scale breaching of the
boundaries between academic medicine and for-profit industry? Two reasons
are usually offered, one emphasized more than the other. The first is that
ties to industry are necessary to facilitate technology transfer — that is,
the movement of new drugs and devices from the laboratory to the
marketplace. The term “technology transfer” entered the lexicon in 1980,
with the passage of federal legislation, called the Bayh-Dole Act, (8) that
encouraged academic institutions supported by federal grants to patent and
license new products developed by their faculty members and to share
royalties with the researchers. The Bayh-Dole Act is now frequently invoked
to justify the ubiquitous ties between academia and industry. It is argued
that the more contacts there are between academia and industry, the better it
is for clinical medicine; the fact that money changes hands is considered
merely the way of the world.

A second rationale, less often invoked explicitly, is simply that
academic medical centers need the money. Many of the most prestigious
institutions in the country are bleeding red ink as a result of the
reductions in Medicare reimbursements contained in the 1997 Balanced Budget
Act and the hard bargaining of other third-party payers to
keep hospital costs down. Deals with drug companies can help make up for the
shortfall, so that academic medical centers can continue to carry out their
crucial missions of education, research, and the provision of clinical care
for the sickest and neediest. Under the circumstances, it is not surprising
that institutions feel justified in accepting help from any source.

I believe the claim that extensive ties between academic researchers and
industry are necessary for technology transfer is greatly exaggerated,
particularly with regard to clinical research. There may be some merit to
the claim for basic research, but in most clinical research, including
clinical trials, the “technology” is essentially already developed.
Researchers are simply testing it. Furthermore, whether financial
arrangements facilitate technology transfer depends crucially on what those
arrangements are. Certainly grant support is constructive, if administered
properly. But it is highly doubtful whether many of the other financial
arrangements facilitate technology transfer or confer any other social
benefit. For example, there is no conceivable social benefit in researchers’
having equity interest in companies whose products they are studying.
Traveling around the world to appear at industry-sponsored symposiums has
much more to do with
marketing than with technology transfer. Consulting arrangements may be more
likely to further the development of useful products, but even this is
arguable. Industry may ask clinical researchers to become consultants more
to obtain their goodwill than to benefit from their expertise. The goodwill
of academic researchers is a very valuable commodity for drug and device
manufacturers. Finally, it is by no means necessary for technology transfer
that researchers be personally rewarded. One could imagine a different
system for accomplishing the same purpose. For example, income from
consulting might go to a pool earmarked to support research or any other
mission of the medical center.

What is wrong with the current situation? Why shouldn’t clinical researchers
have close ties to industry? One obvious concern is that these ties will
bias research, both the kind of work that is done and the way it is reported.
Researchers might undertake studies on the basis of whether they
can get industry funding, not whether the studies are scientifically
important. That would mean more research on drugs and devices and less
designed to gain insights into the causes and mechanisms of disease. It
would also skew research toward finding trivial differences between drugs,
because those differences can be exploited for marketing. Of even greater
concern is the possibility that financial ties may influence the outcome of
research studies.

As summarized by Bodenheimer, (5) there is now considerable evidence
that researchers with ties to drug companies are indeed more likely to
report results that are favorable to the products of those companies than
researchers without such ties. That does not conclusively prove that
researchers are influenced by their financial ties to industry. Conceivably,
drug companies seek out researchers who happen to be getting positive
results. But I believe bias is the most likely explanation, and in either
case, it is clear that the more enthusiastic researchers are, the more
assured they can be of industry funding.

Many researchers profess that they are outraged by the very notion that
their financial ties to industry could affect their work. They insist that,
as scientists, they can remain objective, no matter what the blandishments.
In short, they cannot be bought. What is at issue is not whether researchers
can be “bought,” in the sense of a quid pro quo. It is that close and
remunerative collaboration with a company naturally creates goodwill on the
part of researchers and the hope that the largesse will continue. This
attitude can subtly influence scientific judgment in ways that may be
difficult to discern. Can we really believe that clinical researchers are
more immune to self-interest than
other people?

When the boundaries between industry and academic medicine become as
blurred as they now are, the business goals of industry influence the
mission of the medical schools in multiple ways. In terms of education,
medical students and house officers, under the constant tutelage of industry
representatives, learn to rely on drugs and devices more than they probably
should. As the critics of medicine so often charge, young physicians learn
that for every problem, there is a pill (and a drug company representative to
explain it). They also become accustomed to receiving gifts and favors from
an industry that uses these courtesies to influence their continuing
education. The
academic medical centers, in allowing themselves to become research outposts
for industry, contribute to the overemphasis on drugs and devices. Finally,
there is the issue of conflicts of commitment. Faculty members who do
extensive work for industry may be distracted from their commitment to the
school’s educational mission.

All of this is not to gainsay the importance of the spectacular
advances in therapy and diagnosis made possible by new drugs and devices.
Nor is it to deny the value of cooperation between academia and industry.
But that cooperation should be at arm’s length, with both sides maintaining
their own standards and ethical norms. The incentives of the marketplace
should not become woven into the fabric of academic medicine. We need to
remember that for-profit businesses are pledged to increase the value of
their investors’ stock. That is a very different goal from the mission of
medical schools.

What needs to be done — or undone? Softening its conflict-of-interest
guidelines is exactly the wrong thing for Harvard Medical School to do.
Instead, it should seek to encourage other institutions to adopt stronger
ones. If there were general agreement among the major medical schools on
uniform and rigorous rules, the concern about losing faculty to more lax
schools — and the consequent race to the bottom — would end. Certain
financial ties should be prohibited altogether, including equity interest and
many of the writing and speaking arrangements.Rules regarding conflicts of
commitment should also be enforced. It is difficult to believe that full-time
faculty members can generate outside
income greater than their salaries without shortchanging their institutions
and students.

As Rothman urges, teaching hospitals should forbid drug-company
representatives from coming into the hospital to promote their wares and
offer gifts to students and house officers. (9) House officers should buy
their own pizza, and hospitals should pay them enough to do so. To the
argument that these gifts are too inconsequential to constitute bribes, the
answer is that the drug companies are not engaging in charity. These gifts
are intended to buy the goodwill of young physicians with long prescribing
lives ahead of them. Similarly, academic medical centers should be wary of
partnerships in which they make available their precious resources of talent
and prestige to carry out research that serves primarily the interests of
the companies. That is ultimately a Faustian bargain.

It is well to remember that the costs of the industry-sponsored trips,
meals, gifts, conferences, and symposiums and the honorariums, consulting
fees, and research grants are simply added to the prices of drugs and
devices. The Clinton administration and Congress are now grappling with the
serious problem of escalating drug prices in this country. In these difficult
times, academic medicine depends more than ever on the public’s trust and
goodwill. If the public begins to perceive academic medical institutions and
clinical researchers as gaining inappropriately from cozy relations with
industry — relations that create conflicts of interest and contribute to
rising drug prices — there will be little sympathy for their difficulties.
Academic institutions and their
clinical faculty members must take care not to be open to the charge that
they are for sale.

Marcia Angell, M.D.

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5/17/2000 – Vickery goes after Pfizer and its antidepressant Zoloft

Another article from the Indianapolis Star on yet another case filed against
Zoloft.

Vickery goes after Pfizer and its antidepressant Zoloft

Staff Report

The Indianapolis Star

Last updated 11:01 PM, EST, Sunday, April 23, 2000

Andy Vickery aims to go beyond Prozac.

He’s sighted a new target: Pfizer Inc. and its Prozac-like antidepressant,
Zoloft.

Vickery has three lawsuits pending against Pfizer. Last year, he settled
another: a high-profile case involving Hollywood comedian-actor Phil Hartman.
Hartman was shot to death in 1998 by his wife, Brynn, who then killed
herself. Vickery’s lawsuit alleges she had taken Zoloft and it turned her
violent.

Vickery, who represented the couple’s children, said he settled the case out
of court with Pfizer for $100,000, waiving his legal fee.

The settlement, he said, “was making a statement for them (the children), for
their benefit in the future . . . to know there’s another side to the story
(of their parents’ deaths).”

Vickery recently deposed Pfizer’s scientific experts for a case in federal
court in Kansas City, where he sued last year on behalf of the parents of a
13-year-old boy, Matthew Miller, who hanged himself at home in 1997 after
taking Zoloft for a week.

The trial is set for July 18 in what’s shaping up as a pitched legal battle.

Last year, Pfizer lawyers asked the court to strike Vickery’s entire
complaint in the Miller case, calling it “impertinent” and “scandalous.”

The judge rejected the motion, though Vickery agreed to delete sections.

The clash has Vickery hankering to prod the New York drugmaker again.

“Wait until you see my next pleading on Pfizer. The next one’s going to hit
’em like a turd in a punchbowl,” he said.

“However much they didn’t like the complaint we did in the Miller case, they
will like the next one much much less.”

A Pfizer spokeswoman declined to talk about Vickery, saying, “We don’t
comment on lawsuits.”

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5/16/2000 – RITALIN CLASS ACTION SUIT FILED

Drug giant to face lawsuit over Ritalin

The Express, May 16, 2000

FROM GRAEME BEATON IN WASHINGTON

The first of what could become a barrage of lawsuits over Ritalin, the
controversial medicine prescribed for hyper-active children, has been
launched by American lawyers.

The action seeks unspecified damages against Novartis, the £30billion
Swiss pharmaceutical giant which makes the drug.

Lawyers allege that Novartis failed to adequately warn of Ritalin’s
impact on children’s cardio-vascular and nervous systems.

They have applied for the lawsuit, filed in Texas, to represent
potentially thousands of families who bought the drug.

Novartis said the action was “without merit” and it would fight it
“vigorously.”

The case could spark similar litigation in the UK, where Ritalin
prescriptions for schoolchildren have leapt from 16,000 a year to about
140,000 in the last five years.Ritalin comes with warnings of potential
side-effects, including anxiety and agitation.

© Express Newspapers, 2000
_________________________

RITALIN CLASS ACTION SUIT FILED

May 1, 2000

http://www.breggin.com/classaction.html

A class action suit for “fraud” and “conspiracy” in over-promoting the
stimulant medication Ritalin (methylphenidate) was filed today in a
Texas court. The suit was brought by the Dallas law firm, Waters and
Kraus, and will be nationwide in scope. Peter R. Breggin, M.D., is the
medical consultant.

Three national organizations are named as defendants: (1) Novartis
(formerly Ciba Geigy), the manufacturer of Ritalin, (2) CHADD (Children
and Adults with Attention Deficit/Hyperactivity Disorder), a parents’
organization that is partially funded by drug companies, and (3) the
American Psychiatric Association.

The suit charges that Novartis, CHADD, and the American Psychiatric
Association committed fraud in conspiring to over-promote the diagnosis
Attention Deficit Hyperactivity Disorder (ADHD) and its treatment with
the stimulant drug, Ritalin.

The allegations state that the drug company “deliberately, intentionally,
and negligently promoted the diagnosis of ADD/ADHD and sales of Ritalin
through its promotional literature and through its training of sales
representatives. In so doing, despite knowledge of such problems and/or
adverse reactions,

Defendants willfully failed to address or provide adequate information to
consumers, doctors, and/or schools concerning many significant hazards
of methylphenidate…” The suit also charges the drug company with
“Actively supporting groups such as Defendant CHADD, both financially and with
other means, so that such organizations would promote and support (as a
supposed neutral party) the ever-increasing implementation of the ADD/ADHD
diagnosis as well as directly increasing Ritalin sales.” It further claims
that “Defendant American Psychiatric Association (APA) conspired, colluded and
cooperated with the other Defendants” while taking “financial contributions
from
Ciba as well as other members of the pharmaceutical industry.”

Although the suit was motivated by concern about the over-medicating of
America’s children, the class action is not restricted to children.
Adults who have purchased Ritalin for children or for themselves in the last
four
years are potentially eligible to participate in the suit. The suit seeks
compensation for those who paid for Ritalin, regardless of whether or not the
medication caused any harm or damage.

Anyone interested in joining the class action suit, or in obtaining more
information about its legal basis, should contact the attorneys, C.
Andrew Waters and Peter Kraus (phone: 214 357 6244).

Peter R. Breggin, M.D. (phone 301 652 5580), medical consultant to the
suit, may be contacted about background issues concerning Ritalin, ADHD,
Novartis, CHADD and the American Psychiatric Association. Dr. Breggin
is the director of the International Center for the Study of Psychiatry
and Psychology (ICSPP). However, ICSPP has no role in, and is not a party
to, the class action suit.

Attorneys Waters and Kraus, and Dr. Breggin, are planning a press
conference for late in May after the charges have been reviewed by the
defendants.

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4/16/2000 – More from Boston Globe on Drug Safety Issues

This story ran on page A10 of the Boston Globe on 5/15/2000.
© Copyright 2000 Globe Newspaper Company.

A BOSTON GLOBE EDITORIAL

Better drug reporting deal with a wide range of conditions, from depression
to osteoporosis, doctors are reaching increasingly for their prescription
pads. Patients who consume these drugs have faith that any side effects other
patients have had are carefully reported by physicians and monitored by
officials so that, if need be, warnings can be issued.

That faith is misplaced.

While the drug companies and the US Food and Drug Administration have a
system for maintaining an adverse-event database, doctors are not required to
report the serious problems patients have with a drug. As a result, there are
distinct limitations in the system to track bad reactions and then add new
warnings on the drug’s label or withdraw it altogether. Public Citizen, a
watchdog group in Washington, D.C., reports that actual surveys of medical
records turn up 10 times as many drug reactions as are reported voluntarily
by doctors.

Under current practices, drug companies are required to alert the FDA within
15 days of any severe reactions to drugs and within a year of less serious
reactions, but without more mandatory reporting by practitioners (hospitals
and nursing homes are required to make such reports), companies’ own
awareness of problems will be stalled.

If reporting by doctors of bad reactions were mandatory, both the FDA and Eli
Lilly and Co. would know more than they do about some of the problems
connected with Lilly’s popular antidepressant, Prozac. While Prozac and
similarly acting drugs have been hailed by both doctors and patients for
relieving symptoms that can often presage suicide, there have long been
reports of extreme agitation and anxiety among a small percentage of users.

One argument against mandated reporting of adverse reactions from doctors is
the extra paperwork this would entail. But, for the past several years, the
FDA has maintained a Web site that permits doctors – and patients – to make
online reports with little fuss. Closer monitoring could give both health
professionals and the public a greater awareness of what to be alert for as
they make use of the drugs that are changing American medicine.

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5/16/2000 – Long-Term Side Effects Surface With SSRIs

The following are excerpts from Clinical Psychiatry News about long-term
adverse effects of SSRIs. They could have learned this YEARS earlier by
reading my book, Prozac: Panacea or Pandora? but at least they are FINALLY
talking about it and as many of you have asked, I thought you would want this
reference.

Ann Blake-Tracy, Executive Director,
International Coalition For Drug Awareness

From Clinical Psychiatry News

Long-Term Side Effects Surface With SSRIs

Author: Carl Sherman, Contributing Writer
[Clinical Psychiatry News 26(5):1, 1998. © 1998 International Medical News
Group.]

——————————————————————————

Insomnia, weight gain, sexual dysfunction emerge as problems affecting
compliance.

NEW YORK — Physicians are seeing long-term side effects with selective
serotonin reuptake inhibitors far in excess of what was expected from
clinical trial data, Dr. Norman Sussman said at a psychopharmacology update
sponsored by New York University.

If these particular side effects — sleep disturbances, sexual dysfunction,
and weight gain — are problematic for patients, one of the newer non-SSRI
antidepressants may be a better choice, he said. Of course, these drugs have
their own particular side effect profiles.

When SSRIs first appeared a decade ago, their favorable side effect profile
was a key selling point. They were clearly safer and easier to use than
tricyclics and monoamine oxidase inhibitors and, above all, better tolerated
by patients.

But experience has shown that some side effects are more common and
problematic than initially expected, said Dr. Sussman, director of the
psychopharmacology research and consultation service at Bellevue Hospital
Center in New York. . . . adverse effects that persist as long as the patient
takes the medication, such as sexual dysfunction and sleep disturbances. Also
particularly troubling are those, like weight gain, that don’t even develop
until late in treatment. “These are the ones that are not in the insert,
which is based on short-term studies,” Dr. Sussman said.

Significant insomnia affects 15%-20% of patients taking SSRIs, twice the rate
with placebo. Polysomnography has consistently found that these drugs cause
activation during the night: In addition to insomnia, bruxism, sweating, and
periodic limb movement are common. Vivid dreams and nightmares also occur.
With ongoing treatment, increasing numbers of patients report lethargy and
fatigue, he said.

“There are a lot of data showing that people who sleep poorly are more likely
to relapse and that suicide risk is higher,” he said. . . .

Sexual dysfunctions are among the most distressing SSRI side effects.
Decreased libido and delayed or absent orgasm are the best known, but there
are others, such as the “yawning-excitement syndrome.” Patients experience
sexual arousal when they yawn, often progressing to orgasm. “This is probably
underreported. Patients often say, ‘If you hadn’t asked me, I wouldn’t have
mentioned it,'” he said.

Perhaps the most unexpected SSRI-related problem to emerge has been weight
gain, which often begins only after several months of therapy. This side
effect has not been shown to be frequent or severe in controlled studies but
has been reported to occur in 18%-50% of patients in some open-label studies.

Because this runs counter to the image of the drug, many physicians and
patients are unprepared to deal with it. “Some physicians tell patients, ‘I
can’t understand why you’re gaining weight — you’re on an SSRI,'” Dr.
Sussman said.

Greg Keuterman, a spokesman for Eli Lilly & Co., manufacturer of Prozac
(fluoxetine), declined to comment except to point out that “this is anecdotal
evidence.”

“We’re approved by the FDA for long-term treatment of depression,” he added.

Pfizer Inc., the maker of Zoloft (sertraline), and SmithKline Beecham
Pharmaceuticals, the maker of Paxil (paroxetine), did not respond to requests
for comment.

These observations do contrast with what the clinical trials submitted to the
Food and Drug Administration by pharmaceutical companies show, Dr. Sussman
said. It would be nice if these long-term side effects were studied in
clinical trials comparing different antidepressants. . . .

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5/16/2000 In Houston lawyer, Lilly has a colorful foe

Sorry, we should have gotten this to you sooner. There is too much happening
to keep up with it all! This is an article from the paper in the home of Eli
Lilly, the Indianapolis Star. They did a good job on this article about Andy
Vickery and his firm. The firm has been an answer to prayer for many families
who could not find an attorney with the courage to take on these companies
who manufacture SSRI antidepressants.

Ann Blake-Tracy

In Houston lawyer, Lilly has a colorful foe

Passionate adversary and able phrase-maker has engaged in 14 suits against
the company.

By Jeff Swiatek

The Indianapolis Star

Last updated 12:49 AM, EST, Monday, April 24, 2000

HOUSTON — He’s Eli Lilly and Co.’s legal nightmare: an outspoken,
Yale-educated Texas trial lawyer who loves suing big corporations and has his
sights set on one in Indianapolis.

“The dark side,” Andy Vickery calls his corporate targets, drawing out the
words for effect.

He’s indulged himself in 14 lawsuits against Lilly. The charge: that Lilly’s
best-selling antidepressant, Prozac, made some users “go bonkers,” as Vickery
puts it.

Prozac lawsuits are old hat for Lilly. Fewer than 10 of the nearly 300 Prozac
lawsuits Lilly has faced over the years remain on the dockets. And the
consensus among most trial lawyers is that new Prozac lawsuits aren’t
winnable.

“It’s not an easy litigation. I gave it up,” said Indianapolis lawyer Vernon
J. Petri, who handled numerous Prozac cases in the early 1990s.

But in Vickery, Lilly faces a wise-cracking nemesis-at-law who has brought
new focus and heightened publicity to Prozac litigation. He’s done it despite
the limited legal muscle of his small, three-lawyer firm.

At age 52, with more than 50 trials under his belt, Vickery sees himself as
an advocate for victims of Prozac and similar antidepressants.

“A public health catastrophe,” he calls the alleged tendency of Prozac and
related antidepressants to cause some users to turn violent or suicidal.

Vickery, who says he’s never used Prozac himself, is outspoken, dogged and
prone to outlandish legal tactics.

In one case, he managed to question his rival, Lilly’s chief lawyer for
Prozac litigation, James T. Burns, on the witness stand — a scenario another
Lilly lawyer termed “very unusual.” In another, he sued lawyer Paul Smith of
Dallas, who in 1994 tried the first Prozac case against Lilly.

Such tactics have gotten Vickery called “irresponsible” by a Lilly attorney
and “a vulture” by Smith’s former co-counsel, Chicago attorney Nancy Zettler.

“He belongs to a species that I think represents generally a problem to
American society,” says Mitchell E. Daniels Jr., Lilly’s senior vice
president of corporate strategy and policy.

Vickery shrugs off the criticisms, saying, “I am not going to shy away from
saying what needs to be said.”

Shy is one thing he’s not.

Happy to talk to a reporter from Lilly’s hometown, he shows up for a noon
lunch appointment at his high-rise office near Houston’s downtown, tieless
and complaining of muscle aches from a recent match of handball.

Lunch, it turns out, will be the daily buffet served up in a wooden-beamed
meeting hall of Christ Church Cathedral, a massive stone structure among
downtown’s glass-and-steel skyscrapers.

Vickery heads there in the leather-upholstered Jaguar he bought his wife for
her 40th birthday.

Vickery picked the Episcopal church’s buffet to send a message about himself
back to Indianapolis, a message he makes sure is understood after he polishes
off his plate of Tex-Mex food and strolls outside on smooth stone floors.

“This is my church,” he says, pointing out a niche in a stone wall where he
plans for his ashes to one day be interred. “I get so tired of Eli Lilly
saying it’s only Scientologists that oppose them.”

Passionate adversary

The Prozac basher who wants Lilly to know he doesn’t spend nights reading
science fiction novels by Scientology founder L. Ron Hubbard is a
speed-reading, gadget-obsessed, Georgia native who’s on his second marriage
but still reveling in his first love of trial law.

“He is without question the most passionate person I have ever known,” says
his law partner, Paul Waldner. “I’ve snow-skied with Andy and seen him go
downhill faster than teen-agers ever would, yodeling the whole time.”

A fan of anything high-tech, Vickery embraced computers early for his legal
work and employs the latest software to track the complex litigation he
handles. “He wouldn’t go to the bathroom without his laptop,” Waldner says.

Vickery met his wife, Carol, nine years ago. The divorcees got married two
years later.

At their home in an upscale area of Houston, she says, life with Vickery is
“like summer camp.” Her husband enjoys spending time with her two children,
tending a rose garden, barbecuing for friends and going sea-kayaking at their
Gulf Coast beach house, she says.

So it’s no surprise that, when Vickery’s enthusiasms carry over into the
stuffy profession of law, he sometimes skirts the line of what’s expected.

“He crowds it, he’s right up on it,” says Waldner, a past president of
Houston Trial Lawyers Association, who remembers Vickery beginning one legal
document by quoting lyrics to a B.B. King song.

Settled 11 cases

Because only two Prozac civil lawsuits have ever come to trial, Prozac
litigation is an informational black hole where cases tend to be quietly
resolved out of court and only Lilly knows the details.

Even so, it’s clear that Vickery has fared well in this high-stakes game of
suing over one of the world’s most well-known drugs.

“I have never dropped or dismissed a case,” he boasts.

In the past two years, 11 Prozac suits that Vickery filed or joined as
counsel have been settled out of court, he says. Terms remain confidential,
but presumably include cash payments by Lilly in exchange for clients
dropping all charges.

Last year, in a Hawaii courtroom, Vickery tried only the second Prozac case
to come before a jury. He represented the children of Hawaii retiree William
Forsyth Sr. who, 11 days after going on Prozac to treat panic attacks,
stabbed his wife, June, to death and impaled himself.

The jury voted 11-0 to absolve Lilly of blame. The verdict “ripped my heart
out,” says Vickery, who calls the decision a low point in his career.

Undeterred, Vickery has appealed that decision, continues to pursue two other
Prozac cases, and hints at filing more, possibly in Indianapolis.

Vickery won’t discuss fees from the confidential Prozac settlements, trying
to suggest they leave something to be desired.

“I’m not counting on Eli Lilly for my retirement, I can tell you that,” he
says.

Vickery admits to feeling Quixote-like as he duels Lilly’s lawyers over its
No. 1 drug.

“It takes a kind of idiot to do it,” he says. “You are fighting one of the
richest pharmaceutical companies in the world over the thing most dear to
them.”

Prozac is firm’s focus

Vickery has waged his fight over Lilly’s dearest drug from the 29th floor of
an office high-rise just west of Houston’s downtown.

The heart of Vickery & Waldner is an oversized storage closet dubbed “the
Prozac room.” It overflows with boxes, files and tapes from Prozac
litigation. Newspaper clippings and snapshots of plaintiffs cover part of one
wall.

Lately, Vickery & Waldner has expanded its focus to sue other antidepressant
makers, including Pfizer over its popular drug Zoloft.

Vickery & Waldner drums up business, in part, by soliciting on its Internet
Web site, www.justiceseekers.com.

The site contains a Prozac room of the virtual sort, packed with screenfuls
of documents and articles about the drug. The firm also handles medical
malpractice cases and has represented hemophiliacs who received AIDS
virus-tainted blood.

Vickery took on his first Prozac case at the request of Richard W. Ewing, a
long-time friend who’s the third lawyer at the firm.

Ewing in 1991 sued on behalf of the family of Texas rancher Bernie A.
Winkler, who shot himself in his driveway after taking Prozac for six weeks.
Later, Ewing turned the case over to Vickery, who found Prozac litigation
much to his liking.

He’s spent much of the past four years filling the Prozac Room with
subpoenaed documents.

Vickery & Waldner plans to leave its crowded rented quarters and build its
own office building in a residential area of the city.

For now, Vickery taunts the “dark side” from a worn wooden desk looking out
floor-to-ceiling windows to a grand view of the Houston skyline.

More than 20 photos, most of family, are hung and propped about. On his
computer screen floats a screen-saver of actress Michelle Pfeiffer in a red
dress. Opposite sits an ornate Bible opened to a highlighted verse from
Isaiah with the admonishment “Learn to do well, seek judgment, relieve the
oppressed.”

“To keep my focus,” Vickery says, of the Bible.

The focus of Vickery’s Prozac suits is another book: the Physicians’ Desk
Reference. U.S. doctors rely on the 3,000-plus-page volume to inform them of
a drug’s side effects.

Lilly’s refusal to expressly list violent behavior, including suicide, as a
possible side effect of Prozac, forms the basis of Vickery’s lawsuits. Lilly
contends putting such a dire warning on Prozac’s package label is unwarranted.

“Any label change (about suicide and violence) for Prozac was never on the
table, never negotiable from our standpoint,” says Lilly’s Daniels.

Vickery hauls the weighty red book from a shelf and opens to Prozac and its
long list of side effects.

“They warn about rashes, by god, but nothing about suicide,” he says. “To
satisfy me, and that sounds very egocentric, all Lilly would have to do is
put in a bold-faced, boxed warning. This isn’t lawyer nitpickery. This is
very important how it appears and where.”

Gift of gab

Vickery grew up in middle-class, Southern Baptist family in Atlanta, the
middle son of a homemaker mother and a father who ran an insurance agency.
His father told him at age 11 that the boy’s gift of gab marked him for
lawyering.

Gifted with academic smarts as well, Vickery graduated high school as class
valedictorian and became the first Ivy Leaguer in his family. He enrolled at
Yale University as an American studies major, going on to earn a law degree
at the University of Georgia School of Law.

To pay for Yale, Vickery had enrolled in ROTC. He fulfilled his military
obligation as an Army attorney, serving in one of the Army’s most notorious
cases: the trials of Lt. William Calley Jr. and others who took part in the
massacre of Vietnamese civilians at My Lai.

As a young lawyer, Vickery also clerked for U.S. Appeals Court Judge John R.
Brown in Houston, a man known for his colorfully argued opinions.

It was Brown who impressed on Vickery the value of the trenchantly put phrase.

“The judge told me, ‘An idea poorly expressed dies aborning,”‘ Vickery says,
displaying a book of quotations given him by the man he calls “my judge.”

Vickery has taken the advice to heart. In his latest lawsuit, filed in Hawaii
in January by the parents of teen-ager Hugh Blowers, who hanged himself at
home after taking Prozac, Vickery opined that the boy’s life “was sacrificed
on the altar of Lilly’s profits.”

His legal writing, complete with exclamation marks and sarcastic footnotes,
once provoked U.S. District Court Judge S. Hugh Dillin to call a Vickery
Prozac brief “inflammatory” and “scurrilous.”

The brief in question came in a Vickery lawsuit that was the last of 75
federal Prozac cases consolidated in Dillin’s court in Indianapolis. In
March, the judge remanded the case back to Texas courts.

Those on the receiving end of a Vickery legal blast may cringe on hearing he
has no plans to rein in his colorful self-expression.

He does admit, though, that there’s a limit to the time he’ll invest dueling
Lilly and other antidepressant makers in court.

“They whip my a– three times and I’m outa there. I just can’t take any more
than that,” he says, swiveling in his office seat.

But until Vickery’s third lost verdict, Lilly will remain in his sights, he
vows. “They know damn well I’m not going to quit.”

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5/15/2000 – PROZAC, ZOLOFT, MAYHEM & SUICIDE

The revelations contained in this press release from Vickery and
Waldner are remarkable. It is being sent to major news media
today, Monday, May 15th. Mark
===============================

FOR IMMEDIATE RELEASE:
PROZAC, ZOLOFT, MAYHEM & SUICIDE
Teicher & Cole – Together Again and Still Sounding the Alarm

The February 1990 article by Harvard psychiatrists Martin
Teicher and Jonathan Cole (along with their colleague nurse
Carol Glod) brought the issue of Prozac/SSRI induced suicidality
to the public consciousness. The article spawned immediate
regulatory interest and a whirlwind of publicity in the popular
media.

Primed by company spin doctors, Lilly top scientist Leigh
Thompson blamed the publicity on the Scientologists and the
suicides on the underlying disease of depression. It was a
good public relations tactic, and it has been an effective
products liability stratagem for over a decade.

However, after ten years more experience, on May 7, 2000, in a
rare interview with the Boston Globe, Dr. Teicher said that he
stood by his work, and that the ability of Prozac to induce suicide
in a minority of patients “is a real phenomenon.” Meanwhile, on
April 28, 2000, Dr. Cole, who has been described by Pfizer
experts as a “pioneer” in the field of psychopharmacology,
signed a sworn declaration in a federal wrongful death case
concerning the tragic suicide of a 13 year old boy, only seven
days after he began taking Zoloft promotional samples. Dr. Cole
wrote:

In 1990 I co-authored an article with my colleague Martin Teicher
. . . Our purpose in writing this article was to alert the
profession
to an alarming, probable drug side effect which we had
observed. . . . The SSRI drugs, as a class, clearly have the
potential to cause, and in reasonable medical probability or
certainty do cause, akathisia in some patients. . . . they may also
cause emotional blunting or disregulation. Either of these
conditions could, and probably do, trigger or contribute to violent
or suicidal behavior. . . .

A side effect that occurs in a relatively small percentage of
patients, such as the treatment emergent suicidality which Dr.
Teicher, Nurse Glod and I reported on in 1990, is not likely to be
detectable in a standard RCT [clinical trial] or measured by a
relative risk calculation. That does not mean, however, that the
side effect is not real, not dangerous, and not caused by the
drug.

Although the drug companies continue to deny the existence of
this phenomenon in public and in court, in a 1986 report to the
FDA, Pfizer quietly admitted that “drug-induced activation is a
plausible explanation for the emergence of suicidal behavior in
our patient #4 . . .”, an 8 year old boy who mutilated his feet with
a
razor blade and tried to strangle himself with a necktie. And
Lilly? Well, it paid $90 million for a patent, the ostensible
usefulness of which is that it reduces a few really troublesome
side effects of the original Prozac: “nervousness, anxiety,
insomnia, inner restlessness (akathisia), suicidal thoughts, self
mutilation [and] manic behavior” .

A peer-reviewed journal article this month recounts the
experiences of two healthy, non-depressed volunteers who
became actively suicidal within two weeks of taking Zoloft.
Harvard psychiatrist Joe Glenmullen’s powerfully endorsed but
provocative book, PROZAC BACKLASH, continues to receive
wide public interest and to engender industry obloquy. And the
FDA? Hopefully, they are working right now on a proper warning
for Prozac II, and the entire class of SSRI drugs.

Vickery & Waldner May 11, 2000
www.justiceseekers.com Houston, Texas

——–
ENDNOTES

Teicher, Glod, Cole, Emergence of intense suicidal
preoccupation during fluoxetine treatment. Am.J.Psychiatry
1990: 147: 207-210.
——
Dr. Thompson’s coaching came via a memo dated April 15,
1991 from the now current executive VP of Lilly, Mitch Daniels. It
was introduced into evidence as Px 123 in the case of Forsyth v.
Eli Lilly. Lilly’s hardball litigation tactics through the years
are
well covered in the Lilly’s legal tactics disarmed legions of
Prozac lawyers article by Indianapolis reporter Jeff Swiatek,
available online at the paper’s website, www.starnews.com. and
ours, www.justiceseekers.com.
——–
Leah Garnett, Prozac revisited: As drug gets remade, concerns
about suicide surface, available online at the paper’s website,
www.boston.com and ours, www.justiceseekers.com.
——–
“Q. Is Dr. [Jonathan] Cole a man of considerable stature and
reputation in the field of neuropsychopharmacology in this
country?

A. He’s one of the pioneers of the field.”

March 29, 2000 deposition of retained Pfizer expert
witness,pre-eminent suicidologist and psychopharmacologist, J.
John Mann, M.D. in case of Miller v. Pfizer, No. 99-2326 KHV
(United States District Court, Kansas). Another Pfizer expert, Dr.
Daniel Casey, not coincidentally the chairman of the 1991 FDA
advisory committee that considered this issue, agreed with Dr.
Mann’s description of Dr. Cole’s professional standing.
——-
The term “RCT” refers to randomized, clinical trial. The industry,
which has never conducted such a study to test the hypothesis
that SSRI drugs induce suicidality, nevertheless argues in Court
that only such tests are truly “scientific.” All other opinions, no
matter who renders them or what they base them upon, are
merely “junk”. The Declaration is being filed in federal court in
Kansas City in the case of Miller v. Pfizer, docket number
99-2326 KHV. The case is set for trial before Judge Kathryn
Vratil and jury on July 18, 2000. A copy of Dr. Cole’s
Declaration
is posted on our website, www.justiceseekers.com. Matt Miller’s
story, “He Never Said Goodbye” is available at
www.drugawareness.org and on our site,
www.justiceseekers.com.
——-
Report, Suicide-Related Behavior in Children and Adolescents
in the Sertraline OCD Clinical Development Program, Pfizer, Inc.
(May 23, 1996), Pfizer Exhibit #40 in Miller v. Pfizer pretrial
motions. It based its determination of causality on the clinical
judgment of its own investigator and its scientists’ review of
published “anecdotal case reports” in a 1991 article.
——–
U.S. Patent 5,708,035
——–
Healy, Emergence of antidepressant induced suicidality, Primary
Care Psychiatry 2000, Vol.6 No. 1.

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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
——————

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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5/9/2000 – Prozac Revisited

http://www.boston.com/dailyglobe2/128/nation/Prozac_revisited+
.shtml

Prozac revisited
As drug gets remade, concerns about suicides surface

By Leah R. Garnett, Globe Staff, 5/7/2000

Just as the 14-year patent on Prozac is about to expire and the
drug’s maker, Eli Lilly and Co., is preparing to launch a new
version, a body of evidence has come to light revealing the
antidepressant’s dark side.

The company’s internal documents, some dating to the
mid-1980s, as well as government applications and patents,
indicate that the pharmaceutical giant has known for years that
its best-selling drug could cause suicidal reactions in a small
but significant number of patients. The reports could become
critical as Lilly seeks government approval for its new Prozac.

Among the findings:

– Internal documents show that in 1990, Lilly scientists were
pressured by corporate executives to alter records on physician
experiences with Prozac, changing mentions of suicide attempt
to “overdose” and suicidal thoughts to “depression.”

– Three years before Prozac received approval by the US Food
and Drug Administration in late 1987, the German BGA, that
country’s FDA equivalent, had such serious reservations about
Prozac’s safety that it refused to approve the antidepressant
based on Lilly’s studies showing that previously nonsuicidal
patients who took the drug had a fivefold higher rate of suicides
and suicide attempts than those on older antidepressants, and
a threefold higher rate than those taking placebos.

– Lilly’s own figures, in reports made available to the Globe,
indicate that 1 in 100 previously nonsuicidal patients who took
the drug in early clinical trials developed a severe form of anxiety
and agitation called akathisia, causing them to attempt or
commit suicide during the studies.

– Though Lilly has steadfastly defended the drug’s safety and
downplayed studies linking Prozac to suicide, the patent for the
new Prozac, R-fluoxetine, expected to be marketed by Lilly
beginning in 2002, notes that the new version will not produce
several existing side effects including “akathisia, suicidal
thoughts, and self-mutilation,” which the patent calls “one of its
more significant side effects.”

– A McLean Hospital researcher and associate professor at
Harvard Medical School, Dr. Martin Teicher, whose early 1990s
studies linked Prozac to akathisia and suicide, is a co-inventor of
the new Prozac, which Lilly plans to market, along with Timothy J.
Barberich, the CEO of Sepracor Inc., a Marlborough drug
company, and James W. Young.

– A just-published book, “Prozac Backlash,” by a Cambridge
psychiatrist, Dr. Joseph Glenmullen, has drawn Lilly’s ire for
discussing Prozac’s link to suicide, tics, withdrawal symptoms,
and other side effects of Prozac and similar antidepressants.

Lilly officials continue to defend the drug’s effectiveness, saying
its track record is borne out by the fact it is still the most widely
prescribed drug of its kind. In a written statement, Jeff Newton, a
Lilly spokesman, said: “There is no credible evidence that
establishes a causal link between Prozac and violent or suicidal
behavior. There is, to the contrary, scientific evidence showing
that Prozac and medicines like it actually protect against such
behaviors.”

Using figures on Prozac both from Lilly and independent
research, however, Dr. David Healy, an expert on the brain’s
serotonin system and director of the North Wales Department of
Psychological Medicine at the University of Wales, estimated that
“probably 50,000 people have committed suicide on Prozac
since its launch, over and above the number who would have
done so if left untreated.”

Healy, meanwhile, is conducting a new study that he says is the
first of its kind, giving antidepressants to healthy people to study
possible links to suicide. The results are expected to be
published in June.

Prozac’s success is certainly unquestioned. The introduction of
the drug to the US market in the late 1980s changed the way
Americans viewed their most intimate emotions and limitations.
Billed as a wonder drug to combat depression by boosting
levels of the brain chemical serotonin, Prozac and others like it
were also said to remedy a host of human frailties from poor
self-esteem and concentration to fear of rejection.

By the end of last year, more than 35 million people worldwide
were using the drug, which provided Lilly with more than 25
percent of its $10 billion in 1999 revenue.

Yet the problems with Prozac were known even before it was
introduced to the US market. Figures in a 1984 Lilly document
indicated that akathisia, the severe agitation that can lead to
suicide, occurs in at least 1 percent of patients, a level
considered a “frequent” event, and as such must be disclosed in
a company’s product literature and package inserts. But there is
no such disclosure in Prozac’s US literature, and it is not clear
whether the FDA panel charged with approving Prozac simply
overlooked or did not have access to certain critical data of
Lilly’s.

As a result, researchers say that most US doctors do not know to
warn patients of the potentially dangerous effect which,
according to published literature on the topic, can be alleviated
with sedatives or by going off the drug.

German regulators, who eventually approved Prozac for use in
that country, require a warning label about the risk of suicide and
suggest the concurrent use of sedatives when necessary.

Akathisia is listed in Lilly’s US product literature, but as an
infrequent event in Prozac users. No mention is made of its
potential relationship to suicide.

A relationship, however, was found in a Globe search of US
patents. The patent for the new Prozac or R-fluoxetine (US Patent
no. 5,708,035), which Lilly will market after the existing patent
expires in 2001, contains a wealth of information about the
original Prozac. According to the patent, the new Prozac will
decrease side effects of the existing Prozac such as headaches,
nervousness, anxiety, and insomnia, as well as “inner
restlessness (akathisia), suicidal thoughts and self-mutilation” –
the same effect Lilly has contended has not occurred in any
substantial way in some 200 lawsuits against it over the past
decade. Most of the suits were settled out of court and the terms
kept confidential.

A 1990 communique

In an electronic communique obtained by author Glenmullen
dated Nov. 13, 1990, from Claude Bouchy, a Lilly employee in
Germany, to three Lilly corporate executives at the company’s
Indianapolis headquarters, Bouchy says he and a colleague
“have problems with the directions our safety people are getting
from the corporate group (Drug Epidemiology Unit) and
requesting that we change the identification of events as they are
reported by the physicians. . . . Our safety staff is requested to
change the event term `suicide attempt’ [as reported by the
physician] to `overdose.’ ”

Bouchy continued that “. . . it is requested that we change . . .
`suicidal ideation’ to `depression.’ ”

And then Bouchy makes an appeal to his US Lilly colleagues: “I
do not think I could explain to the BGA, to a judge, to a reporter or
even to my family why we would do this especially on the
sensitive issue of suicide and suicide ideation. At least not with
the explanations that have been given to our staff so far.”

Lilly has also aggressively sought to discredit researchers who
published data linking its product to suicide. One of its early
targets was Dr. Martin Teicher, an associate professor of
psychiatry at Harvard Medical School and a McLean Hospital
researcher, who wrote a crucial paper on the link between
suicide and Prozac in 1990; he found that 3.5 percent of patients
put on Prozac either attempt or commit suicide due to severe
agitation from akathisia. As a result of Lilly’s campaign, many in
the psychiatric community say they believe Teicher has
distanced himself from his original work. But in a rare interview
with the Globe, Teicher said that he stood by his work, and that
the ability of Prozac to induce suicide in a minority of patients “is
a real phenomenon.”

Teicher, Barberich, and Young filed their patent for the new
Prozac in August 1993, the same year Teicher published another
report, this one in the journal Drug Safety titled “Antidepressant
Drugs and the Emergence of Suicidal Tendencies.”

The paper was a direct challenge to data reported in the March
1991 issue of the Journal of Clinical Psychiatry by Drs. Maurizio
Fava and Jerrold Rosenbaum of Massachusetts General
Hospital. Their study found no significant difference in “suicidal
ideation” in patients treated with fluoxetine compared to those
receiving other antidepressants.

Teicher wrote in his 1993 paper that Fava and Rosenbaum’s
statistics were flawed. Using Fava and Rosenbaum’s data,
Teicher came to the opposite conclusion: namely, that patients
on Prozac were at least three times more likely to become
suicidal than those on older antidepressants.

The FDA came up with similar results even before Teicher
published his 1993 data. Dr. David Graham, chief of the FDA’s
Epidemiology Branch, wrote on Sept. 11, 1990, that Lilly’s data
on suicide and Prozac, as well as the Fava and Rosenbaum
study, were insufficient to prove that Prozac was safe. In an
internal FDA memo, Graham wrote: “Because of apparent
large-scale underreporting, the firm’s analysis cannot be
considered as proving that fluoxetine and violent behavior are
unrelated.”

“Prozac Backlash”

Now a decade later, Lilly has targeted Dr. Joseph Glenmullen,
whose book “Prozac Backlash” has apparently incensed Lilly
executives.

Glenmullen, a clinical instructor in psychiatry at Harvard Medical
School and a clinician at the Harvard University Health Services,
says he wrote the book because he was alarmed by the number
of patients who were reporting severe side effects from the
serotonin-boosting antidepressants including Prozac, Paxil,
Zoloft, and Luvox. “The two most upsetting side effects were
patients becoming suicidal on the drugs, and the development
of disfiguring facial tics,” he said in an interview.

After obtaining hundreds of pages of FDA documents through
the Freedom of Information Act, as well as internal Lilly memos
that are part of the public record in lawsuits filed against the drug
company, Glenmullen wrote that Lilly had tried to downplay side
effects of Prozac for years.

Lilly alerted newspapers and TV stations to the book and began
a campaign to discredit the author, saying that Harvard Medical
School professors were unfamiliar with his work and didn’t
recognize his name. Glenmullen, a graduate of Harvard Medical
School, is one of 415 clinical instructors in medicine at Harvard.

Blast from a critic

Chief among Glenmullen’s critics is Mass. General’s
Rosenbaum, a professor of psychiatry at Harvard Medical
School, who, in a written statement sent to the Globe calls
“Prozac Backlash” a “dishonest book” that is ” manipulative” and
“mischievous.”

But Rosenbaum’s objectivity has also been questioned. Not only
was his 1991 study on Prozac and suicide criticized by at least
two sets of researchers as well as the FDA, documents obtained
by the Globe show that Rosenbaum’s relationship to Lilly is a
cozy one: he has served as a Prozac researcher and sat on a
marketing advisory panel for Lilly before Prozac was launched.

When asked in an interview why he was speaking out against
Glenmullen’s book, Rosenbaum said that the suicide
controversy was “old news” and that the book presents the
information as new research. He noted that akathisia is “pretty
rare” and that “it doesn’t occur more than in people given a
placebo.”

But because there is no official reporting system for drug side
effects, no one knows how common drug side effects are, said
Larry Sasich, a research analyst at Public Citizen in Washington,
D.C.

“There is no active surveillance system to look at adverse
events,” he said. “Unless something very unfortunate happens
and a large number of people are harmed in a unique way, no
one is going to look at it; nobody ever puts two and two together.”

Sepracor’s patent

On April 12, the Federal Trade Commission opened the way for
Lilly to market Teicher’s, Barberich’s, and Young’s new Prozac,
for which Sepracor holds the patent. The new Prozac,
R-fluoxetine, is a modified form of an ingredient found in Prozac,
which, according to Sepracor, not only has fewer side effects but
more potential uses and benefits than the original.

In making the decision, the FTC rejected arguments from its
lawyers and the generic drug industry that the agreement unfairly
limits generic Prozac competition.

According to a Sepracor press release dated April 13, the
company will receive an upfront payment and license fee of $20
million from Lilly and an additional $70 million based on the
progression of the drug. Sepracor will receive royalties, and in
exchange, Lilly will get the exclusive world rights to R-fluoxetine
for all indications and uses. Lilly will be responsible for the
development of the drug, regulatory submissions, product
manufacturing, marketing and sales, according to the release.

Glenmullen wonders whether the new Prozac will, in fact, be little
more than an effort to prolong the life of a product with a
soon-to-expire patent.

Although it is touted as having fewer side effects, no one knows
what effects may surface once large numbers of people begin
taking it for months or years. In the epilogue to his book, he
simply says: “Like any new drug, it too will be an ongoing
experiment.”

This story ran on page A01 of the Boston Globe on 5/7/2000. ©
Copyright 2000 Globe Newspaper Company.

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6/10/2000 – CBS Evening News Story on ADHD, Part II Tuesday

Monday evening CBS Evening News did a piece on the over
drugging of children in America. Sorry we did not get that
information to you sooner. Their summary is below. Hopefully
they will include a transcript of tonight’s piece on their site soon.
Tomorrow the news story is continued. Hope you can catch it.

Ann Blake-Tracy
____________________________

CBS Evening News

“On the HealthWatch, our Medical Correspondent Elizabeth
Kaledin will have the first of a two part report on the rising
number of kids being put on prescription drugs to treat Attention
Deficit Hyperactivity Disorder.

Tonight, Elizabeth will look at one Virginia school district where
an amazing 17% of the children are on medication to treat ADHD
and at a family in Texas that has weaned their child from
psychiatric drugs and has teamed with his teacher to shape his
behavior with no-nonsense discipline.”

Dan Rather

“P.S. On Tuesday’s CBS Evening News, we’ll have the second
part of our report on ADHD (Attention Deficit Hyperactivity
Disorder) and the medicating of our kids–in part two, Elizabeth
Kaledin will look at some of the alternatives to drugs. Please join
us.”

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