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Ear, Nose & Throat Associates |
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July 2007 News Archives
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July 1: Nights out ‘harm hearing of many’, BBC News
Nine in 10 young people aged 16–30 experience signs of hearing damage after a night out, research suggests.
The charity RNID found 90% of pub, club and gig–goers experienced dullness of hearing or ringing in the ears after a night on the town.
More than half of the 1,381 surveyed visited a bar where they had to shout to be heard at least once a week.
A quarter said the music in these venues was too loud and a third thought hearing loss would affect their lives.
New noise regulations come into force to protect employees in the music and entertainment sectors in April 2008.
But the RNID is calling on the government to establish a recommended noise exposure level for audiences attending music venues and events, and educate young people about noise as a public health risk.
Dr John Low, Chief Executive of RNID, said: "Our research shows most young people have experienced the first signs of permanent hearing damage after a night out, yet have no idea how to prevent it."
"With regular exposure to music at high volumes in clubs, gigs and bars, it’s only too easy to clock up noise doses that could damage their hearing forever."
He said music lovers, musicians and DJs could take simple steps to protect themselves from damaging decibels on a night out or while performing:
- Taking a five minute rest period for every hour of listening to allow ears to recover
- Standing away from loud speakers in pubs, clubs, gigs and concerts
- Taking regular breaks from the dance floor and using chill out areas to give ears a rest from loud music
- Wearing earplugs designed for use in clubs and gigs, which reduce the volume not the quality of the sound – available for the price of a CD
Carl Hill, 31 and from London, said a decade of running club nights had taken a toll on his hearing.
"I now have tinnitus, which means I have a constant ringing in my ears. It can be quite annoying, especially at night. Sometimes I have to go to sleep with the radio on for distraction."
"With hindsight, I should have worn earplugs."
Noise levels
A quiet room at night – 20 decibels
An ordinary spoken conversation – 60 decibels
A busy street – 70 decibels
A pneumatic drill – 100 decibels
Some personal music players (at high volume) – 105 decibels
Aircraft taking off – 110 decibels
Neil Williams of the British Beer and Pub Association said: "Steps are being taken to raise awareness.
"A new noise regulation is due in 2008 and will cover a range of measures including how to limit the sound exposure of staff and how speakers should be positioned.
"We are working on guidance for our members."
In other workplaces, updated regulations are already in force and the level at which employers must provide hearing protection and hearing protection zones is now 85 rather than 90 decibels (daily or weekly average exposure).
The level at which employers must assess the risk to workers’ health and provide them with information and training is now 80 decibels.
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July 2: Rise in oral cancer among women, The Irish Times
Eoin Burke–Kennedy
A dramatic rise in oral cancer among women in the past ten years has been linked to increased rates of smoking and alcohol consumption.
The Irish Dental Association (IDA) said women now account for approximately 33 per cent of cases diagnosed each year compared to just 12 per cent during the 1990s.
The increase of the disease among women comes at time when the number of men being diagnosed increased only slightly.
Prof Leo Stassen, consultant oral and maxillofacial surgeon at St James’s Hospital, said: "The increase of oral cancer amongst women may be attributed to an increase in the number of women smoking and the frequency with which they consume alcohol.
"If this trend continues we will soon see females replace males as the most likely sufferers of oral cancer," Prof Stassen warned.
The IDA highlighted that although the most dramatic increase over the last decade has been among women there has been a general increase in instances of oral cancer in all groups.
Prof Stassen said the number of younger people presenting with oral cancer continues to increase.
"Instances of oral cancer among younger people are becoming increasingly common. Surprisingly these young people are very often non–smokers and non–drinkers. The increase may be may be as a result of genetics, viral infections or exposure to carcinogens," he said.
People living in towns and cities are more likely to suffer from the disease because of increased incidence of exposure to carcinogens such as tobacco smoke and environmental carcinogens such as car fumes.
Prof Stassen said that early diagnosis of the disease is vital in order to maximise survival rates. Early diagnosis results in an 86 per cent chance of survival, but rates fall to just 10 per cent if the cancer has become advanced, he said.
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July 3: Dulled Sense of Smell Might Be First Indicator of Alzheimer’s, HealthDay News
Losing your sense of smell might be an early sign of cognitive decline, a new study finds.
"It has been reported before that people who already have mild cognitive impairment have difficulty with odors," noted lead researcher Robert S. Wilson, a professor of neuropsychology at the Rush Alzheimer’s Disease Center in Chicago.
However, "no one has started [a study] with people with no cognitive impairment at all," he said. But the new research, published in the July issue of the Archives of General Psychiatry, did just that.
In the study, Wilson’s group enlisted 589 older people, averaging close to 80 years of age, to take a test in which 12 common odors were placed under their noses. The participants were scored from one to 12 on their ability to match a smell to one of four alternatives.
They then were evaluated once a year for five years in tests of neurological and cognitive function.
Over that time, 177 of the participants developed the kind of mild cognitive impairment that can be a warning sign of future Alzheimer’s disease. The risk of developing such mental impairment was associated with a decrease in odor identification ability. Those who scored below the average score on the odor identification test were 50 percent more likely to develop mild cognitive impairment than those who scored above average, the researchers say.
The study results fit in with one leading theory surrounding the development of Alzheimer’s disease, Wilson said. That notion centers on the idea that Alzheimer’s begins with trouble in certain specialized areas of the brain, then spreads more widely until it involves the major thinking areas.
"There could be several years in which you wouldn’t expect to see problems with thinking but problems with functions such as smell," he said.
The theory received lukewarm support from Dr. Sam Gandy, chairman of the Alzheimer’s Association’s National Scientific Advisory Council. Gandy is also director of the Farber Institute for Neurosciences at Thomas Jefferson University in Philadelphia.
"The idea is attractive, since the smell area of the brain is involved in the course of the disease," Gandy said.
And yet, "reports that problems with a person’s sense of smell may be an early indicator of memory and thinking problems have appeared in the scientific literature at several occasions over the past 20 years," he pointed out. Still, "no observation has been particularly strong nor have they been replicated by other scientists," Gandy said.
More detailed studies are needed to assess the possibility of a connection between smelling ability and changes in mental function, he said.
"These tests should be tested on one group of people and then subjected to double–blind assessment in a second or third population before scientists begin to make claims that a particular smell test is associated with or predictive of imminent or incident cognitive dysfunction," he said.
But Richard L. Doty, director of the Smell and Taste Center of the University of Pennsylvania Medical Center in Philadelphia – who developed the smell test used in the Wilson study – said the test has already been used on a limited basis in clinical practice.
"It was given to relatives of persons with both Parkinson’s disease and Alzheimer’s disease who were normal," Doty said. "It showed that there was a loss of the ability to distinguish odors in those who eventually converted to the disease. Some neurologists have been using it in differential diagnosis."
The test used in the Rush study can be administered (or taken by the person being tested) in about five minutes, Wilson said. "But I’m not recommending that everyone run out and have this test administered," he said.
Diagnosis using smell testing or other methods would do a patient no real good, Wilson reasoned, because there’s still no effective treatment to halt the progression of Alzheimer’s disease. However, "the field is expecting that that will change in the next few years," he said.
Medications that target the accumulation of amyloid deposits in the brain, which many believe to be involved with the development of Alzheimers disease, are showing promise, Wilson said. "If these agents are effective in combating the accumulation of amyloid in the brain, they could alter the course of the disease," he said.
Detection of the condition in its earliest stage would then be desirable, because "the treatments should be applied as early as possible," Wilson said.
Even then, a smell test alone would not be the best early detection method, he stressed. "There are several other strategies looking at other ways to detect it early," Wilson said. "There would likely be a variety of methods, a smell test in conjunction with others."
More information
There’s more on Alzheimer’s disease at the Alzheimer’s Association.
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July 8: Stop the Decibel Damage, US News & World Report
By Bernadine Healy M.D.
If your ears were ringing during the Fourth of July fireworks, you experienced firsthand the daggerlike effect of intense sound waves on your inner ear. No surprise. Firecrackers explode with decibels so great that a sudden dose of more than a few minutes in duration could make one permanently stone-cold deaf. This is no old wives' tale, though most of the time noise-induced loss of hearing creeps up painlessly and silently. All too many middle-agers are just finding that out as they line up for their hearing aids in search of relief from those strained conversations in crowded rooms, where everyone around them seems to be mumbling. Waiting to join them in line are the growing ranks of younger people. A Harvard survey of adolescents and young adults reported that more than half had taken a hit to their hearing at loud music events, either tinnitus or temporary deafness. And from my observation, most seem to have iPods attached to their ears. For them, and the others who can still hear a pin drop, it's smart to pay attention to the health of the inner ear, the nerve center for making sense of sound.
Loud noise destroys nerve endings in the inner ear and is a common and preventable cause of hearing loss. Decibels measure loudness: Silence is zero and the explosion of a firecracker, 150 dB. A rock concert can get up to 140; a noisy bar, almost 100. As a general rule, a whisper is 30 dB; the purr of a quiet motor is 40, and a normal conversation, 60. Regular exposures to levels over 85 are toxic to the ear.
The blast of a jet engine or an Indy racing car and an explosion or gunshot are obvious culprits. But it’s the power tools and lawn mowers, the blare of music through earphones, the hair dryers and vacuum cleaners and noisy places that cause damage gradually over time. And you don’t need a decibel meter to know what’s too loud: If you have to raise your voice to be heard above the din, you are in a toxic place.
Deafening sounds are like blinding light, pointedly destroying the very organ that detects them. This irony is testimony to an evolved life, in which the human ear has just not kept up with modern times. That is, the hairlike, specialized nerve endings that are lined up inside a coiled, fluid–filled compartment of the inner ear can be shaken to death by loudness they were not designed to handle. These nerve endings vibrate at different rates in response to different sound frequencies, more slowly for the low pitch of a baritone and faster for the higher pitch of a soprano, transforming them into distinct electrical impulses sent through the auditory nerve to the brain.
Just as you can blow out an electrical circuit by overloading it, these vibrating hair cells can be overexcited by too much noise. When forced into metabolic overdrive, the cells spin off toxic oxidation products that make them swell and sometimes slowly die off. Toxic noise also compromises blood flow to the inner ear, causing further damage. The cells that go first are those that resonate to a higher pitch, and the resulting dropout of higher-frequency sounds is what makes words seem garbled.
Preventive measures. Recognition that these nerve endings were designed for a quieter time, when men hunted with bows and arrows and women washed their clothes in babbling brooks, has inspired preventive efforts that were not even considered a few years back. Neurobiologist Josef Miller from the Kresge Hearing Research Institute at the University of Michigan stresses noise avoidance and when a loud sound environment is unavoidable, earplugs or muffs, which can cut noise by 30 dB or more. These measures have been incorporated into most occupational safety programs and inspired such innovations as quieter hair dryers and volume–limited iPods. Just recently, Apple filed a patent for new software designed to track a headphone user’s exposure to loud music and automatically reduce volume as needed. On the horizon is a nutrient bar to fight off ear damage, says Miller. He and others have shown that a combination of the antioxidant vitamins A, C, and E and magnesium not only protects the inner ear when taken before noise exposure but can limit damage for up to 72 hours after the insult. As Miller points out, this approach would add to current ear–protection devices or help those who can’t or won’t wear earplugs or muffs.
Don’t I know. I pleaded with my girls to use earplugs during last week’s festivities. But the rocking music on the Mall and the loud display of fireworks just drowned me out. I will keep trying.
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July 10: Oden to have tonsils removed later this week, ESPN.news
The Portland Trail Blazers will shut down rookie center Greg Oden’s summer league season after two games so he can have his tonsils removed, the team said Tuesday.
The Oregonian of Portland first reported the team has decided Oden’s swollen tonsils need to come out in the next three–to–four days because they are obstructing his breathing, which in turn is limiting his stamina.
Oden was scheduled to travel to Los Angeles for the taping of the ESPY awards and then will undergo surgery on Saturday at the Vancouver Clinic in nearby Vancouver, Wash., the team said on Tuesday.
His recovery is expected to take about two to three weeks.
"Greg felt that this was the right decision to make in the interests of his health, and we support that decision 100 percent," Trail Blazers general manager Kevin Pritchard said. "The sooner he gets the procedure done, the sooner he can get back on the court at full strength."
Oden will also miss the U.S. Senior National Team’s camp July 20–22 in Las Vegas. He is invited to train with the Americans in August before the FIBA Americas tournament if he has recovered.
That would give him extra time with Portland coach Nate McMillan, who is an assistant under U.S. coach Mike Krzyzewski.
"This is very unfortunate and we wish Greg a speedy and full recovery," said USA basketball managing director Jerry Colangelo. "Provided he is fully recovered, we have invited Greg to participate in the USA Senior National Team’s training camp that starts August 13."
Oden, a 7–foot center who played one season at Ohio State, was the No. 1 pick in the NBA draft.
In his summer league debut, Oden scored six points and had two rebounds before leaving with 10 fouls, the maximum allowed in the summer league. The Blazers lost 74–66 to the Boston Celtics.
In his second game against Dallas, a fatigued Oden finished with 13 points, five rebounds and nine fouls. The Mavericks won 72–68.
"Right now, it’s more of a thing that they are so big, that when I’m running up and down the court, it’s hard for me to breathe," Oden said Monday after scrimmages with the Denver Nuggets and Los Angeles Clippers, The Oregonian reported. "I can’t get any air in there."
While Oden has struggled he did not use his tonsils – which Pritchard said are the size of golf balls – as a crutch for his performance.
"There’s no excuses, because I was out there playing," Oden said, according to The Oregonian. "And if I’m playing, I’m playing, so if I have a bad game, it’s not on my tonsils, it’s on me. A lot of it is I just have to get used to this game, that’s what everyone is telling me."
Oden will miss Sunday’s matchup with Seattle that would have pitted him against No. 2 pick Kevin Durant.
"They’ll make more money during the regular season," Oden jokingly said earlier this week.
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July 12: The Day the Music Died, The New York Times
By STEPHANIE ROSENBLOOM
MICHAEL BELLUSCI’S quotation in his high school yearbook was, “It ain’t rock if it ain’t loud.” Growing up in Flushing, Queens, he played guitar and drums, idolized Jimi Hendrix and performed in cover bands. Later, he went on the road as Ringo in the musical “Beatlemania.”
These days, if his left ear happens to be covered by a pillow, Mr. Bellusci, 47, hears the alarm clock as a faint tick, tick, tick, not a blaring BEEP, BEEP, BEEP. In cacophonous restaurants, he watches people’s mouths so he can follow the conversation.
Years of high decibel noise and trauma from speaker feedback damaged his right ear. Mr. Bellusci, who plays ukulele, recorder, guitar and bass in an acoustic duo, now says, “If I could do it over again ...”
How many boomers are thinking the same thing.
As more members of the generation born after World War II enter their 60s, and the effects of age conspire with years of hearing abuse, a number find themselves jacking up the volume on their televisions, cringing at boisterous parties and shouting “What?” into their cellphones.
About one in six boomers have hearing loss, according to the Better Hearing Institute, a nonprofit educational group. The AARP has reported that there are more people age 45 to 64 with hearing loss (10 million) than there are people over 65 with hearing loss (9 million). And more people are losing their hearing earlier in life, according to the National Institute on Deafness and Other Communication Disorders, one of the National Institutes of Health.
Hearing loss from age (presbycusis) can begin before the Social Security years, but boomers are also likely candidates for noise-induced hearing loss, particularly the kind that results from continuous loud noise over an extended period of time (like a 115-decibel rock concert).
“They’re the first of that rock ’n’ roll generation,” said Sharon Beamer, the associate director of audiology professional practices for the American Speech-Language-Hearing Association, “the first to really grow up with loud music, personal stereo systems.”
But factory noise, construction din or the roar of subways may also be to blame.
“None of us protected our ears at all,” said Pat Benatar, the rock singer and guitarist, who is on tour. Nowadays, Ms. Benatar, 54, also lends her celebrity to Hearing Education and Awareness for Rockers (HEAR), one of several public service groups with campaigns to prevent hearing loss.
“I’m still a junkie,” she said. “I still want it so loud.” Yet noisy restaurants bother her. When her dishwasher is running, she said, “I can’t hear any conversation at all.”
In the grand scheme of things (sending the children to college, paying off the mortgage, menopause), the inability to hear the dialogue on a reasonably adjusted television is a minor nuisance. Nonetheless, boomers said the realization that their hearing is no longer sharp provokes anxiety about age, frailty, dependency and obsolescence.
“When my father didn’t hear well, I remember being annoyed at him,” said Don Henke, 57, who spent 33 years as a meat wholesaler around thunderous machinery.
“I regret that now,” Mr. Henke said. “I remember he would say ‘What did you say?’ and we would repeat it again. And he would say ‘What was that again?’ ” Eventually, Mr. Henke would tell him to forget it.
“That was such a terrible thing to do,” said Mr. Henke, who has difficulty hearing conversation in crowded places and who compensates by saying very little. “And now I understand what he was going through and I hope that people don’t do that to me. I’ve already warned my daughter not to do that to me.”
Still, many of Mr. Henke’s generation will not go gently into that beige abyss of no-frills gadgetry known as the hearing aid. National Institute on Deafness and Other Communication Disorders data from 2001 shows that just 149.6 of every 1,000 adults who have diminished hearing, whether from aging, disease or injury, use a hearing aid.
Yet that reluctance by boomers, who at about 78 million are a potential windfall market, has motivated sound technologists. Companies have not only developed devices to attract age-phobic, style-conscious boomers, but that also address hearing and language issues for everyone else.
But first they had to reinvent the hearing aid so it no longer looked like a chewed Circus Peanut or made wearers feel like they were hearing through a tin can. Rather, today’s newest devices look like the progeny of iPods and Bluetooth.
One company, Oticon, learned about boomer anxiety when it conducted studies to determine why the people who needed hearing aids were not wearing them.
“The stigma was a lot more deeply felt and strongly felt than we had allowed ourselves to believe,” said Gordon Wilson, vice president for marketing at Oticon. “People really saw them as devices that would make them look old, that would make them look ugly, that would make them look decrepit.”
“People would rather go around asking everybody to repeat themselves,” he said.
Amy Arra, 49, of Naperville, Ill., was one such person. For years she ignored her hearing loss because she knew she would need a hearing aid. But when Ms. Arra returned to the work force after 14 years as a stay-at-home mother, she could no longer ignore her loss. “In meetings I wasn’t catching everything,” she said. “It was very tiring.” Finally, she visited an audiologist and was pleasantly surprised when she was not shown the chewed Circus Peanut, but a device called Audéo.
Audéo’s manufacturer, Phonak, does not call it a hearing aid. In a nod to PDAs like BlackBerrys, it calls Audéo a PCA (Personal Communication Assistant). Shaped like a moth’s wing and smaller than a guitar pick, it perches behind the ear and comes in 15 color combinations, like Pure Passion or Green With Envy.
Ms. Arra could have also considered the Bernafon SwissEar hearing aid, red with the white cross insignia of the Swiss flag. Or a Delta by Oticon in Shy Violet. “It was like shopping for sunglasses,” said Ms. Arra, who bought two Audéos in Crème Brûlée (brownish blond) to match her hair. The device has a thin tube coiling toward the ear canal.
Even so, Ms. Arra was worried people would notice her Audéo. At a gathering, she said, “I was so self conscious and I thought everyone was staring.” Turns out, no one spied it.
Such devices are akin to sexy underwear. “No one knows you’re wearing it unless you want them to,” said Mr. Wilson of Oticon.
The ads for these inventions play up the sexy angle, using models who could just as easily be selling Match.com subscriptions.
Hearing aids are not inexpensive, and the cost is rarely covered by insurance or Medicare for adults. Audéo is about $3,000 to $4,000 an ear, though as with all hearing aids, prices vary because they are determined by doctors, not manufacturers.
But some, like Oticon’s Epoq, come with other benefits, and not just for those who strain to hear the waiter recite the specials. The Epoq, which was introduced in May, is the first hearing aid to have integrated wireless and Bluetooth connectivity, so it can stream a cellphone call or music and audio from a radio, computer or MP3 into the ears through a remote control-like device worn on the body. It is, in other words, a wireless hands-free headset.
And that may be just the beginning of sound enhancement breakthroughs. Sergei Kochkin, the executive director of the Better Hearing Institute, predicts that buildings will install wireless transmitters so a voice from many feet away can be streamed into the ears of listeners wearing such devices.
Lectures with enhanced sound and extraneous noise elimination can be piped in that way, and the device could also be equipped with language translation software, he said.
Outside of the hearing aid industry, there is also some progress toward making the soundscape more boomer-friendly.
Research conducted by IDC for Dolby Laboratories found that television volume issues (like extremely loud commercials) are a more significant concern for boomers than other age groups. Dolby Volume control technology, however, monitors and adjusts the perceived volume level played through a television’s speakers and will eventually be incorporated into televisions.
Restaurant ambiance is also a peeve. The National Restaurant Association has not conducted research about noise levels, though a spokeswoman said there are so many more food establishments that diners have the opportunity to choose one that is gentler on the ears.
Good thing, as hearing loss has also been linked to short-term memory loss, fatigue, anxiety, depression, even lower income — on average, up to $12,000 a year less than for their counterparts who use hearing aids, Dr. Kochkin said.
To protect hearing, professionals advise wearing ear plugs or muffs when exposed to noise louder than 85 decibels (a power mower is about 90 decibels) for an extended time. And, yes, if your iPod is loud enough for everyone in the elevator to know you own Jock Jams, turn it down.
Among boomers, though, there are those who have no anxiety about hearing loss. Jeff Davies, 62, a tennis photographer in Orlando, Fla., said that losing his hearing may not be all that bad.
“I think I’d quite enjoy it if I didn’t have to listen to ice cream trucks roaming the neighborhood and people screaming at their kids,” he said.
Then, Mr. Davies, who is from Yorkshire, England, reiterated the maxim about growing old gracefully.
“I certainly don’t want to die,” he added. “But anything short of that I can live with.”
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July 12: Hospital E-Record Systems Pay for Themselves, HealthDay News
Despite many hospitals' reluctance to make the investment, installing an electronic medical records system pays for itself in less than two years, a new study finds.
Such a system was put in place at the University of Rochester Medical Center, N.Y., and recouped its initial cost within 16 months, say the authors of a study in the July issue of the Journal of the American College of Surgeons.
That experience runs counter to the worries of many health care providers, who are often reluctant to invest in such tracking systems.
"Health care providers most frequently cite cost as a primary obstacle to adopting an electronic medical records system. And, until this point, evidence supporting a positive return on investment for electronic health records technologies has been largely anecdotal," study co-author Dr. David A. Krusch, of the department of surgery at the University of Rochester, said in a prepared statement.
He and his colleagues analyzed the return on investment of an electronic health records system used in five ambulatory offices representing 28 health care providers. The study compared the costs of a number of tasks -- such as pulling patient charts, creating new charts, filing time, support staff salary, and data transcription -- in the third quarter of 2005 (after the system was installed) to costs in the third quarter of 2003, when the tasks were still being done manually.
The new system reduced costs by almost $394,000 per year, the study found, and nearly two-thirds of those savings came from a drastic reduction in the amount of time required to manually pull patient charts. The electronic medical records system cost $484,577 to install and operate in the first year, which means the medical center recouped its investment within 16 months.
After the first year, it cost about $114,000 a year to operate the system. That means an annual savings of more than $279,500 for the medical center, which works out to close to $10,000 per health care provider using the system, the researchers said.
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July 16: New Surgery Brings Back a Smile, HealthDay News
Paralyzed patients regain facial function through muscle transplant
By Amanda Gardner, HealthDay Reporter
By detaching, rerouting and reattaching a muscle used for chewing, surgeons were able to restore the ability to smile to seven patients with facial paralysis.
The procedure, called temporalis tendon transfer, is combined with intense physical therapy before and after surgery and could help similarly stricken patients right away.
"It's really a very doable procedure, and we're realizing how it can be done more simply," said study lead author Dr. Patrick Byrne, director of facial plastic and reconstructive surgery in the department of otolaryngology and head and neck surgery at The Johns Hopkins University School of Medicine in Baltimore. "It's very applicable on a wide scale," he added.
According to the study, which appears in the July/August issue of Archives of Facial Plastic Surgery, correcting facial paralysis is one of the biggest challenges facing reconstructive surgeons.
"Facial paralysis in general is really a complicated condition depending on the degree of facial paralysis, the areas involved and especially also on how long they've been paralyzed," Byrne said. "There are a lot of options, but, for patients with longstanding paralysis where we can't get the nerves to reawaken, then the options prior to this have been other forms of muscle transfers."
But those procedures were often problematic.
Temporalis tendon transfer addresses one aspect of facial paralysis -- the inability to smile, as well as an asymmetry in the lower half of the face.
Previously, surgeons used a different portion of the same muscle to try to restore function, a procedure that left the patient with some function but also facial deformity.
"The way it was done produced a depression or cavity in the temple region and a large protrusion around the upper cheek," Byrne said. Furthermore, "The [transplanted] muscle itself has trouble moving well because of its unnatural position," he added.
For the new procedure, surgeons took the temporalis muscle, normally used for chewing, detached it, rerouted it and reattached it to the muscles around the mouth. With physical therapy, patients learned to smile again by contracting the muscle.
"It would be called a 'dynamic' procedure, because it does provide function," Byrne explained.
The current study involved seven patients who, at four months after surgery, reported "very high" satisfaction. Out of a possible 10 points, participants gave appearance an average score of 8.4, feeding 8.1, speech 8.7 and smile function 7.1.
Physicians not involved with the study saw photographs of the patients and rated four of them "excellent to superb." The other three got "good" post-operative results.
One expert said any advance is important for these types of patients.
"It is a slightly easier alternative to the more traditional transfer of muscle that we use," said Dr. Yael Halaas, a board-certified facial plastic surgeon in New York City. "This is a tragic problem. People can have one side of their face essentially a deformed mask, so anything that might be possibly successful really gives an interest and this does look like a nice, possible procedure," she said.
Some of benefits are tough to quantify, Byrne added.
"Facial paralysis is absolutely devastating. When you talk to patients, what bothers them the most of all the myriad problems, the inability to smile is the number one thing mentioned by these patients," he stated.
And recent research lends credence to what your mother always told you: Smile and you'll feel better. The emotions shown on the face affect a person's internal state.
"People who smile are happier, and people who can't smile are depressed. It really affects the brain," Byrne said. "There's no question we've seen this in these patients. They are happier and more upbeat after having this procedure."
SOURCES: Patrick J. Byrne, M.D., director, facial plastic and reconstructive surgery, department of otolaryngology and head and neck surgery, The Johns Hopkins University School of Medicine, Baltimore; Yael Halaas, M.D., board-certified facial plastic surgeon, New York City; July/August 2007, Archives of Facial Plastic Surgery
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July 17: Missing a Larynx, He’s Become the Voice of Antismoking Efforts, The New York Times
By CLAIRE ATKINSON
THE image of Ronaldo Martinez, a smoker who had his larynx removed and speaks through an artificial voice box, was scary enough to prompt thousands of New Yorkers to quit cigarettes last year.
His description — in his synthesized voice — of how he can no longer swim because he would drown if water got into his throat hole helped bring about a threefold increase in calls to the New York City Department of Health and Mental Hygiene from people interested in smoking cessation.
Despite its effectiveness, the future of the campaign, officially entitled “Nothing Will Ever Be the Same,” hangs in the balance as the city health department reviews its anti-tobacco advertising strategy. The city is planning a new television effort against tobacco in the fall, with a projected ad budget of $8 million.
Dr. Thomas R. Frieden, the city’s health commissioner, acknowledged the success of the spots, but on the subject of their future would say only, “We’re looking at all the options.”
The scared-straight campaign — which recalled a California health department ad from years past in which a larynx cancer patient was shown smoking a cigarette through her tracheotomy tube — was only one component of Mayor Bloomberg’s antismoking efforts. Others included higher taxes on cigarettes and smoking bans in bars and restaurants.
These efforts combined to help lower rates among New Yorkers by 19 percent from 2002 to 2006, the city health department said, for an average annual decrease of 5 percent. Nationally, the average annual decline in smoking across the United States was 3 percent during that period, according to a report from the Centers for Disease Control and Prevention.
And Mr. Martinez, a 53-year-old Bronx resident who has lived in Puerto Rico, has become something of a local hero. In a telephone interview, he said that he was currently seeking a job and was prepared to go anywhere to stay involved with the antismoking campaign.
On the street, “people run and call after me, everybody wants to spend a day with me so they can see how I live,” he said. “To the tobacco companies, I have nothing to say except that they are responsible for the pain and consequences of smoking.”
In 2006 alone — the year that the “Nothing Will Ever Be the Same” campaign was introduced — the percentage of New York City residents who smoked declined to 17.5 percent compared with 2005 when it was 18.9 percent, the health department said.
Perhaps because of Mr. Martinez, the statistics were particularly striking among men (who showed an 11.6 percent decline in smoking rates in the city in 2006) and Hispanics (a 15.2 percent decline). The figures were released by city researchers writing for a C.D.C. publication.
Although Mr. Martinez, who appears in four television spots and several print ads, became the most famous person in the campaign, other spots showed a variety of ordinary people telling their stories of suffering caused by smoking.
In New York, the spots ran throughout 2006 as part of a $10 million television blitz and went back into rotation, from April to May this year, as part of an additional $1.2 million in spending. The spots appeared on all the main broadcast networks in addition to Telemundo and Univision, the cable networks TBS and TNT, and on Time Warner Cable and Cablevision systems.
The campaign’s online component encouraged people to send others an e-mail message with an audio download of Mr. Martinez’s unmistakable voice. The message was sent 5,000 times.
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The spots featuring Mr. Martinez are not homegrown, nor are they new. They were created by Geovision, a multicultural ad agency in Watertown, Mass., and were originally produced for the Massachusetts Department of Public Health in the late 1990s.
Despite proving their mettle, they were discontinued in 2001 after Massachusetts, along with many other states, redirected its tobacco settlement funds elsewhere. The landmark tobacco settlement of 1998 involving 46 states and the tobacco companies gave those states some money to spend in antismoking efforts.
Gregory Connolly, a professor at the Harvard School of Public Health, was formerly the director of the Massachusetts Tobacco Control Program, which commissioned the campaign. “We ran ads using athletes, politicians, rock stars and they don’t work,” he said. “We used the U.S. women’s soccer team. And people said, ‘I’m never going to win gold, but I could be Ronaldo.’”
Mr. Connolly praised New York City’s efforts and criticized the administration of Gov. Mitt Romney of Massachusetts for cutting the campaign’s funds earlier in the decade. According to a report in The Boston Globe, the Massachusetts health commissioner, John Auerbach, will decide over the next two weeks whether the state will return its antismoking messages to television.
Geovision’s president and creative director, Juan Mandelbaum, said that he hoped the ads would return, not just for professional reasons.
“I’m from Argentina, and there was always a lit cigarette in the house,” he said. “I can’t tell you how much this means to me. My mother died from smoking aged 71. That is why it is so frustrating that we don’t run the campaign here anymore.”
Even as New York City grapples with the future of its antismoking efforts, Dr. Frieden of the health department praised the “Nothing Will Ever Be the Same” campaign.
“We scoured the world for the best anti-tobacco ads and we ran a variety from Australia, California and some from Massachusetts,” he said. “When we compared ads, Ronaldo made the most impact.”
One of the television ads opens with a doctor snapping on rubber gloves as he prepares to inspect the hole in Mr. Martinez’s throat. In the ad, the cancer survivor tells the viewer how he has to visit the doctor every 12 weeks to see if the cancer in his throat has come back: “I’m always afraid of bad news,” he says, “I will have to do this for the rest of my life.”
A 2006 city report found that 57 percent of smokers who saw the ads said that they were more likely to quit. Ninety-two percent of New Yorkers had seen at least one of the ads, while 78 percent had seen two or more.
After seeing one of the ads, more than half of the smokers interviewed said they had talked to someone about quitting smoking, the report said.
The ads have provoked a strong reaction from smokers and nonsmokers alike.
“They are disgusting, horrible and distasteful and they helped,” wrote one poster to the antismoking Web site bulletin board, trytostop.org.
Bill Mora, a former smoker who lives in Queens, said in a telephone interview that the ads might have kept him from going back to smoking. “They present a very powerful image that I identified with. I recognized him as if I knew him.”
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July 18: Boomers Fuel Need for Head and Neck Cancer Surgeries, Waterloo Record
Aging baby boomers have caused the number of patients needing surgeries for cancers in the neck and head to double over the last five years. In response to the demand for doctors able to perform such delicate surgery, a program at the University of Alberta has been accredited to train doctors from all over the world. Only two facilities in Canada provide such training; the other is at the University of Toronto.
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July 22: Lawsuits claim loss of smell, The Arizona Republic
Ken Alltucker
The Arizona Republic
In the cold and flu aisle of any store in America, there is an unwritten pact.
Over-the-counter medications that plop and fizz and make you sleepy may not prevent or effectively treat the common cold. But these remedies at least follow the most basic command of medicine: Do no harm.
Now, people across the U.S. contend a nasal gel made by a Phoenix company has destroyed or diminished their sense of smell or taste.
Matrixx Initiatives says that its Zicam homeopathic medicines are safe and that it has research from a panel of doctors and scientists to back it up.
Still, in more than 400 lawsuits filed in courts and complaints logged with federal regulators, consumers have alleged that the Zicam nasal gel has triggered a condition called anosmia, or the loss of smell.
Customers have turned to lawyers, complaints and petitions to achieve what they say government regulators have failed to do: protect the public from a potentially harmful product.
After settling a batch of 340 lawsuits for $12 million in early 2006, Matrixx has dug in its heels, fighting off lawsuit after lawsuit with its panel of medical experts and piles of scientific evidence.
Matrixx representatives say the controversy over Zicam boils down to one Colorado doctor, who first publicly linked Zicam to smell loss, and lawyers out to make a quick buck. Since September 2006, six federal courts have tossed out expert testimony from the doctor, Bruce Jafek.
"This all originated from one doctor making an allegation," said Bill Barba, Matrixx's director of investor relations.
Still, some consumers and other experts say the Zicam controversy shows there is a hole in the government's oversight of homeopathic medicine.
Companies that sell homeopathic products such as Zicam are not required to go through the same rigorous approval process and government-vetted clinical trials that pharmaceutical companies must complete before making a prescription drug available for public consumption.
Consumers say the case of Zicam, a zinc-based nasal gel pumped through a long, narrow nozzle, shows the need for tighter Food and Drug Administration oversight.
Among those customers who have urged the FDA to act is David Richardson, a packaging equipment salesman who lives in Greensboro, N.C.
Two years ago, Richardson first tried Zicam after his mother, a registered nurse, brought him a package. At the time, Richardson was suffering from a cold and wanted quick relief because he was about to start a new job.
"I squirted it up my nose and felt a burning sensation," Richardson said.
A few days later, he noticed that scents seemed distorted. Even strong odors, such as gasoline, had a metallic scent. He also claimed he lost his sense of taste as the two senses are linked.
Richardson wants the FDA to require an independent study of Zicam's safety.
"If I took this product and I was just out $6, that's one thing," Richardson said. "This has changed my whole life. . . . Heaven forbid some mother gives it to her 6-year-old kid."
Fast-growing firm
Matrixx Initiatives is a small but growing company with 31 Phoenix employees as of May and $96 million in sales last year. It makes most of its money from sales of Zicam-branded products, which include the nasal gel, swabs, a spray and pills.
The $4 billion cold and cough market is a relatively new business for Matrixx, which, five years ago, was known as Gum-Tech International, a company that developed and sold chewing gum.
The company sold its chewing gum business to Wm. Wrigley Jr. Co. and began to focus on selling its over-the-counter cold and flu products through the Zicam brand. The Zicam gel, which is part of the company's Zicam Cold Remedy category, delivers zinc gluconate to the nasal cavity.
The company woos consumers with its slogan, "Better ways to get better," and sells cold and cough, allergy, and sinus medications at chain retailers such as Wal-Mart, Walgreens, CVS and others. Matrixx also has touted its products in radio and television ads featuring talk-show personality Rush Limbaugh and customer testimonials. All was well for the fast-growing company until 2003, when lawsuits began linking the product to smell loss.
Jafek, a University of Colorado School of Medicine ear, nose and throat doctor, reported in a 2003 medical conference on 10 cases of smell loss linked to use of zinc gluconate.
Other doctors followed, including Terrence Davidson, director of the University of California-San Diego Nasal Dysfunction Clinic and Smell Clinic of Washington, D.C.
It had long been known that zinc could harm nasal tissue when administered in high enough doses. In the 1930s, Canadian doctors used zinc to kill the sense of smell in children as part of a polio experiment.
Jafek and others theorized that the force of the Zicam gel pump could deliver toxic doses of zinc and damage sensitive nose tissues. Some patients likely sniffed the zinc after applying the gel in their nose. That, in turn, triggered anosmia.
The lawsuits began trickling in. In January 2006, Matrixx agreed to pay $12 million to settle 340 lawsuits in Arizona, court and SEC documents show. The company did not admit fault.
It settled the lawsuits rather than pursue potentially expensive litigation, Matrixx spokesman Rob Murphy said.
Faced with the prospect of more lawsuits, Matrixx commissioned its own panel of doctors and scientists. They reviewed existing scientific literature and concluded that there is no evidence that a zinc-based nasal gel such as Zicam can lead to smell loss.
The company-hired experts who conducted their own studies on the incidence of smell loss in the general population, the impact of a zinc gluconate gel on mice and whether the Zicam gel pump could reach sensitive smell tissue in cadavers.
They have concluded that the most likely cause of smell loss is the cold virus itself, sinus problems or nasal injury.
"The company is satisfied the product is safe," Murphy said.
Matrixx has enjoyed a string of court victories, too. Federal judges in Kentucky, Alabama, California and Texas all have excluded Dr. Jafek's testimony based on challenges to standards for expert scientific testimony. Federal courts in California and Michigan have tossed out testimony from other doctors that linked Zicam to smell loss, too. Lawyers in a California case filed an appeal.
Jafek said he respects the legal rulings but is disappointed because patients lost their sense of smell.
He said he is relieved that the company modified Zicam gel's nozzle in a way that makes it less likely that zinc will reach sensitive nose tissue.
Matrixx spokesman Murphy confirmed the company modified its Zicam nozzle, but he said the change was unrelated to concerns about Zicam's safety and was in the works long before any lawsuit linked the product to smell loss.
Despite the court rulings, Jafek said he still worries about over-the-counter sales of the zinc-based cold product.
"I remain concerned about the toxic properties of zinc in the nose," Jafek said. "I have done the best I can to alert the scientific community of this problem so that we can prevent other patients from suffering avoidable loss of smell."
Still, some experts said more studies are needed to learn whether zinc nasal gels are linked to loss of smell.
Jack Gwaltney, a University of Virginia doctor and researcher, has studied the impact of zinc on the common cold. He was among the experts Matrixx initially consulted, but he did not receive any grants from Matrixx or conduct any studies on Zicam.
Gwaltney said one more study needs to be completed to find out whether Zicam nasal gel is linked to smell loss. He suggests a study that measures how many people who have used nasal zinc gel actually lose their sense of smell.
"That figure, at this point, it impossible to determine," Gwaltney said.
Federal oversight
Matrixx has no plans to conduct additional studies about smell loss.
Barba said the company spends about $6 million each year in legal costs related to Zicam and sees no need for more studies.
The Federal Trade Commission conducted an inquiry into the company's advertising and promotion of Zicam products in March. An FTC spokesman declined to comment about the investigation other than confirming it has been finished and the agency announced no enforcement action.
The Food and Drug Administration has received more than 200 complaints from consumers about Zicam gel. The federal agency oversees the safety of all drugs, whether they are sold by prescription or over-the-counter.
"We monitor the safety of all drug products and we prioritize work based on the nature of the safety issue and the public health impact," said Sandy Walsh, an FDA spokeswoman. "I don't know of any immediate action on Zicam. I know it is something the agency gets a lot of inquiries about."
Others who have studied the federal agency's regulation of the food and drug industry doubt an over-the-counter product such as Zicam would generate much urgency.
The federal agency must deal with urgent public health issues such as the contaminated toothpaste ingredients from China as well as problems stemming from high-profile prescription drugs such as Vioxx, which was recalled after being linked to increased risk for heart disease and stroke.
Few over-the-counter products are recalled. The agency banned the nutritional supplement ephedra in 2004 after it was linked to increased blood pressure and irregular heart rhythm. The federal agency had concerns about the substance for years, compiling thousands of "adverse event" reports, before banning its use following the death of a professional baseball pitcher.
"The FDA is understaffed and underfinanced to carry out all of the tasks that we ask of it," said Maxwell Mehlman, a professor of law and bioethics at Case Western Reserve University in Cleveland. "My sense is this (Zicam) falls down pretty low on the priority list, way below food safety and prescription drug safety."
Richardson, who says he lost his smell after using Zicam, said he wants an independent study of the product. At the very least, he said, the company should be required to modify its label to advise people how to irrigate, or wash out, their nasal cavity if the nasal gel causes a burning sensation.
In response to Richardson's complaint, an FDA consumer safety officer said the federal agency would work with Matrixx "should a trend emerge" from voluntary reports from consumers, doctors or others. Possible actions could include changes in labeling, messages to doctors or a product recall.
"It has changed my whole life," Richardson said. "I used to be teased about having a bionic nose. Now I can't smell."
Company's plans
Matrixx will seek to fight off remaining lawsuits as the company attempts to continue its growth. The company is planning to diversify its products, with plans to add new multisymptom cold and flu medicines as well as sinus and allergy products.
Murphy said the lawsuits and complaints about Zicam gel have not affected sales and have not influenced the company's plans to diversify its products.
"There has been absolutely zero effect" on sales, Murphy said. "If there was something wrong with the product, the company would have taken action a long time ago. There has been nothing but anecdotal reports."
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July 25: Dying Patients Fight the FDA, BusinessWeek/span>
A lawsuit could make access to experimental medicines a constitutional right, and alter how drugs for life-threatening diseases are developed
by Catherine Arnst
Everett Davis had been living with a rare, deadly blood disease for more than a decade. By 2005 he needed a new liver to survive, but doctors would not do the transplant unless they could figure out how to keep the disease from destroying the new organ. His one chance: an experimental drug called Soliris from Alexion Pharmaceuticals Inc.. Yet he didn't qualify for the clinical trial. His doctors, friends, and family members all searched for a way to get him the drug, finally calling his senator, Arlen Specter (R-Pa.), who intervened. "I was informed on Thanksgiving of 2006 that I would get the drug," says Davis, 32. "It's the best news I ever got."
Some 97% of the sickest patients are ineligible for or don't have access to the clinical trials that are testing experimental medicines. They're getting help from patient advocates who are aggressively lobbying Congress, other patients, and the Food and Drug Administration to either speed up approval or relax rules restricting access to clinical drugs.
Landmark Case?
Before long, the results of that effort may prove more than anecdotal. A lawsuit by a group of patient advocates could make access to experimental medicines a constitutional right, resulting in a dramatic shift in the way medicines for life-threatening diseases are developed and regulated.
The Abigail Alliance for Better Access to Developmental Drugs filed suit against the FDA in 2003 seeking expanded access to experimental drugs for terminally ill people. The nonprofit group was founded by Frank Burroughs in 2001 after his 21-year-old daughter and only child, Abigail, died of head and neck cancer. She had been turned down for clinical trials for ImClone Systems' (IMCL) Erbitux and AstraZeneca's (AZN) Iressa, both of which went on to win FDA approval. After a long legal battle, a three-judge panel from the District of Columbia Circuit Court of Appeals ruled last year that the case could be heard in district court.
The FDA requested that the court's full, 10-judge panel consider the case, and its decision is widely expected this summer. Whichever side loses is sure to appeal to the Supreme Court. "This could be a landmark civil rights case," Burroughs says. That right, if the Abigail Alliance prevails, would let a terminally ill patient try any drug that has proven safe in early-stage human studies, even if there is no evidence of its efficacy.
Cost Concerns
The prospect of such a right is disquieting to drug companies that say they can ill afford to make experimental drugs more widely available. There are currently more than 600 experimental cancer drugs in development. All must go through years of testing in costly clinical trials. Most will fail at some point.
Very sick patients who can't get into a clinical trial can petition the company and FDA to try some drug on a so-called compassionate use basis, but few companies offer such an option because the drugs are usually provided free of charge (insurers typically will not pay for experimental treatments).
"Very small companies like ourselves don't have the resources to give away drugs free on an ongoing basis," says Timothy Walbert, chief executive officer of IDM Pharma (IDMI), which is seeking FDA approval of a drug for a rare form of childhood bone cancer called osteosarcoma—a disease that has its own advocacy group pushing for approval of the IDM drug. "There are only about 900 kids a year in the U.S. who get this disease," Walbert says. "We can't afford to provide it free to all the kids who need it."
Provenge Firestorm
Even cancer specialists, who often seek compassionate use programs for their patients, aren't keen on expanded access. "I understand emotionally why patients would want this right, but the issues surrounding experimental drugs are very complex, and I think this could potentially backfire," says leading oncologist Dr. George Demetri of the Dana-Farber Cancer Institute in Boston. "Patients really need to know the relative benefit of a drug versus the relative risk, and expanded access could prevent them from gaining that insight."
Activist patients, however, are disinclined to wait for such data when it comes to diseases for which treatments are few to nonexistent. Prostate cancer patient advocates in particular are up in arms these days over the FDA's controversial refusal in May to approve Dendreon's (DNDN) Provenge without further clinical trials, which could take a year or more to complete. Provenge is a novel cancer vaccine meant to prime the body's immune system to attack tumors, and if approved would have been the first new treatment in more than 20 years for advanced, stage-4 prostate cancer, which is almost always fatal. Some 30,000 men die each year in the U.S. from prostate cancer.
In a trial, Provenge failed to stop the disease from progressing, but when it dug into the data it found that patients on the drug lived an average of 4.5 months longer than those on standard treatment. Despite the uneven results, an FDA advisory panel voted 13-4 in March to recommend the drug for approval, and the FDA usually follows such recommendations. So when the agency withheld approval on May 9, a firestorm erupted. Prostate cancer activists (and disgruntled Dendreon investors) have lobbied Congress, held demonstrations, and met with the FDA's Commissioner, Dr. Andrew von Eschenbach.
Success Story
FDA officials say they do listen to such patient pleas. "The patient has a right to be heard," explains Patty Delaney, director of the FDA's cancer liaison program and herself a cancer survivor. "But in the end, it's the data that matters. FDA opinions about safety and efficacy are always based on data."
Delaney also notes that the FDA is very amenable to patient requests for compassionate use of an experimental drug, if the company developing the drug has such a program. Most smaller companies do not, however, including Dendreon, which has never offered Provenge on a compassionate use basis. If the Abigail Alliance wins its case, Delaney worries that disreputable companies might start selling experimental drugs that they know have slim chance of winning FDA approval. "You could really hype something up," Delaney says. "Why would you ever do clinical trials in any meaningful way if you are already allowed to sell the drug?"
If the Abigail Alliance prevails with its lawsuit, patients would have to prove they have exhausted all standard treatments, and are not eligible for clinical trials, before receiving an experimental drug. The group also hopes a successful lawsuit will lead to insurers agreeing to reimburse for experimental drugs under those conditions. "There has to be some kind of incentive for companies," Burroughs says.
If the business approach doesn't work, patient advocates can point to success stories like Davis'. Within months of getting the go-ahead to use Soliris, he was well enough to get a liver transplant, in February, 2007. The FDA approved the drug a month later, on March 19. "I'm quite sure I would not have made it until March," he says. Today, Davis is healthy, working, and, together with his wife, in the process of adopting a child.
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July 27: Doctors still over-prescribing antibiotics, EARTHtimes.org
LONDON, Doctors are prescribing antibiotics for up to 80 percent of cases of sore throat, respiratory tract infections and sinusitis, found a British study.
Although prescriptions of antibiotics for respiratory tract infections declined during the 1990s, primary care physicians still continue to prescribe antibiotics for a high proportion of infections even if the causes of the symptoms are likely to be viral -- which cannot be treated by antibiotics, according to the study published in a supplement to the Journal of Antimicrobial Chemotherapy.
This practice is hindering efforts to prevent the spread of antibiotic resistance, whereby disease-causing bacteria become unresponsive to the most commonly used drug treatments, according to Dr. Douglas Fleming, a member of the United Kingdom's Specialist Advisory Committee on Antimicrobial Resistance.
The researchers searched for all consultations between 1998 and 2001 for conditions that might have resulted in an antibiotic prescription.
The most common causes of antibacterial prescribing identified in the study were upper respiratory tract infection, lower respiratory tract infection, sore throat, urinary tract infection, otitis media, conjunctivitis, vague skin infections, sinusitis, otitis externa and impetigo.
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July 28: Bush Aide Blocked Report, The Washington Post
Global Health Draft In 2006 Rejected for Not Being Political
By Christopher Lee and Marc Kaufman
Washington Post Staff Writers
A surgeon general's report in 2006 that called on Americans to help tackle global health problems has been kept from the public by a Bush political appointee without any background or expertise in medicine or public health, chiefly because the report did not promote the administration's policy accomplishments, according to current and former public health officials.
The report described the link between poverty and poor health, urged the U.S. government to help combat widespread diseases as a key aim of its foreign policy, and called on corporations to help improve health conditions in the countries where they operate. A copy of the report was obtained by The Washington Post.
William R. Steiger has been identified as the HHS official who blocked the report on global health.
Three people directly involved in its preparation said its publication was blocked by William R. Steiger, a specialist in education and a scholar of Latin American history whose family has long ties to President Bush and Vice President Cheney. Since 2001, Steiger has run the Office of Global Health Affairs in the Department of Health and Human Services.
Richard H. Carmona, who commissioned the "Call to Action on Global Health" while serving as surgeon general from 2002 to 2006, recently cited its suppression as an example of the Bush administration's frequent efforts during his tenure to give scientific documents a political twist. At a July 10 House committee hearing, Carmona did not cite Steiger by name or detail the report's contents and its implications for American public health.
Carmona told lawmakers that, as he fought to release the document, he was "called in and again admonished . . . via a senior official who said, 'You don't get it.' " He said a senior official told him that "this will be a political document, or it will not be released."
After a long struggle that pitted top scientific and medical experts inside and outside the government against Steiger and his political bosses, Carmona refused to make the requested changes, according to the officials. Carmona engaged in similar fights over other public health reports, including an unpublished report on prison health. A few days before the end of his term as the nation's senior medical officer, he was abruptly told he would not be reappointed.
Steiger did not return a phone call seeking his comment. But he said in a written statement released by an HHS spokesman Friday that the report contained information that was "often inaccurate or out-of-date and it lacked analysis and focus."
Steiger confirmed that he sharply disagreed with Carmona on the issue of how much the report should promote Bush administration policies. "A document meant to educate the American public about health as a global challenge and urge them to action should at least let Americans know what their generosity is already doing in helping to solve those challenges," Steiger said in the statement.
Steiger said that "political considerations" did not delay the report; "sloppy work, poor analysis, and lack of scientific rigor did." Asked about the report's handling, an HHS spokeswoman said Friday that it is still "under development."
The draft report itself, in language linking public health problems with violence and other social ills, says "we cannot overstate . . . that problems in remote parts of the globe can no longer be ignored. Diseases that Americans once read about as affecting people in regions . . . most of us would never visit are now capable of reaching us directly. The hunger, disease, and death resulting from poor food and nutrition create social and political instability . . . and that instability may spread to other nations as people migrate to survive."
In 65 pages, the report charts trends in infectious and chronic disease; reviews efforts to curb AIDS, tuberculosis and malaria; calls for the careful monitoring of public health to safeguard against bioterrorism; and explains the importance of proper nutrition, childhood immunizations and clean air and water, among other topics. Its underlying message is that disease and suffering do not respect political boundaries in an era of globalization and mass population movements.
The report was compiled by government and private public-health experts from various organizations, including the National Institutes of Health, the Catholic Medical Mission Board and several universities. Steiger's global health office provided the funding and staff to lead the effort because the surgeon general's office has no budget and few staff members of its own.
"It covered all of the contemporary issues of public health, from environmental health through infectious disease transmission," said Jerrold M. Michael, a former assistant surgeon general and a former longtime dean of the University of Hawaii School of Public Health, who worked on the report.
A few of the issues it focuses on, such as AIDS treatment and research, have been public health priorities for the Bush administration. But others -- including ratifying the international tobacco treaty and making global health an element of U.S. foreign policy -- are more politically sensitive. The report calls on the administration to consider spending more money on global health improvement, for instance. And it warns that "the environmental conditions that poison our water and contaminate our air are not contained within national boundaries. . . . The use of pesticides is also of concern to health officials, scientists and government leaders around the world."
Three people involved in the preparation of an initial draft in 2005 said it received largely positive reviews from global health experts both inside and outside the government, prompting wide optimism that the report would be publicly released that year. The Commissioned Officers Association, a nonprofit group representing more than 7,000 current and retired officers of the U.S. Public Health Service, organized a global health summit in June 2005 in Philadelphia where Carmona was expected to unveil the report in a keynote address -- but he was not cleared to release it there.
Richard Walling, a former career official in the HHS global health office who oversaw the draft, said Steiger was the official who blocked its release. "Steiger always had his political hat on," he said. "I don't think public health was what his vision was. As far as the international office was concerned, it was a political office of the secretary. . . . What he was looking for, and in general what he was always looking for, was, 'How do we promote the policies and the programs of the administration?' This report didn't focus on that."
On June 30, 2006, a Steiger aide sent an e-mail saying that the report should not be cleared for public distribution: "While we believe the subject matter of the draft is important, we disagree with the style, tone and messaging," wrote the aide, Mark A. Abdoo, according to a copy of the e-mail. "We believe this document should be focused tightly on the Administration's major priorities in global health so the American public can understand better why these issues should be important to them. As such, the draft should be a policy statement, albeit one that is evidence based and draws on the best available science."
Steiger, 37, is a godson of former president George H.W. Bush and the son of a moderate Republican who represented Wisconsin in the House and hired a young Dick Cheney as an intern. The elder Bush appointed Steiger's mother to the Federal Trade Commission in 1989. A biographical sketch of her on the American Bar Association's Web site states that Steiger's parents, now deceased, were "lifelong friends" of many members of the same congressional class, including the Rumsfelds and the Bushes.
According to a résumé Steiger supplied to Congress, he obtained a doctorate in Latin American history from the University of California at Los Angeles before teaching at a university in the Philippines and consulting in Angola for the International Republican Institute -- a nonprofit group that is associated with the party and promotes democracy around the world. He was an education adviser to then-Gov. Tommy G. Thompson (R) of Wisconsin and came to Washington when Thompson became HHS secretary. He is now awaiting a Senate vote on his nomination as Bush's ambassador to Mozambique.
Bill Hall, an HHS spokesman, said Steiger promoted interest in global health at the department while more than doubling the number of expert staff members overseas and participating in international negotiations on issues such as avian influenza. "You have to look at his skills as an executive leader in spite of the fact that he doesn't have a medical degree or a public health degree," Hall said.
Public health advocates have accused Steiger of political meddling before. He briefly attained notoriety in 2004 by demanding changes in the language of an international report on obesity. The report was opposed by some U.S. food manufacturers and the sugar industry.
According to Walling and three other public health officials familiar with the current dispute, Carmona at one point suggested that Steiger release the global health report in tandem with a separate report of the sort Steiger wanted, but Steiger rejected the idea. An appeal by Carmona to Health and Human Services Secretary Mike Leavitt and his staff produced no relief, a former HHS official said.
"I fought for my last year to try to get it out and couldn't get it past the initial vetting," Carmona testified earlier this month. "I refused to release it [with the requested changes] . . . because it would tarnish the office of the surgeon general when our colleagues saw us taking a political stand."
Thomas Novotny, a former assistant surgeon general who ran the global health office before Steiger, said, "It's embarrassing, just ridiculous that the report hasn't come out." Novotny, who served at HHS in the Clinton and in both Bush administrations, said that many nations have made health issues central to their foreign relations and trade policies, but that the United States has been reluctant to embrace that idea.
"It made perfect sense for the surgeon general to take up the issue because the U.S. used to be a leader in this field," Novotny said. "For the nation's top doctor to be unable to release the report shows that leadership is gone."
The global health document was one of several reports initiated by Carmona that top HHS officials suppressed because they disliked the reports' conclusions, according to a former administration official. Another was a "Call to Action on Corrections and Community Health." It says -- according to draft language obtained by The Post -- that the public has a large stake in the health of the 2 million men and women who are behind bars, and in the health care available to them in their communities after their release.
The report recommends enhanced health screenings for those arrested and their victims; better disease surveillance in prisons; and ready access to medical, mental health and substance abuse prevention services for those released.
But the report has been bottled up at HHS, said three public health experts who worked on it. John Miles, a consultant and former Centers for Disease Control and Prevention official who helped draft it, said he suspects that the proposed health screenings and other recommendations are seen as a potentially burdensome cost. "Maybe they just don't feel it's a priority," Miles said.
Hall, the HHS spokesman, responded in a statement Friday that the Bush administration has always believed that public health policy should be rooted in science. "While we appreciate and respect Dr. Carmona's service as surgeon general, we disagree with his statements," Hall said.
Staff researcher Madonna Lebling contributed to this report.
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July 31: Office printers 'are health risk', BBC News
By Nick Bryant, BBC News, Sydney
The humble office laser printer can damage lungs in much the same way as smoke particles from cigarettes, a team of Australian scientists has found.
An investigation of a range of printer models showed that almost a third emit potentially dangerous levels of toner into the air.
The Queensland University of Technology scientists have called on ministers to regulate these kinds of emissions.
They say some printers should come with a health warning.
The researchers carried out tests on more than 60 machines.
Almost one-third were found to emit ultra-tiny particles of toner-like material, so small that they can infiltrate the lungs and cause a range of health problems from respiratory irritation to more chronic illnesses.
Conducted in an open-plan office, the test revealed that particle levels increased five-fold during working hours, a rise blamed on printer use.
The problem was worse when new cartridges were used and when graphics and images required higher quantities of toner.
The researchers have called on governments to regulate air quality in offices.
They also want companies to ensure that printers are based in well-ventilated areas so that particles disperse.
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July 31: New risks discovered for HPV, Seattle Post
Virus found under men's fingernails, pointing to more ways of it spreading
By TOM PAULSON
P-I REPORTER
Controversy continues to plague efforts to protect young women against cervical cancer by vaccinating them against HPV, the human papillomavirus, but one leading scientist's discovery could throw a monkey wrench into the debate.
"We found HPV under the fingernails of young men," said Dr. Laura Koutsky, a University of Washington epidemiologist.
Koutsky led some of the pioneering research and clinical trials that resulted in an HPV vaccine, Merck's Gardasil, recently approved for use in girls and young women. The reason her fingernail finding is a potential bombshell has to do with why the vaccine is controversial.
HPV, which is the leading cause of most cervical cancers, is primarily a sexually transmitted disease. Opponents of HPV vaccines believe that immunizing girls against this virus sends the message that engaging in sex at a young age is acceptable behavior.
The presence of HPV under fingernails, she said, at the very least suggests another possible route of transmission. It's an additional route of infection, she said, that could explain some previous apparent anomalies such as HPV infection in infants and young girls who had not yet engaged in sexual activity.
Koutsky's not quite sure what to make of the finding, which has yet to be reported in a journal, but she said it is certainly "a surprise."
"In spite of (the debate), a considerable amount of the vaccine has been distributed already," said Dr. Lauri Markowitz, an expert on HPV with the U.S. Centers for Disease Control and Prevention who spoke this week at a Seattle meeting of the International Society for Sexually Transmitted Diseases Research.
More than 40 states have enacted some kind of legislation to encourage wider use of the HPV vaccine, Markowitz said, including a few states, such as Washington, that have avoided the mandated vaccine debate by simply offering the immunizations free.
The CDC, which recommends routine use of the HPV vaccine in females between the ages of 9 and 26, estimates that 25 percent of all women in the U.S. are already infected with the virus.
Not all HPV strains are equally likely to result in cancer, however. The vaccine protects against four strains that are thought to be more likely to cause cervical cancer. There are hundreds of types of HPV, and most people have been infected by one or another. Most infections have no symptoms and go unrecognized.
More severe forms of HPV can cause genital warts and penile and anal cancers. Non-genital strains can cause head and neck cancers. But the greatest cancer risk from HPV is to women. Cervical cancer, if detected early by Pap smear, is treatable but still kills more than 4,000 women a year in the U.S. In the developing world, cervical cancer is massive -- the leading cause of cancer deaths of women, killing nearly 300,000 annually.
The cultural and moral concerns of other countries are sometimes an even bigger barrier to introducing new vaccines or health measures, said Dr. Jacqueline Sherris, vice president at Seattle-based PATH, an organization that specializes in the health needs of the developing world. Widespread acceptance of a vaccine in the industrial world, she added, can often be a necessary precursor to expanding its lifesaving use in poor countries.
But opponents of making HPV immunization widespread argue that if a young woman simply abstains until marriage, no vaccine is needed. Koutsky's finding may give pause to those arguing from this moral perspective. If HPV can be found under fingernails, will these daughters of chastity need to also abstain from a handshake?
There's no evidence to support that kind of transmission, Koutsky noted, but the finding of severe forms of HPV under the fingernails of young men should serve as a reminder of how much we yet have to learn about the behavior and transmission of the human papillomavirus.
"Basically, it's not just about sex," Koutsky said. "You have to know how people get it in order to prevent it."
At some point, she predicted, it will become clear that boys and young men should also be vaccinated against the virus. It would be nice if just living a good, moral lifestyle could protect against microbial invasion, Koutsky said. But right at your fingertips, she said, might be a hint that this is just wishful thinking.
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