Effexor Withdrawal Syndrome Hell

“I want my doctor to go on Effexor for a few months. Then I want him withdrawn.”

 

My physician prescribed Effexor because it was what he had the most samples of. I suffer from genetic depression. All members of my family have it. I have been on SSRI’s since the early 80’s. I hated Effexor from the start. I didn’t realize I had some of the physical problems associated with taking it, but I knew it was hurting my mind. I tried over and over to get off of it ,but within a day I would be so weepy and dizzy, my thoughts stuck in endless circles of failure and regrets. I thought I was a hopeless depressive and quickly resumed the drug. I didn’t know those were withdrawal symptoms.

Two weeks and one day ago I stopped Effexor. I knew that what it was doing to my head wasn’t proper. I investigated natural means of increasing my serotonin levels and felt confident I could handle my depression without pharmaceuticals. Then I entered Hell.

Within 18 hours I was a total wreck, sobbing, dizzy, disconnected, sick. There are only flashes of the past 2 weeks. The unbearable brightness of day, the agony of any noise, the trippy feeling that didn’t leave.

I hurt all over, I vomited, I became unbearably hot with sweat pouring out of me, and then shaking cold. Just today I found a fleece nightgown and a sweat suit near the bed. I wore these clothes under blankets when the weather was in the 90’s with equal humidity. At times just holding my head up was nearly impossible. This was a sickness that changed me forever.

I went in as one person and came out a different one. The serendipitous and cavalier way in which this drug was prescribed enrages me. The boards kept me going through the worst of my withdrawal and gave me the information I needed in order to continue. The drug companies are using us all as guinea pigs. One thought dominated as I wept and ached and suffered, I want my doctor to go on Effexor for a few months. Then I want him withdrawn.

“janiceash” janice@gargoylefolk.com

 

6/25/2002

This is Survivor Story number 19.

Total number of stories in current database is 48

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02/20/2001 – Drug Trials – Give us your children!

This situation is only getting worse and fast! This incredible article by the
Boston Globe shows us the dangerous potential in using our babies as guinea
pigs. As I said in my article “Our Next Generation of Medical Guinea Pigs –
Our Prozac, Zoloft, and Paxil Babies,” warning of this and written two years
ago, “If witnessing our children suffer like this is not enough to wake us up
to this nightmare, I DO NOT WANT TO SEE WHAT IT WILL TAKE TO WAKE US UP!!!!”

This time I made sure to include a link so that if the article is cut off,
you can go to the original Boston Globe site and finish reading it. Please
share this with your family and friends.

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

http://www.boston.com/dailyglobe2/049/nation/Dangerous_dosageP.shtml

Dangerous dosage

To make pediatric medicine safer, thousands of children are being used to
test drugs originally designed for adults. Tragically, the side effects can
sometimes prove deadly

By Alice Dembner, Globe Staff, 2/18/2001

First in a series of occasional articles on medical trials involving children.

Gage Stevens might have taken his first steps that bleak morning in November
1999. And by his first birthday, he would probably have outgrown his one
persistent ailment – acid reflux. Instead, he lay in the Allegheny County,
Pa., morgue.

His mother, Gretchen Stewart, had taken him to a specialist at Children’s
Hospital of Pittsburgh the spring before he died, seeking to ease the baby’s
crying as the acid irritated his esophagus. Dr. Susan Orenstein recommended
Gage enter a study she was running to find ”the safest, most effective
treatment for esophagitis in infants” using the ”best available”
medications, according to the consent form Stewart signed.

But the experimental treatment triggered a heart rhythm disturbance that
killed the 9-month-old, the coroner found. By that time, the key drug,
Propulsid, had also been linked to many adult deaths.

”They told me they were just trying to see how effective it was. Had I known
it was a dangerous drug, I would never have let him take it. Who in their
right mind would?” said Stewart of Homestead, Pa., who has filed a wrongful
death suit against the doctor, the hospital, and the drug’s maker, Janssen
Pharmaceutica.

Medical experiments across the country appear to have killed at least eight
children and subjected hundreds more to harmful side effects in the last
seven years, according to an investigation by The Boston Globe. These
tragedies, ethicists suggest, are a harbinger of troubles ahead as a federal
push to test more medicines in children kicks into high gear this year.

An estimated 45,000 children are participating in industry-sponsored testing
of new drugs, up from about 16,000 in 1997, according to Christopher-Paul
Milne, senior research fellow at the Tufts University Center for the Study of
Drug Development. ”Although researchers are looking pretty hard at the
ethical issues, there’s greater risk if you increase the number of children
being studied,” he said.

The rush to experiment on children has been triggered by federal initiatives
intended to improve the safety of drugs for children. Three-quarters of the
medicines used in children have never been fully tested for safety and
effectiveness in them, including heavily prescribed drugs such as the asthma
medication Albuterol. And children have been hurt when doctors lacking that
information prescribed inappropriate doses of drugs marketed for adults.

In response to appeals from pediatricians, since late 1997, Congress has
offered drug companies a lucrative six-month extension of patents on drugs
already on the market if they test them on children. Also, as of last
December, Food and Drug Administration policy requires that any new drugs be
tested on children as well as adults.

Drug companies are already pouring an estimated $1 billion a year into
pediatric testing, according to CenterWatch of Boston, which tracks the
industry. The additional sales of a single blockbuster drug during an extra
six months without competition from cheaper generics could offset that entire
investment.

The increase in pediatric research, which builds on a longer tradition of
testing children in cancer and AIDS research, has brought some benefits.
Since 1997, 14 drugs have been newly labeled with instructions for use in
children as a result of the push, while studies on dozens more have been
completed and are awaiting review by the FDA. Many of the tests are safe and
ethical.

But an examination of research in children since 1994 shows that the potent
combination of vulnerable children, ambitious researchers, potential profits,
and weak oversight can hold great peril for those children. From deadly
infections in Memphis to a troubling misdiagnosis in Arkansas, children have
suffered in the name of science.

In the case of Propulsid, the manufacturer, the doctor, and Children’s
Hospital deny that the drug caused Gage’s death.

”We believe it’s not possible to establish a direct causal relationship with
the administration of the drug. We learned that the infant had been brought
to the ER several days prior [to his death] with serious respiratory
illness,” said Janssen spokesman Greg Panico.

However, county coroner Cyril Wecht is convinced that a reaction to the drug
– not a respiratory problem – killed the child. Although autopsy can never
prove arrhythmia, he said he ruled out all other possible causes.

”We’re satisfied that … we are not acting prematurely, unwisely, unfairly,
or unscientifically,” said Wecht, who is also a nationally known commentator
on high-profile cases.

Moreover, Propulsid was linked to potentially dangerous heart rhythm problems
even before it was approved for adult use in 1993. By 1997, as doctors
increasingly used their discretion to prescribe Propulsid to children despite
the lack of federal approval, the FDA stepped in. Armed with reports of
cardiac deaths of three young children taking Propulsid, regulators suggested
that Janssen test the drug in children or provide a stronger warning label.

Janssen provided the warning label but held off on its own large trials,
instead providing the drug free to researchers, including Dr. Orenstein in
Pittsburgh. Orenstein enrolled about 100 children in her study, which
compared Propulsid given with and without another drug, Tagamet, against a
placebo.

Neither Orenstein nor her lawyer responded to requests for interviews and
hospital officials declined to explain why the study was conducted in a way
that seemed contrary to the FDA warning that Tagamet might increase
Propulsid’s heart risk.

In the months after Gage’s death, the FDA received reports of more than 100
cardiac deaths in people taking Propulsid, including 19 children whose
doctors had prescribed it. Janssen pulled it from the market last July.

”The country is still learning how to study children ethically,” said
Robert Ward, chairman of the American Academy of Pediatrics Committee on
Drugs, stressing that he could not comment directly on the Propulsid case.

Cancer centers have been at the forefront of clinical testing in children,
with long-standing research programs for all forms of the disease. But even
they may not set the best example, despite good intentions.

Three children died of complications in an experiment at the internationally
known St. Jude Children’s Research Hospital in Memphis in 1998 and 1999, as
researchers tried to improve the five-year ”cure rate” for acute
lymphoblastic leukemia, normally one of the most treatable forms of the blood
cancer.

The children, whom the hospital declined to identify, died of infections or
seizures apparently caused by the first phase of the multifaceted drug and
radiation experiment, according to Dr. William Evans, the hospital’s
executive vice president. The death rate in the first phase of the trial,
three of 53 children, was double the usual rate.

Inspectors with the federal research protection office, acting on a
complaint, faulted the hospital for failing to report the deaths promptly
both to the government and to the hospital’s ethical review board, so they
could decide if other children’s lives were at risk.

An independent review, required by the government, later concluded that the
hospital did not unjustifiably delay reporting the deaths and tried to adjust
the experiment to make it safer. Nonetheless, with the deaths still
unexplained, the hospital abandoned the study and agreed to hire an ombudsman
for patients in future studies.

”We have since modified the treatment and had no problems,” said the lead
researcher, Dr. Ching-Hon Pui, who declined to talk in detail about what
happened, saying, ”I still feel bad and I don’t want to refresh my memory.”

Even when cancer researchers know that an experiment may increase the child’s
risk of death, it’s not clear that they always fully inform the children or
their parents.

Two children died suddenly and two more suffered life-threatening infections
in the first phase of a leukemia experiment conducted in 2000 – nine years
after researchers at Dana-Farber Cancer Institute in Boston warned of an
unusually high rate of death and infection in similar chemotherapy.

Among the first 32 children enrolled in the Pediatric Oncology Group study at
sites across the United States, Canada, and Europe, a 10-year-old girl died
from a fungal infection and a 5-year-old girl succumbed to a septic
infection. In addition, a 12-year-old went into shock and a 19-month-old
suffered a brain inflammation, according to a study report.

Researchers at Dana-Farber had warned about just such a tragedy from using
the same drug, dexamethasone, in a four-drug combination during the first
stage of treatment for acute lymphoblastic leukemia. ”The toxicity
associated with dexamethasone used during induction therapy outweighed its
potential benefits,” the Dana-Farber researchers wrote in the journal Cancer
last April, spelling out their earlier warning.

But doctors at the Pediatric Oncology Group, with the approval of the
National Cancer Institute, believed that a change in an antibiotic prescribed
along with dexamethasone would prevent a recurrence of the toxic reactions in
Boston.

Looking back, Dr. William Bowman, the study chairman, said he wasn’t sure
whether the children and their parents were told of the specific risk
suggested by the Boston study. They were warned, he said, about the usual
risk of death during the induction phase for this type of leukemia – about 2
percent. In this case, the death rate was three times higher.

Ultimately, the Pediatric Oncology Group substituted another drug for the
dexamethasone in the first phase. ”We didn’t want to take the risk any
longer,” Bowman said.

Today, other researchers are reluctant to criticize Bowman’s team, since
dexamethasone shows such promise against cancer. ”Part of our task is to
fine-tune how we use these drugs in an attempt to improve outcomes. Sometimes
very small changes have adverse outcomes and sometimes they have positive
outcomes,” said Dr. Stephen E. Sallan, chief of staff at Dana-Farber.

But Boston University medical ethicist Leonard Glantz said the doctors should
have spelled out the risks and alternatives for the parents. ”Certainly
parents should be told when you have a responsible medical authority who
thinks the risks of a particular regime are especially high. It appears there
were some alternatives that reasonable scientists would argue were less risky
for the children.”

There is strong reason to believe that deaths and injuries in research
involving children are more widespread than what is reported to government
offices that handle complaints. For one thing, parents of children with
serious diseases often see drug trials as their best option and are less
likely to complain later if something goes wrong. In addition, many parents
erroneously believe signing a consent form detailing the risks of the
experiment means giving up their right to a remedy.

”They think if something negative happened, `Well, I accepted it and I have
nothing to complain about,”’ said Abbey Meyers, president of the National
Organization for Rare Disorders, a patient advocacy group.

Adding to the difficulty of assessing the scope of research injuries, neither
drug companies nor the FDA typically release information about problems in
drug trials, unless the drug is approved. And even after approval, the FDA
drags its feet in releasing details of the trials. Moreover, there is no
national effort to track the testing of children or any central review of the
reports of side effects.

”It’s likely we wouldn’t be aware of it unless a patient or their parents
brought it to public attention or there was an investigation by [the US
Department of] Health and Human Services. Things could happen very easily and
no one would know about it,” said Dr. Ralph E. Kauffman, director of
research at Children’s Mercy Hospital in Kansas City, Mo., and a leader of
the movement to test drugs in children.

Kauffman, like many researchers, believes that the new testing program is
much safer than the current system in which doctors prescribe drugs without
knowing their effects. ”The risk to a child in a well-run clinical study is
much less than the risk of a child receiving that drug in a doctor’s office
without specific information on dosing,” he said.

For instance, the antibiotic chloramphenicol was widely used for infections
in premature infants until a study in 1959 discovered that babies were unable
to metabolize the drug and it was killing them. The drug had only been
approved for use in adults for infections resistant to penicillin.

Such problems led the American Academy of Pediatrics to campaign for testing
of drugs in children in the late 1970s. But drug companies resisted, citing
the difficulties of finding qualified researchers and parents willing to
volunteer their children as well as the legal liabilities. While a few
companies pursued the pediatric drug market, many saw no financial reason to
do so since drugs approved for adults could be legally prescribed to children.

But an act of Congress in 1997, giving companies financial incentives to test
drugs in children, has led to a flood of testing. Milne, of Tufts, estimates
600 industry-funded studies are underway, double the number in 1997.

The initiative has spurred the creation of a testing infrastructure,
including government-supported centers around the country. In New England,
Yale University houses one center, where 10 studies are ongoing. New England
is also home to two other big players in the private sector – Parexel
International of Waltham, a contract research organization that recently
established a pediatric division, and Kelson Pediatric Partners of Hartford,
which says it has developed a network of pediatric researchers with access to
a pool of 120,000 children. Boston’s academic medical centers have seen a
small increase in testing.

So far, there are no indications of abuses of the magnitude of those at the
Fernald State School in Waltham during the 1940s and 1950s when retarded
children were given radiation-spiked cereal in a test sponsored by MIT and
Quaker Oats.

But there are plenty of troubling examples of research that demonstrate weak
oversight of the burgeoning wave of studies.

In the case of Propulsid, the FDA finally took Dr. Orenstein to task for
numerous failings in her study. But its review came five months after Gage
Stevens died.

FDA investigators found she failed to report to her hospital review board a
number of earlier problems resulting from the drugs, including the case of a
baby who had to be hospitalized when he briefly stopped breathing.

In addition, the FDA noted egregious errors in the consent form that the
Stevens family signed, including the incorrect claim that Propulsid had been
approved for use in children and a failure to spell out known risks.

Stewart and her husband, Scott Stevens, filed a wrongful death suit last
September that also accuses

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02/15/2001 – RISKING KIDS' HEALTH FOR SAKE OF SCIENCE – AT WHAT COST?

http://www.nypost.com/commentary/23654.htm

RISKING KIDS’ HEALTH FOR SAKE OF SCIENCE

Monday,February 12,2001

By DOUGLAS MONTERO

————————————————————————
AT WHAT COST?
Columbia’s Dr. Laurence Greenhill heads the Ritalin study.
– NYP: Rick Dembow

TWO city research institutions will extend their tentacles into our
communities today, looking for hundreds of kids, some as young as 3, to use
as guinea pigs.

The experiments, to determine the safety and efficacy of Ritalin in
preschoolers, have advocates up in arms – they think researchers are playing
fast and loose with the brains of children.

“Where’s the limit?” asked Dr. Ellen Isaacs, a member of the Coalition
Against the Violence Initiative, a grass-roots group in the Washington
Heights section of Manhattan. “Are they going to give it to kids in the
womb?”

The rationale of the nationwide experiment on the preschoolers seems noble –
Ritalin is already prescribed by doctors like lollipops without any sound
medical evidence to show that it’s safe for a child’s developing brain.

About 2 million kids nationwide, nearly a quarter-million of them between
ages 2 and 4, take Ritalin and other psychiatric drugs, according to a March
2000 report by the Journal of the American Medical Association.

The report inspired then-First Lady Hillary Clinton, who was a candidate for
the U.S. Senate at the time, to prod the White House to look at ways to stop
the alarming trend, and that translates into experiments. Some thought
Clinton’s motives were political, others applauded her.

The National Institute of Mental Health subsequently gave $6 million to a
consortium of six institutions, led by Dr. Laurence Greenhill of Columbia
University, to conduct the Ritalin study. New York University also is part
of the group.

Two-thirds of the more than 300 kids in the nationwide study called
Preschool ADHD Treatment Study (PATS) will be under 6 years old.

They are looking for kids with symptoms of Attention Deficit Hyperactivity
Disorder who have never been medicated.

Members of the coalition two weeks ago protested outside Columbia
Presbyterian Medical Center, which is affiliated with Columbia University,
handing out leaflets alerting parents, schools and community groups.

The coalition is worried researchers will offer money for subjects or give
parents false hopes that their children will be cured. They also worry that
the unknown, long-term side effects of the drugs might harm kids.

Advocates are also wondering how researchers are going to properly diagnose
the preschoolers – some of who can’t express themselves thoroughly.

“Obviously, if it’s the researchers doing the diagnosis, it is in their
interest to diagnose kids with ADHD because they need them for the study,”
said Leonard H. Glantz, a law professor at Boston University and author of a
book on the ethics of researching on children.

“Unlike doctors, researchers don’t have the best interest of the patient in
mind.”

Greenhill said the five-stage, 40-week study has been reviewed and
re-reviewed by five ethics panels “to make sure the rights of the children
and their families’ rights are protected.”

Researchers will seek kids by advertising, by referrals from local doctors
and by sending flyers to private schools – since they are prohibited from
recruiting at public schools, Greenhill said.

The children will be diagnosed by a special group of researchers composed of
up of six institutions, including Johns Hopkins, University of California at
Los Angeles, University of California at Irvine, and Duke, said Greenhill,
who insisted the parents will only be given money to get and from the
hospital.

Greenhill is seeking more than 60 kids whose parents will first receive
training to see if their child’s behavior improves. The second stage
involves low-dose medication that’s later upgraded, Greenhill said.

The fourth stage includes a placebo experiment, where some kids get a sugar
pill. Advocates say children will suffer from withdrawal symptoms because
Ritalin is addictive.

Parents have to sign consent forms for each stage, including the last, which
includes a gradual tapering off or continuation of the drug.

Informed of the study she inspired, Clinton spokeswoman Karen Dunn said,
“Hillary Clinton is very concerned about the increased use of Ritalin in
young children and has strongly supported efforts to determine whether it is
being used appropriately and effectively.”

That sounds politically and morally correct, but the folks in Washington,
D.C., aren’t going to be around to see what becomes of these kids who donate
their brains to science.

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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.”

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