Study details effects of prostate cancer
Wed, 19 Mar 2008 21:06:39 GMTBy MIKE STOBBE, AP Medical Writer
ATLANTA - One of the first large quality-of-life studies on today's prostate cancer treatments suggests that for some men, it's a matter of picking your poison and facing potential sexual, urinary or other problems.
Of the choices studied — surgery, standard radiation, hormone therapy or radioactive seeds — the seeds seemed to carry a lower risk of several of these side effects.
Hormone therapy — when combined with radiation — had a big effect on men's vitality and sexuality. The radioactive pellets sometimes led to sexual problems too, but more often involved discomfort in urinating.
The research, published in Thursday's New England Journal of Medicine, doesn't address the cure rates of different treatments. Moreover, not every treatment is an option for every man. For example, radioactive pellets are generally used only in men with early-stage cancer that is slow-growing.
Nor does the study speak to decisions about whether to treat at all a slow-growing form of cancer that can take 10 or 20 years to become life-threatening.
An 80-year-old man may choose to avoid all treatment and the assorted complications. But for a man of, say, 50, the study provides some insight into the side effects of different options, said Dr. William Oh, a Harvard University prostate cancer specialist.
"We've just never had the data that put patients side-by-side like this before," said Oh, who was not involved in the study.
The researchers surveyed about 1,200 patients, as well as 625 wives, who were enrolled at nine U.S. hospitals from March 2003 to March 2006. Telephone surveys were done before treatment began and at two, six, 12 and 24 months afterward.
Nearly 300 of the men in the study underwent brachytherapy, which involved the implant of radioactive pellets in the prostate to kill cancer cells.
About 300 got more conventional radiation treatments beamed at a tumor. And nearly 600 had their prostate tumors surgically removed, with most of them undergoing nerve-sparing procedures intended to minimize the operation's effect on sexual performance.
About 90 got hormone therapy in addition to conventional radiation, and some got it in addition to brachytherapy. Hormone therapy, which suppresses testosterone production, is used to enhance radiation treatment and improve survival.
Although life-threatening side effects were rare, men in all the groups experienced, to varying degrees, problems with urinating, achieving erections and moving their bowels.
No procedure was clearly best or worst across the board.
The wives of about 13 percent of men who had brachytherapy said they were distressed by problems with their partner's erections one year after treatment. The spouses of about 22 percent of the men in the traditional radiation group and 44 percent in the surgery group reported the same concern.
Incontinence was most common in the surgery group, with about 15 percent reporting the problem a year or two after treatment. For both standard radiation and brachytherapy, the figures were around 6 to 10 percent.
But when other urinary problems were counted, too — including pain and increased frequency — the brachytherapy group looked worse. About 18 percent of men who underwent brachytherapy said they had moderate or worse distress from urinary problems one year after treatment, compared with 11 percent of those who had traditional radiation and 7 percent of those who underwent surgery.
Among the most common problems in the brachytherapy group were a burning sensation or other pain, weak urinary stream and a sense of not being able to empty the bladder.
Bowel problems, such as rectal pain and frequency of having to go to the bathroom, were similar in the brachytherapy and radiation groups at one year, and lower in the surgery group.
Men who had radiation reported the least energy and most depression a year after treatment.
The researchers also found that men who had hormone treatments in addition to traditional radiation had worse recovery of sexual function.
Researchers said the study was not designed to provide a head-to-head comparison between treatments, because not each treatment group was the same.
Younger men, white men and college graduates tended to choose surgery more often. Black men tended to favor traditional radiation. Men with the earliest-stage tumors tended to go for radioactive seeds.
Each man must make his own decision, based on his condition and concerns. But as he weighs particular treatments, this study can give a helpful look at the experiences of men who chose the same option, said study co-author Dr. John Wei, a University of Michigan urologist.
Men should use the study to spark conversations with their physicians about the side effects of different treatments, said Dr. Otis Brawley, national chief medical officer of the American Cancer Society.
Among the men who say they made the right treatment choice is S. Jordan Perlman of Cleveland.
Perlman, 82, for years ran a women's clothing store in Cleveland. He was diagnosed in 1998 with early-stage prostate cancer and chose radioactive seeds, partly out of concern about the impact of surgery on sexual function. He had discomfort sitting down after the seeds were implanted, and a little trouble with incontinence initially.
But those problems quickly ended, and he said he has remained vigorous and continues to take daily power walks.
"I was very lucky," he said.
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On the Net:
New England Journal: http://nejm.org
Contaminant found in heparin identified
Wed, 19 Mar 2008 17:17:23 GMTBy RANDOLPH E. SCHMID, AP Science Writer
WASHINGTON - U.S. health officials have identified a contaminant in batches of the blood thinner heparin associated with 19 deaths and are trying to determine how the chemical got into the drug.
The lots of heparin, whose key ingredient was imported from China, were recalled Feb. 28, and Food and Drug Administration officials said Wednesday that no new deaths have been reported since that time.
Dr. Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research, said the contaminant is oversulfated condroitin sulfate, a chemical that does not occur naturally.
Condroitin sulfate is a natural compound that occurs widely and is used as a dietary supplement but the oversulfated version has not been widely studied.
"We cannot rule in or out whether this was accidentally or deliberately introduced into the product," Woodcock said, "We are investigating how it got in."
The FDA has also initiated testing of imported heparin entering this country and Woodcock said the agency feels "doctors and patients now can be confident that the product on the market has been tested and is safe."
Condroitin sulfate is a compound in the same family as heparin, so preliminary testing did not identify it, Woodcock said. She said more exacting tests by the government and university researchers uncovered the contaminant.
Oversulfated condroitin sulfate would be less expensive to make than heparin, but FDA officials said they could not estimate the cost difference.
The lots of heparin linked to hundreds of allergic reactions were marketed by Baxter International and produced in China.
FDA said Chinese officials have been highly cooperative in the investigation.
The investigation comes just a year after melamine was identified as a contaminate in pet food from China. Officials said an agreement signed at that time with China helped smooth the way for this investigation.
FDA officials said they could not yet directly associate the oversulfated condroitin sulfate to the deaths and side effects, but it is the lone contaminant they have found in the product.
A different brand of heparin has also been recalled in Germany after 80 patients there became sick, and the German manufacturer said it was narrowing down the source of contamination to another Chinese supplier
On Wednesday, German regulators did not say if the contaminant they are investigating is oversulfated condroitin sulfate.
Heparin is derived from pig intestines, and China is the world's leading supplier. Tiny family-run workshops near slaughterhouses send batches of raw ingredients to larger middlemen before they reach factories.
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Associated Press business writers Matthew Perrone in Washington and Matt Moore in Germany contributed to this report.
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On the Net:
FDA: http://www.fda.gov
Gene may help explain stress disorder
Wed, 19 Mar 2008 03:06:49 GMTBy LINDSEY TANNER, AP Medical Writer
CHICAGO - Groundbreaking research suggests genes help explain why some people can recover from a traumatic event while others suffer post-traumatic stress disorder. Though preliminary, the study provides insight into a condition expected to strike increasing numbers of military veterans returning from combat in Iraq and Afghanistan, one health expert said.
Researchers found that specific variations in a stress-related gene appeared to be influenced by trauma at a young age — in this case child abuse. That interaction strongly increased the chances for adult survivors of abuse to develop signs of PTSD.
Among adult survivors of severe child abuse, those with the specific gene variations scored more than twice as high on a scale of post-traumatic stress, compared with those without the variations .
The worse the abuse, the stronger the risk in people with those gene variations.
The study of 900 adults is among the first to show that genes can be influenced by outside, nongenetic factors to trigger signs of PTSD. It is the largest of just two reports to show molecular evidence of a genetic influence on PTSD.
"We have known for over a decade, from twin studies, that genetic factors play a role in vulnerability to developing PTSD, but have had little success in identifying specific genetic variants that increase risk of the disorder," said Karestan Koenen, a Harvard psychologist doing similar research. She was not involved in the new study.
The results suggest that there are critical periods in childhood when the brain is vulnerable "to outside influences that can shape the developing stress-response system," said Emory University researcher and study co-author Dr. Kerry Ressler.
The study appears in Wednesday's Journal of the American Medical Association. Several study authors, including Ressler, reported having financial ties to makers of psychiatric drugs.
Ressler noted that there are probably many other gene variants that contribute to risks for PTSD, and others may be more strongly linked to the disorder than the ones the researchers focused on.
Still, he and outside experts said the study is important and that similar advances could lead to tests that will help identify who's most at risk. Treatments including psychotherapy and psychiatric drugs could be targeted to those people, Ressler said.
About a quarter of a million Americans will develop PTSD at some point in their lives after being victimized or witnessing violence or other traumatic events. Rates are much higher in war veterans and people living in high-crime areas.
Symptoms can develop long after the event and usually include recurrent terrifying recollections of the trauma. Sufferers often have debilitating anxiety, irritability, insomnia and other signs of stress.
Dr. Thomas Insel, director of the National Institute of Mental Health, said the study is particularly valuable for the light it sheds on military veterans, who are known to be vulnerable to PTSD.
He said the results help explain differences in how two people see the same roadside bomb blast. One simply experiences it as "a bad day but goes back and is able to function." The other later develops paralyzing stress symptoms.
"This could be quite a wave that will hit us over the months and years ahead," Insel said. His agency paid for the study.
Study participants were mostly low-income black adults, aged 40 on average, who sought non-psychiatric health care at a public hospital in Atlanta. They were asked about experiences in childhood and as adults and gave saliva samples that underwent genetic testing.
Almost 30 percent of participants reported having been sexually or physically abused as children. Most also had experienced trauma as adults, including rape, attacks with weapons and other violence.
Researchers focused on symptoms of PTSD rather than an actual diagnosis, and found that about 25 percent had stress symptoms severe enough to meet criteria for the disorder, Ressler said.
Childhood abuse and adult trauma each increased risks for PTSD symptoms in adulthood. But the most severe symptoms occurred in the 30 percent of child abuse survivors who had variations in the stress gene.
Researchers were not able to determine if the symptoms were reactions to the child abuse or to the more recent trauma — or both, said co-author Rebekah Bradley, also of Emory University.
The study is an important contribution to a growing body of research showing how severe abuse early in life can have profound, lasting effects, said Duke University psychiatry expert John Fairbank, co-director of the National Center for Child Traumatic Stress. He was not involved in the research.
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On the Net:
JAMA: http://jama.ama-assn.org
PTSD: http://www.nimh.nih.gov/health/topics/post-traumatic-stress-disorder-ptsd
