12/29/2000 – Boston shooting – involvement of Prozac & other antidepressants

As so many of you have been asking since Tuesday, here is
the official data from the Boston Globe on the Prozac use and
use of other antidepressants in the shooting that took place
the day after Christmas in the Boston area. It is very rare that the
information about the drug use comes out to the public so quickly. Generally
it is kept quiet until the case goes to court. We must
commend the Boston Globe for continuing to have the courage
to educate the public about this group of very dangerous drugs.

In the highlighted paragraphs 12 and 13, Kevin Reddington, the
attorney, states that he will ask experts to consider whether
McDermott’s medication (Prozac & other antidepressants)
contributed to the rampage.

Ann Blake-Tracy, Executive Director,
International Coalition For Drug Awareness
www.drugawareness.org

http://www.boston.com/dailyglobe2/364/metro/Questions_and_grief+.shtml

Questions and grief

Police seeking clues to what set off rampage in Wakefield

By Brian MacQuarrie, Globe Staff and Ralph Ranalli Globe Correspondent,
12/29/2000

Three minutes before the shooting rampage that killed seven of his
co-workers, Michael McDermott received a brief telephone call in his work
cubicle at Edgewater Technology Inc.

A Chrysler Financial supervisor informed McDermott that his 1994 Plymouth
Acclaim would be repossessed, according to a source familiar with the call.

”I won’t be needing it; come pick it up,” answered McDermott, seemingly so
unconcerned that the supervisor made a note in her log.

It was 11:07 a.m. Tuesday. Three minutes later, the carnage began. Within 15
minutes, authorities say, McDermott had murdered seven people.

A law enforcement source said yesterday that State Police have heard of the
telephone call and are investigating its connection to the slayings.

The call may have been the final insult for a man squeezed by a tightening
vise of financial worries.

Already informed that the Internal Revenue Service would seize a large
portion of his pay for back taxes, McDermott had a tense confrontation last
week with an Edgewater accountant who rebuffed his plea for a cash advance
and pay raise. The accountant, Rose Manfredi, told McDermott to take his
concerns about money to Edgewater’s president.

Manfredi’s mother said yesterday that her daughter, who handled much of the
company’s billing and payroll, had been so unnerved by McDermott that she
shared her concerns with the family.

”She told me last week, `Mummy, he was kind of nervous,”’ Carmella Manfredi
said. ”She was scared of him.”

On Tuesday, McDermott heard that his car, with a book value of only $5,930,
would be seized for nonpayment of a 1997 loan.

Haverhill police told the Globe they checked McDermott’s Bartlett Street
apartment several times on Christmas Eve and early Christmas morning after
his car had been spotted close to a wooded area where gunshots were reported.

Police said two spent shotgun shells were found on the ground near where
McDermott’s car – with the distinctive license plate MUCKO – had been seen. A
young woman said she also saw a man closing the trunk of the car.

”It sort of sends shivers down my spine,” said Haverhill Police Sergeant
Stephen Brighi, who reported that police did not find McDermott at his
apartment that night.

Yesterday, McDermott’s lawyer said he will consider an insanity defense. The
attorney, Kevin J. Reddington, said he will ask experts to determine whether
McDermott’s medication, which sources have said includes Prozac and other
antidepressants, contributed to the rampage.

”The medication is an issue,” Reddington said. ”It will be explored in
this case.”

McDermott, 42, pleaded not guilty to seven counts of first-degree murder at
his arraignment Wednesday in Malden District Court. He is being held without
bail in Middlesex County Jail in Cambridge, pending a Jan. 31 court
appearance.

Last night, opposite the converted 19th-century mill that houses Edgewater
and other companies, about 800 people filled St. Joseph Catholic Church for
an ecumenical memorial service.

The methodical slaying of seven people at the Internet consulting company
ranks as one of the worst mass murders in Massachusetts history.

After allegedly shooting two people in the reception area and three employees
in Human Resources, McDermott reportedly reloaded and shot open the locked
door to the accounting office, authorities say.

There, he allegedly shot Paul Marceau, 36, of Melrose, three times in the
chest, as Marceau tried to scurry away on his back. Manfredi, 48, was hit
twice in the legs before a shotgun blast to the head ended her life. Another
woman in the room may have survived only because she hid underneath her desk
and behind a coat on her chair.

The other victims were Jennifer Bragg Capobianco, 29, of Brighton; Janice
Hagerty, 46, of Stoneham; Louis Javelle, 58, of Nashua; Cheryl Troy, 50, of
Beverly; and Craig Wood, 29, of Haverhill.

Manfredi, a Lexington resident who handed out paychecks every two weeks,
appears to have been a prime target. Investigators said McDermott allegedly
used both an AK-47 assault rifle and a shotgun to shoot her. A rare Spanish
handgun made in 1914 was tucked in his pants, authorities say.

Manfredi’s mother and one of her three sisters, Florence Holleran, said
McDermott and Manfredi ”had words.” Neither woman knew further details of
McDermott’s request.

”Rose said [McDermott] was perturbed at a lot of people when he heard the
IRS was after him,” according to Nat Manfredi, one of four brothers.
”Naturally, he would have gone to the accounting office Tuesday.”

At the arraignment, Assistant District Attorney Thomas F. O’Reilly said
Edgewater was preparing to garnishee McDermott’s wages at the direction of
the Internal Revenue Service. Under that plan, McDermott said, he would have
been left with only $275 in pay every two weeks, according to Middlesex
District Attorney Martha Coakley.

IRS officials said that they cannot comment on McDermott’s tax situation, but
that he should not have been surprised by the decision to take part of his
salary. They said McDermott should have received at least two notices, by
mail or in person, informing him that a portion of his wages would be seized,
according to IRS policy.

However, the IRS ensures that debtors are left with enough of their salary to
live on, said Peggy E. Riley, an IRS spokeswoman in Boston. Under IRS
regulations, McDermott also should have been offered an installment plan or
another way to pay off the debt.

Edgewater Technology began grief counseling sessions yesterday for its
employees, about 80 of whom were at work Tuesday. The company plans to
renovate the office and move the accounting department out of the area of the
shooting.

Shirley Singleton, the president and chief executive officer, said Edgewater
has donated $70,000 to create a foundation at Fleet Bank for the victims’
families. The company also has given each family an additional $5,000 for
immediate costs, a source said.

Outside the brick building yesterday, a makeshift memorial with flowers and a
teddy bear had been set up by co-workers and other mourners.

The concern also extended to Beacon Hill, where a spokesman for Governor Paul
Cellucci predicted that the state’s strict gun restrictions would be
tightened even more.

”We’re in general agreement and general support of strengthening our gun
laws,” said John Birtwell, the governor’s spokesman, who added that
solutions also should be sought on a national level.

Yesterday, the future seemed far away for the Edgewater worker who escaped
death by hiding under her desk. Her nightmare this week, however, was still
too close.

When approached at her home, where flowers and friends were trying to ease
the recent trauma, the woman greeted a reporter with a sad, slow shake of her
head.

”I’m not ready to talk about it,” she said. ”I don’t think I’ll ever talk
about it.”

Patrick Healy, Stephen Kurkjian, Farah Stockman, Rick Klein, Adam Pertman,
and Jamal Watson of the Globe Staff and Globe correspondent Regina Montague
contributed to this report.

This story ran on page A01 of the Boston Globe on 12/29/2000.
© Copyright 2000 Globe Newspaper Company.

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12/29/2000 – Tis the Season for Drug Pushing

I would hope that you have been carried away by the hustle
and bustle of the Christmas season – celebrating Christmas
as it should be celebrated as you recalled the real purpose
of this holiday season.

Pharmaceutical companies look at this season as the time
of opportunity for recruiting new guinea pigs for their drug
trials. The holidays are a time for families to visit and celebrate
together, but, for some, it can be depressing as they look at a
broken family, loss of a loved one, not enough money for gifts,
etc. In those situations, the drug companies want us to believe
that they have the only answer for those holiday blues – their
little green, blue and pink pills.

Eli Lilly, for one, is most definitely taking advantage of the season
– offering to one and all their own brand of “holiday cheer” – Prozac.
One evening on prime time TV during the CBS Christmas special we
were forced to tolerate their “Welcome back to Prozac” commercial
where we see an athletic young woman jogging through the screen
to come back to Prozac. And another woman in the commercial
opens her shutters to welcome the morning sun again.

The honest commercial would show an overweight woman with
globs of hair falling out, who could barely catch her breath due
to the severe fatigue of the post drug period along with the
involuntary muscle jerking and jumping from the electrical
shocks running through her body. She would also be suffering
the severe panic and anxiety attacks that come with withdrawal
as she then drags herself back to the Prozac bottle! After all,
it is the serious delayed withdrawal with its terrible bouts of
rebound depression caused by the drugs that brings
the large majority of users back to Prozac or any of the
other drugs in the Prozac family of antidepressants.

Then the other woman who opens her shutters would be
welcoming the late afternoon sun, rather than the morning sun,
as she would not be able to get up before noon due to the total
upheaval in her sleep patterns. She would also be covering her
eyes from the sun due to pain the light would cause – a result of
the elevated serotonin levels she is left to deal with after her
first round of Prozac.

Just last month an ad ran in our papers here in Salt Lake City
(better known as “Prozacopolis” or the “Prozac laboratory” due
to our extremely high use of these drugs here) asking for elderly
guinea pigs. The caption above the photo of an elderly oriental
woman read in big bold print “EARN MONEY FOR CHRISTMAS!”
They were offering $750 to those 65 – 85 years of age (most on a
fixed income who could certainly use an extra $750 for Christmas)
to take Prozac for 42 days.

The ad stated that there was no need for these volunteers to be
depressed, but they needed to be healthy in order to take part in
the study. There was no warning at all that these volunteers would
most likely need to use the $750 for burial expenses or for a drug
withdrawal clinic to help them off the drug. And there was no hint
that they might need the extra $750 for additional Prozac to ward
off the terrible withdrawal symptoms.

The drug companies are definitely targeting the weakest among
us – the elderly and the children. Both are far more vulnerable to
the effects ofdrugs as the metabolism is weaker in both plus the
children have systems that are yet developing. US News and
World Report recently published an article on what is going on
with children in the testing of these drugs and the why behind
the testing – extended patents of these drugs bringing in MILLION$
for the drug companies. See it below. Note that the magazine is
protecting their advertising dollars by soft pedaling the most
horrific drug disaster this world has ever faced – the mass
drugging of helpless children with these very powerful
mind-alterning drugs.

How many more mass shootings do we need to witness? How
many more must die to awaken us to the terrible position we are
in as a result of these drugs? The horrors of medical “research”
are indelibly etched in one’s mind with a visit to Auschwitz or
Dachau. The picture of one man grasping his head with both
hands as he screamed out in pain was enough to send me
running out of Dachau as fast as possible and swearing never
to return. The emotions and memory of that experience will be
with me forever. The difference here is that Hitler did not have
mass media to entice people through flowery ads to come to the
camps “drug clinics” willingly to undergo “treatment” and the
human guinea pigs were not offered money to participate in
his horrific medical research projects.

If using the most helpless and dependent upon us as guinea
pigs does not incur the wrath of God as we have never seen
before, I do not know what will. Surely this must serve as a
wake up call to the terrible state of our society. If it does not,
we are not worth saving as a world, as a country, or as a people.

A pharmacist who has witnessed many of his customers end up
with criminal charges after using SSRI antidepressants stated to
me only a few months ago that he fears that in the next 10 to 20
years we will see thousands of “little Hitlers” running around as a
result of our use of these drugs on our children. He then pleaded
with me, “Please tell me that you and I are not the only ones who
see this!”

I urge you to not sit back in silence a moment longer. There is not a
family in our country that has not been adversely affected in some
way by these drugs at this point. Escaping this mass drugging of
our population is impossible in our world today. We are all surrounded
by it and must address such a serious assault on life as we know it. If
you have not yet done so, please contact local radio stations, television
stations, newspapers, government officials, police and firemen who have
to deal with the end result of these drugs, and give them our website as
a reference. Ask them to have one of our directors on as a guest on a
show to discuss this issue. Then warn your own families, friends and
neighbors before you are faced with a death you that you might have
been able to prevent by sharing this information. Stop worrying about
how someone will react to your message. Think of how you will feel
knowing that you did nothing to save a life or several lives that are
now gone as a result of these drugs.

We cannot stand by and watch this happen any longer – especially
at this time of year. I know of no greater gift we can give this
Christmas season than one of truth and life and health and
peace of mind – a life free of these drugs.

Ann Blake-Tracy, Executive Director,
International Coalition For Drug Awareness
www.drugawareness.org

http://www.usnews.com/usnews/issue/000417/nycu/kids.htm

Drug companies are clamoring for kids, but scrutinize the study before
signing up

By Stacey Schultz

Five-year-old Emily Morock is being very brave. As the nurse at Children’s
Mercy Hospital in Kansas City, Mo., draws blood from her left arm, the small
girl watches, fascinated, and doesn’t flinch. It wasn’t so easy for little
Teyonna Latimer, also 5, who, moments earlier, kicked and screamed as her
mom and a nurse held her still for a needle stick.

The girls are not sick: They are enduring the needles in the name of
science. Like thousands of children across the country, Emily and Teyonna
are taking part in a clinical trial of a drug approved for adults but never
studied in children–in this case an antihistamine. Doctors at Children’s
Mercy Hospital are trying to figure out how much is needed to relieve
allergies in a small child. “Up until a few years ago, if you had a
200-pound man and the dose was 200 mg, you would guess that a child who
weighs 10 pounds should get 10 mg,” says Kathy Johnson, clinical research
coordinator at the hospital. “But there is so much more we need to
understand about drug metabolism before we give medicines to young
children.”

A concerted drug-testing effort is filling that gap. In 187 pediatric trials
now planned or underway, researchers are studying the safety of
antidepressants, the proper doses of heart medication, and the best ways to
use potent antibiotics, among other things. The boom was sparked in 1997
when Congress granted drug companies an extra six months of patent
exclusivity, potentially worth millions of dollars, for medicines tested in
children; after December, the Food and Drug Administration will require that
virtually all new drugs be tested in kids.

“I have been doing pediatric research for 25 years,” says Philip Walson,
professor of pediatric pharmacology and pharmacy at Ohio State University.
“And I can honestly say that there has been more research done in the past
three years than in all the others combined.”

Risk and reward.
The effort will require more than 17,000 children–and increasing numbers of
doctors are asking parents to sign up their kids. The decision of an adult
to enter a clinical trial is rarely easy; deciding to sign up a child can be
even trickier.

Some experts worry that the rush to test drugs in kids has led to ethically
questionable behavior, such as taking children off a standard medication to
study the effects of a newer one or offering families large sums of money
for taking part. On the plus side, children in trials get close medical
attention and a chance to make a difference to other kids.

For sick children, a study of a new drug also offers a chance of getting
more-effective therapy. And the risks are small, providing parents choose
trials conducted by experts in pediatric medicine and closely supervised by
local review boards.

Prescribing drugs for children is a kind of experiment in any case, medical
researchers are quick to point out, because 80 percent of the drugs given to
kids have been tested only in adults.

Under FDA regulations, doctors are free to use these drugs in children, but
dosages and toxic effects can be guesswork. In rare cases, those guesses
have been fatally wrong. Decades ago, chloramphenicol, an FDA-approved
antibiotic, killed several infants when it accumulated to toxic levels in
their systems. Doctors later discovered that children do not metabolize the
drug the same way adults do. “We didn’t study it in kids before we gave it
to them,” says Dianne Murphy, associate director for pediatrics at the FDA.
“And we really didn’t understand the harm we were causing.”

The new wave of trials addresses the problem by testing approved drugs in
healthy kids like Emily and Teyonna, to see how their bodies process the
drugs, and by comparing the effectiveness of different drugs in sick kids.
No clinical research is without risks, says Ralph Kauffman, director of
medical research at Children’s Mercy Hospital, but the hazards of pediatric
clinical trials usually amount to inconvenience, not danger. “Studies may
include additional visits to the doctor, extra blood tests, X-rays, and
urine samples,” Kauffman says. “These are not things that inflict lasting
harm on a child.”

Most drugs tested in children have been studied previously in adults,
Kauffman adds. “There is always a small risk of an adverse reaction to a
drug,” he says. But because kids are so closely monitored in clinical
trials, “children are at much lower risk of an adverse event in a study than
they are taking a drug that has never before been tested.”

Still, parents have been spooked by rare but well-publicized clinical trial
disasters such as the death last fall of 18-year-old Jesse Gelsinger in a
study of gene therapy at the University of Pennsylvania. “You ask some
parents to join a clinical trial, and they immediately turn off,” says
Jeffrey Blumer, professor of pediatrics and pharmacology at Case Western
Reserve University School of Medicine in Cleveland.

Other participants sour later, when they discover that their child got the
old therapy during a trial of a new drug or got a dose of the new medication
too small to do any good. When a family doctor or pediatrician suggests
joining a clinical trial, Blumer says, parents should check out who is
running it. Look for researchers who have university affiliations, he
advises, because university-based research often gets more careful ethical
scrutiny.

Committees of experts called institutional review boards (IRBs) act as the
ethical watchdogs, and university-based hospitals are likely to have an IRB
on site, rather than relying on a centralized IRB that may not monitor
individual trials as carefully. On trial. Mark Brown, associate professor
of clinical pediatrics at the University of Arizona, learned how big the
difference can be when he tried to recruit patients for a trial of a new
asthma drug. The study sought kids with asthma who were not already taking
inhaled antinflammatory drugs. “Our IRB felt that it would be unethical to
take a child off medication if it was already controlling the condition,”
Brown says. Every asthmatic child his office could identify was already on
medication, preventing him from recruiting a single patient.

But just blocks away another doctor who was also taking part in the study
exceeded his quota. The reason: The physician encouraged patients to stop
their medication and join the trial. Brown suspects a less stringent IRB had
OK’d this potentially risky step. Parents should also get a full explanation
of the purpose and plan of the study, along with potential risks and
benefits.

Emily’s mother says that a nurse called her and explained the trial. Later,
she signed a six-page consent form detailing the same information. Ben
Wilfond, a bioethicist at the National Institutes of Health, says parents
should discuss these materials with their child’s primary-care physician as
well as with the study staff. “Take your time making the decision,” Wilfond
says. “If someone is trying to pressure you to sign up, that’s a red flag.”
Don’t be surprised if the trial organizers offer money or gifts.

Roughly a quarter of pediatric studies pay for participation, typically from
$200 to $400, according to Jonathan Rackoff, a researcher at NIH. Emily and
Teyonna both received $200 for their cooperation. NIH’s Wilfond says
incentives are not necessarily unethical. But some studies are offering
$1,000 or more, which bothers Wilfond: “When the money becomes too large and
distorts people’s judgment, that’s a problem.”

Ultimately, experts say, taking part in a well-run trial can be rewarding
for children. They stand to gain a sense of pride in helping other kids and,
along the way, learn a little bit about medical science. Loren Persley, a
16-year-old from Kansas City who entered a study of an antihypertensive drug
last year, says she was paid about $400. But her favorite part of the study
wasn’t the cash. It was staying overnight in the hospital and watching
technicians test her blood in the lab. “I got to see a readout on paper of
how high the levels of the drug were in my blood,” Persley says. “I had so
much fun, the money didn’t really matter to me.” But, she adds, “it was a
nice way to say thank you.”

© U.S.News & World Report Inc. All rights reserved. Disclaimer

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12/29/2000 – FDA’s Expedited Drug Approvals Cost Lives

Please excuse the flood of new information. I have
been on the road lecturing for the last six months or
so and have several e-mails that have been waiting
for me to send them out to you.

Keep in mind as you read this article that the SSRI
antidepressants were among the first to be approved
after the expidited drug approvals began. If anyone
thinks these seven drugs have been deadly(and they
have taken a terrible toll while bringing in billions for
the drug companies), just wait until the death toll
comes in on the SSRIs!

Ann Blake-Tracy, Executive Director,
International Coalition For Drug Awareness
www.drugawareness.org
_______________________________________

FDA’s Expedited Drug Approvals Cost Lives

“They’ve lost their compass and they forget who it is that they are
ultimately serving,” said Lemuel Moye, a University of Texas School of Public
Health physician who served from 1995 to 1999 on an FDA advisory committee.
“Unfortu- nately the public pays for this, because the public believes that
the FDA is watching the door, that they are the sentry.”

Friday, December 29, 2000

BY DAVID WILLMAN
LOS ANGELES TIMES

WASHINGTON — For most of its history, the U.S. Food and Drug
Administration approved new prescription medicines at a grudging pace, paying
daily homage to the physician’s creed, “First, do no harm.”
Then in the early 1990s, the demand for AIDS drugs changed the political
climate. Congress told the FDA to work closely with pharmaceutical companies
in getting new medicines to market more swiftly. President Clinton urged FDA
leaders to trust industry as “partners, not adversaries.”
The FDA achieved its new goals, but now the human cost is becoming clear.
Seven drugs approved since 1993 have been withdrawn after reports of
deaths and severe side effects. A two-year Los Angeles Times investigation
has found that the FDA approved each of those drugs while disregarding danger
signs or blunt warnings from its own specialists. Then, after receiving
reports of significant harm to patients, the agency was slow to seek
withdrawals.
According to “adverse-event” reports filed with the FDA, the seven drugs
were cited as suspects in 1,002 deaths. Because the deaths are reported by
doctors, hospitals and others on a voluntary basis, the true number of
fatalities could be far higher, according to epidemiologists.
An adverse-event report does not prove that a drug caused a death; other
factors, such as pre-existing disease, could play a role. But the reports are
regarded by public health officials as the most reliable early warnings of
danger.
The FDA’s performance was tracked through an examination of thousands of
pages of government documents, other data obtained under the Freedom of
Information Act and interviews with more than 60 present and former agency
officials.

Not Needed to Save Lives: The seven drugs were not needed to save lives.
One was for heartburn. Another was a diet pill. A third was a painkiller. All
told, six of the medicines were never proven to offer lifesaving benefits,
and the seventh, an antibiotic, was ultimately judged unnecessary because
other, safer antibiotics were available.
The seven are among hundreds of new drugs approved since 1993, a period
during which the FDA has become known more for its speed than its caution. In
1988, only 4 percent of new drugs introduced into the world market were
approved first by the FDA. In 1998, the FDA’s first-in-the-world approvals
spiked to 66 percent.
The drug companies’ batting average in getting new drugs approved also
climbed. By the end of the 1990s, the FDA was approving more than 80 percent
of the industry’s applications for new products, compared with about 60
percent at the beginning of the decade.
And the companies have prospered: The seven unsuccessful drugs alone
generated U.S. sales exceeding $5 billion before they were withdrawn.
Once the world’s unrivaled safety leader, the FDA was the last to
withdraw several new drugs in the late 1990s that were banned by health
authorities in Europe.
“This track record is totally unacceptable,” said Curt Furberg, a
professor of public health sciences at Wake Forest University. “The patients
are the ones paying the price. They’re the ones developing all the side
effects, fatal and non-fatal. Someone has to speak up for them.”

Fatal Missteps: The FDA’s faster and more lenient approach helped supply
pharmacy shelves with scores of new remedies. But it has also yielded these
fatal missteps, according to the documents and interviews:
— Only 10 months ago, FDA administrators dismissed one of its medical
officer’s emphatic warnings and approved Lotronex, a drug for treating
irritable bowel syndrome. Lotronex has been linked to five deaths, the
removal of a patient’s colon and other bowel surgeries. It was pulled off the
market Nov. 28.
— The diet pill Redux, approved in April 1996 despite an advisory
committee’s vote against it, was withdrawn in September 1997 after
heart-valve damage was detected in patients put on the drug. The FDA later
received reports identifying Redux as a suspect in 123 deaths.
— The antibiotic Raxar was approved in November 1997 in the face of
evidence that it may have caused several fatal heart-rhythm disruptions in
clinical studies. FDA officials chose to exclude any mention of the deaths
from the drug’s label. The maker of the pill withdrew it in October 1999.
Raxar was cited as a suspect in the deaths of 13 patients.
— The blood pressure medication Posicor was approved in June 1997
despite findings by FDA specialists that it might fatally disrupt heart
rhythm and interact with certain other drugs, posing potentially severe risk.
Posicor was withdrawn one year later; reports cited it as a suspect in 100
deaths.
— The painkiller Duract was approved in July 1997 after FDA medical
officers warned repeatedly of the drug’s liver toxicity. Senior officials
sided with the manufacturer in softening the label’s warning of the liver
threat. The drug was withdrawn 11 months later. By late 1998, the FDA had
received voluntary reports citing Duract as a suspect in 68 deaths, including
17 that involved liver failure.
— The diabetes drug Rezulin was approved in January 1997 over a medical
officer’s detailed opposition and was withdrawn last March after the agency
had linked 91 liver failures to the pill. Reports cite Rezulin as a suspect
in 391 deaths.
— The nighttime heartburn drug Propulsid was approved in 1993 despite
evidence that it caused heart-rhythm disorders. The officials who approved
the drug failed to consult the agency’s own cardiac specialists about the
signs of danger. The drug was taken out of pharmacies in July after scores of
confirmed heart-rhythm deaths. Overall, Propulsid has been cited as a suspect
in 302 deaths.
The FDA’s handling of Propulsid put children at risk.
The agency never warned doctors not to administer the drug to infants or
other children even though eight youngsters given Propulsid in clinical
studies had died. Pediatricians prescribed it widely for infants afflicted
with gastric reflux, a common digestive disorder.
Parents and their doctors had no way of knowing that the FDA, in August
1996, had found Propulsid to be “not approvable” for children.
By the time the drug was pulled, the FDA had received reports of 24 deaths
of children under age 6 who were given Propulsid. By then the drug had
generated U.S. sales of $2.5 billion for Johnson & Johnson Co.
Questions also surround the recent approvals of other compounds that
remain on the market, including a new flu drug called Relenza. In February
1999, an FDA advisory committee concluded that Relenza had not been proven
safe and effective. The agency nevertheless approved it. After the deaths of
seven patients, the FDA last January issued a “public health advisory” to
doctors.
A total of 10 drugs have been pulled from the market in just the past
three years for safety reasons, including three pills that were approved
before the shift that took hold in 1993. Never before has the FDA overseen
the withdrawals of so many drugs in such a short time. More than 22 million
Americans — about 10 percent of the nation’s adult population — took those
drugs.
With many of the drugs, the FDA used tiny-print warnings or
recommendations in package labeling as a way to justify approvals or stave
off withdrawals. In other instances, the agency has withheld safety
information from labels that physicians say would call into question the use
of the product.

Lost Compass? Present and former FDA specialists said the regulatory
decisions of senior officials have clashed with the agency’s central
obligation, under law, to “protect the public health by ensuring . . . that
drugs are safe and effective.”
“They’ve lost their compass and they forget who it is that they are
ultimately serving,” said Lemuel Moye, a University of Texas School of Public
Health physician who served from 1995 to 1999 on an FDA advisory committee.
“Unfortu- nately the public pays for this, because the public believes that
the FDA is watching the door, that they are the sentry.”
The FDA’s shift is felt directly in the private practice of medicine,
said William Isley, a Kansas City, Mo., physician specializing in diabetes.
He implored the agency to reassess Rezulin three years ago after a patient he
treated suffered liver failure taking the pill.
“FDA used to serve a purpose,” Isley said. “A doctor could feel sure that
a drug he was prescribing was as safe as possible. Now you wonder what kind
of evaluation has been done, and what’s been swept under the rug.”

Withdrawals’ Consequences: FDA officials said they have tried
conscientiously to weigh benefits vs. risks in deciding whether to approve
new drugs. They noted that many doctors and patients complain when a drug is
withdrawn.
“All drugs have risks; most of them have serious risks,” said Janet
Woodcock, director of the FDA’s drug-review center. She added that some of
the withdrawn drugs were “very valuable, even if not lifesaving, and their
removal from the market represents a loss, even if a necessary one.”
Once a drug is proven effective and safe, Woodcock said, the FDA depends
on doctors “to take into account the risks, to read the label. . . . We have
to rely on the practitioner community to be the learned intermediary. That’s
why drugs are prescription drugs.”
In a May 12, 1999, article co-authored with FDA colleagues and published
by the Journal of the American Medical Association, Woodcock said, “The FDA
and the community are willing to take greater safety risks due to the serious
nature of the [illnesses] being treated.”
Compared to the volume of new drugs approved, they wrote, the number of
recent withdrawals “is particularly reassuring.”
However, agency specialists point out that both approvals and withdrawals
are controlled by Woodcock and her administrators. When they consider a
withdrawal, they face the unpleasant prospect of repudiating their original
decision to approve.
Woodcock, 52, received her medical degree at Northwestern University and
is a board-certified internist. She alluded in a recent interview to the
difficulty she feels in rejecting a proposed drug that might cost a company
$150 million or more to develop. She also acknowledged the commercial
pressures in a March 1997 article.
But last summer — following the eighth and ninth drug withdrawals —
Woodcock said the FDA cannot rely on labeling precautions, alone, to resolve
safety concerns.
“As medical practice has changed . . . it’s just much more difficult for
[doctors] to manage” the expanded drug supply, Woodcock said in an interview.
Yet the imperative to move swiftly, cooperatively, remains.
“We are now making decisions more quickly and more predictably while
maintaining the same high standards for product safety and efficacy,” FDA
Commissioner Jane Henney said in a National Press Club speech on Dec. 12.

The Role of AIDS: The impetus for change at the FDA emerged in 1988, when
AIDS activists paralyzed operations for a day at the agency’s 18-story
headquarters in Rockville, Md. They demanded immediate approval of
experimental drugs that offered at least a ray of hope to those otherwise
facing death.
The FDA often was taking more than two years to review new drug
applications. The pharmaceutical industry saw a chance to loosen the
regulatory brakes and expedite an array of new products to market. The
companies and their Capitol Hill lobbyists pressed for advantage: If
unshackled, they said, the companies could invent and develop more remedies
faster.
The political pressure mounted, and the FDA began to bow. By 1991, agency
officials told Congress they were making significant progress in speeding the
approval process.
The emboldened companies pushed for more. They proposed that drugs
intended for either life-threatening or “serious” disorders receive a quicker
review.
“The pharmaceutical companies came back and lobbied the agency and the
Hill for that word, ‘serious,’ ” recalled Jeffrey Nesbit, who in 1991 was
chief of staff to FDA Commissioner David Kessler.
In 1992, Kessler issued regulations giving the FDA discretion to
“accelerate approval of certain new drugs” for serious or life-threatening
conditions. That same year a Democrat-controlled Congress approved and
then-President Bush signed the Prescription Drug User Fee Act. It established
goals that call for the FDA to review drugs within six months or a year; the
pharmaceutical companies pay a user fee to the FDA, now $309,647, with the
filing of each new drug application.

Reinventing Government: The newly elected Clinton administration climbed
aboard with its “reinventing government” project. Headed by Vice President Al
Gore, the project called for the FDA, by January 2000, to reduce “by an
average of one year the time required to bring important new drugs to the
American public.” As Clinton put it in a speech on March 16, 1995, the
objective was to “get rid of yesterday’s government.”
For the FDA’s medical reviewers — the physicians, pharmacologists,
chemists and biostatisticians who scrutinize the safety and effectiveness of
emerging drugs — a new order had taken hold.
The reviewers work out of public view in secure office buildings
clustered along Maryland’s Route 355. They examine truckloads of scientific
documents. They are well-educated; some are highly motivated to do their best
for a nation of patients who unknowingly count on their expertise.
One of these reviewers was Michael Elashoff, a biostatistician who
arrived at the FDA in 1995 after earning degrees from the University of
California, Berkeley, and the Harvard School of Public Health.
“From the first drug I reviewed, I really got the sense that I was doing
something worthwhile. I saw what a difference a single reviewer can make,”
said Elashoff, the son and grandson of statisticians.
Last year he was assigned to review Relenza, the new flu drug developed
by Glaxo Wellcome. He recommended against approval, citing a lack of proven
effectiveness and potential risks.
An agency advisory committee agreed and on Feb. 24 voted 13-4 against
approving Relenza.
After the vote, senior FDA officials upbraided Elashoff. They stripped
him of his review of another flu drug. They told him he would no longer make
presentations to the advisory committee. And they approved Relenza as a safe
and effective flu drug.
Elashoff and other FDA reviewers discern a powerful message.
“People are aware that turning something down is going to cause problems
with [officials] higher up in FDA, maybe more problems than it’s worth,” he
said.
Elashoff left the FDA four months ago.
In 1994, the FDA’s goal was to finish 55 percent of its new drug reviews
on time; the agency achieved 95 percent. In both 1997 and 1998, the goal was
90 percent and the FDA achieved 100 percent.
From 1993-99 the agency approved 232 drugs regarded as “new molecular
entities,” compared with 163 during the previous seven years, a 42 percent
increase.
The time-limit goals quickly were treated as deadlines within the FDA —
imposing relentless pressure on reviewers and their bosses to quickly
conclude their work and approve the drugs.
“The goals were to be taken seriously. I don’t think anybody expected the
agency to make them all,” said William Schultz, a deputy FDA commissioner
from 1995 to 1999.
Schultz, who helped craft the 1992 user-fee act as a congressional staff
lawyer, added: “You can meet the goal by either approving the drug or denying
the approval. But there are some who argue that what Congress really wanted
was not just decisions, but approvals. That is what really gets dangerous.”
The user fees have enabled the FDA to hire more medical reviewers. Last
year, 236 medical officers examined new drugs compared with 162 officers on
duty in 1992, the year before the user fees took effect.

‘A Sweatshop Environment’: Even so, Woodcock acknowledged in an FDA
publication last fall that the workloads and tight performance goals “create
a sweatshop environment that’s causing high staffing turnover.”
Dozens of officials interviewed by the Times made similar observations.
The perception of coziness with drug makers is perpetuated by potential
conflicts of interest within the FDA’s 18 advisory committees, the
influential panels that recommend which drugs deserve approval or should
remain on the market. The FDA allows some appointees to double as consultants
or researchers for the same companies whose products they are evaluating on
the public’s behalf. Such was the case during committee appraisals of several
of the recently withdrawn drugs, including Lotronex and Posicor, the Times
found.
Few doubt the $100 billion pharmaceutical industry’s clout. Over the last
decade, the drug companies have steered $44 million in contributions to the
major political parties and to candidates for the White House and both houses
of Congress.
The FDA reviewers said they and their bosses fear that unless the new
drugs are approved, companies will erupt and Congress will retaliate by
refusing to renew the user fees. This would cripple FDA operations — and
jeopardize jobs.
Yet even if the user fees remain, the FDA is prohibited from spending the
revenue for anything other than reviewing new drugs. So while the budget for
pre-approval reviews has soared, the agency has gotten no similar increase of
resources to evaluate the safety of the drugs after they are prescribed.
Leading industry officials say Americans have nothing to fear from the
wave of drug approvals.
“Do unsafe drugs enter and remain in the marketplace? Absolutely not,”
said Bert Spilker, senior vice president for scientific and regulatory
affairs for the Pharmaceutical Research and Manufacturers of America, in
remarks last year to industry and FDA scientists.
But during interviews over the last two years, current and former FDA
specialists cited repeated instances when drugs were approved with less than
compelling evidence of safety or effectiveness. They also said that important
information has been excluded from the labels on some medications.

Salt Lake Tribune, December 29, 2000, pg. A10

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12/29/2000 – Sarafem Nation – Renamed Prozac Targets Huge Market: Premenstrual W

http://www.villagevoice.com/issues/0049/spartos.shtml

Published December 6 – 12, 2000

Renamed Prozac Targets Huge Market: Premenstrual Women

Sarafem Nation

by Carla Spartos

A visibly irritated woman yanks on a supermarket shopping cart that’s stuck
in its stack while a soothing female voice-over recites a litany of PMS
symptoms. She asks, “Think it’s PMS? Think again. . . . It could be PMDD.”

Premenstrual Dysphoric Disorder, or PMDD, is a fresh-minted mental illness
that purportedly affects 3 to 10 percent of all menstruating women. Mood
symptoms like depression, anxiety, anger, irritability, or sensitivity to
rejection are said to be so severe the week before a woman’s period that it
impairs her functioning. According to Dr. Jean Endicott, professor of
clinical psychology at Columbia University’s College of Physicians and
Surgeons, “What’s ordinarily irritating becomes enraging.”

To be diagnosed with PMDD, women must keep a daily diary of their symptoms
for the duration of two menstrual cycles. The symptoms must kick in after
ovulation and disappear once menstruation begins. “The timing is exquisite,”
remarks Endicott.

The timing is also exquisite for Eli Lilly and Company to make a financial
killing off of PMDD. Next year, the drug company will lose its patents on the
antidepressant Prozac, and with them its monopoly on the market. To ward off
declining profits, Lilly has found another use for its wonder drug—treating
PMDD.

In July, Lilly got Food and Drug Administration approval to market Prozac
under the new name Sarafem. The company is packaging the drug in pretty pink
and lavender capsules, exclusively for women, most in their late twenties or
early thirties. Says Laura Miller, a spokesperson for Lilly, “Women told us
they wanted treatment that would differentiate PMDD from depression.”

According to Endicott, the symptoms of PMDD primarily interrupt
“interpersonal relationships”—basically, those involving spouses, children,
and coworkers. In one group of women with self-described premenstrual
symptoms, researchers found no increase in absenteeism or decline in work
performance, although the women themselves perceived that to be the case.

“PMDD is unique because there is virtually no other disease that people
insist upon having,” says Dr. Nada Stotland, chair of psychiatry at Illinois
Masonic Medical Center. According to Stotland, the majority of women who go
to PMS clinics have symptoms that aren’t in fact related to their periods.
“Most are depressed everyday. Others have anxiety and personality disorders.
Some are in psychological pain because they are being abused.”

That women might seek help on the pretense their problems are hormonally
based makes PMDD more slippery to recognize and study. Stotland says she’s
particularly concerned that Lilly is targeting almost exclusively OB-GYNs as
Sarafem prescribers, which puts gynecologists in the position of treating
mental illness. She says Lilly’s advertising campaign may convince enough
women they need Sarafem, leading them to pressure their doctors to skip the
two months needed for diagnosis and instead send them straight to the
pharmacy. And since Sarafem will also work for those with chronic depression,
a misdiagnosis can go undetected.

Proponents of Sarafem downplay the potential for misuse. “I doubt that a lot
of people who don’t need the treatment would get it,” argues Endicott.
“First, it’s a prescription drug. Second, women are not big pill poppers.”
Sherry Marts, scientific director of the Society for Women’s Health
Research—a nonprofit organization that promotes research in women’s health
issues—concurs. “This is a real medical condition that requires treatment for
a small percentage of women,” she says.”Not, ‘I’m a little bloated, I’m gonna
pop some Prozac.’ ”

But critics claim that 3 to 10 percent of all menstruating women is no small
number. “That’s a minimum of half a million North American women suffering
from PMDD,” says Paula Caplan, a psychologist and affiliated scholar at Brown
University’s Pembroke Center for Research and Teaching on Women.

Whether PMDD is a real condition is still subject to debate. Although both
sides agree that a certain subset of women may be sensitive to normal
hormonal changes, that’s about all they agree on. The question remains, if
women sometimes snap at their husbands if they don’t pick up after
themselves, or at their kids if they do poorly in school, should they be
branded with a mental disorder? “Women are commonly in situations defined by
stress—responsibility without authority,” says Stotland. ‘That’s almost the
definition of a typical woman’s job.”

Some doctors fear that women who have legitimate reasons to be unhappy will
be silenced by the PMDD diagnosis, and that Sarafem could prove to be the
Valium of the naughts. “Ordinary, healthy changes in mood and emotion are
being pathologized when they happen to women, and since women believe they
shouldn’t feel irritable, angry, or depressed, they are quick to blame
themselves,” says Caplan. For men, “There’s no testosterone-based aggressive
disorder.”

Endicott disagrees. “If men had PMDD, it would have been studied a long time
ago.”

But would it? “To say that a huge proportion of the female population is
disabled represents a potentially horrendous setback for women in the
workplace,” says Stotland. She points to the woman who finally speaks up to
her boss and in return is asked, “Oh, is it that time of the month?” Agreeing
to that kind of put-down might save the woman her job. PMDD could reinforce
the stereotype of the hysterical woman not only to employers, but to women
themselves.

Caplan says that a diagnosis of PMDD will have far-reaching legal
implications as well. Might women who’ve been labeled as mentally ill be
deprived of the right to make their own decisions? Might they lose custody of
their children in divorce cases? In other words, will PMDD sufferers be seen
as the biological equivalent of Dr. Jekyll and Mr. Hyde?

That’s already the most common complaint of PMDD sufferers, says Endicott,
who reports women saying over and over, “This isn’t me.” Lilly promotional
literature echoes this sentiment. “The good news is there is treatment
available that can help you feel more like the woman you are every day of the
month,” the brochures say. But who is this woman? And why are we so concerned
with her hormones?

——————————————————————————

One thing is for sure: Eli Lilly and Company has a financial stake in PMDD.
Lilly’s Prozac patents are expiring in 2001 and 2003. This means the market
will open up to cheaper generic competitors. Analysts have estimated that
Prozac sales will decline drastically—from about $2.51 billion in 2000 to
$625 million in 2003. Sarafem will provide a significant new market—women—to
boost profits. That’s a smart move, since women are the primary users of
drugs that alter mood. And, according to documents posted on the FDA’s Web
site, Lilly has proposed a “pilot study of PMDD in adolescents to estimate
its response to treatment with fluoxetine.” Fluoxetine, by the way, is the
generic name for Sarafem (and Prozac).

Another plus for Lilly is that creating a new and separate trademark for
Prozac lessens the stigma associated with antidepressants, and lets the
company dodge some recent bad press, from the publication of Harvard’s Joseph
Glenmullen’s Prozac Backlash to a new study in Brain Research that suggests
the antidepressant may cut off axons of the nerves they target—in effect
causing brain damage.

By 2004, Sarafem sales are expected to climb to $250 million a year,
according to Bear Stearn’s Bottle Report. Lilly would not divulge projected
sales nor the amount of money spent marketing, researching, and developing
Sarafem, but their financial report shows a lot of zeroes. For the first
three quarters of this year, the corporation spent close to $2.3 billion in
marketing and administrative costs, much more than its research and
development, which totalled about $1.5 billion.

But most extraordinary is that the federal government is convinced of the
existence of PMDD, while the psychiatric community isn’t so sure at all. PMDD
is currently listed in the appendix of the DSM-IV—the psychiatrist’s bible of
mental illnesses—as “needing further study.”

The controversy began in 1987, when the compendium first included specific
criteria for Late Luteal Phase Dysphoric Disorder—the former name for
PMDD—in its appendix as a “proposed diagnostic category” needing more
research. In 1993, as the American Psychiatric Association’s task force was
compiling the fourth edition of the manual, the category was revisited.
Should it remain in the appendix, get moved to the body as a recognized
diagnostic category, or be removed altogether?

The committee decided to keep PMDD in the appendix. According to Psychiatric
News, the APA’s professional newsletter, “Members of the task force agreed
there were a number of problems with methodology within the PMDD literature.
The problems included unclear definitions, small sample sizes, lack of
control groups, lack of prospective daily ratings of symptoms, no
documentation of the timing and duration of symptoms, and failure to collect
appropriate hormonal samples.” However, the committee suggested specific
criteria for diagnosing PMDD, including specs for symptoms and timing.

Five years later, the fate of PMDD was still unclear. In October 1998, the
Society for Women’s Health Research organized a discussion, headed by
Endicott, to answer this question: “Is premenstrual dysphoric disorder a
distinct clinical entity?” Once again, experts reviewed the PMDD literature,
this time in the company of FDA and Lilly representatives.

Dr. Sally Severino, a now retired professor of psychiatry at the University
of New Mexico, reiterated flaws in the research. First, just because women
can be identified by PMDD criteria “is not proof that PMDD exists as a valid
diagnosis.” Second, although cross-cultural studies identified physical
complaints related to menstruation, mood symptoms like anger and irritability
were not found worldwide to the same degree as in America. Severino argued
that if PMDD can’t be identified in other populations, then “consideration
must be given to the criticism that PMDD is a culturally bound syndrome or an
unnecessary pathologizing of cyclical changes in women.”

Ignoring these objections, the round table concluded that PMDD was a
“distinct entity with clinical and biologic profiles dissimilar to those seen
in other disorders.” In other words, a mental illness.

What changed between 1993 and 1998? For one thing, Lilly funded a 1995 study
that showed Prozac was effective in treating PMDD. Published in The New
England Journal of Medicine, the study had a large sample size, and was
placebo-controlled and double-blind (meaning neither the doctor nor the
participant knows who’s getting drugs or a sugar pill)—all the makings of a
pristine scientific inquiry. A slate of studies followed suit, all with the
same results: About 60 percent of women diagnosed with PMDD respond to
Prozac.

Yet one 1998 study discussed by Endicott’s roundtable found that 55 percent
of women diagnosed with premenstrual symptoms got significant relief from
increased calcium intake. The group went on to comment that “the area of
calcium is not well explored.” That leads critics to wonder why other
treatment options are getting the cold shoulder. “Why not spend pages and
pages pushing calcium?” asks Caplan, who served on the 1993 DSM committee.
And although there is evidence that people with PMDD can feel better with
only intermittent doses of Prozac—and suffer fewer side effects like sexual
dysfunction—the studies Lilly presented to the FDA looked solely at the
effectiveness of daily doses, or roughly double the amount some researchers
say is needed.

According to Caplan, almost all of the data the roundtable evaluated fell
into two categories: the old problematic studies available to the DSM-IV
group or the new research into using Prozac to treat PMDD. “There was nothing
that looked at the validity of the PMDD construct,” says Caplan.

Did Lilly railroad Sarafem through? Two members of the 16-person roundtable
conducted PMDD research funded by Lilly, and another member has received
honoraria as a speaker for Lilly. Endicott, who hasn’t received research
funds or speaking fees from Lilly, opened the company’s November 1999
presentation to an FDA advisory committee, which voted unanimously in favor
of the new PMDD indication for Prozac. In addition, the Society for Women’s
Health Research trumpets on its Web site an “unrestricted educational grant
from Eli Lilly and Company,” which they’ve used to promote PMDD awareness,
including a national survey conducted in November to gauge women’s awareness
of PMDD and available treatment (i.e., Sarafem). “Lilly had done an
extraordinary job of getting this to the public,” says Stotland.

Researchers taking a ride on the drug-company gravy train is not unique to
those who studied PMDD, but it can have effects on scientific research. “I
don’t think people falsify results. But what kinds of questions do you ask?
Which results do you publish?” asks Stotland. “When I was a resident it was
the departments who had money to bring in speakers. Now, it’s the drug
companies who are flying people around.”

Incidently, at the time of the interview, Stotland was attending a PMDD
conference held at a Palm Springs resort, courtesy of Eli Lilly.

Tell us what you think. editor@…

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12/02/2000 – Upcoming shows of interest

Judy Coburn, from here in Utah, whose husband killed himself on Paxil, and
whose daugther Amy (14) attempted suicide on Paxil and was featured on the
cover of US News and World Report earlier this year, will be on Montel show
next week. It will air Wednesday at 10:00 AM MST. Check local listings to
find air time in your local area.

And, although I do shows regularly, I have not generally let you know about
when and where those shows will air. I will attempt to keep you better
informed. This week on Tuesday evening 8:00 PM Central Time I will be doing a
radio show with Alex Merkley. If you cannot find him in your local area, you
can find him on the net at www.broadcasttalk.com. There will be another one
this week out of Detroit, but I do not yet have the date and time for that
show.

Ann Blake-Tracy, Executive Director,
International Coalition For Drug Awareness
www.drugawareness.org

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11/02/2000 – Easy Answer May Not Be the Right One

Finally after all these years of working to get this information to
an unsuspecting public, the New York Times is reporting what I
have been writing about, lecturing about, testifying to, etc. all of
this time—that the SSRIs (Prozac, Zoloft, Paxil, etc.) work like
LSD.

As I say on the front of my book `Prozac: Panacea or Pandora?,”
“Turning the 90’s upside down to relive the 60’s.”

This group of drugs was introduced by the same drug company
that gave us LSD, Eli Lilly Pharmaceutical!

Dr. Howard Markel deserves a medal for getting this critical
information to the New York Times. I urge all of you to get this
New York Times article to your local media and get them to
reprint the article. I am sick of seeing so many die or have their
lives destroyed because the media is not printing the truth about
these dangerous drugs.

Ann Blake-Tracy, Executive Director,
International Coalition For Drug Awareness
www.drugawareness.org

http://www.nytimes.com/2000/10/24/science/24CASE.html

October 24, 2000

Cases: Easy Answer May Not Be the Right One
By HOWARD MARKEL, M.D.

About the Author

Dr. Markel is an associate professor of pediatrics and
communicable diseases and of history at the University of
Michigan.

—————————————————-
Steve is a 17-year-old with a scraggly goatee, a propensity to
wear Grateful Dead T- shirts and a strange medical complaint. A
few months earlier, in response to symptoms of clinical
depression, I had placed him on Prozac, a selective serotonin
reuptake inhibitor, known as S.S.R.I.

Although he no longer complained of sadness, poor
concentration and boredom, the problems that gave occasion to
his being prescribed Prozac, he was now experiencing frequent
disturbances of color and occasional moments when people he
was looking at transformed into cartoonlike figures.

Unfortunately, I paid too little attention to his complaint and
reflexively reached for my prescription pad to switch his
medication from Prozac to Zoloft, the equivalent of switching from
Coke to Pepsi, hoping that a different S.S.R.I. might solve the
problem. Because these episodes weren’t particularly
distressing to Steve, we agreed to see each other within a
month. But my therapeutic intervention accomplished nothing,
and, again, I switched him to still another S.S.R.I.

At a later visit, Steve admitted that until seven months ago, when
he was caught selling pot at his high school, he had been a
“garbagehead.” In teenage parlance this means that whatever
drug he came in contact with ˜ alcohol, marijuana, Ecstasy,
over-the-counter cold remedies, you name it ˜ Steve consumed
it, and often daily.

But for the past few years, his drug of choice was LSD. Until he
was arrested and required to enroll in a strict drug abstinence
program, Steve tripped weekly. When we met, he had been clean
for about five months but the episodes he was complaining
about reminded him of “when I was tripping on acid.”

Doctors who treat adolescents deal with drug abuse almost as
often as other pediatricians encounter ear infections; but Steve’s
LSD use was particularly troubling because, like many
physicians, I had little experience recognizing or treating the
problems that can result from it Indeed, before meeting Steve,
LSD was more of historical interest to me than practical or
clinical value: a quaint relic from the flower-power era of the late
1960’s and early 70’s.

As a matter of fact, LSD is again emerging as a serious concern
to pediatricians and parents alike. According to the Monitoring
the Future Study conducted by the University of Michigan’s
Institute for Social Research, the rates of lifetime, annual and
current use of LSD among 8th, 10th and 12th graders have
gradually increased since 1990.

Although LSD use reached its peak in 1996, during 1999, about
12 percent of American high school seniors used LSD at least
once and more than 8 percent of them used it at least annually.
More alarming, about 3 percent of these young adults tripped
monthly.

There are many reasons to avoid LSD, but one of the most
distressing side effects that can result from its chronic abuse is
the flashback syndrome. Flashbacks are recurrent hallucinatory
episodes that are not associated with the presence of the drug
in the brain and may occur months to years after stopping its
use. I wondered if this phenomenon might explain Steve’s
problem.

In the weeks that followed I began to inquire more closely about
the LSD use of other patients I treated for depression with
S.S.R.I.’s. Soon enough three more teenagers admitted to
having used LSD and while none of them had used the
hallucinogen for many months, all began to experience
flashbacks only after initiating treatment with an S.S.R.I. agent.
One patient, an 18-year-old named Lisa, described a few
flashbacks that, unlike Steve’s almost humorous experiences of
watching his teachers transform into Pokemon characters, were
upsetting and debilitating. When I queried these teenagers why
they had not complained to me before about the flashbacks,
each had the same response: you never asked!

Concerned about these four teenagers, I left my clinic one
evening and headed straight for the stacks of the medical library.
When armed with a novel clinical experience this can be one of
the most exciting places on earth for a doctor to conduct a game
of medical detective. Before the night was over, a Eureka-like
moment was to be had.

Serotonin reuptake inhibitors, as their name implies, prevent the
reabsorption of this neurotransmitter from the synapse, the gaps
between two neurons that rely on chemicals like serotonin,
dopamine and norepinephrine to communicate with one
another. Although the exact mechanism for depression remains
unclear, many students of psychiatry say a central role may be
played by abnormally low levels of serotonin in the brains of
depressed people. This theory is supported by the miraculous
impact S.S.R.I.’s have had on millions of Americans who suffer
from what the ancient physicians called melancholia.

Excitedly leafing through the literature on LSD, I learned that the
hallucinogen not only increases serotonin levels in the brain, it
also has a special affinity for many of the same neuroreceptors.
The likely mechanism, then, for my patients’ new onset of
flashbacks was that the S.S.R.I. agents I prescribed were not
only yielding an increased concentration of serotonin in their
central nervous systems but were also overstimulating their
serotonin receptors. Within months of discontinuing the
S.S.R.I.’s, all of the teenagers’ flashbacks ended but could return
unpredictably. Happily, these teenagers all, thus far, remain
clean and sober and free of depression.
After consulting with several pharmacologists who specialized in
the effects of LSD on the brain, we presented these four
teenagers’ cases to my colleagues and ultimately published
their cases in The Journal of Pediatrics to alert others who care
for adolescents with a history of both depression and LSD
abuse. But for me these exercises were more a lesson in
humility than a proud accomplishment.

Steve and other patients who experienced flashbacks, perhaps
as a result of prescriptions, taught me two valuable clinical
lessons: a simple solution to a complex problem has the
potential to worsen things; and, often a patient hands you the
correct answer but the key is figuring out the right question.

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10/26/2000 – Prozac: Unsafe at Any Price

Once again Arianna Huffington has said it like it is! Bravo!! I have
stated repeatedly that lack of insurance or poverty has saved
many a life because they cannot afford these drugs. What a
tragedy it will be if these drugs are made more affordable!

The only thing she neglected to include in the following article is
that it is George Bush’s father, the ex-president, we can thank for
giving us the SSRI antidepressants. It was during his
administration that laws were passed drastically reducing the
length of time needed in clinical trials for a drug to be approved
as “safe.” Prozac was approved on only 5 and 6 week studies.

Ralph Nader is the only candidate I am aware of that is
concerned about dangerous prescription drugs and has worked
to do something about them.

Ann Blake-Tracy, Executive Director,
International Coalition For Drug Awareness
www.drugawareness.org
———–

http://www.ariannaonline.com/columns/files/102300.html

Prozac: Unsafe at Any Price
Filed October 23, 2000

Al Gore, as he will tell you, and tell you, and tell you, is a “fighter.”
And among the many enemies he “fights” for us, he lists the big
drug companies. On the campaign trail, Gore repeatedly rails
against them, hoping to distinguish himself from George W.
Bush and prove his commitment to the “little people.” But at no
point does the vice president name any names or level any
specific accusations against the industry beyond the high prices
they charge seniors. Last week, though, we were reminded that
pricey prescriptions for gramps and granny are not the gravest
offense some drug companies are guilty of.
On Thursday, Eli Lilly announced it was halting development of a
new and improved version of Prozac, its top-selling drug. The
patent for the new formulation — which cost Lilly $90 million —
claimed it would reduce “the usual adverse effects” of the
original Prozac, including “nervousness, anxiety, insomnia, inner
restlessness (akathisia), suicidal thoughts, self mutilation,
manic behavior.” Just the usual.
But if you’re over 65, Al is fighting for you to at least enjoy these
side effects at a reduced price. Yet almost from the time it was
introduced in 1988, Lilly has been maniacally denying claims
that Prozac produces violent or suicidal reactions.
Could the recent startling reversal have anything to do with the
fact that Prozac’s extremely profitable patent — which brought Lilly
$2.6 billion last year — was set to expire in 2004? What’s more,
just this August, a federal appeals court shortened Lilly’s
exclusive patent by three years, allowing generic versions of the
mega-drug to hit the shelves next summer.
The damning admissions in the enhanced Prozac’s patent will
be the center of a federal lawsuit scheduled to go to trial in
Hawaii next summer. This will be the latest round in a legal
battle initiated by the children of a man who, while on Prozac,
fatally stabbed his wife and then himself (in other words,
“suicidal thoughts, self mutilation, and manic behavior”).
During the first trial, Lilly’s lawyers and witnesses repeatedly
claimed that violent or suicidal acts are not a side effect of
Prozac. In fact, the president of Lilly’s neuroscience product
group, Dr. Gary Tollefson, testified under oath: “There is
absolutely no medically sound evidence of an association
between … Prozac and the induction of suicidal ideation or
violence.” Clearly impressed with such expert testimony, the jury
found the drug company not liable for the murder-suicide.
The latest suit charges that “a fraud was committed on the court”
when Lilly failed to disclose the potentially explosive data
contained in the patent, which it had purchased three months
before the first trial began. “It is incredible,” said Karen Barth,
one of the attorneys suing Lilly, “that on the one hand, Lilly
vehemently argues to a federal judge and jury that Prozac does
not cause suicide and/or violence … while on the other, pays $90
million for a patent … which clearly acknowledges Prozac’s
propensity to increase the risk of suicide and violent behavior.”
If there was no problem with Prozac, then why spend all that
money to fix it? Lilly has faced over 200 Prozac lawsuits and has
yet to lose a case –opting to secretly settle the majority of them.
The patent disclosures could be the smoking gun that changes
all that. “The new patent can be compared to the tobacco
papers,” argues Dr. Joseph Glenmullen, a Harvard Medical
School professor and author of “Prozac Backlash.” “It’s a
pharmaceutical company document that acknowledges this
dangerous side effect, which has been downplayed by Eli Lilly
and other pharmaceutical companies for a decade.”
And the damning evidence against Lilly continues to mount. Last
spring, an investigation by the Boston Globe found that,
according to the drug company’s own figures, “One in 100
previously nonsuicidal patients who took the drug in early clinical
trials developed a severe form of anxiety …. causing them to
attempt or commit suicide during the studies.” And a recent
study by brain chemistry expert Dr. David Healy of the University
of Wales estimated that roughly “50,000 people have committed
suicide on Prozac,” people who wouldn’t have had they not been
on the drug. In the final debate, Gore criticized the
pharmaceutical companies for “spending more on advertising
and promotion” than on “research and development.” He’s right
about that: In 1999, each of the five biggest drug companies
spent more than double on sales and marketing than on R&D.
But once again Gore missed the point: The most egregious
aspect of the ads is the creation of an artificial demand for drugs
with side effects far more severe than the ailments they claim to
treat. The latest targets of Eli Lilly’s admeisters are women
suffering from “mood swings, irritability and bloating” brought on
by their monthly periods. The company’s solution: a new drug
called Sarafem, which comes in pretty little pink-and-lavender
pills. The company’s come-on: a marketing campaign urging
consumers to be “More like the Woman you are.” The company’s
secret: Sarafem isn’t really a new drug at all, only Prozac with a
makeover. But even more disturbing than the thought of millions
of already cranky PMS sufferers being pushed over the edge by
this re-packaged Prozac is the trend it exemplifies: the turning of
all of life’s little unpleasantnesses into clinical conditions that
require drugs purporting to get us back to our original perfect
selves. As Dr. Peter Kramer, author of “Listening to Prozac,” puts
it: “The implication is that the premenstrual self is inauthentic,
that irritability is incompatible with the female gender. And that
the truest state is the medicated one.”
Maybe Al Gore’s got it all wrong on health care. Instead of fighting
to make prescription drugs cheaper for people, maybe he
should fight to price certain drugs out of their reach — in an effort
to save their lives.

Discuss this column and more in the Forum

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10/16/2000 – Serious psychiatric disorders produced by Lariam

Warning: Serious psychiatric disorders produced by Lariam
(given for malaria)

Keith Epstein has written a wonderful article for the Washington
Post that exposes the dangers patients are reporting with this
new anti-malaria medication, Lariam.

How often have patients who took one of these new SSRI or
SNRI antidepressants made this same statement?

“I trusted what I’d been told by my government as an American
that this was the thing to do to protect me. I’d done my research!”
she said. “But the warnings are very minor.”

“They only said to be cautious if you have psychiatric problems. I
didn’t have any – until I took Lariam.”

Note that this is the CDC’s drug of choice for prevention of
malaria. Also note that the devastating effects of Lariam have
been ignored for about the same amount of time that the
devastating effects of SSRIs have been ignored. And Lariam’s
adverse effects have been continued to be ignored even though
some estimate that 25% of patients experience these effects. Yet
the manufacturer lists the adverse effects as “rare”.

No wonder the country is wondering what the CDC and the FDA
are doing while so many suffer. Obviously the foxes must be
busily guarding the hen house.

These are warnings coming from patients that most certainly
should not be ignored! These are serious, life threatening
reactions. Reactions so very similar to the serotonergic
antidepressants that it is chilling to read. How many of these
unsuspecting patients are ending up on antidepressants as
treatment for their Lariam-induced psychiatric disorders and find
themselves getting worse, then find it impossible to withdraw
from the antidepressant? Or they might even end up committed
to a psychiatric ward as so many SSRI users have been when
they had a similar psychotic reaction. As you will see one’s
vacation could become a tragic nightmare!

Ann Blake-Tracy, Executive Director,
International Coalition For Drug Awareness
www.drugawareness.org
————————————
http://washingtonpost.com/wp-dyn/articles/A38465-2000Oct9.ht
ml

The Lariam Files

By Keith Epstein
Special to The Washington Post
Tuesday, October 10, 2000

Michael J. Burch, a Washington consultant, had just returned
from a visit to his son, a Peace Corps volunteer working in
Ghana, and was having dinner at a Capitol Hill restaurant last
March. Burch had been feeling dizzy, his legs rubbery. He’d been
battling sleeplessness. Now, during dinner, a sudden surge
rose in his chest. He feared a heart attack. It was, he recalls, as
if “something were taking over my body.”

Elisa von Joeden-Forgey, an experienced traveler with no history
of psychiatric problems, had trouble sleeping within days of her
arrival in Cameroon, where she was to conduct postgraduate
research. She had vivid nightmares. She grew terrified that if she
dozed off she would disappear. Later, after she returned to the
United States, she was too frightened to leave the house. She
couldn’t concentrate or even carry on a conversation very well.
Her dissertation stalled. Her marriage faltered.

Not even Hope Trachtenberg-Fifer, a Virginia registered nurse
and marathon runner who teaches others to recognize
symptoms of medical conditions, had any idea what was going
on. While serving on a volunteer medical mission to Kenya in
1997, she dreaded the night, sensed doom and thought she’d
never see her family again. Though she’d never had mental
problems or trouble sleeping back home in Roanoke, she lay
balled up in bed, sobbing. She slept only for brief periods and
would wake up gasping and sweating. She wouldn’t eat or drink.
She wouldn’t leave her room. Her heart rate soared, her legs
wobbled. She was convinced she would die.

“I was a nut. I was psychotic,” she says. “And I was clueless..
There I was, a nurse and a health educator, and I had no idea
what was happening to me.”

All of these people say they were suffering side effects of
mefloquine, sold in the U.S. under the brand name Lariam. It is
the antimalaria medication recommended as the “drug of
choice” by the federal Centers for Disease Control and
Prevention (CDC) in 79 countries where malaria is resistant to
other drugs. Travel clinics and private physicians in the
Washington area, including those serving the State Department,
the Peace Corps and many public and private groups whose
personnel travel between here and Third World locations,
prescribe it routinely. American travelers headed for business or
pleasure to India, Thailand and Vietnam, on African safaris or on
tours of the Amazon basin typically are given prescriptions for
Lariam.

Mefloquine is used to prevent (and sometimes treat) malaria, a
devastating disease that kills more than 1 million people
worldwide each year, and is the second-most deadly
communicable disease in the world, after tuberculosis.
Mefloquine is over 90 percent effective when used in prevention,
and saves many thousands of lives annually. It is taken by 90
percent of Peace Corps volunteers in Africa and has reduced
their infections dramatically since it was introduced. Last year it
was prescribed at least half a million times. Most who take it for
prevention have only mild side effects or none at all.

But there is convincing evidence that the drug exposes a small
number of otherwise healthy travelers to traumatic and
sometimes bizarre neuropsychiatric reactions ˆ and that they are
often unaware of the risk of such reactions.. Reports of side
effects from mefloquine exposure include hallucinations,
sleeplessness, paranoia, psychotic episodes and suicide
attempts. Some users complain of effects persisting for weeks
or months, even years.

These reactions are documented in scientific studies, surveys
and in thousands of case reports in the files of Lariam’s
manufacturer, the Swiss firm Hoffmann-LaRoche, and the U.S.
Food and Drug Administration (FDA), the agency that regulates
pharmaceuticals. Adverse reactions were noticed by the
manufacturer and public health officials soon after the drug was
approved 11 years ago. The manufacturer twice agreed to revise
the label to list more, and more serious, side effects, including
psychiatric ones. Regulators in the United Kingdom had already
required explicit consumer warnings, and in 1997 the U..K.’s
Malaria Advisory Committee stopped recommending mefloquine
for travelers headed to malarial regions for two weeks or less.

Even so, U.S. travelers are often unaware of the potential for
disturbing effects. Because pharmacies are not required to
distribute the complete product label with most drugs, the
government-mandated warnings are not routinely circulated to
patients. And many physicians ˆ following the advice of the CDC
and drawing on their experience prescribing the drug to patients
with few serious problems ˆ either downplay or are unaware of
the symptoms a minority of people taking mefloquine report.
Despite the accumulating facts about side effects, the CDC has
continued to support mefloquine as the “drug of choice.”

As a consequence, many who take the drug and suffer side
effects are less likely to recognize them until considerable
mental anguish or physical injury has occurred. Many people
continue taking the medication because they do not realize that
the puzzling, even debilitating symptoms are associated with the
drug they are taking to prevent malaria. Patients often report
being treated by doctors who discount the possibility that their
problems are related to the drug.

People who have called the CDC to report or gather information
about the side effects of Lariam, including several people whose
cases were researched for this story, were told by agency staff
that their reactions were unlikely to be the result of the drug and
were advised to consider other causes, including stress.

While few agree on the number of people who suffer side effects
from mefloquine, there is little question that some of them do.

Andrea Meyerhoff, an FDA medical officer with responsibility for
drugs for tropical diseases and a travel medicine clinician at
Georgetown University, says that while cause and effect between
mefloquine and these symptoms may never be conclusively
proven, neuropsychiatric effects are clearly “associated” with the
drug.

Raymond Woosley, chairman of the pharmacology department
at Georgetown University and an authority on drug side effects,
says the reports on mefloquine are sufficiently widespread to
eliminate any doubt about the drug’s ability to produce these
effects at the preventive doses given travelers. “Mefloquine is
one of the more troublesome drugs people use, and causes a
lot of side effects,” he said. “Some of them are quite serious.”

Though Lariam can treat a deadly disease, he continued, its use
for prevention needs to be carefully considered. Unlike drugs
used to treat a patient who has already contracted a serious
disease, where even powerful side effects are tolerated in
service of the greater good of fighting a life-threatening condition,
Lariam is used to prevent a disease in otherwise healthy people
who are usually choosing to travel to infected areas.

Says University of Toronto professor Jay Keystone, a leading
authority on antimalarials who has served as a consultant to the
CDC and to the drug’s manufacturer: “I’m not questioning [the
CDC’s] intentions or integrity, and for most people the drug is
safe and effective. But they are trivializing very real and disabling
side effects.”

Officials at Hoffmann-LaRoche take the position that Lariam has
been proven safe and effective, and that labeling changes
approved by the FDA provide adequate notice of the side effects.

“Lariam has been used since 1985 by more than 12 million
people worldwide for prevention of malaria,” said Charles Alfaro,
a spokesman for Roche (as Hoffmann-LaRoche is widely
known). “The numbers [of side effects] are extremely low.
There’s a lot of data out there, but if you look at the experts
writing
about Lariam, the causal association between mefloquine and
serious adverse health events is unlikely.”

“The pill is well-tolerated by most people, and the drug’s really a
good drug,” said Celia Maxwell, who as an FDA medical officer in
1987 recommended the drug’s approval, and who as a travel
medicine clinician now frequently prescribes it. Disabling side
effects are “very, very rare.”

But when they do occur, she adds, “it’s 100 percent real ˆ no
doubt about it.”

The precise odds of having a bad reaction to Lariam are the
subject of intense debate, at least partly due to disagreement
over what is meant by “bad.” Some scientists tally only the most
severe reactions requiring hospitalization, while others count
users who are unable to continue their daily activities. Others
include only those who stop taking the pill due to the side effects,
thus exposing themselves to the risk of malaria.

A Roche-sponsored study of 145,000 travelers in 1993
estimated the rate of “serious” side effects ˆ identified in this
study as those causing death or hospitalization ˆ at one in
10,000; this figure is often cited by the CDC and those who
support wide use of the drug. In a 1996 English survey of 2,395
users, one in 140 reported problems severe enough to stop
them from carrying out their daily activities.

The latest studies, presented last year at a tropical medicine
conference but not yet published, suggest that somewhere
between 10 and 20 percent of those who take mefloquine suffer
side effects ranging from mild to severe. One of these surveys,
conducted by the Scripps Travel Clinic of La Jolla, Calif.,
estimates the ratio of people suffering some side effects at one
in five.

Just who is likely to suffer these side effects? One-third of all
patients with problems have a history of hypersensitivity to
mefloquine or other quinine-related compounds; had been
taking beta blockers (a common class of drugs prescribed for
hypertension or heart problems); or had been prone to seizure
disorders.

The other two-thirds of patients who experience neuropsychiatric
and other moderate to severe reactions? They have seemingly
solid mental and physical health histories. Medical experts say
there is no way of predicting who they will be, and virtually no
research is being done to find out.

Beyond the statistics from surveys and studies, there are reports
by patients and doctors to various government agencies.

In the United Kingdom, Lariam was suspected of causing 1,505
adverse reactions between 1990 and 1998, according to doctors’
reports compiled by health officials there. The government
subsequently expanded the drug’s warning label. The British
press has reported more on Lariam problems than the U.S.
press ˆ sometimes sensationally, adding to arguments that fear
itself contributes to reports of reactions. Letters to the British
Medical Journal have aired disagreements over the proper role
of Lariam. Just last week, the New England Journal of Medicine
published a similar exchange between doctors about the drug’s
side effect profile.

In the United States, more than 2,070 reports of adverse
reactions have been filed with the FDA in the last 11 years. More
than half of those reports ˆ 1,288 ˆ involved complaints of
“neurological events.” The Washington Post obtained 130 pages
of the reports, covering the period 1997 to 1999, under the
federal Freedom of Information Act.

Such data are anecdotally suggestive but statistically unreliable
ˆ
unreliable because multiple reports may have been filed by a
doctor, patient and drug company for the same patient’s
experience, and because filing a report doesn’t prove reactions
were linked to mefloquine. In addition, nobody knows how many
other people may have experienced problems they did not report.
However, the data do illustrate what some practitioners and
patients believe to be happening.

The reports have few details and consist mostly of the date, the
source of the report (medical professional or patient), a tally of
symptoms, the outcome, a list of drugs reportedly taken and the
“primary suspect” of the reaction’s cause. Page after page, the
list of symptoms repeats: psychosis, anxiety, panic attack,
thoughts of suicide, hallucinations.

Report number 3057866-X, filed with the FDA on March 19, 1998,
lists the unidentified patient’s reactions: “Abnormal behavior,
chest pain, hallucinations, hyperventilation, insomnia, suicidal
ideation.” Outcome: “Required intervention to prevent permanent
impairment/damage.” Primary suspect: Lariam.

Report 330063-5, filed July 9, 1999. Reactions: “Anxiety, asthma,
chest tightness, cough, dehydration, nausea, panic attack.”
Outcome: Prolonged hospitalization. Primary suspect: Lariam.

Report 3413545-8, filed Dec. 3, 1999. Reactions: “Mental
disorder. Paranoia. Suicide attempt.” Primary suspect: Lariam.

Report 3074393-4, filed April 30, 1998. Reactions: “Aortic injury.
Facial bone fractures. Successful suicide.” Outcome: Death.
Primary suspect: Lariam.

During the Vietnam War, the number of malaria infections
among American military personnel sometimes exceeded
battlefield casualties, and U.S. officials knew something had to
be done. Chloroquine, then the drug of choice, wasn’t working as
well as it once had, and neither were two alternatives. The Walter
Reed Army Institute of Research screened a quarter of a million
compounds in a quest for a preventive drug.

Army researchers didn’t know how mefloquine worked, but it did.
Army experiments in the early 1970s on nearly 400 male
subjects, mostly hardy men, showed high effectiveness and few
symptoms besides dizziness, headaches and insomnia.
Hoffmann-LaRoche acquired the rights to develop the drug
commercially and submitted the results of the Army’s human
experiments to the FDA.

Medical officer Celia Maxwell of the FDA, one of many officials
involved with the approval process, predicted few adverse
reactions other than dizziness, vomiting and nausea. Mefloquine,
she concluded in 1987, “appears to be effective and safe.” In
1989 the FDA licensed the drug. A year later it was licensed by
the United Kingdom. It was immediately popular because
malaria was becoming resistant to chloroquine and air travel to
the Third World was growing fast.

Around the time the FDA approved Lariam, troubling reports
began to appear. In 1989, “serious neurological and psychiatric
adverse events attributed to the drug were brought to the
attention of the pharmaceutical company and of WHO,” the World
Health Organization stated in a 1991 report.

A notation on the report states that it was “not issued to the
general public” at the time; it was intended only to guide
discussions of scientists and policymakers. A copy was
obtained by The Washington Post.

“We knew” about adverse reactions, said Maxwell. “That’s why
we included some language about potential effects in the
[original] labeling.. But at that time, we just didn’t have the
numbers of reports” of ill effects that have emerged since.

The list grew. But Maxwell, now a professor of infectious
diseases at Howard University and a physician at the university’s
travel clinic, still favors Lariam, except for use by surgeons or
other people engaged in technical work overseas. (The drug’s
label suggests caution, due to side effects, by those who drive
vehicles, pilot planes and operate machinery. Some airlines,
hospitals and other companies employing travelers in sensitive,
high-risk jobs restrict use of the drug.) She says that, over 16
years of practicing medicine, only one patient reported to her a
neuropsychiatric side effect from the drug ˆ psychotic episodes
in which the woman heard voices and suspected a plot to
murder her.

Even so, the woman instrumental in approving Lariam for the
American public never uses it herself ˆ though, she says, not for
reasons unique to mefloquine. She opts for doxycycline.
Explains Maxwell: “I have a sensitivity to a lot of drugs.”

While the number of people who suffer serious side effects from
mefloquine is unclear ˆ and while it’s difficult to predict who
will
be affected ˆ it is clear that many people traveling to malarial
areas, particularly for the first time, are not well-informed about
possible risks.

At Washington-area CVS and Rite-Aid pharmacies, customers
do not routinely receive the drug’s FDA-approved and
twice-revised label ˆ a folded package insert of almost 50
paragraphs of small print that lay out the adverse reactions and
contraindications. Instead, customers receive a one-page
printout credited to an independent publisher listing milder
effects such as lightheadedness and insomnia, and advising
patients to “call your doctor if you develop unexplained anxiety,
mood changes, depression, restlessness or confusion.” It adds:
“If you notice other effects not listed above, contact your doctor or
pharmacist.”

To get the full package insert, customers must ask the
pharmacist or look up the drug in the Physicians’ Desk
Reference, which compiles information on drugs from all
manufacturers.

A sampling in August of Washington-area travel clinics resulted
in echoes of assertions by CDC officials and the pharmaceutical
manufacturer that severe side effects are very rare. And some
clinical professionals in the area have little personal experience
with travelers’ problems with mefloquine.

Imtiaz Choudhary, director of Howard University’s travel clinic and
an infectious disease specialist, offered a common response
when asked what drug he prescribes for patients traveling to
most malarial regions.

“Mefloquine is the only one we have available,” he said. “I
strongly suggest people take this because its [side] effects are
minimal.”

Said Samuel Scott, senior clinical associate of Washington
Occupational Health Associates, which functions as a clinic for
business travelers and tourists: “[The CDC’s] drug of choice is
mefloquine, and so that’s generally what we use.” He added that
“I’ve not found it to be a problem. Bad dreams is the worst of it,
and so we warn them about that.”

Martin Wolfe, a veteran tropical medicine consultant who advises
the State Department, said a few federal employees have had
problems with mefloquine, but he continues to urge its use as
the primary defense against malaria. Ill effects are “not unheard
of” in his practice, but “we generally follow what the Public Health
Service [CDC] recommends.”

Meanwhile, other practitioners of travel medicine take a more
cautious approach.

“I don’t like using mefloquine [on patients] if I can avoid it. I’m
not
happy with the side effects,” said Robert Edelman, director of the
travelers’ health clinic at the University of Maryland Hospital in
Baltimore. He estimates as many as one in four of his patients
have a reaction ˆ insomnia, dizziness, feeling lightheaded or
nauseated, if not something worse.

“The patients are not happy ˆ and that’s bad, because they’re
going on these trips to get something accomplished or for a
good time. They’re on business and they need to be alert and
quick, and they have enough problems sleeping because of time
zones. People on vacation spend thousands of dollars on a trip
and suddenly find it ruined. They feel anxious and nervous and
have headaches.”

Edelman, who is also associate director of the University of
Maryland’s center for vaccine development, is critical of the
CDC’s Web site for failing to spell out percentages of patients
who have experienced specific categories of symptoms,
including the more moderate ones. The Web site says
neuropsychiatric events “very rarely” occur, and that statement is
deep in the product information. “If it’s one in four,” Edelman
said, “they should put it in there and let the patient decide
whether that’s too high or not. The problem is, most patients
aren’t even aware of these side effects unless you tell them.”

For those seeking protection from malaria, there are several
other options (see box, p. 15). In areas where malaria is not
resistant to it, chloroquine is the best choice. In areas where
malaria is resistant to chloroquine, the antibiotic doxycycline is
cheaper and has milder side effects; indeed, it’s the antimalarial
favored by President Clinton on foreign forays. (Asked why,
former presidential spokesman Joe Lockhart said, “the usual
reasons.” Lockhart also chose doxycycline, he said, because of
“the dreams.”)

Doxycycline must be taken daily, which is one argument against
it: Patients skipping a single dose can expose themselves to
malaria. It’s also not safe for pregnant women or children, and
creates acute sensitivity to the sun ˆ a tendency to burn faster,
a
considerable difficulty for many travelers. Like most antibiotics, it
can also cause yeast infections.

Malarone (See “Malarone: A New Alternative to Lariam,” Page 14)
was approved in July and so far shows effectiveness similar to
Lariam’s but with fewer side effects.

The CDC’s preference for Lariam, despite the availability of such
options and reports of problems for some users, puzzles some
patients and doctors. Hans Lobel, for years the CDC’s chief of
malaria surveillance, published many articles supporting the
drug’s use, dismissing reports of side effects as the result of
“travel-related stress” or underlying health problems. He
encouraged use of the drug for pregnant women and children,
despite the fact that the drug’s label says sufficient research has
not been done on those groups.

In an interview before he retired last fall, Lobel told The
Washington Post, “The scientific data showed us there are no
side effects that can be attributed to mefloquine. . .!=. The long
and the short of it is that scientific studies have not shown any
difference between mefloquine and a placebo.”

The CDC’s current Yellow Book, a biennial compilation of
information on diseases and treatments that is used by doctors,
travelers and the media, describes mefloquine as the “drug of
choice” and says it is “very rarely” associated with
neuropsychiatric reactions.

Jay Keystone, the Canadian authority on antimalarials who has
consulted to both the CDC and Roche, calls the language in the
Yellow Book “unacceptable and incomplete.” The information, he
says, should include a range of estimates for people who are
expected to experience symptoms such as anxiety, irritability,
nightmares and other disturbances that cause them to stop
taking the drug.

As this story was being reported, CDC officials repeated the
agency’s long-standing assertion that the best scientific
evidence shows no difference in tolerance between those taking
mefloquine and those taking a placebo. Officials also said
mefloquine will remain the agency’s “drug of choice.”

But late last week CDC officials indicated they may review new
data on Malarone and suggest its use in cases where
mefloquine or doxycycline cannot be used. Monica Parise, a
medical epidemiologist of the CDC’s infectious disease unit,
said it’s now possible that the next edition of the Yellow Book, to
be published in 2001, will acknowledge that patients and
doctors have three options for malaria prevention in
chloroquine-resistant areas ˆ creating not a single drug of
choice, but three choices.

In January 1999, Charles Perry ˆ a $160,000-a-year hospital
administrator with seven children ˆ had gone downstairs in his
Cincinnati home to retrieve a gallon of milk. Instead he got a
shotgun, angled the barrel against the base of his skull and
pulled the trigger.

He had told his wife, Linda, many times that that was where it
hurt the most.. The pain at the base of his cranium, the
nightmares and the hallucinations ˆ they all had started six
months earlier, during a safari trip to Zimbabwe to celebrate their
30th wedding anniversary.

Because of their public health backgrounds, both Perrys had
asked about Lariam’s safety ˆ at the pharmacy and at the local
health department. They were told it was fine ˆ in fact, the
“drug of
choice.”

After a week canoeing the Zambezi River, Charles Perry began
imagining there were monkeys in their room.

“I was in bed and Chuck was sitting there just kind of enjoying
himself,” Linda Perry recalls, “and he jumps up out of the chair
and says, ‘Hey, there’s a monkey under the bed!’!=” Then he
chased “the monkey” into the bathroom.

Back home a few weeks later, he couldn’t sleep. He had vivid
dreams. He heard voices.

“Chuck went absolutely mad,” she says. “He couldn’t remember
anything. He couldn’t write his name. His eyes were just nuts.”
He called meetings at work, then forgot why he called them. One
night, he called 911 ˆ to report that his wife was going crazy.
Finally, he checked himself into the psychiatric ward.

Then Linda Perry remembered what an African guide had said
about how Lariam can make some people “crazy.” The guide
said that those who live in Africa know better than to take it.

“Oh God,” she remembers thinking. “It’s the Lariam.”

That may or may not be true ˆ doctors originally were unwilling
to
blame Lariam for Charles Perry’s mental problems, though one
physician wrote a letter doing so. And the timing of the suicide,
six months after exposure to the drug, is a complicating factor. In
many ways, the Perrys’ tale is a classic Lariam parable ˆ a
dramatic story of personal suffering and tragedy, but one that is
very hard to prove, either legally or scientifically, was caused by
the drug.

Like many people whose lives have been shattered by what they
believe are side effects of Lariam, Linda Perry has become an
activist for the cause. She filed a lawsuit in federal court in June
charging that the drug was responsible for her husband’s
suicide. In August, Roche filed a response, denying the
allegations, stating it had taken “reasonable care” in making and
distributing Lariam, and “any such injuries and/or damages
alleged by plaintiff were the result of superseding or intervening
causes . . . or caused by the negligence and/or fault of others.”
No trial date has been set.

A number of such lawsuits have been filed charging the
manufacturer with “failure to warn,” but none has been
successful. An attempt to gather plaintiffs in England for a class
action fell apart as legal bills mounted. Similar efforts have
stalled in Canada and the United States. One case in New
Jersey was settled out of court by Hoffmann-LaRoche, but the
case was sealed and the evidence and terms of the settlement
remain secret. An Indiana woman received a $10,000
out-of-court settlement from a pharmacy after suing for “failure to
warn” about Lariam’s dangers.

Perry is doing her best to provoke government action, so far with
only modest results. Ohio senators George Voinovich and
Michael DeWine have arranged a conference call for Perry and
her husband’s doctor with the FDA. The House Commerce
Committee is “actively engaged in conversations with the FDA
over concerns about the drug,” said committee spokesman Pete
Sheffield, and is exploring the possibility of holding hearings.

Meanwhile, individuals who believe they are victims of the drug’s
side effects hope their stories can help the public understand
the possible risks of taking the drug.

Michael Burch ˆ whose son contracted malaria while in the
Peace Corps and who appreciates the role mefloquine plays in
preventing and treating the disease ˆ says he wishes he had
known more before taking the pills.

“I wish I’d known what was happening to me” when he
experienced the cardiac and psychiatric symptoms in the
restaurant and thereafter. “I know we have the best medical
system in the world, and I still believe that.. But the system really
let me down.”

Hope Trachtenberg-Fifer, the nurse and health educator who
says she became “psychotic” after taking Lariam, feels “so used
and abused.” Before taking Lariam, she had consulted solid
information sources she often turned to for professional
decision-making: the Physicians’ Desk Reference and the
CDC’s Web site.

“I trusted what I’d been told by my government as an American
that this was the thing to do to protect me. I’d done my research!”
she said. “But the warnings are very minor.”

“They only said to be cautious if you have psychiatric problems. I
didn’t have any ˆ until I took Lariam.”

Keith Epstein, a former investigative reporter with the
Washington bureau of the Cleveland Plain Dealer, is a frequent
contributor to the Health and Travel sections of The Washington
Post. Dan Olmsted, a Falls Church writer and editor, contributed
reporting to this story.

© 2000 The Washington Post Company

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10/14/2000 – New Suicide Warning in Great Britain

Here’s an email that Circare, a health rights organization, has
sent to the White House recently. Note the new warning that is
eliciting controversy in Great Britain:

“people may feel suicidal in the first few weeks of taking Prozac
and similar antidepressants.”

Also attached are two relevant articles written by Sarah Boseley,
Health correspondent for the Guardian.

Mark

From: Vera Hassner Sharav, President
CIRCARE: Citizens for Responsible Care & Research,
A Human Rights Organization
Tel. 212-595-8974 FAX: 212-595-9086
veracare@…

In response to increasing public concern over suicides among
people taking Prozac and other SSRI anti-depressants, the
British Medicines Control Agency (MCA) (which is the equivalent
to the U.S. Food and Drug Administration) now requires the
manufacturers of Prozac and the other anti-depressants to add
the following warning to physicians and patients:

“people may feel suicidal in the first few weeks of taking Prozac
and similar antidepressants.”

Why has the FDA failed to issue similar warnings to protect the
American public?

In the U.S. these drugs, though associated with an array of
severe adverse reactions in some patients, are widely and
haphazardly prescribed, not only for adults, but for children–even
toddlers and infants. Contrary to industry claims that these
drugs are safe– based on short-term (usually 6 week) clinical
trials before they were approved by the FDA– their long-term
effects have not been studied, nor is it known whether they are
safe for children.

According to FDA compiled data, in 1994 Prozac was prescribed
349,000 times in pediatric patients under 16 years; Zoloft was
prescribed 248,000 times. Furthermore, PROZAC was
prescribed 3,000 times for infants under one year old ! [See,
Psychiatric Times, March 1998, p. 69]

Instead of protecting the public by warning physicians and
patients about the risks associated with the drugs, the FDA is
protecting the profit-margins of drug manufacturers.

http://www.guardianunlimited.co.uk/Archive/Article/0,4273,40677
31,00.html

THE GUARDIAN

Prozac warning comes under fire
Position on suicidal tendencies is ‘dangerously misleading’

Sarah Boseley, health correspondent Guardian
Monday September 25, 2000

A new warning issued by the Medicines Control Agency, stating
that people may feel suicidal in the first few weeks of taking
Prozac and similar antidepressants, is dangerously misleading
and could lead to more deaths, according to a leading authority
on the drugs.

David Healy, director of the North Wales Department of
Psychological Medicine in Bangor, has told the MCA that among
those who are not severely depressed – who are the majority of
those now being given antidepressants – it is the drugs, and not
the illness, that make people want to kill themselves. The
warning will lead to doctors keeping their patients on the drugs
in the assumption that the medication will eventually make them
better, when they need to be taken off.
The new warning is the MCA’s response to increasing public
concern over suicides among people on drugs in the Prozac
class. The agency has instructed manufacturers to include it in
the drug datasheets for doctors and information leaflets for
patients. It states that suicidal thoughts may occur or increase in
the early weeks of treatment, and may continue for some time
until the drug takes effect.

But Dr Healy, the UK’s leading historian of antidepressant
medication, believes it is the drugs themselves that are causing
some people to feel like killing themselves – not depression. And
if, as the patient leaflet warning states, there is an increase in
suicidal thoughts, he says, it can only be due to an effect of the
drug. But increasingly the SSRIs (selective serotonin reuptake
inhibitors) are being given to adults and children who are not
depressed, but merely anxious and who should therefore have
no suicidal feelings.

Dr Healy has written to Keith Jones, director of the MCA, pointing
to two studies – one of them carried out by his own team –
showing that healthy volunteers with no history of depression
have become dangerously suicidal after taking one of the SSRI
class of drugs for a couple of weeks. “This will lead to deaths,”
he told Dr Jones in a letter. “Your advice will lead to a situation
where patients who worsen on treatment will be kept on that
treatment by their GPs in the belief that it is only in this way that
the suicide risk can ultimately be lowered. This is mistaken
advice that is going to increase the rate at which patients move
from emergent suicidality[beginning to feel suicidal] to suicidal
acts.”

Earlier this year, Dr Healy published a study of the effects of one
of the SSRIs, sertraline, on 20 healthy volunteers. Two of them
became suicidal.

One told researchers that she had become obsessed with the
idea of throwing herself under a car or a train, while the other
fantasized about hanging herself from a beam in the bedroom
ceiling.

The MCA also has in its possession a much earlier study of the
effects of sertraline on healthy volunteers. Dr Jones
acknowledged in a letter to Dr Healy that this study similarly
shows a “pattern of severe adverse side-effects and drop outs.”

He goes on to remark that the pattern “seen in this small study
was not replicated in any other study involving sertraline”. Yet it
has been – in the Healy study published earlier this year in
Primary Care Psychiatry and revealed in the Guardian in May.

These two studies, says Dr Healy, would be conclusive enough
for the manufacturers to get a license from the MCA to market
sertraline as a drug to cause agitation – if anybody had a use for
such a medicine. Yet the MCA will not accept that this, and other
SSRIs, can cause people to feel suicidal as a side-effect. The
MCA’s decision to require a new warning with the SSRIs was
taken after a review of the data by the Committee on the Safety of
Medicines.

The MCA said in a statement that the CSM had considered both
the healthy volunteer studies as part of the overall risk
assessment. “The CSM concluded that reports of suicidal
thoughts in healthy volunteers were difficult to explain, however,
other data were reassuring. For this reason, the issue will be
kept under review and further advice will be sought as
necessary.”

Guardian Unlimited © Guardian Newspapers Limited 2000

http://www.guardianunlimited.co.uk/Archive/Article/0,4273,40208
31,00.html

The GUARDIAN

Happy drug Prozac can bring on impulse to suicide, study says
As best-selling pill is prescribed by GPs for ever more sufferers
from mild depression, research brings disturbing evidence to
light

Sarah Boseley, health correspondent
Guardian

Monday May 22, 2000

Alarming evidence from a new British study shows that the
Prozac class of antidepressants can make healthy men, women
and children with no history of depression feel suicidal.

The research undermines the claims of Eli Lilly, makers of
Prozac, that people who kill themselves while on the tablets do
so because of their depression, and that the disease, not the
drug, is to blame for their suicide. Its findings are particularly
worrying because of the increasing numbers of people,
including children, who are being given the drugs by their GP for
mild depression, and who are not seriously clinically ill.

Prozac, the wonder pill of the 1980s and 1990s, became the
biggest drug company blockbuster of all time, prescribed to
more than 38m people around the world. It became a metaphor
for late 20th century life and a cult in its own right, enshrined in
a
book called Prozac Nation.

What began as a medicine for the clinically depressed has been
transformed by use and demand into a pill for minor ills. But
while the happy drug works for many people, in a significant
number it can take them to the edge of despair. The study,
conducted by David Healy, director of the North Wales
Department of Psychological Medicine, reveals the real dangers
for some of the SSRIs (selective serotonin reuptake inhibitors),
as Prozac and its imitators are called.

Nightmare

It found that two out of 20 healthy volunteers on an
antidepressant in the Prozac class called Lustral (or Zoloft in the
USA) became dangerously suicidal, compared with none of
them when they were put on an antidepressant of a different
class called reboxetine.

One 30-year-old woman who took part had a nightmare about
having her throat slit after one week and by the end of a fortnight,
was suicidal. “She felt hopeless and alone. It seemed that all
she could do was to follow a thought that had been planted in
her brain from some alien force. She suddenly decided she
should go and throw herself in front of a car, that this was the
only answer. “It was as if there was nothing out there apart from
the car, which she was going to throw herself under. She didn’t
think of her partner or child,” says the study, published in the
journal Primary Care Psychiatry. Later she completed a diary
entry, describing herself as jumpy, anxious and suspicious. “Her
mind was racing and spiraling out of control. Then it went blank
except for the clear thought that she must kill herself violently by
throwing herself beneath a car or a train.”

Dr Healy says the results of the research should be a warning to
GPs prescribing any SSRIs. “They may not all be equally the
same,” he told the Guardian. “But the risk holds for the whole of
the group.

Generally the findings would indicate that women and children
and those who are least ill may be most at risk.” All the drugs
have been licensed as both safe and efficacious on the basis of
data from clinical trials. But Dr Healy believes that there are
serious problems with the reporting of side-effects in these
trials, and that this has allowed drugs to be handed out to
millions around the globe without their true risks being
understood.

Volunteers taking part in the early trials were never asked
whether they experienced any suicidal feelings or the restless
agitation which can be the precursor of a suicide attempt. If
patients in later trials said they felt suicidal, it was recorded as
part of their depression.

Dr Healey has written to the Medicines Control Agency, which
licenses medicines in the UK, expressing his concern and
pointing out that he believes patients who today become suicidal
on SSRIs are in a state of “legal jeopardy”.

Firms are using data from trials that were not designed to look at
suicidality to prove that their drugs could not have caused it. Until
the system for reporting side-effects is changed, he questions
whether anybody should take part in clinical trials.

The new study’s findings have emerged at a time of acute
embarrassment for Eli Lilly. Its patent on Prozac (fluoxetine), is
soon to expire, but it recently bought the license for a second
version of the drug, called R-fluoxetine. The patent for the new
drug, it has just been revealed in the US, states that R-fluoxetine
is improvement on Prozac specifically as it is less likely to cause
“suicidal thoughts and self-mutilation”.

Eli Lilly argues that the patent was filed by the American scientist
Martin Teicher and the company Sepracor which devised the
new drug. Mr. Teicher, in 1990, was the first to warn that patients
on Prozac were becoming suicidal, but Eli Lilly has always
dismissed his study on the basis that those patients were
suffering chronic depression.

Dr Healy, the UK’s leading historian of antidepressant
medication who has given evidence against Lilly in litigation in
the US, has frequently taken issue with the major study
commissioned by the company to persuade the US Food and
Drugs Administration that Prozac carried no suicide risk. Dr
Healy has argued there has never been a prospective study and
that the retrospective 1991 Beasley study, as it is known,
included only a small selection of the trials that had taken place
on Prozac.

An internal memo released by Eli Lilly during recent litigation
appears to support Healy’s argument. In one of a series of
memos, dated August 27, 1990, a UK-based clinician tells Eli
Lilly management in Indianapolis that critics will be suspicious
of the fact that not all the trials were included and concludes that
it gives “the impression that the question of whether fluoxetine
provokes suicidal thoughts or not has not been properly
considered.”

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