Doctor touts use of experimental therapy
Thu, 27 Sep 2007 18:23:42 GMTBy JENNIFER KAY, Associated Press Writer
MIAMI - If Dr. Barth Green had his way, there would be no space program. His idea of a moon-shot is curing paralysis, and while he's at it, poverty.
"I'd disband NASA for 10 years and take half its budget to avert natural disasters. We could do it, we've got the technology. I'd take the other half to deal with disease and suffering," the neurosurgeon said. "The time has come to do something bold instead of buying wheelchairs."
Those sorts of audacious statements make the Miami Project to Cure Paralysis' president stand out. But some doctors believe there is not enough evidence yet to prove the experimental cooling therapy Green advocates works on people with spinal cord injuries. Still, Green has spent his career redefining what is possible for people who suffer catastrophic injuries in less spectacular ways than Buffalo Bills tight end Kevin Everett.
He suffered a life-threatening spinal cord injury Sept. 9 in the season opener against Denver. Everett, who underwent moderate hypothermia in the ambulance, had immediate access to doctors familiar with the experimental cooling therapy.
"So do you!" Green insisted, barely pausing for breath or a question in a rapid-fire phone interview. Paramedics anywhere can be trained to administer the moderate hypothermia therapy, as emergency responders in Miami will be, said the chairman of the neurological surgery department at the University of Miami school of medicine.
Green described the therapy as analogous to an ice pack for the spine, helping prevent swelling and further damage.
Doctors initially said Everett might not walk again, but he began moving his arms and legs days after the injury. Now continuing his recovery in Houston, he has been able to lift his right arm and sit up in bed for four hours, his doctors said.
Everett's case is no miracle, Green said — just proof the right treatment will help people who suffer catastrophic injuries live normal lives again.
"It's the first high-profile evidence of it. Let's begin to offer this type of treatment to everybody," Green said.
Other neurosurgeons cautioned that Everett's case alone cannot be considered proof that the treatment works, and more evidence is needed before the therapy can be widely applied.
"There's absolutely no way to determine the role that hypothermia played in one case," said Dr. Joe Maroon, a professor of neurological surgery at the University of Pittsburgh and team neurosurgeon for the Pittsburgh Steelers.
Maroon said he used a different variation of spinal cooling therapy on patients in the 1970s, but abandoned the technique because it was difficult to get patients treatment fast enough and wounds were open for too long. He said he would consider using hypothermia treatment again, but only after seeing more evidence of its success.
Green, 62, co-founded the Miami Project to Cure Paralysis in 1985 with three families whose loved ones had suffered spinal cord injuries, including Marc Buoniconti, son of pro football Hall of Fame linebacker Nick Buoniconti.
Green's attitude stood out among the neurosurgeons the Buonicontis consulted after Marc suffered a paralyzing spinal cord injury while making a tackle for The Citadel in 1985.
"It was a real big difference under Dr. Green's care," Marc Buoniconti said. "He made it sound, through his actions and other people under his care, that living with a spinal cord injury, while an inconvenience, you can still live a full and productive life."
Among Green's other surgical patients is Bills owner Ralph Wilson. In 1997, Green operated to relieve a narrowing around the spine that was pinching off the nerves to Wilson's feet.
"What Dr. Green is, he's more of a caretaker," Wilson said Wednesday. "He does it because he wants to help people who can't help themselves."
Wilson also has contributed to Green's spinal cord injury research and Project Medishare, a Haitian charity Green co-founded and describes as an "invasion" of housing, food, electricity and medical supplies.
Green first began working with paraplegics while attending medical school at Indiana University. Paralyzed veterans volunteered in the spinal cord injury research laboratory where he worked.
"I said to myself, if there's a group of these people that are so courageous and so selfless, somebody ought to carry their damn banner and do something about," Green said. "That's 1965. I was 20 years old. I said I was going to commit my career to curing paralysis."
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Associated Press writer Sarah Larimer contributed to this report.
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On the Net:
Miami Project to Cure Paralysis: http://www.themiamiproject.org/
Bush signs drug safety bill into law
Thu, 27 Sep 2007 19:39:36 GMTBy ANDREW BRIDGES, Associated Press Writer
WASHINGTON - The Food and Drug Administration on Thursday gained broad new powers to ensure the safety of prescription drugs used by millions of Americans under a bill President Bush signed into law.
At its core, the new law renews for five years programs to collect fees from drug and medical device manufacturers. The industry money accounts for about one-quarter of the FDA's overall budget, defraying the cost of reviewing products that need agency approval.
Members of Congress, acting in the wake of the withdrawal of the painkiller Vioxx three years ago, seized on the bipartisan legislation as a vehicle to reform the FDA's handling of drug safety.
In part, the legislation shifts more of the FDA's attention from experimental drugs pending approval to those already are on the market, and gives the agency more power to act when worrisome problems emerge.
"It really represents an important addition to the FDA's authority," said FDA commissioner Dr. Andrew von Eschenbach.
It gives the FDA the power both to require drug companies to do further study on the safety of medicines, if needed, and to mandate new label warnings when problems do appear. The FDA also gains the ability to fine companies to ensure compliance with those two new authorities. The legislation further requires companies to publicly release results of all clinical trials that show how well their approved drugs performed. Not yet approved drugs could be subject to the requirement later.
Still, how the Food and Drug Administration Amendments Act of 2007 will change the agency remained unclear, beyond the expected hiring of several hundred new employees.
The FDA was still reviewing the 156-page law and its roughly 200 specific provisions, many with timelines, before deciding how to implement them. The fine-print list of actions the FDA must take runs more than 10 pages, said Randall Lutter, the agency's deputy commissioner for policy. The FDA may have to draft new regulations or guidelines — a process that can take years — to implement some of those provisions, Lutter said.
The legislation does spell out that the FDA will be able to fine drug companies for not completing follow-up studies on their drugs after they've won government approval. Those studies frequently remain undone, often leaving important safety questions unanswered.
The bill calls for drug companies to pay $393 million, and medical device makers $48 million, in various fees next year.
"The increased fees will allow the agency to expand drug safety monitoring, hire additional staff for post-market surveillance, and modernize its information technology systems," said Billy Tauzin, head of the Pharmaceutical Research and Manufacturers of America.
It also requires the FDA to step up its active surveillance for new safety issues with drugs. That system traditionally has been largely passive.
"We welcome the ability to really engage in how those products perform once they are out on the market," said Dr. Janet Woodcock, the FDA's deputy commissioner and chief medical officer, citing the use of data-mining techniques to sift through electronic medical databases for hints of problems.
The manufacturers of certain new drugs will have to draft for each one a so-called "Risk Evaluation and Mitigation Strategy" that can include medication guides distributed with each prescription to ensure the medicine's safe use.
Under the legislation, the FDA will set up a registry to log incidents where adulterated food could pose a health risk. The agency also will have to establish pet food ingredient and processing standards — a provision born of the massive dog and cat food recalls earlier this year.
"It strengthens safety rules for the wave of new miracle drugs coming on the market that Americans count on to protect their health. It brings needed reassurance to families that the food they feed their pets is safe," said Sen. Edward Kennedy, D-Mass.
All types of alcohol raise cancer risk
Thu, 27 Sep 2007 12:50:37 GMTBy MARIA CHENG, AP Medical Writer
BARCELONA, Spain - All types of alcohol — wine, beer or liquor — add equally to the risk of developing breast cancer in women, American researchers said Thursday.
"This is a hugely underestimated risk factor," said Dr. Patrick Maisonneuve, head of epidemiology at the European Institute of Oncology in Italy, who was not connected to the study.
"Women drinking wine because they think it is healthier than beer are wrong," he said. "It's about the amount of alcohol consumed, not the type."
Previous studies have shown a link between alcohol consumption and breast cancer, but there have been conflicting messages about whether different kinds of alcohol were more dangerous than others.
The researchers, led by Dr. Arthur Klatsky of the Kaiser Permanente Medical Care Program in Oakland, Calif., revealed their findings at a meeting of the European Cancer Organization in Barcelona.
Researchers analyzed the drinking habits of 70,033 women of various races and asked them questions during health exams between 1978 and 1985. By 2004, 2,829 of these women had been diagnosed with breast cancer.
Klatsky and his colleagues looked at which types of alcohol the women drank, as well as their total alcohol intake. They compared that to women who had less than one drink a day.
Researchers found no difference in the risk of developing breast cancer among women who drank wine, beer, or liquor. Compared with light drinkers — those who had less than one drink a day — women who had one or two drinks a day increased their risk of developing breast cancer by 10 percent. Women who had more than three drinks a day raised their risk by 30 percent.
"A 30 percent increased risk is not trivial," Klatsky said. "It provides more evidence for why heavy drinkers should quit or cut down."
Some experts said that people might be confused by suggestions that drinking red wine is healthy, since some studies have suggested that it protects against heart disease.
"None of these mechanisms have anything to do with breast cancer," Klatsky said. Though it is not entirely clear how alcohol contributes to breast cancer, some experts think it raises hormone levels in the blood to levels that could potentially cause cancer.
Still, doctors said that other factors, such as genetics, obesity, and age, were more important in raising the breast cancer risk than was alcohol consumption.
More public education may be needed. "Alcohol has had a lot of good publicity. People may not realize the risk they're taking when they have a few drinks," said Tim Key, of the Cancer Research UK Epidemiology Unit at Oxford. Key was not involved in the study.
According to data published in the British Journal of Cancer in 2002, 4 percent of all breast cancers — about 44,000 cases a year — in the United Kingdom are due to alcohol consumption.
Only a small proportion of women are thought to be heavy drinkers. But experts now say there is enough evidence to blame alcohol for breast cancer — and to start educating the public.
"Any alcohol consumption will raise your breast cancer risk," Key said. "Women don't have to abstain from alcohol entirely, but they need to be aware of the risks they're taking when they have a few too many drinks."
WalMart expands 364 drugs program
Thu, 27 Sep 2007 15:11:11 GMTBy MARCUS KABEL, AP Business Writer
Wal-Mart Stores Inc. is expanding its national $4 generic prescription drug program by about 10 percent, adding drugs for some new conditions.
The world's largest retailer said Thursday it has added drugs covering glaucoma, attention deficit disorder, attention deficit hyperactivity disorder, fungal infections and acne.
Two prescription birth control drugs and one fertility drug were added at $9, reflecting a higher cost that the company said could not be brought down further.
The Bentonville, Ark.-based retailer launched the $4 generics program late last year as it pushed a variety of health and environmental initiatives to counter political pressure led by union groups over its labor practices, including health insurance.
"We have taken what we do best, working with suppliers, driving costs out of the supply chain and passing those savings to our customers. Now we're applying that to health care," chief operating officer Bill Simon said on a conference call for reporters and analysts.
The increase adds about 30 prescriptions, made up of 14 drugs in various doses, to a list of 331 prescriptions and 143 drug compounds sold under the first phase introduced last year.
Critics including the National Community Pharmacists Association, which represents non-chain pharmacies that compete with Wal-Mart, have called the discounts a publicity stunt that covers only a fraction of the 8,700 generic prescription drugs approved by the Federal Drug Administration.
Analysts have said the main benefit for Wal-Mart was in drawing more shoppers into its stores who may come for prescriptions and then make purchases in other departments.
Wal-Mart has made the $4 plan, which covers 30 days worth of generic drugs, a central plank of its public relations effort and says the program has cut over $610 million in health care costs since it started. That figure is the difference between the old price it charged for the generics and the new price, times the number of prescriptions sold, Simon said.
Simon said Wal-Mart is not selling any of the $4 prescriptions at a loss. The generics are profitable, he said, without providing detailed figures.
Simon said the $4 generics under the first phase account for just under 40 percent of all prescriptions filled at Wal-Mart pharmacies. He projected that rate will climb to well over 40 percent with the new drugs.
Shares of Wal-Mart Stores rose 30 cents to $43.60 in morning trading Thursday.
Burkina Faso succeeds in reducing female genital mutilation
Thu, 27 Sep 2007 16:29:44 GMTOUAGADOUGOU - The west African nation of Burkina Faso has succeeded in nearly halving the prevalence of female genital mutilation in the ten years since it was banned, a government minister said Wednesday.
Burkina Faso banned the practice in 1996, and the following year it was estimated that its prevalence was roughly 80 percent.
Currently it is believed around 45 percent of girls are subjected to the procedure in the country overall, Social Action Minister Pascaline Tamini told AFP, with the practice nearly rooted out in the country's south but still widespread in the north.
She spoke after officials said four women had been arrested for subjecting a seven-year-old girl and a baby to the procedure.
The practice, which involves the full or partial removal of the clitoris, is still common in many parts of Africa and more than 100 million woman are believed to have been subjected to it in 28 African nations from Senegal to Somalia.
Human parasite genome reveals long past
Thu, 27 Sep 2007 21:21:18 GMTBy Julie Steenhuysen
CHICAGO - An icky parasite that is a major source of tummy trouble for young children and nature lovers appears to have been infecting mammals for a very long time, U.S. researchers said on Thursday.
Giardia lamblia is one of the most common human parasites in the United States, causing more than 20,000 intestinal infections each year.
A complete genetic sequence of this parasite now suggests it had ancestors reaching back more than a billion years.
&;We think it is deep in the evolutionary tree,&; said Hilary Morrison, of the Marine Biological Laboratory in Woods Hole, Massachusetts, whose study appears in the journal Science.
Giardia is a eukaryote, one of a diverse bunch of organisms made up of cells with a nucleus that contains genetic material. But Morrison believes its molecular machinery appears too simple to have evolved from more modern and complex eukaryotes.
&;It is about the size of a yeast genome, which was one of the earliest eukaryote genomes to be sequenced and has about 6,000 genes,&; Morrison said. In comparison, the genome of humans, who are also eukaryotes, contains about 20,000 genes.
She said Giardia lacks a number of proteins such as the structural protein myosin that should be present if it were modern eukaryote.
The evolutionary story of this parasite will likely become clearer as new genomes are sequenced, but the Giardia genome can offer more immediate insights in the search for more effective treatments for giardiasis.
BEAVER FEVER
Spread through oral-fecal contact, giardiasis often strikes children in day-care centers where diapers are changed. It can also infect swimmers who swallow contaminated water.
In the intestine, Giardia swims and feeds, causing gas, diarrhea and discomfort until it is finally expelled through the stool. The whole unpleasant affair can last anywhere from two to six weeks, but some people can have the infection without these symptoms.
In the environment, Giardia takes the form of an infectious cyst that can survive for weeks in water, soil, food and other surfaces.
Hikers drinking what they think to be pristine mountain water fall prey to this parasite. &;It's also known as beaver fever because animals can infect the water,&; Morrison said.
Many people need no treatment for giardiasis, but prescription drugs are available. &;The problem now is people are getting treatment resistance,&; Morrison said.
That is where the genome study should prove most useful.
&;By having the genome and knowing all the proteins in it, people who develop drugs can look at those and develop good candidates,&; she said.
