08/02/1999 – SSRI Prescribing in Primary Care Draws Fire

Note that 8% of all general hospital psychiatric admissions caused by
SSRI-induced psychoses!–Thanks to Ann Blake-Tracy for passing this along.
Mark
———–

FromClinical Psychiatry News

SSRI Prescribing in Primary Care Draws Fire

Todd Zwillich, Senior Writer

[Clinical Psychiatry News 27(6):34, 1999. © 1999 International Medical
News
Group.]

————————————————————————
More primary care physicians are prescribing antidepressants, but some
observers worry that patients aren’t being evaluated closely enough for
potential adverse reactions or monitored appropriately while taking the
drugs.

Research is beginning to show that “large numbers” of prescriptions for
selective serotonin reuptake inhibitors (SSRIs) aren’t accompanied by a
diagnosis of depression or any other mental condition, said Stephen
Crystal, Ph.D., a researcher who studies prescribing trends at Rutgers
University in New Brunswick, N.J.

“We have a massive uncontrolled experiment going on out there,” he
said.

The number of doctor office visits including an antidepressant
prescription more than doubled between 1985 and 1994 to more than 24
million, according to data from the National Ambulatory Medical Care
Survey (NAMCS). Researchers attribute the rise to the popularity of
SSRIs.

While an estimated 11 million psychiatrist appointments included an
antidepressant prescription in 1994, more than 10 million other
antidepressant prescriptions were written by primary care doctors.
Preliminary analysis of survey data extending through 1996 shows that
antidepressant prescriptions are now more common in primary care
offices than in psychiatrists’ practices, according to Dr. Crystal.

Managed care is at least partly responsible for the trend. Primary care
physicians acting as gatekeepers in HMOs have been encouraged to treat
potentially depressed patients rather than refer them to specialists.
At the same time, primary care doctors are becoming more comfortable
with the newer SSRIs because they are relatively easy to use.

Toxicity and overdoses are rare, and potential drug interactions are
far less common than with other drug classes. The drugs may also
provide a convenient way to treat somatizing patients who have a few
depressive symptoms without a full-blown depressive episode.

But relatively few data exist to support SSRIs’ efficacy in treating
the “subthreshold” patients often seen in primary care. Many of those
patients may get SSRIs without any official diagnosis, according to Dr.
Harold Pincus, who last year published a study on psychotropic
prescribing using NAMCS data.

Office-based psychiatry practices tend to aggregate around more
affluent and better-educated patients in medium and large cities. Most
observers agree that primary care’s new dominance in antidepressant
prescribing makes the drugs available to a wider range of patients.

“Those who are underserved by specialists are nonwhite and not wealthy.
They are the ones who benefit most from primary care physician
prescribing,” said Dr. Gregory Simon, a psychiatrist who studies
prescribing patterns at Group Health Cooperative of Puget Sound in
Seattle.

The American Psychiatric Association recommends in its depression
treatment guidelines that patients continue their SSRI prescription for
4-5 months after complete remission of their symptoms. But data from
Group Health Cooperative–an HMO that emphasizes primary care treatment
of mental conditions–show that only 34% of patients on SSRIs refill
their prescriptions often enough to suggest continuous use.

At the same time, new data from the Rutgers group show that Medicare
patients treated in primary care are more than twice as likely as
similar patients treated in psychiatric settings to fill their SSRI
prescriptions only once, Dr. Crystal commented.

Others worry that physicians are not paying enough attention to patient
factors that could make initiation of SSRIs dangerous. Dr. Malcolm B.
Bowers Jr., a psychiatrist at Yale University in New Haven, told
CLINICAL PSYCHIATRY NEWS that SSRI-induced psychosis has accounted for
8% of all general hospital psychiatric admissions over a recent
14-month period. [emphasis added]

The pattern suggests that while SSRIs are a help to the majority of
patients who take them, more needs to be done to make sure that doctors
prescribing the drugs evaluate patients for psychotic predispositions
vulnerable to SSRIs. Such patients may include those with a history of
psychotic illness or early signs of mania.

“What is surprising is that this particular group of side effects is
really
underplayed,” Dr. Bowers said.

Dizzy and Nauseous Withdrawing from Generic Wellbutrin

“I am not going to go away! I want some answers!”

 

I am a 49 year old Wife and Mother of 4 who has been successfully taking Wellbutrin for depression since April of 1996. I take 450 milligrams a day. (2 pills 3x daily) Friday morning July 28, 2000 I woke up feeling dizzy and nauseous with horrible pains in my stomach. I had felt “funny” the night before so I went to bed early. I soon developed severe diarrhea. I thought I had contacted a bad case of the flu. My symptoms got worse as time went on. I was completely drained. I had no energy. I had to drag myself around the house and had to lay down every few minutes. The room was spinning and I constantly felt like I was going to vomit, but I never did.

At one point, late Friday evening, I considered going to the emergency room. A Doctor friend of mine came over to examine me and recommended that I get a colonoscopy. He thought it must be my colon. I had a colonoscopy and had my inner ear examined. I was told I probably had an inner ear infection and that I was experiencing vertigo. I have had vertigo before and it lasted for one, two, maybe 3 days at the most. I was going into my 3rd week and I was still dizzy and nauseous. In addition to all this, I experienced a kind of a strange vibration going on inside my head. It felt like something was shaking, similar to the machines that mix paint! Also, the right side of my face felt a pressure and I truly thought I must have a brain tumor! It was so horrible!

Friday, August 25, 2000, I happen to catch a 20/20 about the withdrawal symptoms after going off an antidepressant. The people they interviewed had the exact same reactions as myself. I could not believe it. Everything they had, I had, including the brain thing. They called it a feeling like an electric shock in the brain! I was curious as to why I was having all of these withdrawal symptoms because I had not stopped taking my antidepressant, Wellbutrin. I looked at my bottle and noted the day I had my last prescription filled was the day before I got so violently ill. I also noted that for the first time since 1996, I had been given the generic brand. I have been on Wellbutrin for a very long time without any symptoms until I had the generic. (Bupropion)
Something has to be done! People need to be warned of these complications. I do not want anyone to go through what I had to go through! I wrote the producer of 20/20 and told her what had happened to me. I want to know if anyone else has had a similar experience with the generic.

I am not going to go away! I want some answers!

Rosemary Durkin Snyder
4kids@compuserve.com

 

8/28/2000

This is Survivor Story number 13.
Total number of stories in current database is 96

8/25/2000 – 20/20 Show Tonight on SSRI Medications

FYI–Tonight (Friday, 8/25/00) on ABC 20/20 at 10pm eastern
time will be another show about the problems with SSRI
medication.

Please check your TV GUIDE for the time in your area. Mark

H I G H L I G H T S
Friday. Aug. 25 Dr. Nancy Snyderman examines the possible
side effects when discontinuing an antidepressant like Paxil and
Zoloft. Chris Wallace confronts a man who was convicted of
trying to get his ex-wife murdered.

Weight Gains on Effexor ER

“In less than a year I have gone from 120lbs to more than 200lbs.”

 

After I had my daughter I became depressed and my family doctor put me on Zoloft and lorazipam. Around the same time my OBGYN put me on the Deproprevara shot for birth control. When I rapidly gained weight the doctor suspected the Deproprevara. I was taken off of it and my Zoloft script was increased. My family doctor said that this would help with weight loss as well as the depression. Why not kill two birds with one stone?

The weight came off but every 3 months or so I noticed that my depression, along with panic and anxiety attacks, would return and be worse, so the Zoloft and lorazipam scripts continued to be increased in dosage. When I approached my family doctor about my concerns on the increased dosage without relief she suggested that I change medications. I was immediately switched to Effexor XR.
I am still taking Effexor XR and since I switched, my weight gain has been tremendous. I am also sleeping most of the day, and I crave alcohol. I am a smoker but as of late, I have increased my habit from less than a pack a day to about 2 and 1/2 packs a day.

In less than a year I have gone from 120lbs to more than 200lbs (I am 5’6″, and 27yrs old). When I started these drugs I was a water aerobics instructor, and taught 6hrs of swimming lessons Fridays, Saturdays, and Sundays. Now I can barely get out of bed in the afternoon to clean the house. I need help. I know what it does to me body and brain when I simply miss a dosage, let alone quit it completely.

D.R.

 

8/17/2000

This is Survivor Story number 14.
Total number of stories in current database is 96

8/16/2000 – Research Hearings on Conflict of Interest

Marcia Angell, former editor in chief of the New England Journal
of Medicine, wrote in an editorial this spring titled “Is
Academic
Medicine For Sale?” This article seems to confirm these
suspicions. Hearings are scheduled next Tuesday in
Washington, D.C. on this issue. Mark
———-

Questioning Research
Hearings on Keeping Conflict of
Interest Out of Clinical Research

Subjects of clinical trials are typically required to sign informed
consent papers that explain every detail about the experiment’s
risks and benefits. But these papers often fail to say whether the
investigators will be profiting from the results. (Art Today)

By Melissa Schorr

B O S T O N, Aug. 14 — An 18-year-old young man dies in a
gene therapy trial led by an investigator at University of
Pennsylvania.Soon after, it is revealed that the investigator and
the school both had a stake in the biotech company planning to
commercialize the study’s findings.
Rezulin, a diabetes drug that was put on the fast track for
Food and Drug Adminstration approval, is yanked when it is
found to have led to the deaths of 63 patients and caused liver
damage in thousands of others. It is later revealed that
members of the review board and trial investigators had received
compensation from the drug’s manufacturer.
In response to cases like these from the past year, and a
rising concern that financial conflicts of interest could be
harming the safety of patients in clinical trials — not to
mention
the integrity of research itself — the Department of Health and
Human Services will kick off a two-day public meeting on the
issue Tuesday in Washington, D.C.

Patients, Not Pocketbooks
The conference, called “Human Subject Protection and Financial
Conflicts of Interest,” will bring together patient advocates,
university academics, clinical researchers, hospital staff,
entrepreneurs and government officials to help the agency firm
up its policy requirements.
The key issue will be ensuring that medical researchers are
always looking out for the best interests of their patients, not
their
pocketbooks.
Of concern: Might some researchers bend the results to get
the answer that will give them the million-dollar payoff? Would
they cover up any adverse effects when signing on new patients?
And should patients always be told of possible investigator
bias?
“Today, we’re living in a world where the primary
investigator
may own the company [conducting the study] or have stock in it,”
says Abbey Meyers, president of the National Organization for
Rare Diseases, a patient advocacy group. “It’s in his best
interest that if the trial isn’t successful, maybe he won’t
release
all that information to the public.”

Gelsinger Case Highlighted
The case of Jesse Gelsinger, the 18-year-old Tuscon, Ariz.,-man
who died in a gene therapy trial last September, has put this
issue in the spotlight.
After Gelsinger’s death, an FDA investigation revealed he
may
not have been properly informed of all the risks of the study and
that he may not have been a suitable candidate for the study, but
was admitted anyway.
“We’re left wondering: Was the scientist’s
financial benefit
linked to the fact that this young man was not told the whole
truth?” says Meyers, who will be voicing such concerns at the
conference. “There should never be that doubt.”
Of course, experts point out, other motivations have always
been at play in the research world: ego, reputation, social
agendas, pressure to “publish or perish.”

Money Conflicts Potentially Enormous
But financial conflicts of interest are of immense interest now
because academic researchers today are more likely to also be
stakeholders or CEOs of companies than ever before.
Marcia Angell, former editor in chief of the New England
Journal of Medicine, wrote in an editorial this spring titled “Is
Academic Medicine For Sale?” that the ties between industry and
academia have gotten out of hand.
“So much clinical work today is co-mingled with
commercialization,” agrees Sheldon Krimsky, a science policy
expert at Tufts University in Medford, Mass.
And that may affect decision-making. “Any time you’ve
invested money into something, it’s going to reinforce any
enthusiasm you have,” Krimsky says. “You wonder, `Are
they
holding on to this trial because their kid’s education is in the
balance?’ It’s a real issue.”

Lapses Exception, Not Rule
But many researchers say that these high-profile cases of
alleged ethical lapses reflect the exception and not the rule.
Adequate protections are already in place and just need to be
better enforced, they say.
“If I invent a new drug and build a start-up company and
begin
to test my invention, I must follow a dizzying set of regulations to
assure a valid and honest test of the drug,” says Dr. Patrick
Lyden, chief of clinical neurology at the University of California at
San Diego. “I believe that further legislation or administrative
rule-making is unnecessary.”
Current policy requires researchers to disclose possible
financial conflicts of interest when applying to the Public Health
Services, including the National Institutes of Health, for a grant,
and when applying for FDA approval. Researchers must then
inform their patients of financial conflicts, as well.

Money Interests Not Disclosed
But no one is ensuring that patients are being told.
At individual hospitals, institutional review boards are
given
the responsibility of evaluating proposed clinical trials and
making sure patients will be protected.
Subjects of clinical trials are typically required to sign
informed consent papers that explain every detail about the
experiment’s risks and benefits — but often omit whether the
investigator will be profiting from the results.
At schools like the University of California at Los Angeles
and
at Johns Hopkins School of Medicine in Baltimore, Md., policy
requires that researchers tell patients when they have a financial
interest in the product being tested.
“We are obligated to fully disclose any information that
a
reasonable person would want to know,” says Steven Peckman,
associate director of human subjects research at UCLA. “A
potential research subject can make a considered decision
whether they want to embark on the project.”

Public’s Right to Know
But Mark Brenner, associate vice president of research at
University of Indiana, who will speak at the conference on behalf
of the American Association of Universities, says the AAU’s
policy will be that researchers disclose possible conflicts of
interest to their review boards, who then make the call as to
whether the information gets passed along to the research
subjects.
“Whenever it’s appropriate, you should inform
patients,” he
says. “But there are times where you may well overdo it. There
are examples of where it is more benign.”
Some worry the public will stop volunteering for trials if
the
suspicion of impropriety is planted in patients’ minds. “This
could have a downside effect, it might turn people away from
entering clinical trials,” says Krimsky. “It produces a kind
of
skepticism that is not really going to be helpful to science.”
But Meyers advocates that patients have a right to know.
“Leave it up to the judgment of the patients,” she says.
“It’s
wrong to hide it.”

Link to at:
http://www.abcnews.go.com/sections/living/DailyNews/fdahearin
gs000814.html

8/2/2000 – Learning about SSRI dangers from the Ecstasy epidemic

Thanks to George Ellis for bringing the following report on Ecstasy to
our attention and for his voice of sanity in this insane serotonin drug
situation. Be sure to note the comment “First patented under a differnet name
as an appetite suppressant, ecstasy releases a neurotransmitter called
serotonin, which heightens energy levels. The drugs short-term side effects
include muscle pain, impaired sexual performance and depression.”

Ecstasy – yet another prescription medication gone bad. With the same end
effect being an increase in serotonin and the side effects being so similiar
to the SSRI antidepressants why is the Ecstasy use considered an “epidemic”
when one eighth of the population of America is on SSRIs?

Ann Blake-Tracy
_____________________

Watching ABC World News tonight, I was watching a segment on the
interception of a million Ecstasy tablets by Customs officials when I saw
an absolute Lewis Carroll absurdity. Peter Jennings narrated that many
people don’t think Ecstasy is harmful, but that others warn of the “Suicide
Tuesday” that follows a weekend Ecstasy high. He then explained, with an
illustration, how Ecstasy works by increasing seratonin production,
flooding the synapses with seratonin. It looked so familiar.

Excuse me, but isn’t this a case of the government putting an alarm label
on Ecstasy while the SSRIs get a clean bill of health for doing exactly the
same thing? I mean, isn’t the real difference a matter of whether a company
and its army of lawyers and paid researchers have spent what it takes to get
FDA approval vs. someone who skips all that and just makes the pills and
sells them to partygoers? So who’s really being protected here, the public or
the pharmaceutical companies? If Ecstasy is so bad for flooding the brain
with seratonin, and Prozac does the same thing, Why is one the target of
federal law enforcement and the other pushed by doctors and HMOs? Does the
difference consist of continuing to pop the pills (can you spell “mandated
addiction”?), and Suicide Tuesday is perhaps moved to a Friday?

Huh? I just don’t get it.

George Ellis
Chief Copy Editor
_______________

Here is the ABC news report:

First patented under a different name as an appetite suppressant,
ecstasy releases a neurotransmitter called serotonin, which heightens energy
levels. The drugs short-term side effects include muscle pain, impaired
sexual performance and depression.

Dangers of Ecstasy

Designer Drug Holds Unknown Health Risks

U.S. Customs Commissioner Raymond W. Kelly holds up a bag full of Ecstasy
during a hearing on Capitol Hill on Tuesday before the Senate Caucus on
International Narcotics Control in Washington. (James R. Tourtellotte, U.S.
Customs/AP Photo)

By Bill Blakemore

July 26 On Saturday, federal agents intercepted 2.1 million tablets, nearly
1,100 pounds, of the drug MDMA, commonly known as Ecstasy at Los Angeles
International Airport. Valued at $40 million, officials said it is the
biggest Ecstasy bust in history and it marked the high point of a 10-month
investigation by the Southwest Border Initiative, a multi-agency task force.
That™s 2.1 million tablets of Ecstasy that won’t go to our kids this
year, Stephen Wiley, FBI special agent in charge, said during a news
conference today.
Three men were arrested Tuesday. Authorities were still searching for
Tamer Ibrahim, 26, of Los Angeles, the alleged ringleader of the operation.
They arrested Ryu Steve Jiha, 35, Mark Edward Belin, 28, and Damon Todd
Kidwell, 29, all of the Los Angeles area.
The group has been linked to several other large seizures around the
world, including 700 pounds found by U.S. Customs agents in December 1999,
authorities said.
The cache confiscated Saturday was found in 15 boxes on an Air France
flight from Paris and represented one-fourth of the 8 million tablets of
Ecstasy seized in the United States this year, officials said. By comparison,
only 400 tablets of the drug were seized in the United States three years
ago.

Unknown Risks Across the Board

Ecstasy, a synthetic drug manufactured mostly in Europe, is a hallucinogenic
stimulant that gives its users a feeling of euphoria.
The popular drug has spread beyond rave parties to college campuses and
even into middle-class, professional America.
Its growing pervasiveness is troublesome because the prevailing belief
is that it’s perfectly safe in part because some scientists think it might
have therapeutic effects. Also, it does not produce extreme behaviors as some
other illegal drugs do. It just seems to make you feel good.
My experience has been very safe with it, and everyone around me has
been safe, says one 29-year-old professional who runs her own business and
choose not to use her name. I don’t know anyone who’s addicted to it or
has
problems with it.
But a number of users do report a depression they call Suicide
Tuesdays. Dozens of people are reported to have died after Ecstasy raised
their body temperature to extreme levels. And scientists who study how
Ecstasy works in the brain say there is a great deal of evidence that should
make us worry.

Irreversible Brain Damage

Repeated Ecstasy exposure has been shown to lead to clear brain damage and
that brain damage is correlated with behavioral deficits in learning and
memory processes, says Alan Leshner, the director of the National Institute
on Drug Abuse, which is a part of the National Institutes of Health. This is
not a benign, fun drug.
Normally, your brain controls mood partly by passing the chemical
serotonin in small amounts from one brain cell to another. But Ecstasy
forces lots of serotonin across the gap. Some new research suggests it leaves
brain cells weakened and may cause irreversible brain loss.
We know from primates, non-human primates, that the damage lasts for
years, says Una McCann, a neuroscientist at Johns Hopkins University.
Some scientists, on the other hand, report Ecstasy may have benefit in
strictly limited cases.
One group were interested in studying are individuals with end-stage
cancer who have severe depression and anxiety and physical pain which have
not responded to conventional measures, says Charles Grob, a psychiatrist at
Harbor UCLA Medical Center.
If medical use is ever allowed, it is far off. For now, government
agents are battling the spread, and the myths, of a pill called Ecstasy,
which for them, at least, is anything but.

The Associated Press contributed to this report.

Suicidal Wife on Paxil Shoots Husband

“I know it’s the Paxil.”

 

Attached is a photo of my sister Suzanne and her family. They live in Silverton, OR. She married Matthew Miles @ 5 years ago and they had Maddie on October 13, 1997. Suzanne’s 2 older girls, Brittany, 17, and April, 13, are from previous relationships. Suzanne began taking Prozac quite a number of years ago (about 7) and everything was fine. Then last year she said it wasn’t helping anymore. Her doctor told her to double her dosage. It started making her feel crazy – twitching, anxiety attacks. So they switched her to Paxil. She began taking Paxil in mid-January 2000. On February 29th, she shot and killed her husband Matthew. He was just 31 years old. Maddie has lost her father. My nieces’ have lost their mother and is in jail for killing him. My sister says that she started feeling suicidal and went to her husband’s work to kill herself in front of him. She doesn’t know why but she shot him instead. She and Matt had recently separated and I know the DA is going to try to say that she was distraught over the breakup, but I know it’s the Paxil. After reading all of the emails sent by you and reading the articles on the internet, we now need to prove that it was the Paxil and not just a woman killing her husband for leaving her.

I hope that your lawsuit will help in the fight of changing how these drugs are prescribed. They are dangerous and should not be prescribed like they are in most cases – “Here – try this. See if this helps.”

I’m so sorry for the loss of your son. I can’t imagine what it might be like losing your child.

Jill Robertson
2321 Eaton Avenue
San Carlos, CA 94070

 

7/31/2000

This is Survivor Story number 15.
Total number of stories in current database is 96

7/27/2000 – TV Interview on 8/4/2000

Jurgen and Brenda Viktor will be on the Queen Latifah Show on August 4, 2000.
They will be interviewed about their son Jared’s tragic experience on Paxil,
an account of which, written by his mother and posted on the
www.drugawareness.org site, follows below. You will need to check your local
TV guide to find times and stations in your area that will cover this program.

16 Year Old Son Convicted Of Murder After 5 Days On Paxil

——————————————————————————

“I was frightened and bewildered. Nothing like that had ever happened before
with any of our children.”

I’m writing regarding the radio show you were interviewed on in June of this
year. I was very fortunate to catch this interview, normally I am not awake
at this hour of the night. I was both delighted and disappointed. Delighted
because you almost never hear the dangers of these “mind altering drugs.”
Disappointed because nobody seems to care. I call these drugs “mind altering”
because the name “anti-depressant” doesn’t fit the consequences they can
have. I feel you are a ray of hope to people like me who have experienced the
horrible effects these drugs have.

I have four children. My youngest child, Jarred was put on Paxil at 16. I
took my son to the doctor because I was concerned about his abuse of alcohol.
After a 15 minute evaluation, the doctor concluded Jarred was depressed. He
gave us sample boxes of Paxil, a month supply. He gave us no instruction
except to take one a day. There were no instructions with or on the sample
packets. After the first day on this drug, my son complained of severe
agitation, he said he felt “weird.” I called the doctor and asked if he had a
smaller dosage. I told him I thought they were too strong for Jarred. The
doctor told me there was not a smaller dosage than 20mg. He said I should cut
them in half. A couple days later my son became combative with me and his
father. The police had to be called. I was frightened and bewildered. Nothing
like that had ever happened before with any of our children. I didn’t connect
these drugs with this incident, I thought it was from alcohol use. Three days
later, a family friend was murdered. Jarred was charged and convicted of
first degree murder. He is in a California state prison serving life without
parole. We were in shock, in total disbelief this happened.

The victim was someone we spent time with. Jarred would play games with her.
He spent nights at her house with my other children. Jarred cared very much
for this special lady. This was extremely out of character for Jarred. We
couldn’t understand what happened. No one believed Jarred could do this. We
didn’t connect the drug to what had happened until Jarred’s attorney asked us
about the Paxil he was taking. He said he found cases where people have taken
these drugs and committing horrible crimes. It puzzled Jarred’s lawyer
because Jarred had never been in trouble or had never been violent.

This has been heavy on my heart for four years. We’re hearing of more and
more cases of horrible crimes committed by people who are on these drugs.
There is definitely a connection.

My question to you is what can I to help get the message across. I have been
silent too long. I want to do something to help. I want to do anything I can
to stop these tragedies from happening. I know they will continue to occur
with some doctors handing these drugs out like aspirin.

I realize you are very busy. I greatly appreciate your work. I would love
very much to hear from you.

Brenda Victor
jvikt@…

Awake for 800 Hours Straight and Unable to Function after just 25mg of Paxil

“Did I undergo a ‘chemical lobotomy?'”

 

In January of 2000 I fell into a deep depression over complications following laser eye surgery.

[Note from Dr. Tracy: Keep in mind that many go into depression after surgery as an after effect of anesthesia and/or pain killers – many of which are also serotonergic medications. The logical thing to do in this instance is to rest, get good nutrition and wait out the after/withdrawal effects rather than adding yet another serotonergic drug as is done so often.

I had no family locally, and was calling them daily for support. I became unable to focus at work, so they urged me to get medical treatment. I asked my psychotherapist for a reference; he sent me to a family practice MD. That is when things went from bad to worse.

I had no psychiatric history prior to this and had always been a healthy, physically active (a real athlete), artistic (songwriter), productive individual. I am a software engineer, and so I also had a mentally demanding job which I excelled at. That all changed after taking Paxil, which this MD gave me after only a 5 minute consultation (he had never seen me before). Unfortunately I was a nervous wreck at that point, and did not ask any questions. He did little more than read from the “starter kit” literature:

“Paxil – indicated for depression, indicated for OCD…”. If it had been Prozac the alarm bells may have gone off, but I had never heard of ‘Paxil’ and was desperate for help. I left with the twenty-one day starter kit.

I took the first 10 mg pill on a Friday, and only took 25mg (2.5 tablets) of Paxil over the next four days. But this seemingly innocuous amount made my life hell. I could no longer sleep, EVEN A MINUTE, for five weeks! That’s correct, I was up 24hrs a day for the next five weeks, staring at the ceiling and locked in a mental fog around the clock. I emphasize this because it is so amazing. I would not have believed that it was humanly possible to go that long without sleep, but I lived through it. It would be five weeks before my eyes would close again.

I should have known I was in trouble when the first pill started the insomnia, made me hop around like a rabbit, while the second 10mg pill gave me the sensation of my frontal lobe being set on fire. It sent me into a drug trip, fantasizing about my death constantly. I didn’t seem to have control of my thoughts either, as my mental processes seized up like gears that haven’t been oiled. My drug sensitivity probably made me very vulnerable to adverse effects. But my very pure organic diet should have helped to counter the adverse effects. I had eliminated all caffeine from my diet years ago due to this chemical sensitivity. It also took much longer than normal to awake from anesthesia after any surgery, and my natural energy level was always very high.

Because of being trapped in this zombie-like state, I was having suicidal urges for the first time in my life. Also, I tried to work, but I would just come in to the office, sit for a few minutes in front of the monitor and then turn around and leave. I couldn’t initiate and complete anything even of moderate mental complexity, even responding to e-mails, so it was hopeless. Thoughts would just fizzle out.

How to escape this living hell? After day four my feeling was “I have to get these things out of my system!”. So I took nothing else (although the MD said “cut it back to half a tablet”). Every day I was desperately wanting to fall asleep, even for a few minutes, but it just wouldn’t happen. When would the Paxil leave my system — what was happening? As the sleepless days progressed, I got foggier and foggier, finally to the point that even dialing a phone number became a mental feat.

This downward spiral progressed for the full five weeks, until my parents came to get me. I was no longer eating, no longer leaving the apartment for anything, and was simply wasting away. So, five weeks after quitting cold turkey and getting zero sleep in that time, I was admitted to a hospital as I was unable to function.

In the psychiatric ward I was given Zyprexa, Klonopin and Depakote, having been diagnosed there as manic (who wouldn’t be after being up day and night for five weeks?). This was a misdiagnosis, I believe, and more drugs in my system just fanned the fire. I was able to finally get 2-3 hours of sleep a night, but I found that a drug induced sleep is not a restful, refreshing sleep.

I then went home to stay with my parents as I was unable to care for myself for the first time in my life (I am 36). A psychiatrist in my parents hometown kept me on these three medications for another week until he switched to Effexor for a week, followed by Neurontin for several weeks, and then he added Zoloft in mid-March. I was reluctant, but my well-meaning parents were completely trusting and would not let me skip any prescribed medication as I was still suicidal. I took just one 50mg dose of Zoloft and I immediately “locked up again” mentally as before. The insomnia resumed, too. I begged my parents to take me to see someone else. Unfortunately this guy was the only psychiatrist in a 50 mile radius, but we persisted and found someone an hour away.

This MD was the first medical professional to actually acknowledge that the psychotropics made me suffer. She recommended that I have nothing else, and return to an organic diet (which I had been on since 1990!). She gave me dietary guidelines for depression, most of which I had been following already. It took less time to get back to sleeping at night after the Zoloft (was my body building a tolerance?), but after a week or so I was sleeping 3-4 hrs. a night.

It is now July and I have had no medication since. Yet, I have a foggy feeling still, my memory is not as sharp, and my abstract reasoning/problem solving ability is compromised. I feel a vague numbness in my forehead also, similar to a mild hangover, a lingering reminder of the near catatonic state I was in originally. Nothing is the same, nothing is as sharp or clear or enjoyable as it was before. Dr. Joseph Glenmullen’s book “Prozac Backlash” has given me some insight into what may have happened to me. Did I undergo a ‘chemical lobotomy’ and lose axons or other brain tissue? It is a scary thought. But I have learned some things.

I now know that the chance of a doctor completely informing you is slim. He may not even be withholding information: He just may not know himself of all of the possible side affects. I also know that there is no “standard dosage” that is safe for everybody. If you are drug sensitive, perhaps it is better to start with a half a tablet of a new medication than to risk an extreme reaction as I did? Or, better still, to avoid drugs at all costs… to be used only as a last resort.

Good health to you all.

Bruce

7/25/2000

This is Survivor Story number 16.
Total number of stories in current database is 96

7/25/2000 – Clinical trial revenue streams lead to more scandals

This article might explain why your doctor’s interest has shifted away from
you as a patient. He may be looking at you with $$$$ signs stamped all over
you as he envision another guenia pig for yet another clinical trial funded
by a large drug company.

Most of you are aware, or certainly should be aware, of the scandal involving
the two researchers in Georgia that are now in prison for their fraudulent
research over a ten year period on drugs such as Paxil, Celexa, Zyprexa and
others. They were out spending their millions that was coming in on the
research while their secretaries conducted the research for them.

Now breaking news out of Oklahoma reminds us once again of the dangers
involved when research is conducted in this way. Can you guess yet where the
old family doc who used to make house calls went? Thanks to the
pharmaceutical industry, medicine in America has become nothing more than
just another big business.

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

http://neurology.medscape.com/LWW/NP/2000/v07.n06/np0706.01.html

Clinical Trials – Drug Studies Provide Benefits for Patients, Knowledge and
Revenue for Neurologists

[Neuro Practice 7(6):41,43, 2000. © 2000 Lippincott Williams & Wilkins]

——————————————————————————

Introduction

A growing number of neurologists are discovering a gold mine in their
clinical practices: Their patient population. Pharmaceutical companies and
contract research organizations (CROs) are looking for patients with a
variety of neurological conditions to participate in clinical studies,
generally for Phase III and Phase IV post-marketing drug studies.
Participating in clinical trials is a worthwhile way to keep current with
medical developments, assure patients access to the latest technology, and
not incidentally, provide a substantial revenue stream for the clinical
practice.

“There are many opportunities for neurologists,” says Matthew D. Heller, MD,
co-author with James A. Boyle, MD, of The Physicians Guide to Clinical
Research Opportunities (Los Angeles: Practice Management Information Corp.;
1996). “You’re going to learn about new drugs way before they’re out on the
market. And when physicians come under the crunch financially, it’s a
wonderful way to earn alternative income.”

Physicians in private practice play a key role in the drug development and
monitoring process. While Phase I and Phase II clinical trials involve
healthy volunteers, primarily males, post-marketing studies and many Phase
III clinical trials require large numbers of patients with the conditions
being studied. The pharmaceutical industry depends on physicians with access
to patient populations to participate in post-marketing studies. Clinical
study subjects are needed in the areas of stroke, Alzheimer and Parkinson
diseases, and movement disorders.

“Phase IV post-marketing studies are very good for the general neurologist,”
says Bill Nikolov, MD, neurologist at New York Hospital Cornell Medical
Center, who is a study coordinator for a 21-site clinical trial of topiramate
(Topamax, Ortho-McNeil Pharmaceutical) for the treatment of amyotrophic
lateral sclerosis. “Being involved in clinical research is very good for
professional development, and you learn about new drugs years before the
papers are published.”

Community Setting

In February, the National Library of Medicine launched a website
(clinicaltrials.gov) to provide physicians and patients easy access to
information about the location of clinical trials. There are presently more
than 440 clinical studies involving diseases of the nervous system,
everything from abetalipoproteinemia to Zellweger syndrome, including 115
studies of nervous system neoplasm, 16 studies of Alzheimer disease, and
eight studies of tremor.

Far greater opportunities for clinical research are found in the private
sector, particularly since accelerated drug-approval processes have placed
greater importance on post-marketing studies to identify potential untoward
effects and interactions of prescription medication.

In 1997, the pharmaceutical and biotech industry spent more than $3.5 billion
on grants to physicians who provide investigator services, and the grants
went to fewer than 10% of U.S. physicians, according to consultant Tracy
Blumenfeld, chief executive officer of Wayne, PA-based Physicians Clinical
Research Solutions.

“The demand for productive, high-quality sites [for clinical research] is
increasing rapidly,” says Blumenfeld, whose company markets the clinical
trial capabilities of physician groups to commercial research sponsors.

While demand for physician investigators is rising, so is competition for
private-sector clinical trial dollars. Heller says that the number of
private-practice physicians participating in drug studies has increased 60%
in the last five years. “It’s tougher to get a study these days than it used
to be,” he says. “There are many more investigators. Everybody wants to get
into it.”

Still, opportunities abound for physicians willing to accept the burdens of
clinical research, even for those without a university affiliation. “Often,
drug companies prefer that you don’t have a university affiliation,” says
Heller. “The patients at tertiary medical centers are quite different than
the populations found in the private practice.”

Revenue Stream

Community-based physicians have something that drug makers desperately need
patients. Post-marketing studies require a broad cross-section of patients,
representing a range of ages and illness severity. “It’s the patients they’re
looking for,” confirms Blumenfeld.

Participating in clinical studies can provide a substantial revenue stream
for medical practices. Blumenfeld says that physicians can expect
compensation ranging from $5000 to $10,000 per patient. One stroke study
presently under way pays $8500 per patient, she says.

The seemingly lucrative money in clinical trials has caused the activity to
come under fire in the popular press, suggesting that pharmaceutical
companies are bribing physicians to change prescription habits. However, the
compensation provided to participating physicians includes reimbursement for
office visits and diagnostic testing, typically leaving about 20% after
expenses.

“Nobody makes a lot of money from post-marketing studies,” says Nikolov. The
most common error made by physicians is underestimating the amount of time
and labor demanded by clinical trials. “It’s important that physicians
realize the time commitment that’s required,” says Blumenfeld. “Physicians
who look at clinical trials as selling data don’t have a clear idea of what’s
involved. It’s not like the pharmaceutical company hands the doctor $5000. He
or she has to work for it.”

U. of Okla. Scandal Leads to Exodus

.c The Associated Press

By KELLY KURT

TULSA, Okla. (AP) – A research scandal that led to the shutdown of 75 human
experiments at the University of Oklahoma medical school in Tulsa has brought
the departure of three top university officials and dismissal proceedings
against a scientist.

“I think we have no choice but to demonstrate we’re making a fresh start,”
university President David Boren said Friday. “We simply have to send a very
strong signal for the sake of all our research programs.”

The scandal broke earlier this month over a skin cancer study. An outside
audit found flaws in the manufacturing the study’s vaccine and lapses in the
monitoring of its participants, all of whom were seriously ill with melanoma.

Twenty-six of the 94 participants who received the vaccine over the three
years of the study died, though officials found no evidence the study
contributed to the deaths.

In the wake of the discovery, the university suspended 70 clinical trials at
the university and the government suspended five others.

Boren said that the university has started termination proceedings against
the study’s lead researcher, Dr. Michael McGee, and that three officials had
either resigned or retired: Harold Brooks, dean of the college of medicine in
Tulsa; Edward Wortham Jr., director of the Office of Research at the Health
Science Center; and Daniel Plunket, chairman of the school’s research
oversight board.

Boren also announced stringent new procedures, including the establishment of
a research compliance office with a hot line for anonymous callers to report
violations.

07-21-00