The Mutual UFO Network is holding a
meeting this weekend for people who saw the object. The non-profit group says
its investigators will begin taking statements at 1 p.m. on Saturday.
The Star-Telegram says this isn't the
first time people in that part of the state have reported seeing strange things
in the sky. Back in 1897, a Stephenville man told The Dallas Morning News that
a 60-foot-long "aerial monster" landed on his farm.
Faster than a speeding bullet — and
bigger than a Wal-Mart.
That's how residents near the west
Texas town of Stephenville described an object they spotted in the sky one
night last week.
Dozens of the town's residents —
including a pilot and a police officer — said a UFO hovered over the farming
community for about five minutes last Tuesday before streaking away into the
night sky.
Pilot Steve Allen saw the object when
he was out clearing brush off a hilltop near the town of Silden. Allen
described the unidentified object as being an enormous aircraft with flashing
strobe lights — and it was totally silent.
He said the UFO sped away at more than
3,000 mph, followed by two fighter jets that were hopelessly outmaneuvered.
Allen said it took the aircraft just a few seconds to cross a section of sky
that it takes him 20 minutes to fly in his Cessna.
The veteran pilot said the UFO, an
estimated half-mile wide and a mile long, was "bigger than a
Wal-Mart."
Military Dismisses Sighting
The Stephenville Empire-Tribune, which
has written about the mysterious object, said about 40 people saw the thing —
though some were too sheepish to admit the sighting until others came forward.
Police officer Leroy Gatin said he was
walking to his car when he saw a red glow that reminded him of pictures he'd
seen of an erupting volcano.
He said the object was suspended 3,000
feet in the air. Gatin said he was so awestruck that he called his son to come
and see — but he didn't talk much about it until he saw a story about a UFO in
the local paper.
Military officials, however, were
skeptical. They said the residents are letting their imaginations run wild and
passed it off as an optical illusion. They said it was likely nothing more than
a reflection of sunlight on two airliners.
Officials at a nearby air force base also
said their fighter pilots didn't chase down anything that night.
The incident was eerily similar to a
UFO sighting a little more than a year ago at Chicago's O'Hare International
Airport.
As many as 12 United Airlines
employees spotted the object and filed reports with United.
Combining a megapowerful magnet,
multiple detectors, and carefully tweaked contrast, a new MRI technique
developed at the National Institutes of Health (NIH) provides an unprecedented
look at the fine structure of the brain. Using an MRI machine equipped with a
magnet more than twice as powerful as one in an ordinary device, the
researchers created a way to measure the magnetic field changes caused by
tissue properties to optimize contrast in the image. They were also able to
compensate for the magnetic field fluctuations created by the patients’
breathing. The technique revealed never-before-seen patterns in the white matter
and gray matter of the human brain.
Picking up on such differences may
help researchers look more deeply into the brain’s subdivisions, allowing them
to map it in greater detail. It may also bring about advances in diagnosing
diseases like Alz–heimer’s and
multiple sclerosis, both of which involve abnormal iron accumulation in the
brain. For patients, the new technique may mean that “you could more
accurately—and maybe earlier—diagnose a disease,” says NIH physicist Jeff Duyn.
Only eight MRI machines this powerful
exist in the United States, and all are housed in research, rather than
clinical, settings. Each costs around $5 million, and that’s before the expense
of setup—which includes installing 380 tons of shielding material to prevent
every metal object in the building from being sucked into the magnet.
http://louis-j-sheehan.us/ImageGallery/CategoryList.aspx?id=a1206a74-5f7f-443f-97f5-9b389a4d4f9e&m=0
Chinese researchers announced (pdf) in
March that they had created glass that can be bent into right angles without
shattering. But this isn’t glass as we know it: The new glass is opaque, twice
as strong as window glass, and made of metal.
As solids, metals have an orderly
atomic structure; in liquid metals, the arrangement becomes random, as in
glass. To create metallic glass, scientists supercool liquid metals,
effectively “freezing” the random array in place. These bulk metallic glasses,
or BMG, are two to three times stronger than the crystalline form of the metals.
Superstrong BMG has already been used
in the manufacture of high-tech golf clubs and tennis rackets; in 2001, the
collector on NASA’s Genesis spacecraft, which caught particles from the solar
wind, was made of BMG.
But since the 1980s, when scientists
began making BMG, the materials have exhibited a fatal flaw. Paradoxically, the
stronger they are, the more vulnerable they are to cracks, says Wei Hua Wang, a
physicist who helped develop the new glass at the Chinese Academy of Sciences.
A tiny fracture in the original type of BMG spreads quickly and becomes
catastrophic.
To create a glass that is both strong
and flexible, Wang and his colleagues altered an existing BMG recipe, combining
zirconium, copper, nickel, and aluminum. Realizing that small changes in the
metal mixture would lead to large variations in brittleness, they sought a combination
that would keep cracks from spreading. “The plasticity of the glass is very
sensitive to the composition,” Wang explains.
After two years, the scientists
produced bendable BMG. It contains hard areas of high density surrounded by
soft regions of low density. The result: When a crack begins in one place, it
dissipates quickly in the surrounding regions, leaving the whole flexible.
Believe it or not, there are some
folks who make a living as professional guinea pigs in tests of experimental
drugs. Some question whether testing that relies on frequent lab fliers takes
advantage of poor people or compromises the quality of the data.
In a recent issue of the New Yorker,
bioethics professor Carl Elliot, from the University of Minnesota, details how
early drug safety testing has become more of a business transaction than a
scientific endeavor in an article called “Guinea-Pigging.” He’ll also be
exploring the topic as part of a book he’s writing on corruption, money and
medicine that he expects to be called “White Coat, Black Hat” and to be
published next year. We asked Elliot, who is on sabbatical in New Zealand, a
few questions via e-mail. Here are the highlights of the long-distance
conversation:
How does professional guinea-pigging
affect the data on experimental drugs?
What I heard about most often was
subjects stretching the truth about their medical histories in order to get
into high-paying studies. That seems to be fairly common. I don’t know what
kind of impact it has on the results, but it shouldn’t be terribly shocking. We
have a safety testing system where subjects don’t have any stake in the results
of the study, where they don’t really trust the research sponsors, and where
they don’t believe they are going to get access to the drugs that are developed
by the studies. If poor people are being asked to test drugs for the benefit of
rich people, then we shouldn’t be surprised if the poor people are not always
perfectly compliant.
Should we change the system to
discourage professional guinea-pigging?
Well, one thing that worries me is the
damage that all these studies could be doing to the long-term health of the
guinea pigs. They are mostly uninsured, so they are in no position to get
regular medical care, and nobody else has any financial interest in monitoring
their health.
Payment itself is a real dilemma. New
drugs need to be tested for safety, and I can’t imagine that many people will
volunteer to test the safety of new drugs for free anymore, especially if it
means checking into a testing site for three weeks to undergo invasive medical
procedures. But it feels unfair to put the burden on poor people who are driven
to volunteer at these testing sites because they can’t get any other kind of
work. If we are going to have a payment-based system, we need to make sure that
poor subjects are not being exploited.
What changes are needed for safety’s
sake?
Apart from watchdog groups like
Circare, which operate on a shoestring budget, and investigative reporters,
there really are very few people outside the research enterprise watching these
studies. Formal oversight has been outsourced to for-profit IRBs [institutional
review boards], which are paid by the companies doing the research, and which
mainly look at studies on paper. The complaints I often heard about from guinea
pigs were conditions on the ground that IRBs have never really thought much
about. I don’t think it ever occurred to an IRB to ask SFBC [SFBC
International, a company that owned the largest drug-testing site in North
America] whether they were testing drugs on undocumented immigrants in a
dilapidated motel. Some testing sites have procedures that are not really
dangerous, but which are uncomfortable or degrading, like requiring subjects to
have a rectal exam whether or not it is relevant to the study. And of course,
somebody needs to make sure that researchers who are crooked or incompetent are
not allowed to keep doing research. http://louis-j-sheehan.biz/page1.aspx
What can or should be done for
participants who are injured or suffer other side effects during a trial?
The very least that can be done is to
guarantee that they will get medical care without being stuck with the bill. As
things stand now, guinea pigs can’t even count on that. That’s not just a
problem with industry studies. Even subjects in federally sponsored trials in
universities don’t get that guarantee. Robert Steinbrook published a piece in the
New England Journal of Medicine a couple of years ago showing that only 16% of
academic health centers in the U.S. provided free care to injured subjects, and
none of them compensated subjects for pain and suffering.
Where do you see this process of human
subject testing headed?
It’s heading overseas to the
developing world. It’s less expensive and the oversight is less rigorous. I
think the problems will be the same as here, only more so.
The sequel is out there.
The conspiracy theories will not be.
Ten years after the first film and six
years after the show went off the air, The X-Files returns to theaters with Fox
Mulder, Dana Scully — and a lot riding on the bet that fans want more of the
FBI's paranormal-investigating agents.
The film, which remains without a
formal title, will dump the long-running "mythology" plotline — that
aliens live among us and are part of a colonizing effort — that made it one of
the most popular television shows in the late 1990s but ultimately drove away
some viewers who found it too complex and ambiguous.
"We spent a lot of time on (the
mythology) and wrapped up a lot of threads" when the show went off the air
in 2002, says Chris Carter, creator of the series and director of the new
movie. "We want a stand-alone movie, not a mythology conspiracy one."
That will come as welcome news to fans
of the show's stand-alone episodes, which included cults, ghosts, psychics and
ancient curses.
Carter refuses to divulge any plot
points of the movie, but says he wanted to make the film immediately after the
show ended. A contractual dispute with 20th Century Fox kept it on the shelf
until the case was settled out of court.
He says the delay may turn out to be a
blessing.
"There's a whole audience I want
to introduce X-Files to," Carter says. "There were kids who couldn't
watch it on TV because it was too scary. Now they're in college. I wanted a
movie that everyone could go to."
Whether they will could be a test of
the show's legacy, says Blair Butler of the G4TV network, which caters to video-game
enthusiasts and science-fiction fans.
"At its strongest, it had really
creepy stand-alone episodes," she says. "They turned it into a great
franchise. But a lot of years have passed. We'll see if it's fallen off the
radar."
She says the film could benefit from
an ironic twist: the Writers Guild strike.
"I think it could be a sort
comfort food for the people who loved how original the show was and aren't
seeing original TV now," she says.
But Carter believes they'll be drawn
by something else: the show's stars, David Duchovny and Gillian Anderson.
"For me, The X-Files has always
been a romance," he says. "They had an intellectual romance that's
very rare and restrained compared to so many relationships on TV. I think
that's what appealed most to the fans. And they're back."
People have been trying to figure out
why we sleep for almost as long as we have been conscious of being awake,
tossing and turning in the dark.
After a few restless nights, most of
us can't even think straight. We are less able to make sense of problems, make
competent moral judgments or retain what we learn, even though studies show our
brain cells fire more frenetically to overcome the lack of sleep. Lose too much
sleep and we become reckless, emotionally fragile, and more vulnerable to
infections and to diabetes, heart disease and obesity, recent research
suggests.
We spend a third of our lives asleep,
yet no one really knows why. We do know that people simply don't perform as
well when they don't sleep enough.
How sleepy are you?
The Epworth Sleepiness Scale can help
you rate how likely you are to doze off or fall asleep.
The American Academy of Sleep Medicine
and the National Sleep Foundation offer general information about sleep and
sleep disorders. The National Institute of Neurological Disorders and Stroke
also offers a detailed rundown on the basics of sleep.
New scientific findings about the
biology of sleep are highlighted at Sleep Research Online
Bedside Reading
The Society for Neuroscience offers
these Brain Briefings on sleep and learning, insomnia and sleep deficits.
For bedside reading about sleep,
Stanford University researcher William Dement, founder of the world's first
sleep disorder clinic, and science writer Christopher Vaughan outline cures for
"a sleep-sick society" in The Promise of Sleep: A Pioneer in Sleep
Medicine http://louis-j-sheehan.net
Yet scientists probing the purpose of
sleep are still largely in the dark. "Why we sleep at all is a strange
bastion of the unknown," said sleep psychologist Matthew Walker at the
University of California in Berkeley.
One vital function of sleep,
researchers argue, may be to help our brains sort, store and consolidate new
memories, etching experiences more indelibly into the brain's biochemical
archives.
Even a 90-minute nap can significantly
improve our ability to master new motor skills and strengthen our memories of
what we learn, researchers at the University of Haifa in Israel reported last
month in Nature Neuroscience. "Napping is as effective as a night's
sleep," said psychologist Sara Mednick at the University of California in
San Diego.
Moreover, slumber seems to boost our
ability to make sense of new knowledge by allowing the brain to detect
connections between things we learn.
In research published last April in
the Proceedings of the National Academy of Sciences, Dr. Walker and his
collaborators at the Harvard Medical School tested 56 college students and
found that their ability to discern the big picture in disparate pieces of
information improved measurably after the brain could, during a night's sleep,
mull things over.
It is these patterns of meaning -- the
distilled essence of knowledge -- that we remember so well. "Sleep helps
stabilize memory," said neurologist Jeffrey Ellenbogen, director of the
sleep medicine program at Massachusetts General Hospital.
The erratic biorhythms of sleep and
behavior are intertwined everywhere in nature. Socially active fruit flies need
more sleep than loner flies, and even zebra fish can get insomnia.
Sleep is controlled partly by our
genes. The difference between those of us who naturally wake at dawn and night
owls who are wide-eyed at midnight may be partly due to variations in a gene
named Period3, which affects our biological clock. Variations in that gene also
make some people especially sensitive to sleep deprivation, scientists at the
U.K.'s University of Surrey recently reported.
How much sleep do you need? And how
much do you actually get? Tell us about your sleep habits in an online forum12.
For many of us, though, sleeplessness
is a self-inflicted epidemic in which lifestyle overrides basic biology.
"In this odd, Western 24-hour-MTV-fast-food generation we have created, we
all feel the need to achieve more and more. The one thing that takes a hit is
sleep," Dr. Walker said. On average, most people sleep 75 minutes less
each night than people did a century ago, sleep surveys record.
Yet, rarely have so many millions of
drowsy people been trying so hard to secure some shut-eye, spending billions on
sleep aids. By one estimate, pharmacists filled 49 million prescriptions for
sleep drugs last year. Even so, we think we sleep more than we actually do,
according to Arizona State University scientists. They recorded how long 2,100
volunteers actually slept each night and compared that with how long the people
reported they had slept. Most people overestimated their sleep by about 18
minutes, the scientists found.
Psychologists Jeffrey Ellenbogen at
Harvard's Mass General Hospital and Matthew Walker at UC/Berkeley found that
sleep boosts our ability to make sense of new knowledge by allowing the brain
to detect connections and patterns between things we learn. They reported their
findings recently in The Proceedings of the National Acemdy of Sciences.
The consequences of too little sleep
can be dire. Almost half of all heavy-truck accidents can be traced to driver
fatigue, while decisions leading to the Challenger space-shuttle disaster, the
Chernobyl nuclear-reactor meltdown and the Exxon Valdez oil spill can be partly
linked to people drained of rest by round-the-clock work schedules. Weary
doctors make more serious medical errors, while sleepy airport baggage
screeners make more security mistakes, researchers reported at the Associated
Professional Sleep Societies.
All told, the frayed tempers, short attention
spans and fuzzy thinking caused by sleep deprivation may cost $15 billion a
year in reduced productivity, the National Commission on Sleep Disorders
Research estimated.
The expectation of a nap, however, is
by itself enough to measurably lower our blood pressure, researchers at the
Liverpool John Moores University in England reported in October in the Journal
of Applied Physiology.
Indeed, regular nappers -- working men
who took a siesta for 30 minutes or more at least three times a week -- had a
64% lower risk of heart-related death, researchers at the University of Athens
reported last February in the Archives of Internal Medicine.
"All of the things we are proving
about sleep and the brain are things that your mother already knew decades
ago," Dr. Walker said. "We are putting the science and the hard facts
behind it."
Scientists have taken a key step
toward understanding the cause of prostate cancer, finding that a combination
of five gene variants sharply raises the risk of the disease. Added to family
history, they accounted for nearly half of all cases in a study of Swedish men.
The discovery is remarkable not just
for the big portion of cases it might explain, but also because this relatively
new approach -- looking at combos rather than single genes -- may help solve
the mystery of many complex diseases.
It also might lead to a blood test to
predict who is likely to develop prostate cancer. These men could be closely
monitored and perhaps offered hormone-blocking drugs like finasteride to try to
prevent the disease.
The Swedish results must be verified
in other countries and races, where the gene variants, or markers, may not be
as common. Researchers already have plans to look for them in U.S. men.
Unfortunately, the markers do not help doctors tell which cancers need
treatment and which do not -- they turned out to have nothing to do with the
aggressiveness of a tumor, only whether a man is likely to develop one.
http://louis-j-sheehan.us/ImageGallery/CategoryList.aspx?id=a1206a74-5f7f-443f-97f5-9b389a4d4f9e&m=0
The study was led by doctors at Wake
Forest University in Winston-Salem, N.C., and involved Johns Hopkins University
in Baltimore and the Karolinska Institute in Stockholm. Results were published
online by the New England Journal of Medicine.
It involved 2,893 men with prostate
cancer and 1,781 similar men who did not have the disease. Sweden was chosen
because the population is so ethnically similar and well suited to gene
studies.
Figuring Out Fido
To better understand
man's best friend, Hungarian scientists are working on computer software that
analyzes dog barks. It could help humans recognize basic canine emotions,
Hungarian ethologist Csaba Molnar told Reuters. Mr. Molnar and his colleagues
at Budapest's ELTE University have tested software which distinguishes the
emotional reaction of 14 dogs of the Hungarian Mudi herding breed to six
situations: being alone, seeing a ball, fighting, playing, encountering a
stranger or going for a walk. "A possible commercial application could be
a device for dog-human communication," the scientist added. The iDog,
perhaps?
John McCain is looking for deep
support from his military brethren to win South Carolina -- the state that
ended his presidential bid eight years ago.
Mr. McCain sees a big difference this
time. "We were not in a war in 2000," he said here yesterday.
"I'm the only one who is really qualified to be commander-in-chief."
After conceding a loss Tuesday night
in Michigan's Republican primary, the Arizona senator turned his attention to
South Carolina's significant population of active-duty military and veterans.
"I have long admired the deep
patriotism of the people of this state," the Navy veteran said in
Charleston. "So many of your sons and daughters risk their lives today to
keep the rest of us safe, as so many South Carolinians have done in past
wars," he said.
The Republican race for president
arrives in South Carolina in some disarray. "It is a chessboard
extraordinaire," with three candidates having won primaries and no clear
leader, said Republican strategist Tony Fabrizio, who isn't affiliated with any
campaign.
Mr. McCain is hoping to nose ahead of the
pack with a win here Saturday, much of it with the support of the state's
sizable military presence. The only one of the major candidates who has served
in the military, he upped the ante yesterday by predicting a South Carolina
victory, something he declined to do before the Michigan primary.
http://louis-j-sheehan.us/ImageGallery/CategoryList.aspx?id=a1206a74-5f7f-443f-97f5-9b389a4d4f9e&m=0
"We will win South
Carolina," he said at a campaign event in Greenville. His aides say a
victory here would propel him through Florida's Jan. 29 contest and into the
all-important "Super Tuesday" primaries Feb 5. They aren't saying
what it means if he loses.
Mr. McCain lost South Carolina in 2000
after outside groups made what turned out to be wild accusations about the
senator's integrity on a host of issues, including his military record. This
time Mr. McCain has a rapid-reaction force, including many veterans, to refute
such attacks.
That force was put into use Tuesday
when a mailer arrived in some South Carolina homes accusing Mr. McCain of
distorting his record as a prisoner of war in North Vietnam. Orson Swindle, a
close McCain ally and former prisoner of war, dismissed the mailer as coming
from "conspiracy-theory people" and saying such attacks on Mr. McCain
aren't new. "It's slander, it affects voters, obviously," he said.
"It's a bit crazy, too."
The military vote is "very
important," senior McCain adviser Steve Schmidt said yesterday. "John
McCain speaks the language of the men and women who serve in the
military." Mr. Schmidt and other campaign aides said the military vote
alone isn't enough to win, but it is a key part of his strategy.
McCain campaign aides are hoping Mr.
McCain and his rivals -- Mike Huckabee, Mitt Romney and Fred Thompson -- divide
the evangelical vote, leaving the state's sizable population of military and
independent voters to Mr. McCain.
http://louis-j-sheehan.us/ImageGallery/CategoryList.aspx?id=a1206a74-5f7f-443f-97f5-9b389a4d4f9e&m=0
Mr. Huckabee is seen as Mr. McCain's
main rival. The Southern Baptist minister has emerged as the favorite of the
state's Christian conservatives, especially since he upset Mr. Romney to win
the Iowa caucuses. Mr. Romney split the state's party establishment early on
with Mr. McCain but has yet to gain traction among rank-and-file Republicans
suspicious of his Mormon faith and social-issue flip-flops. Mr. Thompson
entered the Republican race late and counted on Christian conservatives'
support -- only to see them suddenly flock to Mr. Huckabee amid his Iowa
success.
The McCain team has reason for
optimism on the military front. Veterans carry heavy weight in South Carolina's
Republican politics. They were 14% of the adult population in 2000, according
to the Census Bureau, but 27% of voters in the Republican primary, according to
exit polls. Though Mr. McCain lost South Carolina to George W. Bush in 2000 by
53% to 42%, he won the veteran vote 48% to 47%, according to exit polls.
http://louis-j-sheehan.us/ImageGallery/CategoryList.aspx?id=a1206a74-5f7f-443f-97f5-9b389a4d4f9e&m=0
South Carolina is home to 400,000
veterans, according to the Census Bureau. It has high numbers of military
personnel stationed in-state and abroad. Almost 29,000 active-duty soldiers
claim the state as their legal residence, making up about 1% of its population
-- only nine states have a higher percentage. And there are 66,000 soldiers
stationed here, constituting about 2% of its adult population, greater than all
but eight states.
At campaign stops yesterday, Mr.
McCain hammered home his pro-military message about caring for the troops,
resolving the Iraq war and improving veterans' health care. He spoke glowingly
of the 2,000 South Carolina National Guard and reserve troops who are in
Afghanistan and called out veterans in the audience.
And as he often does on the stump, he
read a quote from George Washington about the importance of looking after
veterans. "The willingness with which our young people are likely to serve
in any war, no matter how justified, will be directly proportional as to how
they perceived the veterans of earlier wars were treated and appreciated by
their country," Mr. McCain said, echoing President Washington.
That message plays well with voters
such as Gary Wells, 73 years old, a Greenville resident and veteran who said he
served as a Russian linguist in military intelligence in Berlin during the Cold
War. He came to a McCain event in Greenville yesterday undecided between Mr.
McCain and Mr. Romney. But he liked what Mr. McCain "said about the
veterans and the military," particularly the senator's plan to give
veterans an insurance card for routine visits to be used at any doctor, rather
than having to go to Veterans Administration hospitals, he said. Mr. Wells
calls VA hospitals "really horrible."
The Arizona senator made his first
stop here after his New Hampshire triumph at the Citadel military college last
week. His last major public event before the primary is scheduled to be Friday
evening on the decommissioned aircraft carrier U.S.S. Yorktown, in Mount
Pleasant, S.C.
Mr. McCain's surrogates also spread
the military message yesterday. "Let's make sure the military is well-led
by somebody who understands their world," said Republican South Carolina
Sen. Lindsey Graham.
Cindy McCain, the senator's wife,
talked about their two sons who are serving, one at the Naval Academy, the
other in the Marines. At a McCain townhall meeting in Spartanburg, S.C., Mrs.
McCain said she supported her husband's run, in part because "it's about
my children being safe, my sons particularly, your sons and daughters...that
they serve with honor and dignity and come home with dignity."
Veterans and their spouses fill the
seats at almost every McCain event, donning blue "Veterans for
McCain" stickers. Yet even they acknowledge their ranks are only part of
what will make up a McCain victory. "John McCain has a very loyal base
among the veterans," said John McGraw, 65, who served in the Navy's River
Patrol Force in Vietnam. Speaking before a McCain event yesterday here in
Greenville, he said the military vote is "not enough. He has to get other
individual Republicans."
http://louis-j-sheehan.us/ImageGallery/CategoryList.aspx?id=a1206a74-5f7f-443f-97f5-9b389a4d4f9e&m=0
"We hear that
phone calls are being made. We will not let it go this time," John McCain
told reporters, in reference to calls like those made to South Carolina voters
from a group calling itself Vietnam Veterans Against McCain, which accuses the
Republican presidential candidate, senator and former prisoner of war of
selling out fellow POWs to save himself, the New York Times reports. Another
group called Common Sense Issues, which supports rival candidate Mike Huckabee,
has begun making what it said were a million automated calls to households in
South Carolina telling voters that Mr. McCain "has voted to use unborn
babies in medical research," the Times adds. (Mr. Huckabee's campaign says
it has no ties to the group.) Burned in the 2000 South Carolina primary by one
of the most notorious smear campaigns in recent American politics -- which
contributed to his loss to President Bush -- Mr. McCain this time seems more
determined to fight back aggressively and is deploying a "Truth
Squad" in the state with the help of South Carolina's Republican political
establishment.
http://louis-j-sheehan.us/ImageGallery/CategoryList.aspx?id=a1206a74-5f7f-443f-97f5-9b389a4d4f9e&m=0
The effectiveness of 12 popular
antidepressants has been exaggerated by manufacturers' selective publication of
favorable results, researchers asserted in a new review of unpublished data
that were submitted to the Food and Drug Administration.
As a result, the review concludes,
doctors and patients are getting a distorted view of the effectiveness of
blockbuster antidepressants like Wyeth's Effexor and Pfizer Inc.'s Zoloft. The
review was published in the New England Journal of Medicine.
A review of research submitted to the
FDA:
• Of 74 studies reviewed, 38 were
judged to be positive by the FDA. All but one were published, researchers said.
• Most of the studies found to have
negative or questionable results were not published, researchers found.
Source: The New England Journal of
Medicine
Since the overwhelming amount of
published data on the drugs show they are effective, doctors unaware of the
unpublished data are making inappropriate prescribing decisions that aren't in
the best interest of their patients, according to researchers led by Erick
Turner, a psychiatrist at Oregon Health & Science University. Sales of
antidepressants total about $21 billion a year, according to IMS Health.
Wyeth and Pfizer declined to comment
on the study results. Both companies said they had committed to disclose all
study results, although not necessarily in medical journals. GlaxoSmithKline
PLC, maker of Wellbutrin and Paxil, said it has posted the results of more than
3,000 trials involving 82 medications on its Web site, and also has filed
information on 1,060 continuing trials at a federal government Web site.
Schering-Plough Corp., whose Organon
Corp. unit markets Remeron, and Eli Lilly & Co., which makes Prozac, said
their study results were indeed published -- not individually, but as part of
larger medical articles that combined data from more than one study at a time.
The New England Journal study counted a clinical trial as published only if it
was the sole subject of an article. "Lilly has a policy that we disclose
and publish all the results from our clinical trials, regardless of the
outcomes from them," a Lilly spokeswoman said.
Pharmaceutical companies are under no
obligation to publish the studies they sponsor and submit to the FDA, nor are
the researchers they hire to do the work. The researchers publishing in the New
England Journal were able to identify unpublished studies by obtaining and
comparing documents filed by the companies with the FDA against databases of
medical publications.
"There is no effort on the part
of the FDA to withhold or to not post drug review documents," an FDA
representative said. For newer drugs, information is posted online "as
soon as possible." Older documents aren't always available online and
efforts to add those files to the Web are slowed by "a lack of
resources," the agency said, acknowledging that there is a backlog in
complying with records requests.
A total of 74 studies involving a
dozen antidepressants and 12,564 patients were registered with the FDA from
1987 through 2004. The FDA considered 38 of the studies to be positive. All but
one of those studies was published, the researchers said.
The other 36 were found to have
negative or questionable results by the FDA. Most of those studies -- 22 out of
36 -- weren't published, the researchers found. Of the 14 that were published,
the researchers said at least 11 of those studies mischaracterized the results
and presented a negative study as positive.
Five Trials
For example, Pfizer submitted five
trials on its drug Zoloft to the FDA, the study says. The drug seemed to work
better than the placebo in two of them. In three other trials, the placebo did
just as well at reducing indications of depression. Only the two favorable
trials were published, researchers found, and Pfizer discusses only the
positive results in Zoloft's literature for doctors.
One way of turning the study results
upside down is to ignore a negative finding for the "primary outcome"
-- the main question the study was designed to answer -- and highlight a
positive secondary outcome. In nine of the negative studies that were
published, the authors simply omitted any mention of the primary outcome, the
researchers said.
The resulting publication bias
threatens to skew the medical professional's understanding of how effective a
drug is for a particular condition, the researchers say. This is particularly
significant as the growing movement toward "evidence-based medicine"
depends on analysis of published studies to make treatment decisions.
Colleagues' Questions
Dr. Turner, who once worked at the FDA
reviewing data on psychotropic drugs, said the idea for the study was triggered
in part by colleagues who questioned the need for further clinical drug trials
looking at the effectiveness of antidepressants.
http://louis-j-sheehan.us/ImageGallery/CategoryList.aspx?id=a1206a74-5f7f-443f-97f5-9b389a4d4f9e&m=0
"There is a view that these drugs
are effective all the time," he said. "I would say they only work 40%
to 50% of the time," based on his reviews of the research at the FDA,
"and they would say, 'What are you talking about? I have never seen a
negative study.'" Dr. Turner, said he knew from his time with the agency
that there were negative studies that hadn't been published.
The suppression of negative studies
isn't a new concern. The tobacco industry was accused of sitting on research
that showed nicotine was addictive, for instance. The issue has come up before
notably with antidepressants: In 2004, the New York state attorney general sued
GlaxoSmithKline for alleged fraud, saying it suppressed studies showing that
the antidepressant Paxil was no better than a placebo in treating depression in
children. Glaxo denied the charge and eventually settled with the attorney
general. The company later posted on its Web site the full reports of all of
the studies of Paxil in children.
But publication of negative studies is
an issue that cuts across all medical specialties. And it has engendered some
strong reactions in the medical-research world: To make it harder to conceal
negative study findings, an association of medical journal editors began
requiring in 2005 that clinical trials be publicly disclosed at the outset to
be considered for publication later. The system isn't foolproof, since
manufacturers often run exploratory studies without registering them and can
selectively disclose favorable results. The rule only applies to studies
intended for publication in a medical journal.
Some studies that don't eventually get
published are registered with online trial registries, including the federal
government's www.clinicaltrials.gov. Nonetheless, many studies still aren't
being registered or reported, says Kay Dickersin, the director of the Center
for Clinical Trials at the Johns Hopkins Bloomberg School of Public Health.
"We need something more meaningful," she said. "The average
person has no idea that www.clinicaltrials.gov is not comprehensive."
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