Noteworthy News Articles on Mental Health Topics, April 4-6,
2004
Cough Medicine: A Bad Trip That Kills
Robert Salladay, Los Angeles Times- 4/4/2004
SACRAMENTO Some users claim to see aliens conjured from the
collective unconscious. Others temporarily lose their ability to walk.
Some have written stories on the Internet: "I felt my soul being
ripped from my body," and, "Are you a vampire? No, I just
met God." But it's not heroin or PCP they are taking. It's cough
syrup. An underground network of abusers hooked on the potent
ingredients in cough suppressants and cold remedies is thriving
in California and across the nation, while police and poison control
officials report more and more young people getting high from what
they call "robo-tripping" and "skittling."
Abusers have been getting high from
cough syrup for five decades, ever since the main ingredient in modern
cough medicines dextromethorphan was patented. But in
recent years coroners have issued warnings about the practice and
health officials have started tracking statistics on it for the first
time as the stories stack up: a teenager commits murder and blames
cough tablets; a mother loses her son and finds out too late he was
a robo-tripper.
Poison control experts point to a four-fold
increase in abuse cases since 2000, mostly among teenagers and young
adults who have developed their own lingo for the culture robo-tripping
refers to the use of Robitussin to achieve a high and skittling is
derived from Skittles candy, which resembles some cough tablets. "We're
now seeing it in middle schools. We're seeing it at an earlier age,"
said Det. Wayne Benitez of the Palo Alto Police Department. Authorities
need to "make people aware this abuse is going on and that this
is not just a passing fad," he said.
The situation is alarming enough to
some California officials that legislation has been introduced to
prohibit the over-the-counter sale of products containing dextromethorphan
to anyone under 18 without a prescription. No state has outlawed sales
of cough medicine to minors so far, even though products containing
dextromethorphan and incidents of people abusing it
have been around since the 1950s. But this year, New York and California
have started exploring a prohibition for minors. California law already
prohibits the sale to minors of spray paint, etching fluid, glue and
dietary supplements containing ephedrine.
Health officials estimate that at least
a dozen people have died from dextromethorphan abuse in recent years.
The statistics are compiled from news reports across the country about
accidents, psychotic behavior and violence linked to abuse of the
over-the-counter drug.
On July 16, Misty Fetko said, she entered
her son's room like she always did to kiss him awake and get
him ready for the day. But he did not stir. He was dead. Only after
she received an autopsy report and read her son's computer journals
did Fetko discover that he had overdosed on highly toxic levels of
a prescription pain medication that, to her surprise, was a key ingredient
of cough syrup. Except for one empty bottle of Robitussin found in
his room the year before, there were never any signs of drug use.
Her son was 18, and on his way to college in just two days. Fetko
said she had yet to discover how he came across the pain medication,
Duragesic, but his journals indicated that he had tried robo-tripping
several times. "Carl was very artistic and very musically gifted,
and I think some of the attraction," suggested in his writings,
was that he thought it expanded his artistic ability and his creativity,
said Fetko, who lives in Ohio but is working with two Southern California
groups on the medication abuse issue.
In September, 19-year-old Nathaniel
Bell was convicted of first-degree murder for stabbing Jose Felix-Martinez
"amid a blaze of drugs in an apartment illuminated by only a
strobe light," wrote the Wichita Eagle newspaper. Bell admitted
to police that he had taken up to 16 Coricidin cold tablets, which
contain dextromethorphan, also known as DXM, as well as beer and cocaine.
Felix-Martinez was 22, and died of stab wounds.
In Pennsylvania, a 14-year-old boy
killed his only brother by smashing his head with a claw hammer, then
turned up the music in his room to muffle his brother's cries. The
boy had been "eating pills" all day Coricidin HBP
Cough and Cold tablets, the Pittsburgh Tribune-Review reported. The
boy was convicted of third-degree murder and is serving a 20- to 40-year
sentence.
In rare cases, public health officials
have reported deaths from DXM overdoses. But they usually have been
attributed to mixing DXM products with other drugs. In late 2002,
two central Ohio teenagers died within weeks of each other after ingesting
Coricidin tablets and morphine. The Franklin County, Ohio, coroner
issued a warning to parents saying the deaths "represented a
new trend."
The California legislation emerged
from a "There Oughta Be a Law" contest sponsored by Assemblyman
Joe Simitian (D-Palo Alto), who asked his constituents to suggest
problems that should be fixed. This is the third year for his contest,
which has prompted hearings on high gas prices and a new law, effective
this year, requiring car headlights to be turned on whenever windshield
wipers are used.
Benitez and a colleague, Lt. Ronald
Lawrence, convinced Simitian the issue was important after uncovering
a suicide pact by three students who had planned to overdose on cough
tablets. Benitez would write his master's degree thesis on robo-tripping.
In large amounts, cough suppressants
can cause extreme anxiety, hallucinations and misperception about
the outside world. Some users have likened it to opium or PCP overdoses,
depending on the level ingested. Dextromethorphan can be purchased
through the Internet in powder form, but most people obtain the drug
by buying or stealing medications that contain DXM an array
of more than 125 products such as cough drops, syrup and tablets.
State poison control experts consider the most dangerous in large
amounts to be Coricidin HBP, which contains an additional antihistamine
that makes abuse far riskier than with other DXM products.
Even though the first DXM product was
introduced five decades ago, California poison control officials recently
started tracking abuse cases reported through their hotline. The California
Poison Control System said among patients ages 6 to 19, there were
58 cases of DXM overdoses in 2000; that jumped to 284 last year. Dr.
Ilene Anderson, a clinical toxicologist and pharmacist with the California
Poison Control System, called DXM abuse among teenagers "a serious
problem. We've seen a significant increase in the abuse and overdose
of DXM-containing cold products in the last four years." A survey
taken over the last decade by the Drug Abuse Warning Network, a federal
monitoring agency, has shown a steady number of DXM abuse cases over
the years. In 1994, there were 2,274 overdose cases of cough suppressants
reported by emergency room doctors, compared to 2,311 reported in
2001. Newer figures were not available.
The abuse of cough syrup appears to
come and go in cultural waves, from bored Utah teenagers littering
school fields with empty bottles to hard-core punk rockers taking
a "vacation" from reality. Others have sought out specific
hallucinatory plateaus there are four, depending on the dosage
where reality distorts, reaching a point where sometimes aliens
appear, or the user hears voices. On one Internet site devoted to
DXM, "Raoul" wrote: "I got caught in a nasty time-loop.
I experienced Hell. I thought that my basement was the only existent
Universe and Jason and I were doomed to live it out in this horrible
state for all eternity. God was finally punishing us for our foolish
sins."
Brad Strode, a 22-year-old from West
Memphis, Ark., said he visits the chat rooms to warn people about
some of the dangers of DXM. Strode said he started taking DXM pills
a few years ago, enough to get on the fourth plateau where he heard
voices talking to him "I just tell them it's not something you
want to take," Strode said. "It's not something that is
going to make you a better person. It's going to end up with long-term
damage. Ten years down the road, you aren't going to have a heart
left."
Simitian's bill, AB 1853, passed its
first Assembly committee hearing last week on a 11-4 vote, suggesting
that it will receive support as it makes its way through the Assembly
and state Senate, which are controlled by Democrats. Gov. Arnold Schwarzenegger,
a Republican, has not taken a position on the measure. Drug companies
and store owners oppose the Simitian bill, arguing that it would keep
legal products from people who need them. Pharmaceutical firms, such
as Schering-Plough, which makes Coricidin HBP, have been working with
the federal Partnership for a Drug Free America on DXM-abuse education
programs for teenagers, including an Internet site on its dangers.
Drug firms say they would like to see drug and grocery stores voluntarily
put DXM products behind the counter if they notice a problem. "It's
sort of a sporadic thing that has peaks and valleys very small
peaks," said Virginia Cox of the Consumer Healthcare Products
Assn., the industry trade group in Washington, D.C. "We don't
have any data on the problem, and I think that is something we need
more information on."
A Los Angeles police detective who
works on juvenile narcotics cases said he has not noticed a dramatic
increase in DXM abuse, mainly because parents usually call poison
control centers or take their child to an emergency room rather than
call police. Det. Eric Sage said he has been disturbed by recent TV
media reports that he said is hyping the problem of DXM abuse among
teenagers. "I hate to see too many laws thrown down," Sage
said. "When people ask me why kids use drugs, there are a number
of different reasons. It's rebellion. It's curiosity. It's boredom.
If we start putting too many laws and you say, 'You can't do this,'
the first thing they think is, 'Bet me.' I think the best way is to
limit sales, which makes it harder for them to get it."
Psychiatrists Key in Recent Child Murder Cases
Associated Press, 4/5/2004
TYLER, Texas -- Andrea Yates and Deanna Laney were both loving mothers
who home-schooled their children and gave them names from the Bible.
Both also suffered from severe mental illness that ultimately led
them to kill their children. The verdicts they faced, however, could
not be more different.
Yates is serving a life sentence for
murder for drowning her five children in the bathtub in 2001. Laney,
who smashed her sons' skulls with rocks last May, killing two of them,
was acquitted last week by reason of insanity. Experts in Texas law,
psychology and jury behavior say the opposite verdicts are largely
due to strikingly different psychiatric testimony in the cases.
Psychiatrists in Yates' case disagreed
on her sanity. But all five mental health experts consulted in Laney's
case -- including two for the prosecution, two for the defense and
one for the judge -- agreed she was insane, or unable to tell right
from wrong. ``It's a lot easier for the jury in a case like to that
to find someone guilty by reason of insanity because they can rationalize
`Who are we to question the uniform conclusions of all the experts
here?''' said Brian Serr, a law professor at Baylor University. ``In
the Yates case, when you've got the experts disagreeing, now you're
leaving it up to the jury to decide which experts to agree with.''
Another potentially significant difference: The jury in Laney's case
learned that she believed God told her to kill the children. Yates
said she was prompted by Satan.
Dr. Park Dietz, the psychiatrist who
testified at Yates' trial that she knew her actions were wrong and
therefore wasn't insane under state law, testified last week that
Laney was a ``textbook'' case of insanity. He concluded that psychotic
delusions made Laney incapable of knowing right from wrong during
the killings -- the legal standard in Texas for insanity. Dietz called
Laney's description of her actions ``the most consistent accounting''
he had ever seen in more than a thousand criminal insanity evaluations.
He also considered the sources of Yates' and Laney's promptings to
kill. He testified that the deeply religious Laney, who like other
Pentecostals interprets the Bible literally and believes that God
is infallible, believed she was right to kill her children because
God would never order her to do wrong. But in Yates' case, he concluded
that if she believed Satan ordered her to kill, she must have known
it was wrong. He also saw Yates' attempts to conceal her murder plans
as a sign that she knew it was wrong.
Experts said the nature of the crimes
may have also swayed jurors. As brutal as both cases were, it may
have been easier for jurors to stomach beating children to death than
drowning them, they said. Stoning has an obvious biblical significance
and the beatings were over relatively quickly. But Yates had to hold
each child under water an average of three minutes -- longer for those
who came up for air. Jurors heard testimony that the last children
were drowned not only in water, but vomit, urine and feces left in
the bathtub by their struggling siblings.
Finally, prosecutors in the Yates case
picked a jury willing to deliver a death sentence, while prosecutors
in Laney's case chose not to seek the death penalty. ``A death-qualified
jury will be significantly less understanding, less sympathetic to
the defense of legal insanity,'' said George Parnham, a lawyer for
Yates.
Fatal Heroin Overdoses on Rise in Massachusetts
Associated Press, 4/5/2004
BOSTON -- Fatal opiate overdoses among teens and young adults tripled
in Massachusetts over a four-year period, and hospitalizations have
doubled as cheaper heroin floods cities and suburbs, according to
the state Department of Public Health. In 2001, 54 Massachusetts 15-
to 24-year-olds overdosed on opiates, which include heroin and similar
drugs -- up from 17 in 1998. There were 2,532 people between 15 and
24 hospitalized in 2002 for opiate use, up from 1,174 in 1998. The
public health department monitors rehab admissions, emergency-room
visits, overdoses and hospital discharge data.
``In all of those indicators we are
seeing significant increased use of heroin and OxyContin, particularly
among younger kids,'' Michael Botticelli, assistant commissioner for
substance abuse, told the Boston Herald. ``We're hearing that kids
are moving very quickly from OxyContin to heroin.'' Lowell police
Capt. Robert DeMoura said ``it can happen to anyone's kids.'' He described
catching a thief breaking into a minivan, and discovering that the
culprit was a former wrestler he had coached who had turned to heroin
use. ``Don't for one minute think I'm not worried about my kids getting
hooked up on heroin,'' DeMoura said.
Even as the state wrestles with a heroin
epidemic, the state could lose more than $9 million in federal aid
for drug treatment as a penalty for three years of cuts to substance
abuse services, The Boston Globe reported. The Department of Public
Health has cut nearly $11 million from drug treatment, and drug and
alcohol abuse prevention. Gov. Mitt Romney is proposing another $2
million in additional cuts for next year.
States that receive funds from the U.S.
Substance Abuse and Mental Health Services pledge to maintain consistent
levels of support for drug treatment. The agency told Massachusetts
late last year that because of the cuts, the state could lose $9.2
million from the $34.3 it was to receive for next year. ``The potential
loss of another $9 million in substance abuse funding would be disastrous
to the Commonwealth,'' said John Auerbach, executive director of the
Boston Public Health Commission. Federal authorities, who denied an
appeal from the state last month, said they have little choice. ``As
much as it may pain us to this, it's the law,'' said Mark Weber, spokesman
for the federal agency.
Study Links ADHD Drugs to Growth Delays
Associated Press, 4/5/2004
CHICAGO -- New research bolsters evidence that stimulants like Ritalin
used for attention deficit problems may stunt children's growth, but
it does not address whether the affect is permanent.
Children who took stimulants during the two-year study grew more than
half an inch less and gained over eight pounds less than those who
weren't medicated. The study involved 540 youngsters with attention
deficit hyperactivity disorder, who were aged 7 to 9 at the outset
of the study and were randomly assigned to receive common treatments
including medication, behavior management and a combination of the
two. Girls generally reach their final height around age 16 and boys
around age 18, so it's too soon to tell if the growth delays continued
or were permanent, the researchers said.
American Academy of Pediatrics' guidelines
that recommend treating ADHD with stimulants and behavior therapy
say evidence collected by following youngsters into adulthood indicates
the drugs don't cause any significant height reduction. Weight loss,
however, is a known potential side effect from long-term stimulant
use.
The study, led by University of California
at Berkeley researcher Stephen Hinshaw, was funded by the National
Institute of Mental Health and appears in the April issue of Pediatrics.
Initial results after 14 months of follow-up, published in 1999, showed
that drugs alone or used with behavior therapy were the most effective
treatment. The 24-month follow-up found that drug treatment with or
without behavior therapy remained superior, though the effect diminished
somewhat over time. The researchers attributed this in part to patients
stopping or starting medication.
ADHD, the most common neurobehavioral
disorder in childhood, affects 4 percent to 12 percent of U.S. school-age
children. Symptoms may include short attention span, impulsive behavior,
and difficulty focusing and sitting still.
Study Details Midwest Binge Drinking
Associated Press, 4/5/2004
CEDAR RAPIDS, Iowa -- Despite the publicity, a new study shows Iowa's
binge drinking problem isn't entirely in Iowa City. The Quad Cities
is listed as No. 6 and Cedar Rapids is listed as No. 7 in binge drinking
ratings out of 120 largest U.S. metropolitan areas surveyed in the
study released in this month's American Journal of Public Health.
``I'm very concerned and surprised,'' said Melissa Walker, coordinator
of the Underage Drinking Task Force of Linn County. ``Unfortunately,
there's a lot of work that needs to be done.'' Binge drinking is defined
as imbibing five or more alcoholic drinks over a few hours.
Of those surveyed in the Cedar Rapids
area, 20.6 percent said they had engaged in binge drinking recently.
Of those between 18 and 34, 36.2 percent were recent binge drinkers.
The study said the number was 13.8 percent for respondents 35 and
older. The Quad Cities reported 21.1 percent overall and No. 18 Des
Moines reported 18.2 percent. The study did not look at Iowa City,
which has been identified as having a binge drinking problem in similar
studies. Nationally, the overall rate is 14.5 percent, the study said.
More emphasis should be placed on telling
the public about the dangers of excessive alcohol use, said Barb Gay,
director of prevention services for the Area Substance Abuse Council.
``Kids who drink early and drink quite a bit do (often) go on to have
substance abuse problems later in life,'' she said.
The survey, which relied on data provided
by states to the Centers for Disease Control and Prevention and focused
on those 18 and older, had bad news for the Midwest as a whole. Six
of the top 10 metropolitan areas are in Iowa, Illinois, Minnesota,
Nebraska, North Dakota, South Dakota and Wisconsin.
The study, which used 1997 and 1999
data, did not address the reasons for heaving drinking in particular
geographic areas. Over consumption has more to do with societal acceptance
and the availability of alcohol, said one of the study's authors,
Robert Brewer, of the National Center for Chronic Disease Prevention
and Health Promotion. ``In general, I think we give people mixed messages
about intoxication,'' Brewer said. ``People often regard getting intoxicated
as something not serious.'' Local drinking ordinances, religious views
and perceptions about drinking are all factors in determining binge
drinking rates, Brewer said.
The Altered Human Is Already Here
James Gorman, New York Times- 4/6/2004
In the popular imagination, the technologically altered human being
is a cross between RoboCop and the Borg. The hardware that would make
such a mating of humans, silicon chips and assorted weaponry a reality
is, unfortunately, still on back order. Many people, however, have
already made a different kind of leap into the posthuman future. Their
jump is biochemical, mediated by proton-pump inhibitors, serotonin
boosters and other drugs that have become permanent additives to many
human bloodstreams.
Over the past half century, health-conscious,
well-insured, educated people in the United States and in other wealthy
countries have come to take being medicated for granted. More people
shift to the pill-taking life every year, to the delight of pharmaceutical
manufacturers. Indeed, drug sales suggest how willing people are to
pursue better living through chemistry. Last year retail drug sales
worldwide were $317 billion. In the United States alone, consumers
spent $163 billion on drugs. In North America, the use of drugs that
affect the central nervous system, antidepressants and others, increased
17 percent. No group has escaped. Last week the Centers for Disease
Control and Prevention reported that 10 million children took prescription
medication for three months or longer in 2002, and preschoolers, another
study found, are now the fastest growing group of children receiving
antidepressants.
This is a social change on the same
order as the advent of computers, but one that is taking place inside
the human body. Just 50 years ago, according to a report by IMS Health,
a company that tracks the pharmaceutical industry, the two biggest-selling
over-the-counter drugs were Bufferin and Geritol. The prescription
drug business was tiny. In 1954, according to IMS, Johnson & Johnson
had $204 million in revenue. Now it is about $36 billion. In 1954,
Merck took in $1.5 million in drug sales; in 2002, that figure was
$52 billion.
To look at it in another way, Americans
take so many drugs that some researchers Dr. Christian G. Daughton
of the Environmental Protection Agency's National Exposure Research
Laboratory in Las Vegas, for example are worried about the
effects on the environment. What does it mean if the sewers run rich
with Zoloft? Or to be more precise, what might happen to fish eggs
if the rivers soak up waste water with discarded and excreted pharmaceuticals
and personal care products, like shampoo? No one has the answer yet,
but the idea that what runs through our collective bloodstream is
a potential environmental hazard makes you look at your medicine cabinet
in a different way.
In short, while the Six Million Dollar
Man is still a fantasy, Pharmaceutical Man is already here, and largely
unnoticed. Swallowing a pill at a business lunch is likely to elicit
little curiosity. A high-powered executive who did not have blood
pressure or cholesterol problems might be suspect. There are concerns
about the widespread use of antidepressants, but they do not seem
to have affected sales. In fact, the group of antidepressants that
includes Zoloft is the third biggest class of pharmaceuticals by sales
in the United States, totaling $11 billion in 2003.
Drugs in the top two categories
statins to reduce cholesterol levels and proton pump inhibitors to
prevent heartburn, gastritis, ulcers and other digestive problems
had sales of about $14 billion and $13 billion, respectively.
Critics of the national medicine cabinet have noted that behaviors
and physiological changes that were once simply aspects of life
menopause, the inability to keep still as a child, baldness, decreasing
potency in old men have been medicalized, turned into syndromes
or diseases.
Dr. Thomas Szasz, a psychiatrist who
in the 1960's defined himself as far outside the mainstream by arguing
that mental illness was a myth, recently wrote a book called "Pharmacracy,"
about the invasive rule of medicine as it defines our lives. Last
fall, the President's Council on Bioethics issued a report called
"Beyond Therapy: Biotechnology and the Pursuit of Happiness."
The report included material on genetics and embryo selection, but
it also addressed performance enhancement and behavioral drugs. One
of its concerns was the way everything in life becomes a medical problem.
When new technologies, including drugs, come through doctors, the
report said, many aspects of life become medicalized, raising concerns
that "the pursuit of happiness and self-perfection would become
part of the doctor's business." The report also cataloged "other
aspects of human life that formerly had little to do with doctors
and hospitals: childbirth, infertility, sexual mores and practices,
aspects of criminal behavior, alcoholism, abnormal behavior, anxiety,
stress, dementia, old age, death, grief and mourning."
One might argue that any extension
of medicine should be welcome. The prevention of heart attacks is
obviously a worthy effort. Antidepressants can ease anguish, which
for many people who take them is overwhelming. In many countries of
the world, people would jump at the chance to worry about having too
much medicine; they don't have nearly enough of it. Yet some of the
new miracles of the pharmaceutical industry are not intended to save
lives, but to improve and prolong them.
Ana-Maria V. Zaugg vice president of
corporate strategic planning for IMS Health, said that there were
two streams of change in pharmaceutical research and use. Acute care
is giving way to chronic or preventive care managing cholesterol
levels rather than treating heart attacks, for example. At the same
time, disease treatment is being extended to treatment whose goal
is to increase well-being. Drugs for baldness, incontinence, sexual
performance and the effects of menopause may be included in the latter
category. Both trends are expected to increase, Ms. Zaugg said. Some
areas that she is confident will grow are drugs to improve male sexual
performance, anti-Alzheimer's drugs, and drugs for incontinence and
osteoporosis. If new psychostimulants and anti-obesity drugs appear
in the future, she said, they will quickly take off. Compounds that
increase intelligence and greatly improve memory will undoubtedly
be best-sellers as well.
Whether or not the growing use of drugs
has altered our essential humanity, there is now almost no bodily
system that cannot be adjusted by them. Blood, respiration, the nervous
system, hormonal regulation, muscles and bones, the cardiovascular
system, reproduction, sexuality drugs are available to nudge
them all in one direction or the other. It is not unusual for someone
to begin the day with a cocktail of antidepressants, statins and blood
pressure medications.
The result does not yet seem to be
the epidemic of dull, well-managed emotionless humanity that some
forecasters have worried about. For instance, among professionals
in journalism and publishing in the New York metropolitan area, who
no doubt take as much Zoloft per capita as anyone on the planet, it
is no small trick to find someone who is either calm or happy. Perhaps
in the future, stronger drugs will produce the well-sedated zombies
that will make the streets of Times Square disturbingly docile and
well mannered, but it has not happened yet.
There are concrete results of the medicated
life, however. Dr. Isaac Schiff, chief of obstetrics and gynecology
at Massachusetts General Hospital in Boston, said he found that "most
people, men and women who are in their 50's, are taking something
every day." He added, "One of the reasons is that our life
expectancy has changed dramatically. Our whole concept of aging is
very different." Dr. Schiff said that many people in their 40's
and 50's "are now taking medication to prevent diseases in their
70's." In the case of osteoporosis, for example, the point of
taking medication at age 50 is to prevent a hip fracture at age 75
or 80.
What that means for medicine is that
as old problems recede, new ones arise. Dr. Neal L. Benowitz, professor
of medicine and chief of clinical pharmacology at the University of
California at San Francisco, said that doctors had seen a shift in
"what you can expect to die from." There are fewer deaths
from heart attack, he said, and more from congestive heart failure,
cancer and Alzheimer's. One problem, of course, is that it is the
well-off and the well educated who are most likely to take advantage
of the many drugs available. Another is that need can be manufactured
by advertising. Even children know from television that if you are
sad and worried, there is a pill for you. If you have heartburn there
is a pill for you. It is a lot harder to find out that there are other
ways to feel better, physically and emotionally, than taking drugs.
By and large, however, the pharmaceutical
road is paved with pretty good intentions. The president's report
addressed "the pursuit of happiness." A similar report on
the dangers of computers and other hard technology might have a different
subtitle the pursuit of power, perhaps. Even the dystopian
fantasies of cyborgs and the overmedicated are fundamentally different.
Drugs are an easy way to contentment and the absence of pain
even if they are ultimately unsatisfying. Hardware is something else.
It enhances the senses, increases strength, adds weapons. As a cyborg,
you can be your own telescope, your own computer, your own gun. It
may not be so bad that the pharmaceutical human is arriving first.
Jittery? Peevish? Can't Sleep? What Are You Drinking?
Richard Friedman, M.D., New York Times- 4/6/2004
The patient was led reluctantly into my office by his girlfriend.
Over the course of the past month, she explained, Adam had become
uncharacteristically nervous and snappish. He hardly slept, and when
he did she noticed that his muscles twitched. Adam's own account did
not differ from his girlfriend's. He was a graduate student and he
needed to study for his qualifying exams, he said, explaining his
irritability.
I noticed during the consultation that
Adam was sweaty and nervous and that the muscles around his eyes twitched.
He had already seen his internist, who told him that his physical
exam and routine lab tests were entirely normal. This is nothing more
than stress, his doctor declared. In my office, Adam's resting heart
rate was 110, which is on the fast side for a fit 31-year-old man.
His blood pressure was mildly elevated at 140/80, but just talking
to a psychiatrist can be nerve-racking for many people.
After a review of his psychiatric history,
which was entirely negative, I asked him whether he was using any
recreational drugs. Aside from experimenting with marijuana as a teenager,
he said he had not. I never stop at the first denial, so I inquired
about specific drugs like cocaine and amphetamines, which are well
known to cause anxiety states. "No way," he said, and I
believed him.
Maybe this was just plain old-fashioned
anxiety. After all, Adam was facing enormous academic pressure in
a prestigious institution, and he felt that his future was riding
on the outcome of an exam. So I gave him some reasonable advice about
dealing with stress, and sent him on his way with a clean psychiatric
bill of health.
Two weeks later, I got a call from
Adam's girlfriend saying that he was worse than ever. When I saw him,
he looked haggard and anxious, and I was convinced that I had missed
something important the first time around. Did he have an undiagnosed
medical disease? Covert substance abuse? Exposure to an environmental
toxin?
In painstaking detail, we reviewed
his medical and psychiatric history, but nothing stood out. Exasperated,
I asked him to tell me what he did from the moment he got out of bed
until he went to sleep: activities, diet, everything. Then I got it.
After the habitual two cups of Starbucks coffee, Adam set to work.
So far, so good. But as the academic pressure mounted, he had to work
longer hours, and that meant more coffee a lot more coffee
than he had ever consumed in his life. In fact, for six weeks, he
had been drinking up to 10 cups of Starbucks coffee daily.
That is a lot of caffeine, considering
that each large cup contains on average about 375 milligrams, according
to a 2003 study of caffeinated coffee published in The Journal of
Analytical Toxicology. With 10 cups a day, Adam was turbocharged with
nearly four grams of caffeine. So Adam was not just nervous about
his academic work; he was also suffering from caffeine intoxication.
How, you might wonder, could such a
ubiquitous substance be toxic? With an average of one to three cups
of coffee a day, most people get 100 to 300 milligrams of caffeine.
With chronic exposure, though, people become accustomed to the stimulant
effects of caffeine. In contrast, a sudden increase in caffeine consumption
can easily produce caffeine intoxication. In general, more than 1.5
grams of caffeine a day can cause the typical symptoms of caffeinism:
anxiety, insomnia, irritability and palpitations.
Caffeine is far and away the most widely
used stimulant in the world. It is actually a member of a class of
compounds called xanthines that includes theobromine, which is abundant
in chocolate and theophylline, the major xanthine in tea. Caffeine
works by blocking the calming and analgesic effects of the neurotransmitter
adenosine in the brain. In moderate doses, caffeine enhances arousal
and performance. At higher doses, caffeine blocks a majority of adenosine
receptors and can produce anxiety and hypersensitivity to pain.
Of course Adam's response to caffeine
was an extreme example. But the effects of this popular stimulant
encompass a broad spectrum, from the pleasant activation of morning
coffee to the extreme agitation and anxiety of caffeine intoxication.
Judging from the sheer number of consumer products spiked with caffeine,
one would think we were a nation of narcoleptics, desperately trying
to stay awake. From "enhanced" water to sports drinks to
dietary supplements, caffeine is a common additive. And as the food
and supplement industries search for new stimulants following the
recent ban on ephedra, it would hardly be surprising to find caffeine
use on the rise. After all, the hectic pace of our modern life practically
demands that we can switch ourselves on and off. Sure, we can stave
off fatigue with caffeine, but sometimes nature pays us back richly
with anxiety and sleeplessness if we are lucky or caffeine
intoxication if we indulge in excess.
A Smokeless Alternative to Quitting
Salley Satel, M.D., New York Times- 4/6/2004
For decades, public health advocates have championed harm reduction
for people who cannot stop taking health risks or do not want
to. Needle exchange is a classic example. Intravenous drug users get
clean needles because, the reasoning goes, contracting and spreading
AIDS is worse than making heroin use a little easier.
But harm reduction for hard-core smokers
is another matter. At issue is a form of smokeless tobacco, a popular
Swedish product called snus (rhymes with loose) that satisfies smokers'
nicotine addiction with negligible health risks of its own. But to
many foes of smoking, it is not a lifesaver, but the devil's instrument.
Snus, moist oral tobacco, comes in a tiny tea bag. It sits discreetly
between lip and gum. Because it does not stimulate saliva production,
there is no spitting. Even better, there is no smoke. "It is
the tobacco smoke, with its thousands of toxic agents, that leads
to cancer, heart disease and emphysema," said Dr. Brad Rodu,
a pathologist at the University of Alabama at Birmingham. Eliminate
the smoke, and you significantly reduce the risk.
Snus, a Swedish version of snuff, is
especially attractive to smokers because it produces nicotine levels
comparable to smoking. Gum and the patch administer too little nicotine
to reliably prevent craving and withdrawal symptoms. The health benefits
are impressive. Forty percent of Swedish men use tobacco products.
Yet Sweden has the lowest rate of lung cancer by far. Why? Largely
because of snus, which represents half of all the tobacco that Swedish
men use. (The other half smoke.) Snus has not caught on with women.
Smoking opponents should herald snus.
But instead, the very notion of harm reduction inflames them. "It's
like trying to play God trading oral cancer for lung cancer,"
said Dr. Gregory Connolly of the Massachusetts Tobacco Control Program.
Over 20 epidemiological studies show that smokeless tobacco is far
safer for mouth cancer than cigarettes. Even traditional smokeless
products bring one-third to one-half the risk. Users of snus, which
contains low levels of tobacco-specific nitrosamines, a carcinogen,
incur a risk of developing oral cancer no greater than nonsmokers,
the journal Tobacco Control reported last year.
What about gateway effects? Clearly,
if using smokeless tobacco turns people on to nicotine and they "graduate"
to smoking, it fails as a public health strategy. But Sweden has the
best record of smoking reduction in Europe. Moreover, the proportion
of current smokers who are former snus users is far less than the
proportion of snus users who once smoked. In short, snus has largely
been a pathway away from smoking, not vice versa. Dr. Lynn T. Kozlowski
of the biobehavioral health department at Penn State, found that more
than three-fourths of men from 18 to 34 who used smokeless tobacco
never went beyond it to cigarettes or had used cigarettes before using
smokeless products.
Swedish snus and brands of compressed
tobacco like Ariva, Exalt and Revel are available in this country
but are hard to find. Most smokers have never heard of them, and many
doctors are unfamiliar with the products. The government, rather than
clearing the air, is muddying it. Last year, the surgeon general,
Dr. Richard H. Carmona, told Congress, "There is no significant
scientific evidence that suggests smokeless tobacco is a safer alternative
to cigarettes." This is simply wrong in the case of smokeless
tobacco in general, and snus in particular. "Tips for Teens"
from the Department of Health and Human Services answers the question,
"Isn't smokeless tobacco safer to use than cigarettes?"
with an emphatic and erroneous "no."
"I suppose you could argue that
shooting yourself in the leg poses less of a health risk than shooting
yourself in the head," a former president of the American Dental
Association, Dr. D. Gregory Chadwick, said. "But do we really
need to have that discussion?" Yes, we do. Experts have for years
endorsed harm reduction as a pragmatic last resort for addicts, because
they are convinced of the relative safety that accrues to the user
and society. No one disputes that quitting is optimal. But that is
not practical in every case. Snus in particular, and smokeless tobacco
in general, provide clear, lifesaving advantages over smoking that
antitobacco activists refuse to acknowledge.
Patterns: Violent Games Teenagers Play
Eric Nagourney, New York Times- 4/6/2004
They may be rated as suitable for young teenagers, but many of the
video games sold for use at home are hardly kid stuff. Researchers
from Harvard analyzed 81 "T-rated" games and found violence
in almost all of them: the number of "deaths" per hour averaged
122. Under the guidelines of the Entertainment Software Rating Board,
an industry group, T-rated games are for children 13 and over. The
study, led by Kevin Haninger, appears online in the journal Medscape
General Medicine. The authors also published a report this year in
The Journal of the American Medical Association.
The researchers made no effort to judge
the quality of the games, said an author of the study, Dr. Kimberly
M. Thompson of Children's Hospital Boston. Nor did they spend much
time discussing how the games might affect the young players (though
they noted that studies had linked video game violence and aggressive
behavior). Instead, they simply rated the videos for every act of
violence. Ninety-eight percent of the games contained intentional
violence, with 42 percent showing blood, they said. Sixty-nine percent
rewarded players for killing characters or required them to do so.
Dr. Thompson said she believed that
many parents would be surprised at the violence. "You really
have to pay attention not only to the rating but to what's actually
in the game," she said. The researchers also said the ratings
board should consider adding new categories, like the PG and PG-13
ratings of the movies. The board president, Patricia Vance, said in
a statement that "current rating categories serve consumers well,
with sufficient breadth to capture the wide range of content offered."
New Lesson for College Students: Lighten Up
Sara Rimer, New York Times- 4/6/2004
BRUNSWICK, Me. It was intended as a statement against the
kind of perfectionism that drives some Bowdoin College students to
spend two hours a day on the treadmill: plastered all over campus
recently were photographs of naked undergraduate Bowdoin women
or at least their bodies, as the pictures had been shot from the neck
down in all their short, tall, thin, not-so-thin, fit and unfit,
anonymous, unairbrushed glory. Far from being shocked, Craig W. Bradley,
dean of student affairs, said he supported the women's group that
came up with the poster campaign anything to get students to
stop worrying so much about body image, grades, careers. Mr. Bradley,
along with other college officials, has been telling students to get
off the treadmill. Go for a walk, go surfing. Read a novel just for
pleasure. Eat ice cream. Hang out with the knitting club. Find your
passion.
Bowdoin's efforts reflect the ever-increasing
attention colleges across the country are giving to undergraduates'
personal growth and emotional well-being. It has been more than a
decade since colleges became mindful of the new generation of students
arriving on campus with serious mental health illnesses. But these
days, as they respond to the rising number of students seeking help
for stress-related conditions on campus and the expectations of consumer-minded
parents, many colleges are extending the therapeutic culture far beyond
treatment for clinical depression and bipolar disorders. Private and
public colleges alike have begun offering a wide range of services
and activities intended to help students negotiate what used to be
considered the ordinary rites of passage: homesickness, sophomore
existential angst, romantic relationships. There are now free massages
and dogs to cuddle in exam seasons, biofeedback workshops and therapists
available to help students work through their first C.
At Harvard, the training given to graduate
students who live in the undergraduate houses has in recent years
expanded to include ways to help students fight perfectionism
a theme on many campuses as well as negotiate matters involving
race, class and sexual identity. At Amherst College in Massachusetts,
students can have unlimited sessions with the counseling center's
therapists. They are free to discuss more mundane concerns like their
futures and their relationships with family members, roommates,
boyfriends and girlfriends as well as more serious issues like
depression and eating disorders. Washington University in St. Louis
has established stress-free zones during finals, where students can
get chair massages and listen to New Age music. Addressing the notoriously
poor sleeping habits of undergraduates, the university recently celebrated
Sleep Awareness Week by handing out sleep quizzes and reminding residential
advisers not to brag about how little sleep they can get by on.
Kevin Kruger, the associate executive
director for the National Association of Student Personnel Administrators,
with nearly 1,500 members, said the new services were the natural
extension of the awareness raised by students with serious mental
health problems. "This movement is an indication of colleges
trying to be more proactive," Mr. Kruger said, rather than waiting
for students to "flunk out, have a breakdown or whatever the
outcome is going to be."
But many college officials also acknowledge
that they are responding to the heightened consumer mentality of many
parents. "If you're paying a lot, you expect a lot in return,"
said Craig McEwen, dean of academic affairs at Bowdoin, one of the
nation's top liberal arts colleges. "Unhappiness is not something
you're supposed to feel." Some college officials say that these
services are not only driving up higher education costs but some may
also be an extension of a therapeutic culture that has gone too far.
While it is important that colleges
talk about "the whole student," said Steven E. Hyman, the
provost at Harvard, and the former director of the National Institute
of Mental Health, "that doesn't mean they should all be in group
therapy." Dr. Hyman said he also doubted the value of the biofeedback
and massage, suggesting that it might be more helpful if students
learned to organize their lives. "It's a difficult tightrope
to walk," said Dr. Hyman, who is a psychiatrist. "There's
a risk that we will medicalize what are really developmental issues:
negotiating independence, deciding what your goals are in life, having
the courage to explore your interests rather than follow the straight
and narrow path of careerism. At the same time, we have to be very
careful that we don't miss serious treatable illnesses like depression,
anxiety disorders and eating disorders."
Colleges have been steadily increasing
the availability of treatment and counseling, and students have responded.
At the University of Michigan, for example, the number of students
seeking counseling has risen 22 percent in three years, said Todd
Sevig, director of counseling and psychological services. Some college
officials see the contradiction inherent in their new efforts to offset
stress and encourage the joys of reflection and unstructured time.
After all, it was multitasking, hyperorganized, résumé
building behavior that helped some students get admitted to their
schools in the first place.
"We admit only the most over-scheduled
children and we boast of how many sports they play, how many clubs
they organize, how many hours of volunteer service they provide,"
said Elaine Hansen, president of Bates College, in Lewiston, Me.,
in her inaugural address two years ago. How then, she went on, could
Bates encourage those same children to risk "moments of woolgathering,
daydreaming, improvisation" that she viewed as an essential component
of a liberal arts education? Ms. Hansen said she had thought about
calling off classes on the spur-of-the-moment so everyone could enjoy,
say, a glorious spring day in Maine. But, she said: "If we do
it without a conversation first about why we're doing it, we're afraid
people will just go to the library and get caught up."
In his January letter to parents, Bowdoin's
president, Barry Mills, expressed his concern about what appeared
to be a national increase in stress-related conditions among college
students. Expanding on the president's letter, Dean Bradley spoke
to the college's trustees recently about creating a culture that emphasizes
the joy of learning for learning's sake, "a culture that can
itself ameliorate the anxiety many students feel about grades, jobs,
grad school admissions." At the same, Bowdoin officials say they
do not want their students to relax too much. "You still have
to accomplish," President Mills said. "You still have to
succeed. This is not about relax and schmooze your way through Bowdoin."
Many students here said they welcomed
the emphasis on the joy of learning. And many said they were having
fun at college. But they were quick to point out the realities of
the world they live in. Travis Brennan, a Bowdoin senior who wants
to be a lawyer, said all his love of learning would not get him into
a good law school. What he needs, Mr. Brennan said, are high law board
scores. "You have to be mindful that you're operating in a larger
system," he said.
In the 1960's and 1970's, with students
demanding liberation from administrators, colleges relinquished their
role as in loco parentis chaperones. Now, some of the students who
once told administrators to get out of their lives are parents paying
high tuition and expecting colleges to smooth over everything from
their children's relationships with roommates to grades. Colleges,
in the meantime, are coaching their students on how to manage their
overmanaging parents. At Austin College, in Sherman, Tex., Rosemarie
C. Rothmeier, director of student services and counseling, coaches
pre-med students who are afraid to tell their parents that they hate
organic chemistry and do not want to be doctors after all. One piece
of advice, "Don't drop the bomb at Thanksgiving dinner."
Some college officials say parents
must share responsibility for their children's difficulties in coping
with the inevitable stresses of college. "Rather than seeing
late adolescence as a time of learning by trial and error," Mr.
Bradley told the trustees, "many parents put great energy into
trying to eliminate the error." He suggested that perhaps parents
were creating a generation of students afraid to take risks.
Another factor contributing to stress
is the high price of education. "If you break it down, it's about
$75 a lecture," said Karen Jacobson, a Bowdoin senior, quoting
a faculty member who had made the calculation based on Bowdoin's $37,950-a-year
price tag. Ms. Jacobson said she had sought her mother's advice about
taking a dance class. "She said, `Are you sure you don't want
to take something more intellectual?' " said Ms. Jacobson at
a meeting of the college knitting club. Ms. Jacobson said she figured
her mother might have been thinking, quite understandably, that she
was not paying that much so her daughter could take a dance class.
"I ended up taking statistics," she said. "I realized
I needed it for grad school."
FDA Sat on Report Linking Suicide, Medications
Elizabeth Shogren, Los Angeles Times- 4/6/2004
WASHINGTON - Ten months ago, when concerns arose about a possible
link between children taking antidepressant drugs and suicide attempts,
senior officials at the Food and Drug Administration ordered their
leading expert to head up an examination of the evidence. When the
government scientist filed his report last winter, however, his bosses
decided to keep it secret -- even though it found that children who
took the drugs were twice as likely to be involved in serious suicide-related
behavior as those who did not.
Instead of revealing the findings,
senior FDA officials ordered more studies, which were not expected
to be completed until summer. They also squelched plans to have the
author, Dr. Andrew Mosholder, present his conclusions to an FDA advisory
committee when it took up the issue in February. And in March, when
the agency issued a warning about the possibility of problems for
young patients taking the drugs, FDA officials said no conclusive
scientific evidence existed on the link between antidepressants and
potentially suicidal behavior by children. Officials said they based
their action on anecdotal complaints from physicians and families
that had been presented to the advisory committee. They gave no hint
that their own chief expert on the subject had examined the results
of more than two dozen clinical trials conducted by antidepressant
manufacturers, and that he had found an unusually high correlation
between their use and potentially suicidal behavior in young patients.
The report still has not been made
public, but news of Mosholder's conclusions first surfaced in a CBS
News report last week. His findings were detailed in an internal FDA
document obtained by the Los Angeles Times and authenticated by government
officials. In defending their decision to hold back Mosholder's report,
his superiors questioned the reliability of the data on which he based
his conclusions. They suggested drug companies, which manufacture
antidepressant drugs and conducted the clinical trials in order to
market them, might have been too quick to count some behavior as potentially
related to suicide -- that is, too quick to raise questions about
their products. Among the kinds of actions the officials said should
not necessarily have been counted as potentially suicide-related were
instances of children who deliberately cut themselves.
Some FDA officials defended the decision
to sit on the report and seek more analysis of the data, but some
psychiatrists and congressional leaders were angered that the agency
had kept Mosholder silent. "Evidence that they're suppressing
a report like this is an outrage, given the public health and safety
issues at stake," said Dr. Joseph Glenmullen, a Harvard psychiatrist
who wrote a book on problems with the drugs known as serotonin reuptake
inhibitors, which alter brain chemistry to manage depression. "They've
been claiming that there's no evidence. Here's the evidence."
Congress Asks for Data
Senate and House committees have ordered the FDA to hand over documents
-- such as the ones obtained by The Times -- that might illuminate
what the agency knew about the possible link between the drugs and
suicidal behavior. They specifically asked for any of Mosholder's
reports, e-mails, correspondence or notes on pediatric or adolescent
antidepressant trials. These members of Congress are concerned that
the FDA may be keeping information from Americans that would help
them better assess the possible risks of taking antidepressants or
giving them to children. "It would have been very wrong for the
FDA to withhold any information it had about unintended consequences
that might result from the use of antidepressants, especially for
children and adolescents," Sen. Charles E. Grassley (R-Iowa),
chairman of the Senate Finance Committee, said in a statement. "The
public deserves to know of every possible risk so that family members
can closely monitor any changes in behavior," he said.
Suicide is the third leading cause
of death in teenagers ages 15 to 19. From 1980 to 1997, the rate of
suicide among this group increased by 11%. Suicide is rare but growing
among younger children. The suicide rate for those 10 to 14 years
old increased by 109% between 1980 and 1997, according to the Centers
for Disease Control and Prevention. Since peaking in the late 1990s,
suicide rates appear to be declining among teenagers, but remain a
serious problem. Experts say depression is the leading factor in suicide.
Depression affects 1 in every 33 children
and 1 in every 8 adolescents, according to the National Mental Health
Assn. Although only one antidepressant, Prozac, is explicitly approved
by the FDA for children, doctors routinely prescribe others to their
young patients, and the use of these drugs by children has been steadily
rising. The antidepressant drugs -- Prozac, Zoloft, Paxil, Luvox,
Celexa, Lexapro, Effexor, Wellbutrin, Serzone and Remeron -- are taken
by 30 million Americans, according to some estimates. The first seven
are serotonin reuptake inhibitors, and their sales in 2003 exceeded
those of any other drug class except the group of painkillers that
includes codeine. An estimated 7% of the Americans taking the medications
are children. Drug use is tracked by the number of prescriptions written.
A total of 2.7 million antidepressant prescriptions were dispensed
for children younger than 12 and 8.1 million were written for adolescents
in 2002, according to the FDA, although some individuals received
more than one prescription a year.
In studying reports from 28 clinical
trials, most of them unpublished and thus not open to public inspection,
Mosholder concluded the data showed a "statistically significant"
risk of serious suicidal events among children taking the drugs. And
he stressed that what he acknowledged were limitations in the data
he was analyzing would not change his conclusion. "Finding a
statistical association despite these limitations makes the finding
difficult to dismiss," he wrote in one of the documents, which
was authenticated by government officials familiar with the document.
FDA officials would not comment directly on the documents.
Dr. Robert Temple, associate director
for medical policy at the FDA's center for drug evaluation, said Mosholder
"thought those data were persuasive just as they were."
But his superiors believed that it was "premature" to come
to the conclusion that the drugs were linked to suicide, he said.
Temple and other senior FDA officials think that some of the data
from the drug companies were flawed because they were based on the
firms' own decisions about what constituted serious suicide-related
events. For instance, there were several cases of teenagers who cut
themselves but were not planning to kill themselves. Still, those
cases were counted as serious suicide-related events by the drug companies;
senior FDA officials decided they should not have been counted. The
FDA is having suicide experts at Columbia University reexamine the
data. "We would be doing something bad if we made them look like
they are more dangerous than they are, just as we would be doing something
bad to make them look much less dangerous than they are," Temple
said. "It's important to do this right." Although drug trials
have yet to show efficacy for most of the drugs in children, many
doctors and patients think that they help depressed kids, FDA officials
said.
Expert's Results Differ
Mosholder was assigned in June to head up the FDA's assessment of
a possible association between Paxil and suicidal behavior in children,
but his mandate was broadened to include other antidepressants. By
January he had come up with conclusions that did not jibe with the
FDA's official position, according to internal FDA e-mails and interviews
with FDA officials other than Mosholder. The FDA's official public
position was that there was not adequate data to support a link between
antidepressants and possible suicide.
At first, FDA officials had planned
to have Mosholder tell the advisory panel about his conclusions. One
of the internal documents was a trial question-and-answer session,
rehearsing what Mosholder would tell the committee. In italic type,
Mosholder was asked questions about his analyses and coached on how
he should handle them. Mosholder's answers, summarizing his findings,
appeared in normal type.
Mosholder wrote that trials of eight
antidepressant drugs, involving 4,100 pediatric patients, showed 108
suicide-related events -- 74 on drugs and 34 on placebo. About a quarter
of the events could be classified as serious; and most of the suicide-related
events were among children suffering major depressive disorder, not
from the other diseases treated with the medications, such as obsessive-compulsive
disorder. In these seriously depressed patients, there was one serious
suicide-related event per five patient years on the drug, compared
with one per 10 patient years on the drug for placebos. Patient years
are a statistical measure of the frequency of drug side effects. Mosholder
also wrote that the risk was most evident for paroxetine, or Paxil,
and venlafaxin, or Effexor. His findings also suggested that patients
should not quickly stop taking the drugs. About a quarter of the suicide-related
events on paroxetine occurred within four days of discontinuing the
drug, he wrote.
In italics, Mosholder was advised not
to give any recommendations to the panel and to acknowledge the limitations
of his analyses "relative to the definitive analyses being prepared."
Later, senior officials decided Mosholder should not appear before
the advisory committee, and it was not told of his work During the
panel session, FDA officials explained that the Columbia University
experts would analyze the data from the drug company trials, and their
results would be published this summer.
One of the reasons that some senators
and representatives decided to investigate the FDA's approach to regulating
antidepressants was that the British government -- faced with the
same information -- took a much more protective action, warning doctors
not to prescribe any of the drugs to children except Prozac, or fluoxetine,
according to congressional staffers. Mosholder wrote that his conclusion
"essentially mirrors the conclusions" of the Medicines and
Healthcare products Regulatory Agency, the FDA's British counterpart.
Glenmullen said that given Mosholder's
findings, the FDA should have given a stronger warning to Americans
about the possible risks of using the drugs. "For the FDA to
issue an ambiguous warning when they had unambiguous data like this
is an outrage," Glenmullen said.
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