Doctors sell hip resurfacing to boomers

Tue, 30 Jan 2007 03:23:00 GMT
By LAURAN NEERGAARD, AP Medical Writer
WASHINGTON - Doctors are beginning to offer a new alternative to hip replacement, one aimed at younger, athletic baby boomers who've worn out their joints too soon. Now they no longer have to wait until they hit their 60s for a fix.
It's called hip resurfacing, covering a damaged hip's ball and socket with smooth metal rather than cutting away worn bone and replacing it.

The operation hit the U.S. market last spring with Food and Drug Administration approval of the British-designed Birmingham Hip Resurfacing System. Competitors are in clinical trials here, and expected to clear FDA later this year.

It's not the first time orthopedic surgeons have tried resurfacing worn-out hips. But where earlier attempts failed, data from Europe suggest this latest approach uses longer-lasting materials — with the additional promise of a joint that may hold up to the heavy recreation of today's 40- and 50-somethings better than traditional hip implants.

"I do have people that call me and say, 'My father had hip resurfacing in 1970 and it didn't work. Why are we doing that now?'" says Dr. Michael J. Anderson, an orthopedic surgeon in Milwaukee who estimates that about 15 percent of his hip implants now are resurfacings.

His response: Comparing today's resurfacing with yesteryear's is like comparing a modern car to a Model T.

Not everyone's a good candidate, specialists caution. Resurfacing isn't for patients with thinning bones — part of the joint could break — or those who have poorly functioning kidneys that can't eliminate microscopic metal particles produced when the joint's reinforced pieces rub together.

Moreover, while patients typically recover quickly, resurfacing is harder to perform than a hip replacement, and only a small fraction of the nation's orthopedic surgeons so far are trained to do it.

But interest is growing, as evidenced by a focus on hip resurfacing at next month's annual meeting of the American Academy of Orthopaedic Surgeons — and a growing demand for hip repair from ever-younger patients.

Until now, "you might have told someone to soldier on for as long as you possibly can," because a standard hip replacement before age 60 is itself likely to wear out, explains academy spokesman Dr. Scott Rubinstein, of the Illinois Bone and Joint Institute.

With the new resurfacing option, "people may be a little more aggressive" in treating younger creaky joints, he adds.

More than 400,000 total or partial hip replacements are performed each year, a number growing as the population ages.

Typically, surgeons replace a hip by cutting off the femoral head, the joint's ball, and replacing it with a metal ball mounted on a rod implanted deep in the thigh bone. A plastic socket replaces the original. Those artificial hips can bring tremendous relief to people crippled by hip pain.

But the metal-on-plastic friction means the implants can begin wearing out in about 15 years, sooner if sports or other activities increase pressure on the joint. For the average 65-year-old, that's no problem. A 50-year-old, in contrast, could very well wear out an initial replacement and have little thigh bone left to fit another.

"You're dealing with Swiss cheese," is how hip replacement pioneer Dr. Mitchell Sheinkop describes the remaining bone.

Enter resurfacing. Surgeons lightly shave the damaged femoral ball and fit a metal ball snugly over it. That ball rolls in a metal cup reinforcing the socket. The idea: Metal-on-metal shouldn't wear out as fast, and if patients do need another replacement in 15 or 20 years, the thigh bone is largely intact.

"This resurfacing initiative has interest because we're sparing bone," explains Sheinkop, a Rush University professor and joint replacement director of the Neurologic and Orthopedic Institute of Chicago.

What's the evidence? The FDA cited studies showing the Birmingham Hip resurfacer lasted at least five years, approving its sale on condition that manufacturer Smith & Nephew Inc. continue tracking its endurance for 10 years.
Doctors differ on what age is the cutoff for resurfacing, somewhere between 60 and 65, largely dependent on the patient's bone strength. Nor do all insurers cover it. The implant costs about 20 percent more than a standard artificial hip, adding to the $35,000 tab.
Complicating the choice is that surgeons call newer artificial hips — ceramic-on-ceramic balls and sockets, or tougher plastic designs — good options for even the most active person just turning 60.
So resurfacing is emerging as a niche for the younger sports enthusiast. Dr. Marc Wiener, a Chicago-area internist, chose resurfacing when his own hip degenerated in his 40s, because it came with few restrictions on his activity. Wiener exercised before surgery to be in prime condition for physical therapy afterward — and played 18 holes of golf a month after his resurfacing, hit the basketball court at seven weeks and the tennis courts in three months.
Milwaukee's Anderson cautions that average patients shouldn't expect as much. "If you find your exercise level can increase, we like that, but I'm not going to promise you'll be playing doubles at Wimbledon next year."
___
EDITOR'S NOTE — Lauran Neergaard covers health and medical issues for The Associated Press in Washington.

Couple awarded 361.5M in hormone lawsuit

Mon, 29 Jan 2007 23:36:44 GMT
By MARYCLAIRE DALE, Associated Press Writer
PHILADELPHIA - A couple who contended that a hormone-replacement drug caused the woman's breast cancer was awarded $1.5 million Monday in a jury verdict against drug maker Wyeth.
The jury also found that Wyeth acted with malice or reckless disregard, prompting a hearing set to start Tuesday on possible punitive damages.

The Philadelphia jury awarded $1 million in compensatory damages to plaintiff Mary Daniel and $500,000 to her husband, Tom, a courtroom clerk said.

Mary Daniel, 60, of Hot Springs, Ark., developed breast cancer after taking the Wyeth drug Prempro, a combination of estrogen and progestin, every other day for about 16 months to relieve hot flashes.

Daniel had two surgeries and underwent chemotherapy and radiation following her July 2001 diagnosis. She has since been cancer-free.

Her lawyer said Wyeth knew of research indicating a link between Prempro and cancer, but put profits ahead of patients.

"Wyeth has known for decades that postmenopausal drugs cause breast cancer but the company deliberately failed to do studies to understand or quantify that risk," lawyer Zoe Littlepage said. "Wyeth protected their bottom dollar instead of protecting the patients."

At its height, Wyeth sold $2 billion a year in drugs that treat menopausal symptoms, including Premarin and Prempro. But many women stopped taking them after the federal Women's Health Initiative study in July 2002 found higher rates of breast cancer and heart problems in women who took estrogen-progestin pills.

Wyeth spokesman Christopher Garland declined comment after Monday's verdict, citing a request by the trial judge.

In closing arguments, Wyeth denied any malice and noted that doctors still prescribe Prempro for some women. Lawyer Peter Grossi suggested that Daniel's breast cancer was caused by other risk factors, including the density of her breasts and a family history of cancer.

The jury deliberated for about two days following a three-week trial.

Daniel's lawsuit is the third of about 4,500 against Wyeth to reach a jury.

Wyeth won its first trial in Arkansas in August, and a mistrial was declared in the second trial in Philadelphia in October.

Other suits are pending in the courts.

FDA OKs contraceptive for acne control

Mon, 29 Jan 2007 23:33:47 GMT

BERLIN - The U.S. Food and Drug Administration has approved a new use of Bayer Schering Pharma AG's drug YAZ to allow it to be used to treat moderate acne in women who also want to use an oral contraceptive for birth control, the company said Monday.
With the approval, YAZ becomes the first oral contraceptive approved by the FDA for three distinct uses, Bayer said in a statement. In addition to being approved for birth control use and now for acne control, it is also approved to treat the emotional and physical symptoms of premenstrual dysphoric disorder.

"YAZ is the fastest growing oral contraceptive brand in the U.S.," said Phil Smits, head of Bayer Schering Pharma's women's healthcare unit. "We are convinced that through its unique features, YAZ will further strengthen our worldwide leading market position in the field of female contraception."

Another outbreak of bird flu hits Japan

Tue, 30 Jan 2007 11:10:26 GMT
By HANS GREIMEL, Associated Press Writer
TOKYO - Another outbreak of bird flu was suspected in southern Japan on Tuesday after 23 chickens were found dead at a farm, fueling concern about a string of cases in the country's poultry industry.
The latest outbreak occurred in the town of Shitomi in southwestern prefecture of Miyazaki, which saw two separate bird flu cases earlier this month, Agriculture Ministry official Yasushi Yamaguchi said.

The case would mark Japan's fourth bird flu incident in the past month. Authorities found 23 chickens dead at the farm in Shitomi, and seven of 13 birds that were tested showed initial signs of bird flu, Yamaguchi said.

"We found the dead birds today and are investigating whether the virus is present," the official said. Results could take days.

The farm was quarantined and chicken ranchers within a six-mile radius were told not to transport poultry out of the area.

Separately Tuesday, officials were trying to determine whether the virus that killed dozens of chickens in the western prefecture of Okayama was the deadly H5N1 variety.

The H5N1 was pinpointed in the earlier Miyazaki outbreaks, which forced the slaughter of thousands of chickens in the region.

The H5N1 virus has prompted the slaughter of millions of birds across Asia since late 2003, and caused the deaths of at least 163 people worldwide, according to the World Health Organization.

Japan has confirmed only one human H5N1 infection, and no human deaths.

The bird flu virus remains hard for humans to catch, but international experts fear it may mutate into a form that could spread easily among people and possibly kill millions around the world.

Cannabis drug may help fight obesity

Tue, 30 Jan 2007 16:11:49 GMT
By Amie Ferris-Rotman
LONDON - Human trials of an experimental treatment for obesity derived from cannabis, which is commonly associated with stimulating hunger, are scheduled to begin in the second half of this year, Britain's GW Pharmaceuticals Plc announced Tuesday.
Several other companies, such as Sanofi-Aventis, which is investigating Acomplia, are working on new drugs that will switch off the brain circuits that make people hungry when they smoke cannabis.

GW Pharma, however, says it has derived a treatment from cannabis that could help suppress hunger. "The cannabis plant has 70 different cannabinoids in it and each has a different affect on the body," GW Managing Director Justin Gover told Reuters in a telephone interview.

"Some can stimulate your appetite, and some in the same plant can suppress your appetite. It is amazing both scientifically and commercially," he said.

Drugs have to pass three stages of tests in humans before being eligible for approval by regulators in a process that takes many years.

Sanofi-Aventis' Acomplia, which it believes can achieve $3 billion in annual sales, is already on sale in Europe and it is waiting for a U.S. regulatory decision in April.

Several other big drug companies also already have similar products to Acomplia in clinical trials.

GW is best known for developing Sativex, a treatment derived from cannabis that fights spasticity in multiple sclerosis patients. Sativex, an under-the-tongue spray, has been approved in Canada, but has hit delays with regulators in Britain.

GW submitted Sativex for assessment by several European regulators in September, and hopes to secure approval for the UK, Denmark, Spain and the Netherlands in the second half of this year at the earliest, the company said on Tuesday.

GW's marijuana plants are grown indoors in a secret location in Southern England.

Brothel owners accuse backpackers of selling sex in Australia

Tue, 30 Jan 2007 03:22:11 GMT

SYDNEY - Foreign backpackers funding their Australian travels through illegal sex work are robbing the legitimate industry of profits and threatening clients' health, a brothel lobbyist has warned.
Many young tourists to sun-soaked northeastern Queensland state were making a quick buck as black market prostitutes, undermining registered operators' attempts to uphold health and safety standards, the Queensland Adult Business Association's Nick Inskip claimed.

&;Especially when you go up to northern Queensland, it's not unusual for them to be working in the illegal escort industry,&; Inskip said.

Having fewer overheads, they could often undercut the legal sex industry on price, making it harder for the state's 23 legal brothels to make a profit, he said.

&;They can charge less because they are not paying GST , staff costs for managers and receptionists,&; Inskip said.

The tax office, which recently began a drive to collect tax from the industry, was also hard pressed to keep tabs on their undercover activities, he said.

&;No one asks to see their passports. If you go to a licensed brothel the first thing they do is ask for your passport and whether you are here legally.&;

Although prostitution at registered brothels is legal in many parts of Australia, recent research suggests the taxman's attempts to target the industry has sparked an exodus towards riskier illegal sex work.

Academics have also noted that the crippling cost of higher education in Australia has forced some foreign students to seek work as illegal prostitutes to make ends meet.

Thai pharma group slams generic drugs approval

Tue, 30 Jan 2007 17:09:22 GMT

BANGKOK - Thailand's top pharmaceutical group slammed the government's decision to allow generic versions of AIDS and heart drugs, saying it damaged the nation's image in the global business community.
The army-installed government said Monday it had approved generic versions of the anti-AIDS drug Kaletra and the blockbuster heart drug Plavix.

That followed a November decision to allow generic versions of the HIV/AIDS drug Efavirenz.

But the Pharmaceutical Research and Manufacturers' Association of Thailand said it was &;a stunning blow to the foreign investment climate in this country and seriously damages Thailand's image among the global business community.&;

&;Our country has been an economic success story because of our Thai nature to always enter into dialogue and never resort to such heavy-handed government action,&; the group, which comprises 38 drug firms, said in a statement.

Thailand's universal HIV/AIDS treatment programme has been hailed as a success in the fight against the disease, largely because of the country's ability to provide anti-retroviral drugs to patients.

In 2002, the Thai government launched a generic version of HIV/AIDS triple therapy and was able to cut the cost of treatment 18-fold.

Thailand's treatment program has been widely credited with slashing the number of deaths from AIDS by about 75 percent last year and the number of new annual HIV infections continues to drop.

Treatment with the anti-AIDS drug Kaletra currently costs 11,580 baht per month, and could drop to 4,000 baht per month with the generic version, according to the Nobel Peace Prize-winning medical relief agency Doctors Without Borders.

Plavix, a blood-thinning treatment to prevent heart attacks, is believed to be one of the biggest selling drug treatments in the world and rang up global sales of 5.9 billion dollars in 2005.

The popular heart drug is sold by French-based Sanofi-Aventis and its US partner, Bristol Myers-Squibb

Sleep apnea may persist after tonsillectomy

Tue, 30 Jan 2007 17:42:23 GMT
By David Douglas
NEW YORK - Only about one quarter of children who have their tonsils and adenoids removed to relieve obstructive sleep apnea syndrome have a complete response, according to researchers.
"We should not assume that all children undergoing tonsillectomy and adenoidectomy for obstructive sleep apnea will be cured," senior investigator Dr. David Gozal told Reuters Health. "Only a small percentage will."

Obstructive sleep apnea syndrome is when person wakes up repeatedly during the night because airways become blocked for brief periods and breathing stops, also referred to as apnea. The condition can lead to daytime sleepiness and impaired concentration.

In the Journal of Pediatrics, Gozal and colleagues at the University of Louisville, Kentucky describe their study of 110 children who were evaluated using a polysomnograph, a tool to detect sleep disorders, before and after the surgery was performed.

Following surgery, only 25 percent of the children had one or no episodes of breathing interruption per hour of sleep, 46 percent had as many as four episodes per hour; and 29 percent had five or more episodes per hour of sleep.

Five or more apnea episodes per hour were significantly more common in obese children than in non-obese children (36.4 percent versus 17.6 percent), and significantly fewer obese than non-obese children had one or no episodes per hour.

Overall, 25 percent of the children had complete normalization of sleep after surgery.

Given the relatively low response rate, Gozal said, "it is important, and particularly so in more severe cases or in the presence of obesity, to repeat the sleep study after surgery to identify those children who may need additional interventions."

He suggests these might include treatment to reduce inflammation or continuous positive airway pressure, a procedure in which a face mask fitted over the nose is worn at bedtime to supply air pressure in the throat so the airways don't collapse when the patient inhales during sleep.

SOURCE: Journal of Pediatrics, December 2006.

Neurological disease common survey finds

Tue, 30 Jan 2007 14:06:02 GMT

WASHINGTON - Multiple sclerosis, Parkinson's disease and other neurological diseases may be far more common than most people had believed, according to new estimates published on Monday.
Nearly one out of 1,000 Americans has multiple sclerosis or MS and one out of 100 elderly Americans has Parkinson's disease the survey found.

"Our estimate of MS prevalence is about 50 percent higher than a comprehensive review from 1982," said Dr. Deborah Hirtz of the National Institute of Neurological Disorders and Stroke, who led the survey.

It is not clear whether the disease is actually more common or if it is being diagnosed more accurately, she said.

The new survey, published in the journal Neurology, also found the rate of Alzheimer's disease was up substantially from past estimates, with 67 out of 1,000 Americans over the age of 65 affected.

Nearly 10 out of 1,000 older Americans have Parkinson's disease, and four out of every 100,000 has amyotrophic lateral sclerosis, also called ALS or Lou Gehrig's disease, the survey found.

The survey projects that the number of people with Parkinson's will double from about 4.3 million people now to 9 million people worldwide over the next 25 years.

It corroborated other studies on childhood neurological disorders, finding that nearly six out of every 1,000 children has autism, and two out of every 1,000 children has cerebral palsy.

Hirtz and colleagues reviewed studies from nearly 500 medical papers published between 1990 and 2005 for their report.

They found that 101 out of every 100,000 Americans has a traumatic brain injury each year, 50 percent fewer than previous estimates.

More than 180 out of every 100,000 people suffer a stroke each year, and close to five out of every 100,000 have a new spinal cord injury each year.

Steven Albert of the Department of Behavioral and Community Health Sciences at the University of Pittsburgh said the impact of Alzheimer's will be substantial as the population ages.

"Current projections of AD suggest that there will be about 10 million cases in the United States in 2050, of which 6 million are expected to have moderate or severe dementia," Albert wrote in a commentary in the journal.

There is currently no cure and treatments only delay the progression of Alzheimer's slightly. There is also no cure for MS or for Parkinson's, although drugs can also delay their progression.

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