10/12/2000 – A Wonder Drug That Carried the Seeds of Death

I have been meaning to send this out to you for some time now as a reminder
of the terrible aftermaths that so often follow a so called “Wonder Drug.”
Note that this little wonder was distributed free of charge by the most noted
health agency in the country, the National Institutes of Health. We can add
one more terrible tragedy to the very long list of “wonder drugs” gone bad.
It makes one think back to the government admission several years ago that
they hired family practitioners to pick out several of their patients to
inject, without the patient’s knowledge of course, with plutonium to learn
the effects of this substance on humans. Ever so often the doctor would bring
the patient in for a “check up” to note any changes. The families learned of
this after the deaths of their loved ones and sued. The government settled
the suits and apologized on the evening news.

Funny, I thought true sorrow included stopping the thing you are doing that
is wrong. Obviously it has never stopped. Only the names of the drugs have
changed. The standard practice remains the same: deny the truth, then hide
the evidence, then deny you knew what the outcome would be when you did know,
then fight the victims in court to avoid having to pay for what you did to
them and badger them enough so that they will drop their suit against you.

This is also a wake up call to the dangers of mad cow disease in this
country. Any blood product, which human growth hormone is, can carry this
disease. (Of course now that it is synthetically produced we are to believe
it is now safe.) The last mad cow (CJD) death in Utah was a young man who got
it from eating Elk that he had hunted. The CDC came into Utah to investigate
as they have thought the wild animals did not yet have the disease. There was
great alarm generated by the fact that this young father had given blood over
the years. As CJD lies dormant for many years before manifesting the
symptoms, they were afraid that several years down the road we would see many
more cases of mad cow due to the blood transfusions that came from this man’s
blood. Blood products of any kind are suspect.

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

Sunday, May 21, 2000 | L A Times

A Wonder Drug That Carried the Seeds of Death

Human growth hormone held promise for thousands, but contamination of early
samples has been linked to a fatal disease. A purification method was known
but not used.

By EMILY GREEN, Times Staff Writer

In 1958, an American scientist managed to do what nature had failed to.
He made a dwarf grow. For the first time, man had harnessed human growth
hormone.

By 1963, while technically still an experimental drug, the hormone was
being supplied free of charge by the National Institutes of Health to
pediatricians across America. For the next 22 years, the drug was
administered to more than 8,000 stunted children.

It worked. The children grew–collectively, more than a mile. They went
on to become soldiers, doctors, journalists and secretaries. They married and
had children. But then, decades after taking the hormone, a small but steady
succession of recipients began to develop strange symptoms.

First they lost their balance. In the case of a 32-year-old foot surgeon
from Brooklyn, N.Y., Dr. Stacey Crair, she suddenly started toppling over. As
a child, Crair had received growth hormone treatment for 12 years.

Nearby on Long Island, a water safety engineer named Mike Nofi remembers
that his 30-year-old wife, Wendy, suddenly started feeling like “she was on a
boat.” She had received growth hormone for six years.

Soon they began to stagger and drool. Their personalities changed.
Within months they were in comas. Their brains were turning to sponge.

They had Creutzfeldt-Jakob disease, or CJD, a human variant of the
so-called mad cow disease. CJD is incurable. The agent that causes it is
unknown. How they got it, however, was clear. They had been infected by
contaminated hormone. Twenty other hormone recipients in the United States
have also died from CJD, and the toll continues to rise.

But the NIH has not apologized, or even helped with the care of victims.
Having investigated the debacle, the NIH has insisted for the last 15 years
that the deaths were unforeseeable.

“It was an experimental treatment, and people signed informed consents,”
NIH spokeswoman Jane Demouy said recently.

However, The Times has unearthed British court documents showing that
the deaths were not only foreseeable, they were foreseen. The NIH lab called
in to investigate the deaths in 1985 had been warned of the danger of
contamination seven years earlier.

Moreover, a body of research shows that a safer method for processing
the drug had been available from the inception of the program. But scientists
under contract to the NIH chose a cheaper, less labor-intensive method.

Shown the documents, Demouy said the NIH involvement was limited to
funding the program:

“Physicians around the country administered the hormone. Decisions
regarding the program were made more than 35 years ago, and the people
involved are deceased or retired. In 1985, when it was learned that three
patients who had received human growth hormone had contracted CJD,
distribution of human growth hormone [from cadavers] was ended.”

Plundering the Pituitary Gland

Today human growth hormone is synthetic, and safe. So it is easy to
forget how crude its early forms were–or that it was an important medicine.
A sign of how fast its development has been is that, at the turn of the 20th
century, the word “hormone” did not even exist. Endocrinology–the study of
the network of glands that produce hormones responsible for growth, sexual
maturation, reproduction and digestion–was a new science.

Early research was brutal but effective. Experimenting on animals,
mainly dogs, scientists in Europe and North America deduced what endocrine
glands did by surgically removing the organs and seeing what happened.
Usually the dogs died.

In 1921, a University of Toronto team found not only that removal of a
dog’s pancreas caused diabetes but also that injecting the dog with
pancreatic extract appeared to cure the disease. The extract contained the
lifesaving hormone insulin. Within a year, insulin from the pancreases of
cows was being injected into diabetic children. The first American recipient
went on to live to the age of 74
and came to describe the hormone as “unspeakably wonderful.”

Plundering the pituitary gland proved a good deal trickier. Located
behind the bridge of the nose, the bean-size organ was difficult to remove
without killing the test animal. By the 1950s, however, not only had
scientists managed this, but it had also become clear that the pituitary was
home to a complex cache of hormones governing growth, maturation and
reproduction.

The first pituitary hormone to receive the insulin-style extraction
treatment was human growth hormone. But unlike insulin from cattle, bovine
growth hormone had no effect on people. Scientists needed human pituitary
glands to make people grow. They would have to look to morgues.

In 1958, a Boston-based researcher named Maurice Raben at the Tufts
University School of Medicine produced another first. A 17-year-old boy, whom
Raben had experimentally injected with human growth hormone, grew 2.1 inches
in 10 months.

For parents of stunted children, this offered precious hope: Their
children might be spared lives as dwarfs.

But then they were asked to wait. Dwarfism wasn’t diabetes. It wasn’t
life-threatening. Unlike insulin, human growth hormone was not seen by drug
companies as commercially viable.

Almost immediately, the most enterprising parents enrolled their
children in small trials, very like the first Raben experiment. Even then
there were not enough pituitaries for steady production of the growth
hormone. Some parents turned organ scavengers, personally petitioning
hospitals and morgues for pituitary glands from cadavers.

By 1963, pressure from parents, pediatricians and endocrinologists had
become so intense that the NIH stepped in. It formed the National Pituitary
Agency out of Baltimore’s Johns Hopkins University. The agency would organize
collection and redistribution of the glands to three universities for
processing into growth hormone: Emory in Atlanta, Tufts in Boston and Cornell
in Ithaca, N.Y.

Soon, the NIH was guardian of a sweeping experimental drug trial. For 22
years, from 1963 to 1985, it supplied the hormone to 8,157 children
nationwide and to about 50 foreign-born children who came to America for
treatment.

For the first 14 of these years, the largest seat of hormone production
was at Emory, supervised by Alfred E. Wilhelmi. A former Rhodes scholar, he
was at the peak of a charmed career. He had received a doctorate from Oxford
University in England and taught at Yale before moving to Emory. Soon to
become president of the Endocrine Society, he was the NIH expert of choice.

But more advanced work was going on in Sweden, at the University of
Uppsala, where chemists had observed problems with the human growth hormone
being extracted using Wilhelmi’s method; it caused immune responses and was
far from pure.

The Swedes, by contrast, had developed a method to produce hormone that
was 95% pure. It did not spark immune response and appeared to be more potent
in inducing growth. The difference was part effort–the Swedes took a much
more labor-intensive approach to gland collection and storage–and part
technology–they filtered their drug using a process called Sephadex gel
filtration.

Wilhelmi chose not to use the filter.

“Wilhelmi’s philosophy was that the material was human protein, and
human protein cannot harm human beings,” said Albert Parlow, a
Harvard-educated biochemist who was at Emory at the time.

The result was that the NIH supplied thousands of American children with
a drug that could have been pure, but wasn’t. In 1969, Wilhelmi unveiled what
he described as an “improved method” for hormone extraction. But the
improvement was in yield, not purity. The resulting hormone was, Wilhelmi
wrote in the Journal for Clinical Endocrinology, “clinically useful and . . .
may be purified further for chemical use and immunochemical studies.”

Put more simply, this meant that Wilhelmi regarded the hormone as safe
for children but in need of further refinement for use in experiments.

Another believer in the acceptability of clinical grade hormone was Anne
Stockell Hartree, an American-born biochemist then on staff at Cambridge
University in England. She co-wrote the 1969 Wilhelmi paper announcing the
“improved” hormone and was using the method to process the hormone being
employed in an almost identical program in Britain.

By 1973, both Wilhelmi and Hartree were facing questions. A member of
the British hormone program’s steering committee raised concerns about the
safety of the drug.

Wilhelmi replied: “We have been preparing hGH since 1958 in increasing
quantities, and in all that time there has never been a complaint of that
kind of contamination. . . . We are presently going to modify our procedure
to include a step of filtration on Sephadex G-100, and this, I think, will
provide further assurance of removing virus from the system.”

The Times could find no record that Wilhelmi or Hartree ever used the
Swedish-style Sephadex filtering.

The method wasn’t officially adopted until after Wilhelmi’s retirement
in 1977. That year, the NIH put hormone production out to bid. The winner was
Parlow, by then a research professor of obstetrics and gynecology at the UCLA
School of Medicine. Written into his proposal was strict incorporation of
Swedish-style protocols.

The same year, British purification was moved from Hartree’s lab to one
that also began filtering the drug.

Even so, for the next seven years, Wilhelmi’s confidence in his method
seemed justified. As he had once observed to those questioning his methods,
nobody seemed to “have caught anything.”

Woman’s Death Sparks a Crisis

But in March 1984, in the English cathedral town of Winchester, that
changed. What began as an off day for a 22-year-old woman quickly escalated
into an international public health crisis.

Alison Lay, a secretary at a local Barclay’s bank, noticed that her
balance was unsteady. “She progressed from not being able to go to work,”
recalls her mother, Mavis Lay, “to not being able to feed herself and not
being able to walk without help.”

On Feb. 12, 1985, eight days short of her 23rd birthday, Alison Lay died
from CJD.

When she was 2, surgery to remove a brain tumor had also taken out her
pituitary gland. To compensate, between the ages of 10 and 14, she had
received more than 550 injections of human growth hormone.

Unbeknown to the Lays, CJD cases were also being recognized in young
people in the U.S.: a 22-year-old in Buffalo, a 34-year-old in Dallas, a
21-year-old in San Francisco. All had received human growth hormone.

CJD is among the rarest of diseases, striking about one in a million
people per year. It is rarer yet in the young. Of more than 3,000 cases
recorded in international literature, before 1985 only nine were in patients
younger than 30. The typical age was between 55 and 65.

But when autopsy results from the first four hormone recipients came in,
the average age was 25.

Alarms blared. After an urgent meeting on April 20, 1985, the NIH
suspended the National Pituitary Program. The anguished reaction of
University of Virginia pediatrician Robert Blizzard was typical. He wrote
British colleagues: “Just an hour ago I left a meeting at NIH and I am very
depressed. . . . I realize full well the implications of this worldwide–both
for investigators and for patients. The implications are tragic.”

By June, programs had been stopped in Belgium, Finland, Greece, the
Netherlands, Sweden, Britain and Australia. An estimated 27,000 children
worldwide had been given the drug. In the U.S., the Centers for Disease
Control and Prevention in Atlanta was brought in to track down the 8,157
American recipients.

Meanwhile, the NIH switched hats from overseer of the program to its own
accident investigator. Sponsor of the hormone program had been the National
Institute of Diabetes and Digestive and Kidney Diseases. Assessing the
disaster fell to a sister institute, the National Institute of Neurological
and Communicative Disorders.

A pediatrician there, Dr. Daniel Carleton Gajdusek, had received the
Nobel Prize for physiology or medicine in 1976 for his work on CJD. In 1968,
he had published in Science magazine an article showing that CJD was
transmissible through exposure to infected brain tissue.

However, the man who would lead the institute’s investigation was
Gajdusek’s colleague, Dr. Paul Brown, then establishing himself as a
world-class epidemiologist on the spread of CJD.

When the first CJD case appeared in a growth hormone recipient, Brown
thought it was a coincidence. Then, as other cases rolled in, he became
convinced that the hormone was the culprit. He began systematically testing
remaining stocks of the drug.

“One of the lots that was inoculated did in fact transmit disease to an
animal,” he told The Times.

It took Brown six years to publish an estimate of how many glands
infected with CJD might have entered the system. By 1991, the official
estimate was 140.

As shocking as this seems in retrospect, Brown takes pains to stress
that, at the time, too little was known about CJD. “Before 1985, nobody had
any idea it [the hormones] would be contaminated,” he said.

Veterinary Geneticist Raises the Alarm

That is where American knowledge stood for the next 15 years. It was
regrettable, but unavoidable. Nobody could have known.

Except, it emerges, someone did.

In reviewing the documents generated during the 1996 British human
growth hormone trial, The Times found a paper trail between the British
government and the NIH. Its existence had remained unknown in America and its
significance unrecognized in Britain.

The man who raised the alarm was not a Nobel laureate, not a
neurologist, but a specialist in an obscure disease of sheep: veterinary
geneticist Alan Dickinson, founder of the Neuropathogenesis Unit at the
University of Edinburgh in Scotland.

Dickinson specialized in the sheep form of CJD, called scrapie. In
decades of experimentally infecting mice with scrapie, he had observed that
the pituitary glands became both infected and infectious.

On Oct. 5, 1976, nine years before the first cases of CJD appeared,
Dickinson called to warn the British Medical Research Council of the danger
posed by its growth hormone program.

“My intrusion came after the sudden realization that they were using
human pituitaries,” he said.

But it was only four months later, after Gajdusek reported that CJD
could be spread by surgical instruments, that curiosity among the British
officials was roused. Even so, a member of the British pituitary program took
more than a year to write Gajdusek, seeking his opinion about Dickinson’s
warning. By then Gajdusek was traveling abroad.

On May 8, 1978, a visiting Australian pathologist named Colin Masters
answered on his behalf. Masters echoed Dickinson’s warning: “It would be
reasonable to expect that the pituitary gland and/or surrounding tissue taken
from a case of CJD disease would be contaminated with the virus.”

At Masters’ invitation, the British then forwarded the purification
protocols to the NIH for review. But there is no record that Masters ever
made good on his offer to evaluate either the Swedish or Wilhelmi methods for
their ability to remove CJD contamination.

And in spite of the now-acknowledged danger, neither the British nor the
Americans moved to exclude the use of glands from organ donors who had died
of CJD. Nor did Masters warn the NIH’s National Pituitary Program.

Masters subsequently returned to Australia, where he is now head of the
Australian National CJD Surveillance Unit at Melbourne University. Asked why
he did not relay the warning, he responded, “Presumably the people who were
running the pituitary programs should have been aware of the warnings that
were being sounded in the medical press.”

Both Brown and Masters were in Gajdusek’s lab at the NIH. But, while
Brown insists that the danger of CJD contamination was unforeseeable before
1985, to the mind of Masters, it was too obvious to mention.

By 1979, the British were worried enough to give Dickinson money to test
the Swedish protocol for its ability to eliminate CJD. Pituitaries were
deliberately infected, then purified and injected into test mice. The
Wilhelmi-Hartree method, however, was not tested. In 1982, Dickinson had his
answer: The Swedish method appeared to be safe.

The results were not published for three years. Both Dickinson and the
British hormone program sponsors were sensitive to the potential for a scare.
But in the wake of Alison Lay’s death in 1985, the results showing the
Swedish method’s safety were seen to have a calming effect. They were
published in the same issue of the Lancet as her case history.

The drug appeared safe for children, including 4,000 Americans, who had
received the drug after 1977, the year Parlow took over production and
insisted on the filtration.

The other roughly 4,000 American children treated before 1977 with
hormone from Emory, Tufts and Cornell no longer needed Dickinson to test the
drug on mice. They were the mice, and it was official: The drug was
potentially deadly.

After the Lancet report, in September 1985, Brown reported on the three
American deaths in the New England Journal of Medicine. America faced, Brown
wrote, the “ominous possibility of a burgeoning epidemic” of CJD.

Survivors Mired in Legal Battles

Public displays of concern about a potential epidemic of CJD were one
thing. Doing something to help the victims proved to be another. When Wendy
Nofi first descended into madness between July and November 1995, her
husband, Mike, sought assistance from the NIH. “I was in contact with the NIH
when she first got sick,” he said. “I told them I wanted to keep apprised. I
haven’t received one thing.”

The Crairs say they too were rebuffed. “We called the NIH to seek help,
but we received no counseling, no support whatsoever,” said Stacey’s sister,
Lisa Crair. “At first we couldn’t even get a doctor who would take Stacey
on.”

By 1996, Gajdusek’s lab was in turmoil. In March, as the laureate
addressed a scientific meeting in Europe, the mad cow crisis erupted in the
Britain. The next month, Gajdusek was arrested in Maryland on charges of
child molestation. Found guilty in April 1997, he served a year of an
18-month sentence and then left for France.

Mike Nofi had his wife placed on a feeding tube in a rest home. It took
her 2 1/2 years to die. The Crairs nursed Stacey at home for four years.

Both Lisa Crair and Mike Nofi are now lost in legal battles that they
say they neither relish nor understand. Crair’s lawsuit has been thrown out
of court over legal technicalities in three states where the hormone was
processed. Nofi has been given leave in New York state courts to sue numerous
doctors, technicians and every university that handled the hormone–even
Parlow’s UCLA lab, the very place that in 1977 cleaned up the hormone.

But Nofi is not suing the NIH. According to Pamela Liapakis, former
president of the Assn. of Trial Lawyers of America, the agency enjoys what
the legal profession calls “sovereign privilege” and is exceedingly difficult
to sue under federal tort law.

In Britain, however, outraged families did sue the government. In 1990,
an English lawyer named David Body tracked Dickinson down in a drafty stone
house outside Edinburgh, where he had been living in retirement for three
years. Body then represented three of what are now 34 families of British
hormone victims. He was going to try something nobody had ever done
successfully in Britain: sue the Department of Health in a personal injury
case.

He needed an expert witness. After interviewing Dickinson, Body realized
that he could “never put him on the stand.”

The scientist was frail and prone to severe migraines. But he typed out
a statement that both outlined the state of knowledge about CJD 25 years ago
and recounted his 1976 warning about the risk of contamination. In July 1996,
the court decided against the British government to the tune of more than
$7.5 million. Anyone treated with the potentially contaminated hormone after
Dickinson’s warning was issued would be compensated. Damages are now even
going to the “worried well.”

Although Alison Lay’s death sparked the 1985 crisis in Britain, her
parents were excluded from the settlement, because their daughter was treated
before Dickinson sounded the warning.

“At least in this country we did have the trial,” said Mavis Lay. “And
the government admitted that it was at fault and caused the deaths.’

By the time of the trial, Hartree had returned home to Nashville. She
refuses all contacts with the media, lawyers and hormone recipients. In her
absence, the British judge concluded that Hartree’s failure to use Sephadex
was, by analogy, “a commercial decision: quantity before quality.”

The court stopped short of finding the government negligent in the
preparation of the hormone. “In the English claims, the issue of purification
became secondary to the policy failures,” said Body. “I’d like to see
purification explored further in the United States.”

The more time that passes, the more difficult this will be. In 1994, at
the age of 84, Wilhelmi died at his home in Atlanta.

However, Parlow, his former colleague who upgraded the purity of the NIH
hormone, said clear “warning bells” were ignored. Describing the early
hormone, he said, “It was painful on injection. This signaled impurities.”

That was confirmed by a second side effect. “Ten to 15% of the kids
treated developed antibody formation,” said Parlow. “Though this is not
life-threatening, it is not a good thing, and it means that there is
something wrong with the product.”

In addition to the 22 Americans who have died from Wilhelmi-era hormone,
CJD has killed five New Zealanders and one Brazilian who received pre-1977
American hormone. In Britain, 34 people have died, and the global toll stands
at more than 125. The Centers for Disease Control says the rate of CJD cases
among hormone recipients worldwide is increasing.

Tracing the Growth Hormone

* * *
1901-05: The word “hormone” coined

* * *
1921: Creutzfeldt-Jakob disease (CJD) discovered in Germany.

* * *
1925-45: Growth and reproductive hormones found in the pituitary glands
in the brains of animals

* * *
1958: Maurice Raben at Tufts University School of Medicine in Boston
spurs 2.1 inches of growth in a dwarf by injecting him with human growth
hormone extracted from pituitary glands taken from the brains of cadavers

* * *
1963: The National Institutes of Health takes up sponsorship of the
National Pituitary Program.

The largest seat of production is the lab of Alfred E. Wilhelmi, head of
the biochemistry department at Emory University in Atlanta. Swedish
scientists notice that American growth hormone causes immune reactions and
publish an alternative method for making the drug.

* * *
1968: NIH doctor Daniel C. Gajdusek writes in Science magazine that CJD
is transmissible via infected brain tissue. *

* * *
1976: Edinburgh-based veterinary geneticist Alan Dickinson warns the
British government that its pituitary program might spread CJD.

* * *
1977: Wilhelmi retires. The NIH moves production of human growth hormone
to the UCLA lab of Albert Parlow, who begins filtering the drug. The British
hormone program also switches from the Wilhelmi protocol to the Swedish
extraction method.

* * *
1978: Dickinson’s fears of CJD contamination in the hormone are passed
to Gajdusek’s lab at the NIH. In May, a visiting Australian pathologist
replies on NIH letterhead that pituitary glands could be contaminated with
CJD. But he does not pass the warning to the NIH’s own pituitary program. *

* * *
1985: Alison Lay, a hormone recipient, dies in Britain. Three
unidentified American recipients also die. The NIH suspends the human growth
hormone program. Paul Brown of Gajdusek’s lab is called in to investigate. He
warns of a potential “epidemic” of CJD.

* * *
1991: Brown and others report in the Journal of the American Medical
Assn. that 8,157 American children received the drug and that as many as 140
glands infected with CJD may have entered the system.

* * *
1996: A class-action lawsuit on behalf of hormone recipients is brought
against the British government. A London high court awards the plaintiffs
$7.5 million.

* * *
2000: The CJD death toll among American recipients of pre-1977
unfiltered hormone stands at 22. The Centers for Disease Control and
Prevention in Atlanta reports that the incidence of CJD in hormone recipients
is rising from one case a year to two.

* * *

Failed Warnings

NIH epidemiologist Paul Brown was called in by the human growth hormone
program to investigate CJD contamination in 1985. Since then, he has
insisted,”Before 1985, nobody had any idea it [the hormone] would be
contaminated.” But newly discovered letters show that in 1978, a colleague in
Brown’s own lab acknowledged the danger and failed to alert the hormone
program.

* * *
Letter to British government acknowledging danger in 1978.

* * *
Robin Mayper in the Times library contributed to this story.

Search the archives of the Los Angeles Times for similar stories about:
National Institutes Of Health, Medical Research, Experiments, Drugs, Medical
Treatments, Human Growth Hormone, Creutzfeldt Jakob Disease, Health Hazards.
You will not be charged to look for stories, only to retrieve one.

752 total views, no views today

10/09/2000 – Congressman attributes son’s suicide to Accutane

msnbc.com

Lawmaker tells of acne drug’s risk

Rep. Bart Stupak.

NBC’s Dr. Bob Arnot discusses the possible health risks of Accutane and
alternative treatments for severe cases of acne.

Congressman attributes
son’s suicide to Accutane

MSNBC STAFF AND WIRE REPORTS

TRAVERSE CITY, Mich., Oct. 5. A Michigan congressman whose
17-year-old son committed suicide earlier this year went public Thursday with
criticism of the Food and Drug Administration, charging on NBC’s Today
show that the agency had failed to warn consumers that the popular acne
medicine Accutane may cause depression.

If it can happen to our family it certainly can happen to you, and we
don’t want anyone to have to go through that. REP. BART STUPAK

BART STUPAK JR., known as B.J., shot himself in the head with his
father’s gun in the early hours of May 14. Stupak, a popular football player,
killed himself after a prom-night party.

His father, Rep. Bart Stupak, a four-term Democrat from Menominee,
said Thursday that he blames Accutane, a powerful acne drug B.J. had taken
for six months prior to his death. We knew our son, we loved our son, he
said.

The congressman and his wife, Laurie, said they had considered every
possible explanation for B.J.’s suicide and the only thing we can find is
Accutane.

FDA ADVISORY

In 1998, the Food and Drug Administration advised doctors who
prescribe Accutane to watch their patients for signs of depression.
Afterward, the company notified doctors that the drug may cause depression,
psychosis, and, rarely, suicidal ideation, suicide attempts and suicide.

But Stupak said the FDA had done a poor job spreading the word. B.J.’s
medication package included no warning and the doctor didn’t tell the parents
about the link to depression, his father said.

If it can happen to our family it certainly can happen to you, and we
don’t want anyone to have to go through that, Stupak said.

Hoffmann-La Roche, which manufactures Accutane, contends no
link has been proven between the drug and depression or suicide. In 1998, the
company argued that more than 4 million Americans have taken Accutane since
it was approved in 1982, and the possible side effect is very rare. It said
teen-agers, prime acne sufferers, often suffer depression, and hormones
involved with acne also may contribute to depression.

B.J.’s death stunned family and friends. In the Today interview,
his parents said he was a happy young man with a bright future.

COMPLETELY OUT OF CHARACTER

This is contrary to everything he lived for, everything he thought,
everything he wanted in life … completely out of character for him, Stupak
said. He would not do something like this.

B.J. left no note and the autopsy showed no drugs in his system,
although he apparently had taken a couple of drinks.
Advertisement

The only suggestion of odd behavior came the night before his death.
During a party following his junior prom, B.J. began reading the Bible and
said he wasn’t going to college because of his grades, and that his parents
probably hated him for that, according to an account on the Today program.
The Stupaks said there was no reason for him to think such a thing.

An FDA science advisory panel last month suggested requiring
Hoffman-LaRoche to give patients information about potential risks, agency
drug chief Janet Woodcock said.

INSUFFICIENT DATA

But Woodcock said there still was insufficient data to establish a
definite connection between Accutane and depression or suicide.

It’s really hard to nail this down, she said in a telephone
interview Wednesday. The bottom line is there is evidence against there
being a link and evidence for being a link.

During the advisory panel meeting, FDA staffers presented evidence
that some people had become depressed when taking the drug and had gotten
over their depression after stopping use of the drug, Woodcock said.

But experts for Hoffman-LaRoche countered with evidence suggesting no
link, she said. The committee recommended further study.

The Associated Press contributed to this report.

732 total views, no views today

9/28/2000 – Learning from Fido’s accidental use of SSRIs

Thanks once again to Robin Eisner for another insightful article about SSRIs.

Warning: Be very careful of your pets around medications and read closely to
see what you might learn from the effects of SSRIs on Fido. This will leave
you asking why these drugs are intentionally given by vets to our pets.

Ann Blake-Tracy
____________

Accidental Antidepression
Dogs Hurt Inadvertently Swallowing Popular People Pills

More dogs these days are unintentionally chomping down their owners’
serotonin-enhancing antidepressants, such as Paxil and Prozac, than they were
five years ago. (Pat Wellenbach/AP Photo)

By Robin Eisner

N E W Y O R K, Sept. 28 Pooches across America are developing a dangerous
drug habit accidental consumption of their owners¹ Prozac-like drugs.
The National Animal Poison Control Center of the American Society for
the Prevention of Cruelty says more dogs these days are chomping down
unintentionally, that is their owners serotonin-enhancing antidepressants,
such as Paxil and Prozac, than they were five years ago.
Dogs are very dogged, explains Dr. Steve Hansen, director of the
Poison
Control Center, which is located in Champaign-Urbana, Ill. They will crush a
bottle of pills with their back molars and lap up the drugs or they will
quickly eat a tablet that an owner inadvertently dropped on the floor.

Established in 1978, the fee-for-service National Animal Poison Control
Center is the only 24-hour emergency telephone hotline staffed by 20
full-time veterinarians and five board-certified veterinary toxicologists in
North America.

Unintended Use

While veterinarians now prescribe antidepressants to dogs to treat canine
sadness, separation anxiety and other behavioral problems, the increasing
problem with unintended ingestion of these drugs by dogs is due, most likely,
to the rising popularity and use of this class of drugs by humans, Hansen
says.

In 1995, 50 percent of the antidepressants accident cases were of the
Prozac type, according to Jill Richardson, a veterinary poison information
specialist at the animal poison center. By 1999, that number jumped to 80
percent of 500 total antidepressant case calls.

The danger antidepressant drugs pose to Fido depends on the amount
wolfed down, the size of the dog and whether the dog had any pre-existing
medical conditions that might make it susceptible to an overdose, Hansen
says.

Danger Depends on Many Factors

Lethargy, vomiting and disorientation are among the symptoms a small dog,
such as a Chihuahua, could experience with a large dose of a Prozac-like
drug. The animal will walk around with its front legs not in sync with its
back legs, looking drunk, Hansen says.
Â
If the owner calls the poison control line before these symptoms develop,
the hotline veterinarians might recommend the owner induce regurgitation with
hydrogen peroxide easily found in most medicine cabinets. The dose with a 3
percent peroxide solution is one milliliter per pound of the dog, which
translates into 2 ounces for a 50-pound dog.

If the dog already is tipsy, however, the vets will probably ask the
owner to take the animal for emergency care, since the animal might need more
specialized treatment. The telephone vets also will suggest an older dog with
kidney disease get to a vet as soon as possible.

Homes Need to Be Pet-Proofed

To prevent an animal from accidental consumption of drugs, owners need to
dog- and cat-proof their house. Medications should be kept in a closed
cabinet beyond their reach, Hansen says. The No. 1 problem drug accidentally
consumed by pets are non-steroidal anti-inflammatory drugs, or medications
like acetaminophen, aspirin or ibuprofen.

While drugs can poison animals, pets also are susceptible to
insecticides, rodenticides and will drink spilled antifreeze and gasoline.
The antifreeze propylene glycol is less toxic to pets than ethylene glycol,
Hansen says.

Cat owners also should not use dog products containing the anti-flea
chemical permethrin on their felines. Owners should not assume because it is
OK for dogs, it is OK for cats, Hansen says. Cats may experience tremors
and seizures from the insecticide.

Why Vet Line Charges?

Pet owners must pay a $45 fee to get assistance from the vets at the
Animal Poison Control Center. The amount covers subsequent calls to the
hotline.

Unlike human poison control centers which are free because they receive
funding from federal, state and local government sources, the animal line
must charge because it only receives partial funding for its operation from
manufacturers of pet care products. The phone number is 1-888-426-4435.

Because large emergency veterinary centers are usually located in large
communities, a pet owner or a veterinarian in a rural community may only have
the hotline to get important toxicological information in a emergency
situation, according to Sharon Granskog, spokeswoman for the American
Veterinary Medical Association, in Schaumberg, Ill. They play a vital
service, she says.

673 total views, 1 views today

9/28/2000 – LA Times – Antidepressants Can Have a Range of Unpredictable Side E

Los Angeles Times

Monday, September 25, 2000

Antidepressants Can Have a Range of Unpredictable Side Effects

By JOE GRAEDON, TERESA GRAEDON

Question: Our house burned down in December 1995. When my husband went
for a blood pressure refill in April 1996, the doc asked how he was doing.
My husband said, “A little depressed,” and was put on Prozac.

Soon I started seeing personality changes, and by fall he was suicidal,
having nightmares about death, tremors and feelings like electric shocks.
The doctor just kept adding drugs. I read that Prozac could cause the
symptoms he was experiencing, but when I brought this research to his
doctor, he basically said, “Nonsense.”

The next year, my husband attempted suicide six times and was
hospitalized in the psych ward three times. They tried more medications than
I can list, but he was depressed and suicidal throughout. When the
psychiatrist recommended electric shock treatment, my husband and I realized
we had to get him off all the meds or he was going to die, from the drugs or
by his own hand.

He went off cold turkey in October 1997. This caused severe side
effects, but in about four weeks the worst passed. It took him eight months
to get back to the way he was before taking Prozac–never having suicidal
thoughts, working every day and loving his job.

Answer: Many people find that antidepressants such as Paxil, Prozac,
Zoloft, Celexa and Effexor are lifesavers, lifting them out of a pit of
depression. Others report severe side effects.

Nausea, dizziness, anxiety, sexual difficulties and insomnia are not
uncommon. Occasionally such medications cause unbearable restlessness. Some
manufacturers maintain that suicidal thoughts are no more likely among
patients being treated with such drugs than among untreated depressed
people. We have heard many stories like yours, however, especially regarding
the difficulty of discontinuing such drugs suddenly.

* * *
Q: After using Preparation H for several days, my blood pressure went
to 206 over 98, and I ended up in the emergency room for hours.

Later that week, I read in your column that someone else had
experienced the same problem. My doctor was skeptical, to say the least, so
I lent him the clipping. Now he can’t find it to return it.

Would you write about this again? I never had high blood pressure
before in my life. It is always around 130 over 65.

A: Preparation H was reformulated several years ago and now contains
phenylephrine. This compound constricts blood vessels, which can cause an
elevation in blood pressure.

There is a warning on the label: “Do not use this product if you have
heart disease, high blood pressure, thyroid disease, diabetes, or difficulty
in urination due to enlargement of the prostate gland unless directed by a
doctor.” Your experience suggests some healthy people also should be wary.

* * *
Q: After being diagnosed with prostate cancer three years ago, I have
been reading about various treatments, using both conventional and
alternative medications. I had radiation and surgery.

A friend of mine, diagnosed with advanced prostate cancer 15 months
ago, has been taking PC-SPES, an herbal mixture. It costs $90 a month and is
not approved by the FDA. He swears that his PSA is now 0.9. Do you know
anything about this treatment?

A: PC-SPES is a mixture of eight herbal extracts that has estrogen-like
properties. A surprising amount of research has shown that it can lower
testosterone and PSA (prostate-specific antigen, a marker of prostate
cancer). If your physician searches the literature, he or she will discover
reports that might allow this herbal medicine to be part of your treatment.

* * *
Joe Graedon is a pharmacologist. Teresa Graedon has a PhD in medical
anthropology and is a nutrition expert. Their column runs every Monday. Send
questions to People’s Pharmacy, King Features Syndicate, 235 E. 45th St.,
New York, NY 10017, or e-mail them at pharmacy@…

660 total views, no views today

9/27/2000 – Further study on Accutane’s mental effects

Once again we ask how many children are being prescribed antidepressants due
to the effects of their acne medication?
__________________________________________

Further study urged on Accutane, mental effects
Updated 9:07 PM ET September 19, 2000By Lisa Richwine

GAITHERSBURG, Md. (Reuters) – A federal advisory panel Tuesday recommended
further study to shed light on whether some psychiatric problems may be
linked to Roche Holding Ltd.’s prescription acne drug Accutane.

Patients and physicians also could benefit from new efforts to boost
awareness that Accutane may be linked to cases of depression, mood disorders
or suicide, panel members said. Some suggested a plain-English pamphlet
attached to Accutane packaging that would explain signs of depression or
other problems.

Since 1998, Accutane has come with a warning that users have reported
depression, suicidal thoughts or mood disorders. But the label notes that the
link is uncertain.

Neither the Food and Drug Administration nor Roche could provide evidence
settling the question of whether there is a certain connection. A large
number of patients taking Accutane are teenagers, a group already commonly
affected by depression.

The data “suggest an association with Accutane but do not allow a definitive
determination;” said Diane Wysowski of the FDA.

Accutane, made by Roche unit Hoffmann-La Roche Inc., has been sold in the
United States for nearly two decades and is widely known to cause birth
defects. On Monday, the advisory panel urged health officials to limit
prescriptions for Accutane in order to minimize pregnancies among women
treated with the drug.

The panel, a group of outside experts that advises the FDA, said evidence of
psychiatric side effects were much less certain and did not require such
extensive measures.

Further study might provide clues, particularly by providing signs of whether
certain Accutane patients are more at risk for psychiatric effects, panel
members said.

Also, a federally approved medication guide that gives consumer-friendly
information about depression could help patients recognize symptoms, panel
members said. The committee also suggested new efforts to advise doctors of
depression risks and urge them to tell patients about potential problems.

The FDA usually follows its panels’ advice.

Roche Vice President Russell Ellison said the company would meet with FDA
officials to discuss the panel suggestions. Regarding new research, Ellison
said Roche "will be discussing with FDA what we think is useful, and
what has the best chance of reducing uncertainty the most."

Roche also presented data on a new once-a-day formulation of Accutane that
can be taken with or without food. Directions for the current version of
Accutane, Roche’s second-best-selling product, are for twice-a-day with food.

Roche said the new formulation may be more convenient for patients. The FDA
is considering whether to approve the newer version, but the agency did not
ask the panel’s input on whether it should go to market. REUTERS

645 total views, no views today

9/26/2000 – Adderall Maker Sued in Case of Death and Attempted Suicide

Andy Vickery, who has led the way in filing SSRI
death cases, has taken on the case of Ryan Ehlis
who was aquitted last year in the death of his baby
daughter while in a psychotic break produced by
the prescription drug Adderall.

Notice in the following article that the drug makers
admit that in a “small number” of patients the drug
does produce psychois and that they are sorry
for what happened in this case, BUT they still
stand by the safety and effectiveness of their drug.

Obviously they are not sorry enough to stop what they
are doing. So now we will hear that they are sorry for
the next death, and the next, and the next?

If you happen to be that individual for whom this drug,
or any other drug, opens the flood gates to hell via a
“rare” psychotic break, who cares if it is listed as a “rare”
reaction! For you it was not “rare”!

How can what happened to the Ehlis family be considered
an “acceptable risk”?

And yet for Eric Harris at Columbine High School who was
on Luvox the psychosis was listed as a “frequent” reaction, not
even “rare,” and the FDA considers that as an “acceptable
risk” while the whole country clammers for safer schools
because of Eric’s Luvox-induced psychotic break that took
15 lives at Columbine.

Thanks to these drugs we live in a world gone mad!
Hats off to the Ehlis family for having the courage to
fight back for the damage they have suffered! It is not
an easy task!

Ann Blake-Tracy
———————————————-

Man Sues Prescription Drug Maker

by BRIAN WITTE
Associated Press Writer

BISMARCK, N.D. (AP) — A man acquitted of killing his
infant daughter after taking a prescription drug that he
says put him in a psychotic state is suing the drug’s maker
to recover medical, legal and funeral expenses.

Ryan Ehlis, 26, of Grand Forks, had been taking Adderall,
designed to improve mental concentration, when he shot
5-day-old Tyra on Jan. 30, 1999.

Psychiatrists testified in court and the judge agreed that
Ehlis lacked the capacity to understand what he was doing
because of the drug. Its label warns that in very rare
circumstances, it can cause ”psychotic episodes at
recommended doses.”

Ehlis said that through the lawsuit he hopes to bring
more attention to the danger of some prescription drugs.

”I think more needs to be known about these drugs in
general,” he said.The lawsuit, filed Friday in federal
court, asks drug maker Shire Richwood Inc., of
Florence, Ky., for more than $100,000 in damages,
said Ehlis’ attorney, Andy Vickery.

Shire Richwood spokesman Stefan Antonsson
declined comment on the lawsuit, but said: ”We
are deeply saddened by the tragedy that took
place in North Dakota.”

Medical experts and the drug’s manufacturer say
Adderall remains a safe and effective drug for
controlling Attention Deficit-Hyperactivity Disorder,
or ADHD.

Ehlis, diagnosed with ADHD as a child, was a student
at the University of North Dakota when he started taking
Adderall in January 1999 to help him manage the disorder.
Weeks later, he fatally wounded his newborn, then shot
himself in the abdomen.

The drug is to be prescribed under close medical supervision.
But Ehlis did not seek medical attention at the time of the killing,
apparently because he did not realize he was having a psychotic
event, Vickery said.

AP-NY-09-23-00 2007EDT

906 total views, 3 views today

9/19/2000 – Memory and the Theraputic Effect of Sage

I discussed both in my book as well as in my tape on safe withdrawal the
efficacy of essential oils for theraputic use. There is much scientific
research on the value of using essential oils via aroma therapy and
theraputic use. As memory is so adversely affected by serotonergic
medications, I thought you might all be interested in this latest research on
the benefits of the theraputic use of sage oil reported in Britan yesterday.

Excuse me while I grab my bottle of sage oil. 🙂

Ann Blake-Tracy
____________________

From Britain as reported in The Globe & Mail 18th Sept. 2000..

Rubbing sage into the scalp can improve memory and may protect against
dementia, according to Dr. John Wilkinson of Britain’s Middlesex University.

The research suggests that essential oils derived from the plant can
prevent the breakdown of a key chemical messenger in the brain involved in
storing and recalling events, says The Daily Telegraph.

Researches are so impressed by early tests on the herb that they are
starting clinical trials to see if it can delay symptoms of aging and
Alzheimer’s disease.

555 total views, no views today

9/17/2000 – Two new lawsuits seek to halt the use of Ritalin

Thursday, 14 September 2000

2 new lawsuits seek to halt the use of Ritalin

THE NEW YORK TIMES

Lawyers involved in class-action lawsuits against the tobacco
industry, gun makers and health maintenance organizations yesterday filed
two lawsuits against another target, the widely used drug Ritalin.

The lawsuits, filed in federal courts in California and New Jersey,
charge that Novartis Pharmaceuticals Corp., the drug’s manufacturer, and the
American Psychiatric Association, a professional group, conspired to create
a market for Ritalin and expand its use.

For more than a decade, Ritalin has been increasingly prescribed for
children who have been given a diagnosis of attention deficit disorder or
attention deficit hyperactivity disorder. That trend has prompted debate
over the medicine, its dosage and the diagnoses.

Representatives of Novartis Pharmaceuticals, a unit of Novartis AG,
and the American Psychiatric Association said the accusations sound similar
to those in a class-action suit brought this year in Texas.

Then, Novartis said that Ritalin had been used safely and effectively
in thousands of children for more than 40 years and that it was the
most-studied drug used for attention deficit hyperactive disorder.

The new lawsuits seek to halt what they call unlawful practices and
ask that profits from the sales be returned to consumers.

662 total views, no views today

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.

554 total views, 1 views today