AstraZeneca says data support new Seroquel use
Anglo-Swedish drugmaker AstraZeneca Plc said on Friday new clinical trial data underlined the potential of its schizophrenia drug Seroquel as a treatment for bipolar disorder, a form of manic depression.
Europe's third-biggest drugmaker said it planned to file for a U.S. license extension for Seroquel to treat depressive episodes associated with bipolar disorder around the year-end.
Results of an 8-week study called BOLDER II showed patients taking Seroquel achieved a statistically significant reduction in levels of bipolar depression compared with placebo, AstraZeneca said in a statement.
The firm said bipolar disorder affects about 3-4 percent of the adult population and is the sixth leading cause of disability in the world.
Seroquel made around $1.3 billion of sales in the first half of this year.
AstraZeneca shares closed at 25.81 pounds on Thursday, valuing the business at about 41 billion pounds.
Diuretics Can Help Control Blood Pressure
Two low-cost alternative drugs -- amiloride and spironolactone -- may help patients who still have high blood pressure despite taking standard hypertension drugs, an Indiana University School of Medicine study has found.
Amiloride and spironolactone are diuretics (water pills) that have been available for many years but are often overlooked by doctors, the researchers noted. The drugs work by limiting the amount of sodium the kidneys reabsorb or take back into the body during the process of producing urine.
This study included 98 black Americans with high blood pressure. Some were given either amiloride or spironolactone, some were given both drugs, and some were given a placebo. All of the patients continued to take their standard medications to treat high blood pressure, also known as hypertension.
On average, patients taking the drugs separately or together showed significant blood pressure declines. The findings were published in the September issue of the journal Hypertension.
"The kidneys do an incredible job of holding on to sodium, which was important to the survival of our early ancestors who lived in a salt-poor world, but today there's so much salt in the food we eat that the kidneys end up holding onto too much sodium," and that can lead to high blood pressure, researcher Dr. Howard Pratt said in a prepared statement.
By limiting the amount of sodium that's retained in the kidneys, amiloride and spironolactone help lower blood pressure, Pratt said.
He noted that doctors treating patients who don't respond to standard therapy for high blood pressure often prescribe higher doses of the medicine already being used or add a new blood pressure drug that could be expensive and often is also ineffective.
The findings of this and other studies may convince doctors to try amiloride or spironolactone alternatives instead, Pratt said.
New Diabetes Drug Poses Danger to Patients, Cardiologists Say
A diabetes drug about to be approved by the U.S. Food and Drug Administration doubles the risk of death, heart attack and stroke, and it should not be approved until its safety is further explored, a team of prominent cardiologists reports.
"I wanted our actions to put a roadblock in a rapid approval that I thought would present a danger to patients. I'm trying to avoid another Vioxx," said study author Dr. Steven Nissen, medical director of the Cleveland Clinic Cardiovascular Coordinating Center. "In the manuscript, I have clearly requested that a large outcomes trial be done before approval, and I believe that the FDA will see that that's a wise thing to do."
Ironically, Nissen and study co-author Dr. Eric Topol were the ones who first raised safety issues about Vioxx back in 2001. "Nobody listened then because it was already on the market being advertised," Nissen said. "I saw this as a potential to stop a potentially risky drug before it got out of the gate."
His study and an accompanying editorial were released Thursday by the Journal of the American Medical Association because of the public health implications.
The medication, muraglitazar, is one of a class of drugs called dual peroxisome proliferator-activated receptors (PPARs), which affect both cholesterol levels and blood sugar levels in diabetic patients. Many people with diabetes suffer from both problems, and this drug was earlier hailed as a way to kill two big birds with one stone or one pill, as it were.
Two other drugs in the class, pioglitazone and rosiglitazone, are already on the market. A third, troglitazone, was withdrawn due to liver toxicity problems.
Muraglitazar was developed by Bristol-Meyers Squibb, which has signed a marketing agreement with Merck.
Briefing documents on muraglitazar were made available to the public on Sept. 8, and were reviewed by an FDA advisory committee a day later. The committee voted 8-to-1 in favor of approving the drug to control blood sugar in patients with type 2 diabetes.
On Oct. 18, the FDA issued an "approvable letter" for the drug, meaning that muraglitazar could be approved once the agency received and reviewed additional information.
Nissen said he accessed the briefing documents as soon as they became available on Sept. 8, and saw "what appeared to be a very strong signal for excess cardiovascular events." He immediately set about doing an analysis, writing a manuscript and submitting it for publication. A process that usually takes months or even years was completed in only slightly more than a month.
"I treated this as a public health emergency," Nissen said. "A drug that had an 8-to-1 vote in favor of approval and that could any day be approved by the FDA to be used by any of 18 million Americans with type 2 diabetes was, by my analysis, doubling of risk of serious irrevocable cardiovascular events like death, heart attacks and stroke. I dropped everything."
Nissen, Topol and biostatistician Kathy Wolski, all of the Cleveland Clinic, analyzed the information that had been made available by the FDA. In all, it included data from five clinical trials that involved 3,725 people randomized to receive either muraglitazar, pioglitazone or a placebo, either alone or in combination with other diabetes drugs. Participants took the drugs from 24 to 104 weeks, considered to be a relatively short period of time.
In the muraglitazar group, 1.47 percent of participants experienced death, heart attack or stroke, compared with 0.67 percent of those in the two other groups, meaning that those taking muraglitazar had a 2.23 times higher risk of one of these outcomes.
When congestive heart failure and mini-strokes were added to the analysis, the combined incidence of these events was 2.62 times higher in the muraglitazar group.
Because people with type 2 diabetes already have a high incidence of cardiovascular disease (it represents the cause of death in about 80 percent of these patients), drugs need to be carefully screened in terms of heart attack and stroke risk, the researchers noted.
The accompanying editorial also pointed out numerous methodological issues in the original studies that may have skewed the results. For one thing, those researchers included doses of 2.5 milligrams or less, doses that were significantly lower than the 5-milligram dose for which FDA approval is being sought. Overall, this made the drug look safer. The populations studied also appeared to be healthier than the general diabetic population. In addition, an increased incidence of cancer was seen and needs to be studied further. Last but not least, the editorial stated, the researchers limited peer-review publication of the results before going for FDA approval "so as to minimize scrutiny and debate."
Nissen acknowledged the studies yielded a relatively small number of actual adverse events, which does introduce "some uncertainty" into the equation.
When any drug is developed and brought to market, benefits need to be weighed carefully against risks. In this case, the researchers stated, the efficacy is not so dramatic that it overrules safety concerns.
"The drug's benefits are simply to lower blood sugar, something that is not a morbidity and mortality advantage, so my view is that safety has to be very clear before you're going to approve it, and we have 15 other drugs to lower blood sugar," Nissen said. "In my view, it didn't make any sense to approve the drug."
In response to the journal article, Merck & Co. issued a formal statement Thursday that said, "Following the receipt of an approvable letter for Pargluva (muraglitazar) earlier this week, Bristol-Myers Squibb and Merck said that we are eager to begin discussions with the FDA to address more fully the cardiovascular safety profile of the compound and to determine what additional information may be necessary. Pargluva was extensively studied and all available data were reported to the FDA."
The new findings points up now familiar problems with the U.S. drug approval and regulatory process.
"I felt that that committee that voted 8-to-1 was simply missing the boat," said Nissen, who has served on FDA advisory committees. "I didn't think they connected the dots."
Problems on the committee reflect problems at the FDA, Nissen added.
"There are some big problems," he acknowledged. "The FDA is under-funded. Given all the things that seem to get money in the United States, the FDA is not pork. It is protecting the public health, and it is under-funded and under-supported, and getting good advisory panels is hard."
The question now, the editorial points out, "is which safety message will the FDA buy?"
"We are fully aware of the results of the Pargluva clinical trials, both with regard to safety and efficacy, and likewise appreciate the need for careful assessment of risk vs. benefit for all drugs, particularly those indicated for long-term, preventive therapy," said FDA spokeswoman Crystal Rice. "The application is still pending before the agency and, as such, we can't comment further at this point."
"While we cannot specifically discuss this particular drug further, the FDA has made significant investments of resources and expertise in developing fundamentally better methods for identifying and monitoring cardiovascular safety issues with all drugs," she added.
Gene That Helps Control Heartbeat Found
Researchers have identified a gene that plays an important role in making sure the heart beats properly -- a discovery that could cast light on the abnormal heartbeats called arrhythmias that often lead to major cardiac problems.
It's a complicated business that centers on the tiny channels through which potassium pours into the heart, explained Benoit G. Bruneau, an assistant professor of molecular and medical genetics at the University of Toronto, and lead author of a paper about the finding in the Oct. 21 issue of Cell.
"The main role of potassium channels is to help the heart relax after each heartbeat," Bruneau said. "But potassium channels aren't expressed the same throughout the heart. There is a slope of density, with greater density of the channels on the outside of the heart. This gradient coordinates the relaxation of the heart," he explained.
"When this gene we discovered is not present, the gradient disappears. This causes a higher propensity for arrhythmias," he said.
The discovery was made in mice that were genetically engineered to lack the gene, which the researchers have named Irx5. "What we've shown is that taking out the gene flattens the gradient," Bruneau said.
Mice are admittedly very different from humans, but the same effect has been seen in dogs, "which are very similar to humans," he said. "When we looked at dogs' hearts for the gradient effect of Irx5, indeed it was present."
Other researchers now are looking for the same effect in humans, Bruneau added.
If the human work is successful, "right now the clinical applications as far as treatment is concerned are not obvious," Bruneau said. "But as far as understanding how arrhythmias happen, this defines an important pathway, so scientists and drug companies can use it. It is a very good starting point to develop therapy. We know it might be amenable to some kind of drug treatment."
One possible therapy would be development of drugs that open and close ion channels, he said. "Another would be to modify the genetic pathway," Bruneau added.
Another possibility is that mutations in the Irx5 genes in humans can cause arrhythmias. "That is something we are investigating as well," Bruneau said.
One specific syndrome, called "short QT," which causes very severe arrhythmias and is inherited, is a leading possibility. "It resembles what we have seen in the mice," Bruneau said.
Protein 'Pump' May Aid in Alzheimer's Prevention
A protein well known to scientists appears to clear the brain of amyloid beta, the main component of the plaques that are found in Alzheimer's patients, according to a new study with mice.
The protein, P-glycoprotein (Pgp), has long been known to obstruct chemotherapy drugs and other drugs used in treating brain disorders. But, by creating drugs that alter the natural levels of Pgp, it may be possible to prevent and treat Alzheimer's disease, the researchers suggest.
"We found a new way of getting amyloid out of the brain," said lead author John Cirrito, a postdoctorate research fellow at Washington University School of Medicine in St. Louis. "Now there are avenues we can explore to try to find a treatment. Anything you can do to prevent amyloid beta from being produced or helping get it cleared is good."
The study findings appear Oct. 20 in the online edition of the Journal of Clinical Investigation.
Pgp is one of several molecular transporters that form the blood-brain barrier, a layer of cells that limits the ability of many types of molecules -- including many drugs -- to enter the brain through the circulatory system, Cirrito said. "In the blood-brain barrier, it normally acts to keep molecules out of the brain," he explained, adding the protein actually pumps molecules out of brain cells.
Earlier research had hinted that Pgp could also transport amyloid beta molecules out of the brain, Cirrito said. "We basically show that if we inject amyloid beta into the brains of mice, Pgp can pump amyloid beta out of the brain," he said.
The researchers also found that when specially bred mice were given a Pgp inhibitor, amyloid beta levels significantly increased in just a few hours. Also, mice bred not to produce Pgp had higher levels of amyloid beta, compared with mice that were able to make the protein, the researchers said.
Cirrito believes these findings might be used one day to both treat and prevent Alzheimer's disease. "If you could enhance Pgp activity, perhaps you could get amyloid beta out of the brain and not let it build up," he said.
"There are drugs that are used to inhibit Pgp in cancer therapy to help chemotherapy drugs get into tumor cells," Cirrito said. "These inhibitors could make Alzheimer's worse," he noted. There are also common drugs such as statins that inhibit Pgp activity, Cirrito said. And there are compounds, such as St. John's wort, that enhance Pgp activity, he noted.
One expert thinks these findings add to the understanding of how amyloid beta plaque could be removed from the brain.
"This is an exciting paper, and it dovetails well with existing knowledge about the biology of Pgp," said Dr. Sam Gandy, chairman of the Medical and Scientific Advisory Council of the Alzheimer's Association, and director of the Farber Institute for Neurosciences at Thomas Jefferson University in Philadelphia.
There have been fewer studies about how amyloid beta can be removed from the brain than studies examining how it is generated, Grandy said. "But now we can add Pgp to the growing list of molecules that control amyloid beta catabolism," he said.
Grandy thinks this discovery might lead to new treatments for Alzheimer's. Some dietary substances or medications may block Pgp and increase the risk for Alzheimer's disease, while others may enhance the protein, he said.
"It might be possible to develop Pgp modulators that accelerate clearance of amyloid beta in a beneficial way," Gandy said.
Food Fact:
Why drink water?
Your body is 60% water -- and not drinking enough can wreak havoc from head to toe. Up to half of all Americans suffer chronic mild dehydration that can cause fatigue, headache, loss of appetite, dry eyes and mouth. As we age, thirst becomes a less sensitive indicator of dehydration, so don't wait until you're thirsty to grab a glass. If you work out, drink more during intense physical activity, when dehydration is a real threat -- your body rapidly loses water through sweat and vapor in exhaled air. A rapid water loss of 5% of body weight can reduce muscular work by 20 - 30%.
Fitness Tip of the day:
Be a road scholar.
It's easy to find out where you can work out on a business trip, if you know where to look online. Before you leave, go to a travel or city guide Web site for your destination and research the parks, community centers, tracks and fitness centers where you can get a little exercise. Nothing boosts your energy, creativity and effectiveness on the road like a workout. Bonus: Explore the local jogging paths, and you'll get a taste of city life you'll never find in a hotel or pitch meeting.
FAQ of the day:
What is "good" and "bad" cholesterol?
There are two kinds of cholesterol carriers in the blood: HDLs (high-density lipoproteins) and LDLs (low-density lipoproteins). They are also commonly referred to as "good" and "bad" cholesterol -- to remember which is which, think "H" for Healthy and "L" for Lousy. Another tip: Keep the bad LDLs "Low," because their cholesterol ends up in arterial plaques, while you want the good HDLs "High," because they carry cholesterol away from arteries. A desirable level for LDL cholesterol is less than 130 mg/dL. For HDL, a level below 40 mg/dL increases risk, while 60 mg/dL or higher protects against heart disease.
Friday, October 21, 2005
Thursday, October 20, 2005
Health Headlines - October 20
Herceptin 'Revolutionary' for Breast Cancer
Studies Confirm Survival Benefit When Drug Used Early
In May 2005, oncologists attending the annual meeting of the American Society of Clinical Oncology heard presentations about the breast cancer drug Herceptin (trastuzumab) that many considered a treatment breakthrough. Researchers had found that using Herceptin early in the course of breast cancer could cut recurrences in half and improve survival for women with a particularly aggressive form of the disease.
Now those studies have been published, giving doctors and patients more details about the advantages and side effects of this new treatment strategy. They appear in this week's issue of the New England Journal of Medicine and are again being hailed by experts.
"Clearly, the results reported in this issue of the journal are revolutionary," writes Gabriel Hortobagyi, MD, in an editorial discussing the findings. Hortobagyi is professor and chair of Breast Medical Oncology at the University of Texas M.D. Anderson Cancer Center in Houston and a noted expert in the field of breast cancer care. He was not involved in the studies.
The published reports justify the excitement generated by the presentations earlier this year, according to Len Lichtenfeld, MD, deputy chief medical officer for the American Cancer Society.
"There's always that nagging caution that maybe the results were premature, or that perhaps the data wasn't accurately analyzed, or that the study was not as well done as it seemed at the time," he said. "Experience has taught us that it is usually best to wait until the study is published in a peer-reviewed journal before accepting it as truly legitimate."
The newly published studies do not disappoint. "The editorial says the results are 'stunning' and I certainly agree," he said.
Thousands of Women Could Benefit
Herceptin is a monoclonal antibody, a targeted drug that only works in breast cancers that have too much of a protein called HER2/neu. About 15%-25% of breast cancers are HER2-positive. These cancers tend to grow quickly and do not respond as well to certain types of chemotherapy or to tamoxifen.
Until now, Herceptin has been used only in women whose breast cancer has returned after initial treatment or spread beyond the breast. These new reports, however, promise to change the standard of care for women with early-stage breast cancer that is HER2-positive.
"Our care of patients with HER2-positive breast cancer must change today," Hortobagyi writes.
Herceptin Given After Adjuvant Chemotherapy
The first report in the journal presents the results of the HERA trial, an international study that compared women who took Herceptin after adjuvant chemotherapy to women who had no further treatment after chemotherapy. All of the women had cancers that overexpressed the HER2/neu protein. The women had all received standard treatment with surgery and tamoxifen (if they had hormone-responsive tumors). Researchers excluded women whose cancers had already spread to the skin, chest wall, distant lymph nodes, or other parts of the body, as well as women with heart problems (including congestive heart failure, angina, unstable heart rhythms, and poorly controlled high blood pressure).
The researchers randomly assigned 1,694 women to take Herceptin for 1 year after finishing their chemotherapy. They were taken off the drug if they developed serious heart problems or other severe side effects. Another 1,693 women were assigned to get no further treatment after chemotherapy. (A third group of 1,694 women was assigned to 2 years of Herceptin after chemotherapy, but results are not yet complete for these subjects.)
After 1 year of treatment, Herceptin cut the risk of breast cancer returning almost in half. Just 127 women (7.5%) in the Herceptin group had a relapse, developed a second cancer, or died, compared to 220 women (13%) in the chemotherapy-only group. The researchers calculated that Herceptin improved disease-free survival by 8.4% after 2 years -- a very large amount for a chemotherapy trial, especially after such a short period of time. The type of chemotherapy drug given (various ones were allowed) did not appear to make a difference in outcome.
"This is probably the biggest evidence of a treatment effect I've ever seen in oncology. It's quite remarkable," said Richard Gelber, PhD, of the Dana-Farber Cancer Institute in Boston. Gelber led the statistical analysis on the study.
The researchers did not find a difference in overall survival between the groups of women, but they say one could become evident as the trial continues. The women will be followed through 2008.
There were more side effects in the women who got Herceptin than the women who received no further treatment: 132 women (7.9%) in the Herceptin group had a serious side effect compared to just 75 (4.4%) in the other group. Women taking Herceptin were more likely to develop congestive heart failure and other heart problems -- known side effects of the drug. Still, just 0.5% of women on Herceptin developed severe heart problems. The researchers acknowledge, though, that longer follow-up may show that more heart problems develop down the line.
Herceptin Given Along With Adjuvant Chemotherapy
The second report in the journal describes the combined results of 2 studies (National Surgical Adjuvant Breast and Bowel Project trial B-31 and North Central Cancer Treatment Group trial N9831), which compared women who got Herceptin at the same time as chemotherapy to women who took only chemotherapy. As in the HERA trial, the women in these studies had HER2/neu-positive cancers. They had already received standard treatment with surgery and radiation (if necessary) and with tamoxifen or an aromatase inhibitor (if their tumors were hormone-receptor positive). Women with metastatic cancer or heart problems were excluded. The NEJM report includes results from 2,043 women enrolled in the B-31 trial and 1,633 women enrolled in the N9831 trial.
All the women were given chemotherapy with doxorubicin and cyclophosphamide, followed by paclitaxel. Some of the women in each study were randomly assigned to take Herceptin along with the paclitaxel; they continued taking Herceptin for 1 year.
As in the HERA trial, Herceptin cut the risk of recurrences almost in half. After about 2 years of follow-up, 133 women on Herceptin had had a relapse, second cancer, or had died, compared to 261 women in the group that got only chemotherapy. After about 3 years, 87% of Herceptin patients were still alive and cancer-free, compared to 75% of women who got only chemotherapy. At 4 years, more than 85% of the women on Herceptin were still alive and cancer-free, compared to 67% of women in the chemotherapy-only group. The difference was so significant that the trials were stopped early.
Unlike the HERA trial, researchers conducting these 2 studies did see a significant difference in overall survival between women who took Herceptin and those who did not. More than 91% of patients on Herceptin survived 4 years, compared to about 87% of patients on chemotherapy alone. Overall, 92 women in the chemotherapy-only group died, and 62 women who took Herceptin died.
Heart problems, especially congestive heart failure, were also a problem for women who took Herceptin in these studies. In the B-31 trial, just 4 women (0.8%) who got chemotherapy alone developed congestive heart failure after 3 years, while 31 women (4.1%) in the Herceptin group developed this side effect. In N9831, none of the women on chemotherapy alone developed heart failure, but 20 Herceptin patients (2.9%) did.
Questions Remain Over Side Effects, Scheduling
More research must be done to best determine how to deal with the heart problems that Herceptin can cause, Hortobagyi said. Doctors need to learn how serious these problems are, if they can be reversed, and how long they must be treated.
Researchers also need to find out if it's better to give Herceptin at the same time as chemotherapy, or if it should be taken afterward. From the new reports, it appears that giving Herceptin after chemotherapy may be less damaging to the heart, Hortobagyi writes, but it's not clear whether one of these schedules is more effective at controlling cancer than the other.
Another issue, raised in a second editorial, is how to deal with resistance to Herceptin. Doctors have seen drug resistance develop in some patients, but they don't yet understand how it happens -- or how to stop it.
Exercise can ward off osteoporosis: report
Doctors used to think a good, calcium-rich diet was enough to avoid the crippling bone disease known as osteoporosis, but it is now clear that regular exercise is just as important, a new report released on Thursday said.
"One of the best ways to build and maintain healthy bones is through exercise," Dr Helmut Minne, a leading German osteopath and board member of the International Osteoporosis Foundation (IOF) said in the IOF's new report, "Move it or Lose it."
The IOF is a non-governmental organization of scientific experts and national societies which focus on the disease.
Osteoporosis, in which the bones become fragile and break easily, is one of the world's most common chronic diseases. It strikes one in three women over 50 worldwide -- more than breast cancer -- and one in five men -- more than prostate cancer, the the report said.
Because bone is living tissue which renews itself continuously, it requires regular stimulation from physical activity. Like muscles, bones should be used regularly or they will deteriorate, the report said.
People develop a peak bone mass during their adulthood, which eventually begins to decline.
"Physicians once thought that reaching this peak depended primarily on diet, including sufficient calcium intake and exposure to vitamin D in the skin," the report said.
"But recent studies have (shown) that in laying down the bone foundation that will serve for a lifetime, exercise is just as important as diet," it added.
The report, which was released in Berlin for "International Osteoporosis Day" on Thursday, says women who sit for more than nine hours a day are 50 percent more likely to have a hip fracture than those who sit less than six hours a day.
Exercising the back during middle-age can help prevent vertebrae from weakening or fracturing when people get older, the report said.
Not all types of exercise stimulate bone mass growth. Weight-bearing and high-impact exercise like running or dancing are best for stimulating bone formation.
"Exercise builds strong muscles, which in turn builds strong bones," Minne said. "Exercise also improves muscle control, balance and coordination, and reduces the risk of falling or suffering a fracture during a fall."
Plain soap just fine to kill germs: experts
Proper washing with regular soap and water works just fine to prevent the spread of germs and there is no clear evidence that antibacterial soaps, wipes and other products are any better, scientists told a U.S. advisory panel on Thursday.
U.S. Food and Drug Administration scientists and other experts said studies showed clear benefits from hand washing with plain soap, especially when people are taught when and how long to wash. Data on antibacterial soap was limited, they said.
"There is a lack of evidence that antiseptic soaps provide a benefit beyond plain soap in (the) community setting," said University of Michigan epidemiologist Allison Aiello.
The panel is weighing the risks of such products for consumers and whether the FDA should curb their use because they may help create drug-resistant bacteria.
The FDA, which has been grappling with the issue for more than 30 years, has yet to make a final decision on how to regulate such products, which face many issues similar to antibiotic drugs, but are available over-the-counter.
The agency is asking its advisers to recommend which consumers should use such products. It is also seeking advice on how to decide whether the soaps are effective and what risks it should consider in making its final rule.
"We're reexamining the risks to consumers," said FDA microbiologist Colleen Rogers.
The FDA, which usually follows its experts' advice, could take a variety of actions, from changing product labels to restricting marketing claims.
Soaps with bacterial-killing agents, such as Procter & Gamble Co.'s Safeguard and Henkel's Dial have been used for years are now common households products.
At issue are antibacterial products that include chemicals such as triclosan, which targets a certain enzyme that bacteria need to live and may linger in the environment. Bacteria can mutate to adapt to such chemicals, scientists say.
Doctors and other experts are concerned that excessive use of the products, like overuse of antibiotic drugs, will create bacteria-resistant "superbugs."
"Bacteria are not going to be destroyed. They've been here, they've seen dinosaurs come and go... so any attempt to sterilize our home is fraught with failure," said panelist Dr. Stuart Levy, a microbiologist at Tufts University in Boston.
Signs of drug-resistant bacteria in hospitals show the bugs are already adapting, he added.
Alcohol-based hand sanitizers, such as Pfizer Inc's Purell, caused less concern.
While one expert said data did not show they were better than plain soap, others said they do prevent the spread of germs. They also do not leave a residue that can trigger resistance.
Some doctors also worry antibacterial products can prevent children's immune system from properly developing by shielding them from bacteria needed to create natural resistance.
"This is still a controversial hypothesis," FDA's Rogers said.
Industry groups defended their antibacterial products as safe and necessary to protect consumers.
"The importance of controlling bacteria in the home is no different than in the professional setting," said Elizabeth Anderson, a lawyer for the Cosmetic, Toiletry and Fragrance Association. "We believe consumers should be assured that the products they are using are the most effective available."
The FDA has been sorting through the issue since 1972. Six years later it asked for more data on triclosan and again in 1994.
In the proposed rule issued more than a decade ago, the agency said such products were "practical for home use." It was not immediately clear when the agency would finalize its rule.
Bleach treatment neutralizes mold allergens
Treatment with household bleach reduces the allergy-inducing ability of mold spores, a new study shows.
Current efforts to remediate mold-contaminated buildings require replacement of contaminated materials, Dr. John W. Martyny of the National Jewish Medical and Research Center in Denver and colleagues note in the Journal of Allergy and Clinical immunology.
Also, the Environmental Protection Agency and many investigators argue that killing mold is not enough to reduce its allergenicity. Dilute sodium hypochlorite is known to kill mold, but it is not clear if it reduces mold's ability to produce allergic reactions.
Martyny and his team conducted the current study, funded by the Clorox Co., to determine if diluted bleach would destroy the ability of mold to produce an allergic response as well as kill the organism. Several studies, they point out, have found bleach can neutralize other types of household allergens, such as dust mite and cockroach proteins.
The researchers grew Aspergillus fumigatus on samples of three types of construction materials, as well as in solution. The samples and cultures were then treated with dilute bleach; Tilex, a cleaning product containing detergent and bleach; or water only.
The researchers then evaluated the number of spores using scanning electron microscopy and tested for viable mold. They also checked treated samples for antigens using ELISA and skin prick testing.
While bleach or Tilex treatment did not reduce the number of spores, surface allergens were no longer detectable in the treated samples. The surface of the spores treated with bleach or Tilex also showed changes in appearance. After adding bleach to the mold in aqueous solution, A. fumigatus allergens were no longer detectable by ELISA.
Skin prick tests found bleach treatment eliminated a response in five of eight mold-allergic individuals, while Tilex treatment inhibited response in seven of eight.
Some authorities on mold contamination, as well as some government agencies, recommend against treating fungi contaminated surfaces with bleach solutions, given the concern that substantial amounts of organic material may neutralize their disinfectant capacities, Martyny and colleagues note.
"On the basis of the results of our study, sodium hypochlorite-containing products should be reconsidered as one of the tools in the remediation of mold-contaminated buildings," the researchers conclude.
Roche Increasing Tamiflu Production
The manufacturer of a drug used to inhibit the effects of the bird flu virus will negotiate with generic drug companies to increase production, two U.S. senators announced Thursday.
Tamiflu is the most effective drug in treating bird flu.
Swiss-based Roche Holding AG will meet with four companies and maybe more in coming weeks, all in an effort to work out a licensing agreement that would allow other companies to produce Tamiflu, which is in great demand throughout the world.
"The bottleneck on Tamiflu has basically been broken," said Sen. Charles Schumer, D-N.Y., who announced the agreement along with Sen. Lindsey Graham, R-S.C.
The two senators met with George Abercrombie, head of Roche Pharmaceuticals in North America.
Generic manufacturers cannot legally sell the patented drug in the West and parts of Asia. Roche holds the patent, but it agreed to sub-license the production of Tamiflu to any company that can produce it in quantities large enough to help meet anticipated demand, Schumer said.
The determination of who gets the license will be made in cooperation with the U.S. government and other governments around the world, the senators said.
Health Tip: Stay Safe in Your Yard
Are you itching to get your yard in shape?
While the task may seem like child's play, some outdoor chores can be accidents waiting to happen.
St. John Ambulance Canada offers these safety tips:
Rake your lawn before you mow to ensure you've collected objects that could become projectiles under the mower blade.
Give your mower a tune up and perform a safety check before you start it.
Don't use electrical appliances in wet or damp areas.
Don't burn debris. There's always the risk of the fire getting out of control.
Health Tip: Blueberries Are Healthy
Blueberries are more than a tasty, decorative addition to a fruit plate.
One serving of blueberries contains a cup full of goodness, says Moses Taylor Hospital in Pennsylvania.
Here are the facts:
One cup of blueberries has 15 percent of your daily vitamin C requirement.
One cup contains 14 percent of required daily dietary fiber.
Blueberries have no cholesterol or fat.
They are low in calories.
Food Fact:
Water works.
Water has no calories, vitamins or minerals, but drinking plenty of it it can reduce your risk of disease. Drinking more than six glasses of water each day cuts the risk of developing bladder cancer in half. Some evidence suggests that staying well hydrated cuts the risk of colon and breast cancer, and lessens your chances of developing kidney stones -- even if you've already passed one or more. Women should aim for about nine cups of fluids daily. Men should shoot for 12 cups.
Fitness Tip of the day:
Lose 5 lbs. a year without dieting.
One simple change in your daily routine can help you burn extra calories and shed excess pounds. Anything you do every day to burn an extra 50 calories will save you the equivalent of five extra pounds over the course of a year. It can be as easy as parking your car a mere five minutes further from your office each morning and then walk briskly to your desk and back again after work. That's easy weight loss in just 10 minutes a day!
FAQ of the day:
Should I throw out my saltshaker?
If you're concerned about sodium, your saltshaker isn't your biggest concern. For starters, eat fewer processed foods, which tend to be high in salt, and more fruits and vegetables. But typically, rather than limiting sodium, blood pressure control depends more on maintaining a healthy weight and getting enough calcium, potassium (found in all fruits and vegetables) and magnesium (in green vegetables, whole grains and nuts). In the large DASH (Dietary Approaches to Stop Hypertension) study, more than 600 volunteers who ate 10 servings of fruits and vegetables a day, along with three servings of calcium-rich low-fat dairy foods, significantly reduced blood pressure across all age groups and ethnicities.
Studies Confirm Survival Benefit When Drug Used Early
In May 2005, oncologists attending the annual meeting of the American Society of Clinical Oncology heard presentations about the breast cancer drug Herceptin (trastuzumab) that many considered a treatment breakthrough. Researchers had found that using Herceptin early in the course of breast cancer could cut recurrences in half and improve survival for women with a particularly aggressive form of the disease.
Now those studies have been published, giving doctors and patients more details about the advantages and side effects of this new treatment strategy. They appear in this week's issue of the New England Journal of Medicine and are again being hailed by experts.
"Clearly, the results reported in this issue of the journal are revolutionary," writes Gabriel Hortobagyi, MD, in an editorial discussing the findings. Hortobagyi is professor and chair of Breast Medical Oncology at the University of Texas M.D. Anderson Cancer Center in Houston and a noted expert in the field of breast cancer care. He was not involved in the studies.
The published reports justify the excitement generated by the presentations earlier this year, according to Len Lichtenfeld, MD, deputy chief medical officer for the American Cancer Society.
"There's always that nagging caution that maybe the results were premature, or that perhaps the data wasn't accurately analyzed, or that the study was not as well done as it seemed at the time," he said. "Experience has taught us that it is usually best to wait until the study is published in a peer-reviewed journal before accepting it as truly legitimate."
The newly published studies do not disappoint. "The editorial says the results are 'stunning' and I certainly agree," he said.
Thousands of Women Could Benefit
Herceptin is a monoclonal antibody, a targeted drug that only works in breast cancers that have too much of a protein called HER2/neu. About 15%-25% of breast cancers are HER2-positive. These cancers tend to grow quickly and do not respond as well to certain types of chemotherapy or to tamoxifen.
Until now, Herceptin has been used only in women whose breast cancer has returned after initial treatment or spread beyond the breast. These new reports, however, promise to change the standard of care for women with early-stage breast cancer that is HER2-positive.
"Our care of patients with HER2-positive breast cancer must change today," Hortobagyi writes.
Herceptin Given After Adjuvant Chemotherapy
The first report in the journal presents the results of the HERA trial, an international study that compared women who took Herceptin after adjuvant chemotherapy to women who had no further treatment after chemotherapy. All of the women had cancers that overexpressed the HER2/neu protein. The women had all received standard treatment with surgery and tamoxifen (if they had hormone-responsive tumors). Researchers excluded women whose cancers had already spread to the skin, chest wall, distant lymph nodes, or other parts of the body, as well as women with heart problems (including congestive heart failure, angina, unstable heart rhythms, and poorly controlled high blood pressure).
The researchers randomly assigned 1,694 women to take Herceptin for 1 year after finishing their chemotherapy. They were taken off the drug if they developed serious heart problems or other severe side effects. Another 1,693 women were assigned to get no further treatment after chemotherapy. (A third group of 1,694 women was assigned to 2 years of Herceptin after chemotherapy, but results are not yet complete for these subjects.)
After 1 year of treatment, Herceptin cut the risk of breast cancer returning almost in half. Just 127 women (7.5%) in the Herceptin group had a relapse, developed a second cancer, or died, compared to 220 women (13%) in the chemotherapy-only group. The researchers calculated that Herceptin improved disease-free survival by 8.4% after 2 years -- a very large amount for a chemotherapy trial, especially after such a short period of time. The type of chemotherapy drug given (various ones were allowed) did not appear to make a difference in outcome.
"This is probably the biggest evidence of a treatment effect I've ever seen in oncology. It's quite remarkable," said Richard Gelber, PhD, of the Dana-Farber Cancer Institute in Boston. Gelber led the statistical analysis on the study.
The researchers did not find a difference in overall survival between the groups of women, but they say one could become evident as the trial continues. The women will be followed through 2008.
There were more side effects in the women who got Herceptin than the women who received no further treatment: 132 women (7.9%) in the Herceptin group had a serious side effect compared to just 75 (4.4%) in the other group. Women taking Herceptin were more likely to develop congestive heart failure and other heart problems -- known side effects of the drug. Still, just 0.5% of women on Herceptin developed severe heart problems. The researchers acknowledge, though, that longer follow-up may show that more heart problems develop down the line.
Herceptin Given Along With Adjuvant Chemotherapy
The second report in the journal describes the combined results of 2 studies (National Surgical Adjuvant Breast and Bowel Project trial B-31 and North Central Cancer Treatment Group trial N9831), which compared women who got Herceptin at the same time as chemotherapy to women who took only chemotherapy. As in the HERA trial, the women in these studies had HER2/neu-positive cancers. They had already received standard treatment with surgery and radiation (if necessary) and with tamoxifen or an aromatase inhibitor (if their tumors were hormone-receptor positive). Women with metastatic cancer or heart problems were excluded. The NEJM report includes results from 2,043 women enrolled in the B-31 trial and 1,633 women enrolled in the N9831 trial.
All the women were given chemotherapy with doxorubicin and cyclophosphamide, followed by paclitaxel. Some of the women in each study were randomly assigned to take Herceptin along with the paclitaxel; they continued taking Herceptin for 1 year.
As in the HERA trial, Herceptin cut the risk of recurrences almost in half. After about 2 years of follow-up, 133 women on Herceptin had had a relapse, second cancer, or had died, compared to 261 women in the group that got only chemotherapy. After about 3 years, 87% of Herceptin patients were still alive and cancer-free, compared to 75% of women who got only chemotherapy. At 4 years, more than 85% of the women on Herceptin were still alive and cancer-free, compared to 67% of women in the chemotherapy-only group. The difference was so significant that the trials were stopped early.
Unlike the HERA trial, researchers conducting these 2 studies did see a significant difference in overall survival between women who took Herceptin and those who did not. More than 91% of patients on Herceptin survived 4 years, compared to about 87% of patients on chemotherapy alone. Overall, 92 women in the chemotherapy-only group died, and 62 women who took Herceptin died.
Heart problems, especially congestive heart failure, were also a problem for women who took Herceptin in these studies. In the B-31 trial, just 4 women (0.8%) who got chemotherapy alone developed congestive heart failure after 3 years, while 31 women (4.1%) in the Herceptin group developed this side effect. In N9831, none of the women on chemotherapy alone developed heart failure, but 20 Herceptin patients (2.9%) did.
Questions Remain Over Side Effects, Scheduling
More research must be done to best determine how to deal with the heart problems that Herceptin can cause, Hortobagyi said. Doctors need to learn how serious these problems are, if they can be reversed, and how long they must be treated.
Researchers also need to find out if it's better to give Herceptin at the same time as chemotherapy, or if it should be taken afterward. From the new reports, it appears that giving Herceptin after chemotherapy may be less damaging to the heart, Hortobagyi writes, but it's not clear whether one of these schedules is more effective at controlling cancer than the other.
Another issue, raised in a second editorial, is how to deal with resistance to Herceptin. Doctors have seen drug resistance develop in some patients, but they don't yet understand how it happens -- or how to stop it.
Exercise can ward off osteoporosis: report
Doctors used to think a good, calcium-rich diet was enough to avoid the crippling bone disease known as osteoporosis, but it is now clear that regular exercise is just as important, a new report released on Thursday said.
"One of the best ways to build and maintain healthy bones is through exercise," Dr Helmut Minne, a leading German osteopath and board member of the International Osteoporosis Foundation (IOF) said in the IOF's new report, "Move it or Lose it."
The IOF is a non-governmental organization of scientific experts and national societies which focus on the disease.
Osteoporosis, in which the bones become fragile and break easily, is one of the world's most common chronic diseases. It strikes one in three women over 50 worldwide -- more than breast cancer -- and one in five men -- more than prostate cancer, the the report said.
Because bone is living tissue which renews itself continuously, it requires regular stimulation from physical activity. Like muscles, bones should be used regularly or they will deteriorate, the report said.
People develop a peak bone mass during their adulthood, which eventually begins to decline.
"Physicians once thought that reaching this peak depended primarily on diet, including sufficient calcium intake and exposure to vitamin D in the skin," the report said.
"But recent studies have (shown) that in laying down the bone foundation that will serve for a lifetime, exercise is just as important as diet," it added.
The report, which was released in Berlin for "International Osteoporosis Day" on Thursday, says women who sit for more than nine hours a day are 50 percent more likely to have a hip fracture than those who sit less than six hours a day.
Exercising the back during middle-age can help prevent vertebrae from weakening or fracturing when people get older, the report said.
Not all types of exercise stimulate bone mass growth. Weight-bearing and high-impact exercise like running or dancing are best for stimulating bone formation.
"Exercise builds strong muscles, which in turn builds strong bones," Minne said. "Exercise also improves muscle control, balance and coordination, and reduces the risk of falling or suffering a fracture during a fall."
Plain soap just fine to kill germs: experts
Proper washing with regular soap and water works just fine to prevent the spread of germs and there is no clear evidence that antibacterial soaps, wipes and other products are any better, scientists told a U.S. advisory panel on Thursday.
U.S. Food and Drug Administration scientists and other experts said studies showed clear benefits from hand washing with plain soap, especially when people are taught when and how long to wash. Data on antibacterial soap was limited, they said.
"There is a lack of evidence that antiseptic soaps provide a benefit beyond plain soap in (the) community setting," said University of Michigan epidemiologist Allison Aiello.
The panel is weighing the risks of such products for consumers and whether the FDA should curb their use because they may help create drug-resistant bacteria.
The FDA, which has been grappling with the issue for more than 30 years, has yet to make a final decision on how to regulate such products, which face many issues similar to antibiotic drugs, but are available over-the-counter.
The agency is asking its advisers to recommend which consumers should use such products. It is also seeking advice on how to decide whether the soaps are effective and what risks it should consider in making its final rule.
"We're reexamining the risks to consumers," said FDA microbiologist Colleen Rogers.
The FDA, which usually follows its experts' advice, could take a variety of actions, from changing product labels to restricting marketing claims.
Soaps with bacterial-killing agents, such as Procter & Gamble Co.'s Safeguard and Henkel's Dial have been used for years are now common households products.
At issue are antibacterial products that include chemicals such as triclosan, which targets a certain enzyme that bacteria need to live and may linger in the environment. Bacteria can mutate to adapt to such chemicals, scientists say.
Doctors and other experts are concerned that excessive use of the products, like overuse of antibiotic drugs, will create bacteria-resistant "superbugs."
"Bacteria are not going to be destroyed. They've been here, they've seen dinosaurs come and go... so any attempt to sterilize our home is fraught with failure," said panelist Dr. Stuart Levy, a microbiologist at Tufts University in Boston.
Signs of drug-resistant bacteria in hospitals show the bugs are already adapting, he added.
Alcohol-based hand sanitizers, such as Pfizer Inc's Purell, caused less concern.
While one expert said data did not show they were better than plain soap, others said they do prevent the spread of germs. They also do not leave a residue that can trigger resistance.
Some doctors also worry antibacterial products can prevent children's immune system from properly developing by shielding them from bacteria needed to create natural resistance.
"This is still a controversial hypothesis," FDA's Rogers said.
Industry groups defended their antibacterial products as safe and necessary to protect consumers.
"The importance of controlling bacteria in the home is no different than in the professional setting," said Elizabeth Anderson, a lawyer for the Cosmetic, Toiletry and Fragrance Association. "We believe consumers should be assured that the products they are using are the most effective available."
The FDA has been sorting through the issue since 1972. Six years later it asked for more data on triclosan and again in 1994.
In the proposed rule issued more than a decade ago, the agency said such products were "practical for home use." It was not immediately clear when the agency would finalize its rule.
Bleach treatment neutralizes mold allergens
Treatment with household bleach reduces the allergy-inducing ability of mold spores, a new study shows.
Current efforts to remediate mold-contaminated buildings require replacement of contaminated materials, Dr. John W. Martyny of the National Jewish Medical and Research Center in Denver and colleagues note in the Journal of Allergy and Clinical immunology.
Also, the Environmental Protection Agency and many investigators argue that killing mold is not enough to reduce its allergenicity. Dilute sodium hypochlorite is known to kill mold, but it is not clear if it reduces mold's ability to produce allergic reactions.
Martyny and his team conducted the current study, funded by the Clorox Co., to determine if diluted bleach would destroy the ability of mold to produce an allergic response as well as kill the organism. Several studies, they point out, have found bleach can neutralize other types of household allergens, such as dust mite and cockroach proteins.
The researchers grew Aspergillus fumigatus on samples of three types of construction materials, as well as in solution. The samples and cultures were then treated with dilute bleach; Tilex, a cleaning product containing detergent and bleach; or water only.
The researchers then evaluated the number of spores using scanning electron microscopy and tested for viable mold. They also checked treated samples for antigens using ELISA and skin prick testing.
While bleach or Tilex treatment did not reduce the number of spores, surface allergens were no longer detectable in the treated samples. The surface of the spores treated with bleach or Tilex also showed changes in appearance. After adding bleach to the mold in aqueous solution, A. fumigatus allergens were no longer detectable by ELISA.
Skin prick tests found bleach treatment eliminated a response in five of eight mold-allergic individuals, while Tilex treatment inhibited response in seven of eight.
Some authorities on mold contamination, as well as some government agencies, recommend against treating fungi contaminated surfaces with bleach solutions, given the concern that substantial amounts of organic material may neutralize their disinfectant capacities, Martyny and colleagues note.
"On the basis of the results of our study, sodium hypochlorite-containing products should be reconsidered as one of the tools in the remediation of mold-contaminated buildings," the researchers conclude.
Roche Increasing Tamiflu Production
The manufacturer of a drug used to inhibit the effects of the bird flu virus will negotiate with generic drug companies to increase production, two U.S. senators announced Thursday.
Tamiflu is the most effective drug in treating bird flu.
Swiss-based Roche Holding AG will meet with four companies and maybe more in coming weeks, all in an effort to work out a licensing agreement that would allow other companies to produce Tamiflu, which is in great demand throughout the world.
"The bottleneck on Tamiflu has basically been broken," said Sen. Charles Schumer, D-N.Y., who announced the agreement along with Sen. Lindsey Graham, R-S.C.
The two senators met with George Abercrombie, head of Roche Pharmaceuticals in North America.
Generic manufacturers cannot legally sell the patented drug in the West and parts of Asia. Roche holds the patent, but it agreed to sub-license the production of Tamiflu to any company that can produce it in quantities large enough to help meet anticipated demand, Schumer said.
The determination of who gets the license will be made in cooperation with the U.S. government and other governments around the world, the senators said.
Health Tip: Stay Safe in Your Yard
Are you itching to get your yard in shape?
While the task may seem like child's play, some outdoor chores can be accidents waiting to happen.
St. John Ambulance Canada offers these safety tips:
Rake your lawn before you mow to ensure you've collected objects that could become projectiles under the mower blade.
Give your mower a tune up and perform a safety check before you start it.
Don't use electrical appliances in wet or damp areas.
Don't burn debris. There's always the risk of the fire getting out of control.
Health Tip: Blueberries Are Healthy
Blueberries are more than a tasty, decorative addition to a fruit plate.
One serving of blueberries contains a cup full of goodness, says Moses Taylor Hospital in Pennsylvania.
Here are the facts:
One cup of blueberries has 15 percent of your daily vitamin C requirement.
One cup contains 14 percent of required daily dietary fiber.
Blueberries have no cholesterol or fat.
They are low in calories.
Food Fact:
Water works.
Water has no calories, vitamins or minerals, but drinking plenty of it it can reduce your risk of disease. Drinking more than six glasses of water each day cuts the risk of developing bladder cancer in half. Some evidence suggests that staying well hydrated cuts the risk of colon and breast cancer, and lessens your chances of developing kidney stones -- even if you've already passed one or more. Women should aim for about nine cups of fluids daily. Men should shoot for 12 cups.
Fitness Tip of the day:
Lose 5 lbs. a year without dieting.
One simple change in your daily routine can help you burn extra calories and shed excess pounds. Anything you do every day to burn an extra 50 calories will save you the equivalent of five extra pounds over the course of a year. It can be as easy as parking your car a mere five minutes further from your office each morning and then walk briskly to your desk and back again after work. That's easy weight loss in just 10 minutes a day!
FAQ of the day:
Should I throw out my saltshaker?
If you're concerned about sodium, your saltshaker isn't your biggest concern. For starters, eat fewer processed foods, which tend to be high in salt, and more fruits and vegetables. But typically, rather than limiting sodium, blood pressure control depends more on maintaining a healthy weight and getting enough calcium, potassium (found in all fruits and vegetables) and magnesium (in green vegetables, whole grains and nuts). In the large DASH (Dietary Approaches to Stop Hypertension) study, more than 600 volunteers who ate 10 servings of fruits and vegetables a day, along with three servings of calcium-rich low-fat dairy foods, significantly reduced blood pressure across all age groups and ethnicities.
Wednesday, October 19, 2005
Health Headlines - October 19
N.J. to Create Umbilical Cord Blood Bank
New Jersey plans to create a storage bank for umbilical cord blood to aid stem cell research, a program that state officials said will be the first of its kind in the nation.
Two nonprofit community blood banks will accept donations from healthy newborns made with parents' permission. Under the one-year pilot program, the blood will be used for treatment of illnesses, such as leukemia, or to conduct research.
An estimated $300,000 each will be given to the Elie Katz Umbilical Cord Blood Program at Community Blood Services in Paramus and the Coriell Institute for Medical Research in Camden, said Cynthia Kirchner, senior policy adviser to the state's public health commissioner.
The executive order was signed Tuesday by acting Gov. Richard J. Codey.
Stem cells are undeveloped cells found in embryos, umbilical cord blood, placentas and certain types of adult tissue. Most clinical use for cord blood is for cancer, said Rick Cohen, director of Coriell's stem cell program.
"A number of children literally owe their lives to the generous donations of those New Jersey moms and dads who chose to donate their children's cord blood to our public bank," Dennis Todd, president and chief executive officer for Community Blood Services.
The state health department plans a campaign to educate medical professionals and mothers about the donation program and its benefits.
"Basically, it's taking something that we would have discarded and process it so research can benefit," said Ellen Harris, program director for the bank in Camden.
Doping: BALCO head Conte sentenced in steroid scandal
A federal judge sentenced the head of the BALCO nutritional lab to four months in prison on Tuesday in a global sports steroid scandal that has badly damaged some of the top names in international sports.
District Judge Susan Illston also sentenced BALCO founder Victor Conte to four months home confinement and to two years of court supervision.
Conte, his deputy James Valente, and Greg Anderson, personal trainer to baseball superstar Barry Bonds, all admitted guilt to steroid distribution in July in plea deals that knocked out almost all of the original charges against them.
News two years ago that BALCO was the source of a previously undetectable steroid prompted an effort across many sports to clamp down on performance enhancing drugs.
The scandal sullied some of the top names in global sports and raised questions about achievements such as home run records by muscular baseball players.
Study: Obesity Surgery May Be Riskier
Obesity surgery, the most drastic way to lose weight, is far more than a cosmetic procedure and involves considerably higher risks of death than previously thought, new research suggests.
Some previous studies of people in their 30s to their 50s -— the most common ages for obesity surgery -— found death rates well under 1 percent. But among 35- to 44-year-olds in a new study, more than 5 percent of men and nearly 3 percent of women were dead within a year, and slightly higher rates were seen in patients 45 to 54.
Among patients 65 to 74, nearly 13 percent of men and about 6 percent of women died. In patients 75 and older, half of the men and 40 percent of the women died.
"The risk of death is much higher than has been reported," said University of Washington surgeon Dr. David Flum, lead author of the study of 16,155 Medicare patients. "It's a reality check for those patients who are considering these operations."
The study, involving patients who underwent obesity surgery between 1997 and 2002, appears in Wednesday's Journal of the American Medical Association.
The study offered no breakdown on causes of death, but obesity surgery's potentially deadly complications can include malnutrition, infection, and bowel and gallbladder problems. Also, surgery in general can be a deadly shock to the system, especially in older patients.
Dr. Neil Hutcher, president of the American Society for Bariatric Surgery, said that Medicare patients are probably sicker than the general U.S. population and that complication rates have declined as surgeons' expertise has increased.
But Flum said some previous research on the safety of obesity surgery consisted of "reports from the best surgeons reporting their best results," while the new study is more of a real-world look.
The American Society for Bariatric Surgery predicts obesity surgery will be performed more than 150,000 times this year in the United States. That is more than 10 times the number in 1998, according to a second JAMA study. The increase parallels a surge in the portion of U.S. adults who are at least 100 pounds overweight, from about 1 in 200 in 1986 to 1 in 50 in 2000, that study said.
Supporters of stomach-reduction surgery say the operation can save their lives by reducing the workload on the heart and lungs and eliminating related illnesses, such as diabetes and sleep apnea.
Flum said the new study suggests that in many cases, obesity surgery may not be right for an older person "who already has the burden of 60 years of obesity on their heart" and other organs.
Medicare covers obesity surgery if it is recommended to treat related conditions such as diabetes and heart problems. The government is considering whether to cover surgery to treat obesity alone.
Medicare is for younger Americans with disabilities and for patients 65 and older. Flum said most of the patients he studied were under 65 and probably qualified for Medicare because of obesity-related ills, including heart and joint problems.
There are several types of obesity surgery, but the most common U.S. variety, gastric bypass, involves creating an egg-size pouch in the upper stomach and attaching it to a section of intestine. That reduces the amount of food patients can eat and results in less food being absorbed. Flum's study lumped together data on the different operations.
Researchers said one reason men may have higher post-surgery death rates is that they tend to wait longer than women to seek medical help and may be sicker when the operation is performed.
A third JAMA study cast doubt on whether obesity surgery reduces health-care costs. It found that among patients followed for about three years, an average of 8 percent were hospitalized before surgery, mostly for obesity-related complications, compared with 20 percent a year afterward, mostly for surgery-related complications.
That study's lead author, Dr. David Zingmond of the University of California at Los Angeles, said some people mistakenly view obesity surgery as a cosmetic procedure and "may greatly discount the chances that they're going to have problems after surgery."
Hutcher said patients should seek experienced surgeons who meet his group's guidelines. Those include thoroughly evaluating patients before and after surgery and giving them long-term follow-up care.
Most patients "will receive a good outcome. A good outcome does not mean there's no risk for complications or mortality," Hutcher said.
World Stem Cell Foundation Announced
South Korean scientists have announced the creation of a World Stem Cell Foundation, to be headquartered at Seoul National University but with tentacles reaching to the United States, the United Kingdom and beyond.
The new venture, unveiled early Wednesday morning, is intended to accelerate international progress in the field by bypassing ethical and regulatory constraints in the United States, according to Dr. Susan Okie, who wrote a perspective article in the Oct. 20 issue of the New England Journal of Medicine that was released to coincide with the Seoul announcement.
"Korea is being very entrepreneurial, not just in creating novel stem cells but in how they're marketing and doing business," added Paul Sanberg, director of the Center for Aging and Brain Repair at the University of South Florida College of Medicine in Tampa. "The [Korean] government is putting significant amounts of money into it. I think Korea sees that it can be a global player."
This particular group of scientists, led by Hwang Woo-suk, made headlines earlier this year when they created 11 disease-specific embryonic stem cell lines without using fertilized embryos, and when they successfully cloned human embryonic stem cell lines.
The new foundation will make disease-specific embryonic stem cell lines by somatic-cell nuclear transfer in South Korea. Those cells will then be shipped to paying scientists around the world.
Somatic-cell nuclear transfer, or "research cloning," involves taking a cell from an adult or child (usually with a disease), then using it to replace the nucleus in a donated egg and, from that, creating a new line of cells.
"This particular way of making embryonic stem cells is the one that is the most limited in the U.S.," Okie, a contributing editor to the New England Journal of Medicine, explained. "No one is doing it here." The issue of getting donated eggs is particularly problematic.
U.S. labs are prohibited from producing these stem cell lines using equipment or facilities paid for with government funds. "Not many institutions can afford to do it," Okie explained. Some larger institutions such as Harvard and Stanford are planning their own centers, but they are hobbled by ethical issues surrounding the donation of eggs.
In South Korea, however, Okie added, "they are making these cell lines fast and furious, and it has the potential for more." So U.S. scientists would be able to order the cell lines and work on them, as long as the labs or equipment are not federally funded.
"It would be potentially much less onerous than trying to start a program from scratch. And, if you just want to study cells, you sidestep the whole technical process," Okie said. "In eight states, it's illegal to make embryonic stem cells by this method, but it's legal to import them in every state but South Dakota."
Under the plan, the consortium would be headquartered in Seoul and would operate smaller laboratories in San Francisco and England, each of which would be associated with an in vitro fertilization clinic where donor eggs would be collected.
Three Korean technicians would travel regularly to the satellite labs to perform all the nuclear-transfer procedures.
Gerald Schatten, of the University of Pittsburgh who will chair the foundation's board of trustees, estimated the foundation could produce 100 new disease-specific stem cell lines each year.
According to Okie, U.S. scientists have mixed feelings about the venture.
Some, such as those at the University of California at San Francisco (UCSF), which is setting up its own center, are unhappy about the centralization of technological expertise that the scheme entails, she said.
"They thought a lot of what you could learn grew out of making the cell lines," she said. UCSF said it would not participate in the World Stem Cell Foundation, but would work towards being able to develop its own lines.
But Okis said George Daley of Harvard Medical School told her that his institution would do both: make its own cell lines and participate in the Korean venture. "It offers opportunities to use more different kinds of embryonic stem cells and learn from them, and do different studies," Okie said.
"The positive side is it allows people to get cell lines made for specific diseases, do it quickly and to do research on it," Sanberg added.
But Okie thought that the combined strengths of the United States and South Korean strengths could create a powerhouse effect.
"The problem with the U.S. is we don't have this technology very much in hand yet, so there are going to be a lot of cell lines from eggs that will fail before we get our expertise up to where the Koreans have it," she said. "Because eggs are such a precious resource and the ethics are so difficult, you don't want a lot of eggs to go to waste."
On the other hand, many people feel the United States has a deeper understanding of biology.
"Ideally, we could cooperate," Okie said.
Health Tip: Protecting Kids Who Lift Weights
Your preteen has told you he wants to start pumping iron, but you think he's too young and could hurt himself.
Well, if your son is 12 years old or older, weight training is generally safe, provided the program is supervised and properly designed, according to St. Louis Children's Hospital. Young girls usually can lift weights from age 10.
But tell your child not to expect too much buildup of muscle mass, since this requires certain hormones that pre-adolescent kids lack. Weight training at this age will increase muscle fibers to develop strength, but not muscle mass.
It's also a good idea for your child to have a medical checkup before starting a weightlifting program.
Health Tip: Your Child Doesn't Eat Meat
Some children go through a vegetarian phase -- declaring that they'll never eat meat again.
Whether this is a lasting dietary change or a fleeting fancy, you need to make sure your child's eating regimen is sufficiently varied.
Akron Children's Hospital suggests you include the following nutrients in your child's diet:
Calories and fat: peanut butter, nuts, cheese, sunflower seeds, and soy products.
Protein: legumes, meatless chili, and dairy and soy products.
Calcium: milk and orange juice, tofu and dark green, leafy vegetables.
Iron: enriched grains, legumes, and dried fruit.
Vitamin B12: fortified soy milk, and some breakfast cereals.
Zinc: legumes, hard cheeses, whole grain products, wheat germ, nuts and tofu.
Food Fact:
Outsmart the menu.
It's possible to eat out and still keep a healthy diet -- if you master a few key strategies. Start by getting the food you want in the amounts you need. If restaurants insist on serving gigantic portions, take advantage of appetizers, soups, salads, a la carte items and side dishes. Split oversized menu items with a dining partner. When eating in a group, order one or two fewer dishes than the number of people at the table, and eat family style.
Fitness Tip of the day:
Hit that perfect beat.
Dancing raises your pulse -- a key to a healthy heart. Running and biking will do the same. Regular physical activity has many other disease-fighting benefits. It reduces your risk of developing Type 2 diabetes, lowers your risk of developing cancer, and helps you prevent bone loss (osteoporosis), and maintain mobility and independence in later years.
FAQ of the day:
What causes heart attacks?
Usually, a cholesterol-laden plaque becomes unstable and bursts, causing clots that block blood flow completely, starving the heart muscle. Today, medical personnel can treat clots en route to the hospital with enzymes that chew them up, restoring blood flow in the blocked arteries. Cholesterol-lowering drugs make plaques more stable and less likely to burst. Better yet, a diet rich in whole foods and low in red meat keeps your blood cholesterol levels low, helps prevent clots, maintains healthy blood pressure, assists in weight control, and reduces the risk of diseases such as diabetes and certain cancers to boot.
New Jersey plans to create a storage bank for umbilical cord blood to aid stem cell research, a program that state officials said will be the first of its kind in the nation.
Two nonprofit community blood banks will accept donations from healthy newborns made with parents' permission. Under the one-year pilot program, the blood will be used for treatment of illnesses, such as leukemia, or to conduct research.
An estimated $300,000 each will be given to the Elie Katz Umbilical Cord Blood Program at Community Blood Services in Paramus and the Coriell Institute for Medical Research in Camden, said Cynthia Kirchner, senior policy adviser to the state's public health commissioner.
The executive order was signed Tuesday by acting Gov. Richard J. Codey.
Stem cells are undeveloped cells found in embryos, umbilical cord blood, placentas and certain types of adult tissue. Most clinical use for cord blood is for cancer, said Rick Cohen, director of Coriell's stem cell program.
"A number of children literally owe their lives to the generous donations of those New Jersey moms and dads who chose to donate their children's cord blood to our public bank," Dennis Todd, president and chief executive officer for Community Blood Services.
The state health department plans a campaign to educate medical professionals and mothers about the donation program and its benefits.
"Basically, it's taking something that we would have discarded and process it so research can benefit," said Ellen Harris, program director for the bank in Camden.
Doping: BALCO head Conte sentenced in steroid scandal
A federal judge sentenced the head of the BALCO nutritional lab to four months in prison on Tuesday in a global sports steroid scandal that has badly damaged some of the top names in international sports.
District Judge Susan Illston also sentenced BALCO founder Victor Conte to four months home confinement and to two years of court supervision.
Conte, his deputy James Valente, and Greg Anderson, personal trainer to baseball superstar Barry Bonds, all admitted guilt to steroid distribution in July in plea deals that knocked out almost all of the original charges against them.
News two years ago that BALCO was the source of a previously undetectable steroid prompted an effort across many sports to clamp down on performance enhancing drugs.
The scandal sullied some of the top names in global sports and raised questions about achievements such as home run records by muscular baseball players.
Study: Obesity Surgery May Be Riskier
Obesity surgery, the most drastic way to lose weight, is far more than a cosmetic procedure and involves considerably higher risks of death than previously thought, new research suggests.
Some previous studies of people in their 30s to their 50s -— the most common ages for obesity surgery -— found death rates well under 1 percent. But among 35- to 44-year-olds in a new study, more than 5 percent of men and nearly 3 percent of women were dead within a year, and slightly higher rates were seen in patients 45 to 54.
Among patients 65 to 74, nearly 13 percent of men and about 6 percent of women died. In patients 75 and older, half of the men and 40 percent of the women died.
"The risk of death is much higher than has been reported," said University of Washington surgeon Dr. David Flum, lead author of the study of 16,155 Medicare patients. "It's a reality check for those patients who are considering these operations."
The study, involving patients who underwent obesity surgery between 1997 and 2002, appears in Wednesday's Journal of the American Medical Association.
The study offered no breakdown on causes of death, but obesity surgery's potentially deadly complications can include malnutrition, infection, and bowel and gallbladder problems. Also, surgery in general can be a deadly shock to the system, especially in older patients.
Dr. Neil Hutcher, president of the American Society for Bariatric Surgery, said that Medicare patients are probably sicker than the general U.S. population and that complication rates have declined as surgeons' expertise has increased.
But Flum said some previous research on the safety of obesity surgery consisted of "reports from the best surgeons reporting their best results," while the new study is more of a real-world look.
The American Society for Bariatric Surgery predicts obesity surgery will be performed more than 150,000 times this year in the United States. That is more than 10 times the number in 1998, according to a second JAMA study. The increase parallels a surge in the portion of U.S. adults who are at least 100 pounds overweight, from about 1 in 200 in 1986 to 1 in 50 in 2000, that study said.
Supporters of stomach-reduction surgery say the operation can save their lives by reducing the workload on the heart and lungs and eliminating related illnesses, such as diabetes and sleep apnea.
Flum said the new study suggests that in many cases, obesity surgery may not be right for an older person "who already has the burden of 60 years of obesity on their heart" and other organs.
Medicare covers obesity surgery if it is recommended to treat related conditions such as diabetes and heart problems. The government is considering whether to cover surgery to treat obesity alone.
Medicare is for younger Americans with disabilities and for patients 65 and older. Flum said most of the patients he studied were under 65 and probably qualified for Medicare because of obesity-related ills, including heart and joint problems.
There are several types of obesity surgery, but the most common U.S. variety, gastric bypass, involves creating an egg-size pouch in the upper stomach and attaching it to a section of intestine. That reduces the amount of food patients can eat and results in less food being absorbed. Flum's study lumped together data on the different operations.
Researchers said one reason men may have higher post-surgery death rates is that they tend to wait longer than women to seek medical help and may be sicker when the operation is performed.
A third JAMA study cast doubt on whether obesity surgery reduces health-care costs. It found that among patients followed for about three years, an average of 8 percent were hospitalized before surgery, mostly for obesity-related complications, compared with 20 percent a year afterward, mostly for surgery-related complications.
That study's lead author, Dr. David Zingmond of the University of California at Los Angeles, said some people mistakenly view obesity surgery as a cosmetic procedure and "may greatly discount the chances that they're going to have problems after surgery."
Hutcher said patients should seek experienced surgeons who meet his group's guidelines. Those include thoroughly evaluating patients before and after surgery and giving them long-term follow-up care.
Most patients "will receive a good outcome. A good outcome does not mean there's no risk for complications or mortality," Hutcher said.
World Stem Cell Foundation Announced
South Korean scientists have announced the creation of a World Stem Cell Foundation, to be headquartered at Seoul National University but with tentacles reaching to the United States, the United Kingdom and beyond.
The new venture, unveiled early Wednesday morning, is intended to accelerate international progress in the field by bypassing ethical and regulatory constraints in the United States, according to Dr. Susan Okie, who wrote a perspective article in the Oct. 20 issue of the New England Journal of Medicine that was released to coincide with the Seoul announcement.
"Korea is being very entrepreneurial, not just in creating novel stem cells but in how they're marketing and doing business," added Paul Sanberg, director of the Center for Aging and Brain Repair at the University of South Florida College of Medicine in Tampa. "The [Korean] government is putting significant amounts of money into it. I think Korea sees that it can be a global player."
This particular group of scientists, led by Hwang Woo-suk, made headlines earlier this year when they created 11 disease-specific embryonic stem cell lines without using fertilized embryos, and when they successfully cloned human embryonic stem cell lines.
The new foundation will make disease-specific embryonic stem cell lines by somatic-cell nuclear transfer in South Korea. Those cells will then be shipped to paying scientists around the world.
Somatic-cell nuclear transfer, or "research cloning," involves taking a cell from an adult or child (usually with a disease), then using it to replace the nucleus in a donated egg and, from that, creating a new line of cells.
"This particular way of making embryonic stem cells is the one that is the most limited in the U.S.," Okie, a contributing editor to the New England Journal of Medicine, explained. "No one is doing it here." The issue of getting donated eggs is particularly problematic.
U.S. labs are prohibited from producing these stem cell lines using equipment or facilities paid for with government funds. "Not many institutions can afford to do it," Okie explained. Some larger institutions such as Harvard and Stanford are planning their own centers, but they are hobbled by ethical issues surrounding the donation of eggs.
In South Korea, however, Okie added, "they are making these cell lines fast and furious, and it has the potential for more." So U.S. scientists would be able to order the cell lines and work on them, as long as the labs or equipment are not federally funded.
"It would be potentially much less onerous than trying to start a program from scratch. And, if you just want to study cells, you sidestep the whole technical process," Okie said. "In eight states, it's illegal to make embryonic stem cells by this method, but it's legal to import them in every state but South Dakota."
Under the plan, the consortium would be headquartered in Seoul and would operate smaller laboratories in San Francisco and England, each of which would be associated with an in vitro fertilization clinic where donor eggs would be collected.
Three Korean technicians would travel regularly to the satellite labs to perform all the nuclear-transfer procedures.
Gerald Schatten, of the University of Pittsburgh who will chair the foundation's board of trustees, estimated the foundation could produce 100 new disease-specific stem cell lines each year.
According to Okie, U.S. scientists have mixed feelings about the venture.
Some, such as those at the University of California at San Francisco (UCSF), which is setting up its own center, are unhappy about the centralization of technological expertise that the scheme entails, she said.
"They thought a lot of what you could learn grew out of making the cell lines," she said. UCSF said it would not participate in the World Stem Cell Foundation, but would work towards being able to develop its own lines.
But Okis said George Daley of Harvard Medical School told her that his institution would do both: make its own cell lines and participate in the Korean venture. "It offers opportunities to use more different kinds of embryonic stem cells and learn from them, and do different studies," Okie said.
"The positive side is it allows people to get cell lines made for specific diseases, do it quickly and to do research on it," Sanberg added.
But Okie thought that the combined strengths of the United States and South Korean strengths could create a powerhouse effect.
"The problem with the U.S. is we don't have this technology very much in hand yet, so there are going to be a lot of cell lines from eggs that will fail before we get our expertise up to where the Koreans have it," she said. "Because eggs are such a precious resource and the ethics are so difficult, you don't want a lot of eggs to go to waste."
On the other hand, many people feel the United States has a deeper understanding of biology.
"Ideally, we could cooperate," Okie said.
Health Tip: Protecting Kids Who Lift Weights
Your preteen has told you he wants to start pumping iron, but you think he's too young and could hurt himself.
Well, if your son is 12 years old or older, weight training is generally safe, provided the program is supervised and properly designed, according to St. Louis Children's Hospital. Young girls usually can lift weights from age 10.
But tell your child not to expect too much buildup of muscle mass, since this requires certain hormones that pre-adolescent kids lack. Weight training at this age will increase muscle fibers to develop strength, but not muscle mass.
It's also a good idea for your child to have a medical checkup before starting a weightlifting program.
Health Tip: Your Child Doesn't Eat Meat
Some children go through a vegetarian phase -- declaring that they'll never eat meat again.
Whether this is a lasting dietary change or a fleeting fancy, you need to make sure your child's eating regimen is sufficiently varied.
Akron Children's Hospital suggests you include the following nutrients in your child's diet:
Calories and fat: peanut butter, nuts, cheese, sunflower seeds, and soy products.
Protein: legumes, meatless chili, and dairy and soy products.
Calcium: milk and orange juice, tofu and dark green, leafy vegetables.
Iron: enriched grains, legumes, and dried fruit.
Vitamin B12: fortified soy milk, and some breakfast cereals.
Zinc: legumes, hard cheeses, whole grain products, wheat germ, nuts and tofu.
Food Fact:
Outsmart the menu.
It's possible to eat out and still keep a healthy diet -- if you master a few key strategies. Start by getting the food you want in the amounts you need. If restaurants insist on serving gigantic portions, take advantage of appetizers, soups, salads, a la carte items and side dishes. Split oversized menu items with a dining partner. When eating in a group, order one or two fewer dishes than the number of people at the table, and eat family style.
Fitness Tip of the day:
Hit that perfect beat.
Dancing raises your pulse -- a key to a healthy heart. Running and biking will do the same. Regular physical activity has many other disease-fighting benefits. It reduces your risk of developing Type 2 diabetes, lowers your risk of developing cancer, and helps you prevent bone loss (osteoporosis), and maintain mobility and independence in later years.
FAQ of the day:
What causes heart attacks?
Usually, a cholesterol-laden plaque becomes unstable and bursts, causing clots that block blood flow completely, starving the heart muscle. Today, medical personnel can treat clots en route to the hospital with enzymes that chew them up, restoring blood flow in the blocked arteries. Cholesterol-lowering drugs make plaques more stable and less likely to burst. Better yet, a diet rich in whole foods and low in red meat keeps your blood cholesterol levels low, helps prevent clots, maintains healthy blood pressure, assists in weight control, and reduces the risk of diseases such as diabetes and certain cancers to boot.
Tuesday, October 18, 2005
Health Headlines - October 18
No Link Between Diabetes, Aggressive Prostate Cancer
Type 2 diabetes has no effect on the aggressiveness of prostate cancer, but prostate cancer patients with diabetes do have poorer long-term survival rates, U.S. researchers report.
Previous studies had suggested that insulin promoted the growth of prostate cancer cells. In people with type 2 diabetes, the body fails to use insulin properly, which can result in excess insulin in the blood.
This study included more than 1,500 men with localized prostate cancer treated with radiation therapy between 1989 and late 2001. Of these patients, more than 1,300 had no history of type 2 diabetes, while about 200 did have type 2 diabetes managed with diet, exercise or medications other than insulin.
"We looked a several key pretreatment factors used to stage the prostate cancer," study author Dr. Khanh H. Nguyen, a resident in the radiation oncology department at Fox Chase Cancer Center, Philadelphia, explained in a prepared statement.
"These factors include the initial PSA (prostate-specific antigen), Gleason score and T-stage. The men with type 2 diabetes didn't have a significantly different initial profile for their prostate cancer than the men without diabetes," Nguyen said. "Additionally, type 2 diabetes did not appear to influence the rates of PSA failures or distant metastases. However, men with type 2 diabetes had significantly worse long-term overall survival."
Among men with diabetes, the death rate from all causes was about 23 percent, compared to 19 percent for the men without diabetes. The death rates from prostate cancer were 3 percent for men with diabetes, and 2.4 percent for men without diabetes.
Even though diabetes doesn't appear to influence the aggressiveness of prostate cancer, the use of diet, exercise and medications to control diabetes may improve the survival odds for prostate cancer patients, the study authors noted.
Drug Improves Type 2 Diabetes Outcomes
The diabetes drug pioglitazone can reduce the risk of death, heart attack and stroke in high-risk type 2 diabetes patients, a new study finds.
The study authors noted that diabetics have a two- to four-fold increased risk of suffering a cardiovascular event compared to people who don't have diabetes. Before this study, there was only indirect evidence that pioglitazone may reduce the risk of cardiovascular illness and death in people with diabetes.
Appearing in this week's issue of The Lancet, the study included more than 5,200 type 2 diabetes patients with evidence of cardiovascular disease. In addition to their existing medications for diabetes and cardiovascular disease, half of the patients were given pioglitazone while the other half received a placebo.
Patient outcomes were tracked for an average of 34.5 months. According to the group of European researchers, the pioglitzone group experienced 803 cardiovascular events -- deaths, heart attacks, strokes, cardiac or leg interventions and acute coronary syndrome -- while the placebo group experienced 900 events.
The patients in the pioglitazone group also took longer before they needed to begin insulin therapy compared to those in the placebo group, the study said.
The treatment group did experience an increase in reported heart failure, but the number of heart failure deaths in both groups was similar.
The researchers concluded that, in a group of 1,000 type 2 diabetes patients, pioglitzone use could prevent 21 first heart attacks, strokes or deaths over three years.
Government warns against Enteryx
The U.S. Food and Drug Administration told doctors on Monday to stop using Enteryx, a device used to treat acid-reflux disease that Boston Scientific Corp. recalled last month.
The FDA said doctors should immediately stop injecting Enteryx, due to serious adverse effects, including death, occurring in patients treated with the liquid chemical polymer used for gastroesophageal reflux disease.
Enteryx is intended to be injected into the lower esophageal sphincter where it polymerizes into a spongy material that cannot be removed, the FDA said in a notice on its Web site (www.fda.gov).
Boston Scientific issued a recall of its Enteryx procedure kits and its Enteryx injector single packs on September 23, the FDA said.
While some problems with the device related to how it was injected, not all injuries were the result of user technique, the FDA said.
It said one reported death was due to injection of Enteryx into the wall of the aorta and cited two cases of possible inflammatory reactions occurring even when proper procedures were followed.
A representative of Boston Scientific was not immediately available for comment.
Food Fact:
Buttermilk? Spread the word.
Despite the name, buttermilk is a great secret for low-fat cooks to keep up their sleeves. Buttermilk is either skim or low-fat, and fermented with beneficial bacteria that leaves its characteristic tang. Its acidity helps keep baked goods tender without adding fat, and its creamy texture makes a good base for salad dressings. It's a delicious addition to mashed potatoes and makes a thick, tangy, low-fat soup base. It also makes a fine smoothie: Combine frozen berries, buttermilk and sugar (to taste) in a blender. Blend until smooth.
Fitness Tip of the day:
Huffing, not puffing.
Exercise increases your chances of quitting smoking or cutting back on cigarettes. It also helps you maintain a healthy weight after you've completed a weight loss program, increases muscle strength and endurance, and pumps up the size of your working muscles, which reduces the number of calories converted into body fat.
FAQ of the day:
Do I have to give up all red meat?
There are ways to make your sauce taste meaty without meat. Try adding extra mushrooms, sauteed eggplant, textured soy protein, ground turkey or chicken, or any combination of them. If meat's a must, buy the leanest ground beef, use about 1/4 your usual amount and try one of the above ingredients to stand in for the rest.
Type 2 diabetes has no effect on the aggressiveness of prostate cancer, but prostate cancer patients with diabetes do have poorer long-term survival rates, U.S. researchers report.
Previous studies had suggested that insulin promoted the growth of prostate cancer cells. In people with type 2 diabetes, the body fails to use insulin properly, which can result in excess insulin in the blood.
This study included more than 1,500 men with localized prostate cancer treated with radiation therapy between 1989 and late 2001. Of these patients, more than 1,300 had no history of type 2 diabetes, while about 200 did have type 2 diabetes managed with diet, exercise or medications other than insulin.
"We looked a several key pretreatment factors used to stage the prostate cancer," study author Dr. Khanh H. Nguyen, a resident in the radiation oncology department at Fox Chase Cancer Center, Philadelphia, explained in a prepared statement.
"These factors include the initial PSA (prostate-specific antigen), Gleason score and T-stage. The men with type 2 diabetes didn't have a significantly different initial profile for their prostate cancer than the men without diabetes," Nguyen said. "Additionally, type 2 diabetes did not appear to influence the rates of PSA failures or distant metastases. However, men with type 2 diabetes had significantly worse long-term overall survival."
Among men with diabetes, the death rate from all causes was about 23 percent, compared to 19 percent for the men without diabetes. The death rates from prostate cancer were 3 percent for men with diabetes, and 2.4 percent for men without diabetes.
Even though diabetes doesn't appear to influence the aggressiveness of prostate cancer, the use of diet, exercise and medications to control diabetes may improve the survival odds for prostate cancer patients, the study authors noted.
Drug Improves Type 2 Diabetes Outcomes
The diabetes drug pioglitazone can reduce the risk of death, heart attack and stroke in high-risk type 2 diabetes patients, a new study finds.
The study authors noted that diabetics have a two- to four-fold increased risk of suffering a cardiovascular event compared to people who don't have diabetes. Before this study, there was only indirect evidence that pioglitazone may reduce the risk of cardiovascular illness and death in people with diabetes.
Appearing in this week's issue of The Lancet, the study included more than 5,200 type 2 diabetes patients with evidence of cardiovascular disease. In addition to their existing medications for diabetes and cardiovascular disease, half of the patients were given pioglitazone while the other half received a placebo.
Patient outcomes were tracked for an average of 34.5 months. According to the group of European researchers, the pioglitzone group experienced 803 cardiovascular events -- deaths, heart attacks, strokes, cardiac or leg interventions and acute coronary syndrome -- while the placebo group experienced 900 events.
The patients in the pioglitazone group also took longer before they needed to begin insulin therapy compared to those in the placebo group, the study said.
The treatment group did experience an increase in reported heart failure, but the number of heart failure deaths in both groups was similar.
The researchers concluded that, in a group of 1,000 type 2 diabetes patients, pioglitzone use could prevent 21 first heart attacks, strokes or deaths over three years.
Government warns against Enteryx
The U.S. Food and Drug Administration told doctors on Monday to stop using Enteryx, a device used to treat acid-reflux disease that Boston Scientific Corp. recalled last month.
The FDA said doctors should immediately stop injecting Enteryx, due to serious adverse effects, including death, occurring in patients treated with the liquid chemical polymer used for gastroesophageal reflux disease.
Enteryx is intended to be injected into the lower esophageal sphincter where it polymerizes into a spongy material that cannot be removed, the FDA said in a notice on its Web site (www.fda.gov).
Boston Scientific issued a recall of its Enteryx procedure kits and its Enteryx injector single packs on September 23, the FDA said.
While some problems with the device related to how it was injected, not all injuries were the result of user technique, the FDA said.
It said one reported death was due to injection of Enteryx into the wall of the aorta and cited two cases of possible inflammatory reactions occurring even when proper procedures were followed.
A representative of Boston Scientific was not immediately available for comment.
Food Fact:
Buttermilk? Spread the word.
Despite the name, buttermilk is a great secret for low-fat cooks to keep up their sleeves. Buttermilk is either skim or low-fat, and fermented with beneficial bacteria that leaves its characteristic tang. Its acidity helps keep baked goods tender without adding fat, and its creamy texture makes a good base for salad dressings. It's a delicious addition to mashed potatoes and makes a thick, tangy, low-fat soup base. It also makes a fine smoothie: Combine frozen berries, buttermilk and sugar (to taste) in a blender. Blend until smooth.
Fitness Tip of the day:
Huffing, not puffing.
Exercise increases your chances of quitting smoking or cutting back on cigarettes. It also helps you maintain a healthy weight after you've completed a weight loss program, increases muscle strength and endurance, and pumps up the size of your working muscles, which reduces the number of calories converted into body fat.
FAQ of the day:
Do I have to give up all red meat?
There are ways to make your sauce taste meaty without meat. Try adding extra mushrooms, sauteed eggplant, textured soy protein, ground turkey or chicken, or any combination of them. If meat's a must, buy the leanest ground beef, use about 1/4 your usual amount and try one of the above ingredients to stand in for the rest.
Monday, October 17, 2005
Health Headlines - October 17
Marriage Won't Affect Breast Cancer Prognosis
Marital status does not affect prognosis for women with early stage breast cancer who are treated with lumpectomy and radiation.
This finding, presented Sunday at the 47th annual meeting of the American Society for Therapeutic Radiology and Oncology in Denver, is in contrast with previous cancer research.
It's unclear how the results will influence treatment decisions, other than to reassure women that, whether they are single, married, widowed or divorced, their prognosis is the same, said Dr. Jay Brooks, chairman of hematology/oncology at the Ochsner Clinic Foundation in Baton Rouge, La.
Dr. Shelly B. Hayes, lead author of the study and chief resident in the radiation oncology department at Fox Chase Cancer Center in Philadelphia, borrowed the idea for the study from similar research done on survival rates of men and women with head and neck cancer who underwent radiotherapy.
In those cases, men who did better in terms of survival were married, although there was no apparent association between survival and marital status for women.
The differences may have been attributable to psychosocial factors. For someone with head and neck cancer, every day of treatment missed decreases the cure rate by 3 percent. Married men, it is surmised, may be more compliant with treatment, with their wives making sure they get to treatment sessions, researchers said.
Women also may be getting themselves to treatment sessions. "Women, in general, tend to be more compliant with treatment than men," Hayes confirmed.
Women with breast cancer are an entirely different patient population, however. "People with head and neck cancer are generally smokers and drinkers," Hayes explained. "The risk factors are quite different than for breast cancer so there's a whole set of psychosocial issues that generally aren't present with breast cancer patients."
Hayes' study involved 2,143 women with early stage breast cancer treated with both lumpectomy and radiation at Fox Chase Cancer Center between 1984 and 2003.
Participants were divided into four groups based on marital status: married (63 percent), single (10 percent), divorced or separated (10 percent) and widowed (18 percent). They were followed for a median of 76 months.
The research team found no statistically significant association between marital status and relapse-free survival. "Marital status alone wasn't significant as an independent predictor of outcome in terms of freedom from cancer," Hayes said.
Age, on the other hand, was found to be predictive of relapse-free survival, with women younger than age 40 doing worse than women over 70, despite similar tumor characteristics and treatment factors.
"Because marital status wasn't independently predictive of outcome while age was, maybe with younger women we need to be more aggressive in treating breast cancer," Hayes said.
There were, however, other differences corresponding to marital status. Women younger than 40 were more likely to be single, while women older than 70 were more likely to be divorced. Divorced women on the whole were younger than married women. Women who had been widowed were more likely to have tumors detected by mammography rather than a physical exam.
Two other studies, also from Fox Chase Cancer Center, addressed differences in breast-cancer outcome based on treatment decisions.
One study found that the order in which tamoxifen and radiation are given following a lumpectomy for early stage breast cancer does not affect recurrence, survival or complication rates. Giving tamoxifen at the same time as radiation, however, has negative cosmetic results, the researchers said.
The second study found only a marginal benefit in giving an aromatase inhibitor drug to women with invasive breast cancer who have already undergone lumpectomy, radiation and five years of tamoxifen. Adding an aromatase inhibitor to this group of women, all of whom were disease-free after their treatment, would result in just a 1 percent to 2 percent clinical benefit.
Usually, a benefit level of 3 percent is needed before adding another therapy. Women with node-positive breast cancer along with women aged 60 or younger would be more likely to benefit from an aromatase inhibitor after an initial five years of tamoxifen, the researchers said.
Health Tip: Jumping for Joy Over a Trampoline?
No matter how much your child begs you to buy a home trampoline, your answer should always be "no," advises the American Academy of Pediatrics.
Every year, emergency rooms treat thousands of children with trampoline-related injuries, most of which occurred at home.
The academy recommends that trampolines be used only in supervised training programs at outdoor playgrounds or in schools.
Because of their immature motor skills, children under age six shouldn't use trampolines at all, the AAP warns.
Health Tip: Don't Leave Your Infant Alone
Although your young infant may not be able to get around much, she may still be able to wiggle her way to harm.
Here are some safety tips, courtesy of Cincinnati Children's Hospital.
Never leave your baby at home alone.
Only leave your baby alone in a room when she is in a playpen or crib.
Stay with your baby when she is on a dressing table, bed or couch.
Stay near your infant when she is in an infant seat, swing or high chair.
Never leave your baby alone in a room with a dog, cat or any uncaged pet.
Marital status does not affect prognosis for women with early stage breast cancer who are treated with lumpectomy and radiation.
This finding, presented Sunday at the 47th annual meeting of the American Society for Therapeutic Radiology and Oncology in Denver, is in contrast with previous cancer research.
It's unclear how the results will influence treatment decisions, other than to reassure women that, whether they are single, married, widowed or divorced, their prognosis is the same, said Dr. Jay Brooks, chairman of hematology/oncology at the Ochsner Clinic Foundation in Baton Rouge, La.
Dr. Shelly B. Hayes, lead author of the study and chief resident in the radiation oncology department at Fox Chase Cancer Center in Philadelphia, borrowed the idea for the study from similar research done on survival rates of men and women with head and neck cancer who underwent radiotherapy.
In those cases, men who did better in terms of survival were married, although there was no apparent association between survival and marital status for women.
The differences may have been attributable to psychosocial factors. For someone with head and neck cancer, every day of treatment missed decreases the cure rate by 3 percent. Married men, it is surmised, may be more compliant with treatment, with their wives making sure they get to treatment sessions, researchers said.
Women also may be getting themselves to treatment sessions. "Women, in general, tend to be more compliant with treatment than men," Hayes confirmed.
Women with breast cancer are an entirely different patient population, however. "People with head and neck cancer are generally smokers and drinkers," Hayes explained. "The risk factors are quite different than for breast cancer so there's a whole set of psychosocial issues that generally aren't present with breast cancer patients."
Hayes' study involved 2,143 women with early stage breast cancer treated with both lumpectomy and radiation at Fox Chase Cancer Center between 1984 and 2003.
Participants were divided into four groups based on marital status: married (63 percent), single (10 percent), divorced or separated (10 percent) and widowed (18 percent). They were followed for a median of 76 months.
The research team found no statistically significant association between marital status and relapse-free survival. "Marital status alone wasn't significant as an independent predictor of outcome in terms of freedom from cancer," Hayes said.
Age, on the other hand, was found to be predictive of relapse-free survival, with women younger than age 40 doing worse than women over 70, despite similar tumor characteristics and treatment factors.
"Because marital status wasn't independently predictive of outcome while age was, maybe with younger women we need to be more aggressive in treating breast cancer," Hayes said.
There were, however, other differences corresponding to marital status. Women younger than 40 were more likely to be single, while women older than 70 were more likely to be divorced. Divorced women on the whole were younger than married women. Women who had been widowed were more likely to have tumors detected by mammography rather than a physical exam.
Two other studies, also from Fox Chase Cancer Center, addressed differences in breast-cancer outcome based on treatment decisions.
One study found that the order in which tamoxifen and radiation are given following a lumpectomy for early stage breast cancer does not affect recurrence, survival or complication rates. Giving tamoxifen at the same time as radiation, however, has negative cosmetic results, the researchers said.
The second study found only a marginal benefit in giving an aromatase inhibitor drug to women with invasive breast cancer who have already undergone lumpectomy, radiation and five years of tamoxifen. Adding an aromatase inhibitor to this group of women, all of whom were disease-free after their treatment, would result in just a 1 percent to 2 percent clinical benefit.
Usually, a benefit level of 3 percent is needed before adding another therapy. Women with node-positive breast cancer along with women aged 60 or younger would be more likely to benefit from an aromatase inhibitor after an initial five years of tamoxifen, the researchers said.
Health Tip: Jumping for Joy Over a Trampoline?
No matter how much your child begs you to buy a home trampoline, your answer should always be "no," advises the American Academy of Pediatrics.
Every year, emergency rooms treat thousands of children with trampoline-related injuries, most of which occurred at home.
The academy recommends that trampolines be used only in supervised training programs at outdoor playgrounds or in schools.
Because of their immature motor skills, children under age six shouldn't use trampolines at all, the AAP warns.
Health Tip: Don't Leave Your Infant Alone
Although your young infant may not be able to get around much, she may still be able to wiggle her way to harm.
Here are some safety tips, courtesy of Cincinnati Children's Hospital.
Never leave your baby at home alone.
Only leave your baby alone in a room when she is in a playpen or crib.
Stay with your baby when she is on a dressing table, bed or couch.
Stay near your infant when she is in an infant seat, swing or high chair.
Never leave your baby alone in a room with a dog, cat or any uncaged pet.
Sunday, October 16, 2005
Health Headlines - October 16
Amish Split on How to Face Polio Threat
Residents of an isolated Amish community appear divided on what to do after doctors diagnosed four cases of the polio virus in their children. Some have decided on vaccinations to ward off future polio cases, while others prefer leaving the matter in God's hands.
About two dozen Amish households dot the hillsides in central Minnesota's rolling farm country. On Thursday, state health officials announced the four polio infections -— the first known cases in the United States in five years.
The Amish community -— it has no official name -— has seen a flurry of visitors from the state Health Department after three siblings under 16 were diagnosed. Two weeks earlier, an infant from the community had been diagnosed with polio, and state doctors expect more cases to turn up.
None of the four have developed symptoms, and health officials say most polio cases do not result in paralysis. But they have urged members of the community to be immunized as soon as possible to reduce the chances the virus will spread. Only unvaccinated people are at risk.
"The doctors were here to talk to us," said Susie Borntreger, a young Amish mother who was hunting down snakes with a hoe in her yard Friday. "They talked with my husband. They told us we should think about the vaccine."
The Borntregers decided to vaccinate their two sons, aged 2 and 1. But that decision is not universal. Some Amish families here don't trust vaccinations. Borntreger was vague when asked to explain her family's thinking, saying the decision was made by her husband.
"Some people are very open, some people want to think about it, some people just say no," said Harry Hull, the state epidemiologist.
After consulting with Amish community leaders, state and county officials decided to approach families separately about vaccinations to avoid social pressures in the extremely close-knit community.
Unlike other Amish communities that cater to tourists, this small, conservative settlement in sparsely populated Todd County has little interaction with modern society. The closest town, Clarissa, has hitching posts outside stores on Main Street, but residents say their Amish neighbors keep to themselves.
"They come to town to shop," said Diane Hanson, a drug store clerk. "They're nice, friendly, but they never stick around long. I don't know any of them, and I don't know many people who do."
Many of the Amish settled here in the last five years or so, migrating from communities in Wisconsin in search of inexpensive farmland. They raise turkeys, cows and pigs and cultivate corn and wheat.
On Friday, a group of Amish men and boys were building an addition to one family's home. They declined requests to talk, expressing fears that a public airing of concerns over the polio cases could drive a wedge between neighbors.
Seventeen-year-old Alma Miller said her mother was spending the weekend at the Minneapolis hospital where the infant was staying so its parents could come home and care for their other children.
"The mothers are taking turns going down there," said Miller, who became upset when a camera was pointed toward her.
Miller said she herself had not been vaccinated and was waiting to see what her parents decide.
The last reported cases of paralytic polio in the United States were three in 1999, and three the year before that. There was a significant outbreak in 1979 in Amish communities in Iowa, Wisconsin, Missouri and Pennsylvania.
Many Amish people were vaccinated after that outbreak, said Jane Seward, chief of the viral-vaccine preventable disease unit at the Centers for Disease Control.
Until 2000, the United States used a live virus vaccine for polio -— which caused about eight cases of paralytic polio a year. The United States and Canada now use an injected vaccine made from the killed virus, but some Amish still fear that a vaccination could inadvertently infect their children with polio.
State doctors don't know the source of the recent infection. Hull said it appears to be a mutated version of a live polio vaccine, which is still used in some countries.
Health officials consider polio eliminated in the Western Hemisphere. It persists in other parts of the world, including India, Nigeria, Yemen and Pakistan, according to the World Health Organization.
Deadly bird flu confirmed in Romania's Danube delta
Laboratory tests showed on Saturday that the same deadly H5N1 strain of bird flu as that found in Turkey and Asia had infected ducks in Romania, confirming the virus had reached mainland Europe.
A British laboratory testing Romanian samples established that three birds found dead in the Danube delta last week contained the H5N1 strain, which has killed more than 60 people and caused the death of millions of birds in Asia since 2003.
The World Health Organization's top influenza expert, echoing previous warnings, said the virus could mutate into a form that could kill thousands or millions of people around the world and urged governments to prepare for such a pandemic.
But encouraging news came from China, where state media said a new, improved vaccine for birds had been developed, a low-cost spray that could protect them from the H5N1 strain of avian flu.
The spread of the virus in Asia has been blamed on backyard farms and open-air markets where humans and birds mingle in often unsanitary conditions, and authorities have been unable to wipe it out despite large-scale culling and vaccination.
In Turkey, the state Anatolian news agency reported that nearly 1,000 chickens had died in the east, near the Iranian border, after being transported from the west of the country. It said samples had been sent for tests for possible bird flu, but did not say where exactly the birds had been moved from.
A Turkish Health Ministry official said earlier that nine people under observation in hospital for possible bird flu had been allowed to go home as tests showed they were not infected.
Turkish officials also said the incubation period for the avian flu found on a farm in the northwest was over, and the danger to humans had passed.
The EU Commission in Brussels confirmed that the H5N1 strain found in Romanian ducks was exactly the same as that detected in Turkish birds. "The link has now been confirmed," Health and Consumer Protection Commissioner Markos Kyprianou said in a statement.
Kyprianou said the European Union had already banned poultry and live bird imports from Romania, so no further measures were needed. EU veterinary experts will meet on Thursday to review the situation, he added.
"TERRIBLE PANDEMIC"
Klaus Stoehr, director of the WHO influenza program, said "the virus has the potential to change and mutate and thus spark a terrible pandemic," echoing the fear of other experts that H5N1 may change into a form that spreads easily among humans.
"We don't know whether a pandemic will break out in the coming weeks, months or only in years," he told German NDR radio. "But there's no question that if such a pandemic occurs we'll be looking at hundreds of thousands or even millions of deaths worldwide."
Countries so far unaffected must assume the virus will spread further, Stoehr said. "It's not about speculating, it's about actually getting ready for an outbreak to occur, even in Europe."
In Romania, pharmacies ran out of regular flu vaccine and local media reported that worried citizens had bought up to 2 million doses of the vaccine in the past few days.
Flu vaccine protects people only against the latest strain of regular flu. Only if H5N1 mutates into a form that passes easily between humans will pharmaceutical firms be able to develop a vaccine specifically against that strain.
In Romania's southeast Danube delta area, six counties were cordoned off. Vehicles leaving the area were being disinfected at checkpoints and residents were being given antiviral drugs, officials said.
Television footage showed masked and gloved veterinarians gassing poultry and disinfecting farms in the delta village of Ceamurlia de Jos, part of a cull of more than 60,000 birds aimed at stopping the virus from spreading.
The Danube delta contains Europe's largest wetlands and is a major resting place for migratory wild birds -- the carriers of the virus -- coming from Russia, Scandinavia, Poland and Germany and heading for North Africa for winter.
Poland, responding to European Commission calls, said all poultry must be kept indoors from Monday to keep it away from migratory wild birds.
"The situation means quite a large danger for poultry in Poland, so I decided to impose some restrictions ... including a ban on keeping poultry in open spaces," Farm Minister Jerzy Pilarczyk told a news conference.
Hundreds May Have Used Botox Knockoff
Plastic surgeon Frederic Corbin was intrigued last year when he saw an ad for a product that offered the same protein used in the wildly popular wrinkle treatment Botox -— only much, much, cheaper.
"My initial reaction was, 'Hmm, Botox now has some competition,'" recalled Corbin, who practices in Beverly Hills, Calif.
But when he received a vial of the botulinum toxin in the mail, he was puzzled by the warning: "For Research Purposes Only. Not for Human Use."
He says he returned it and more or less forgot about it until he heard about four people last December whose mysterious paralysis was linked to the use of a Botox knockoff.
Authorities have found that dozens of doctors around the country bought unapproved botulinum, which in its raw form is one of the most potent neurotoxins on Earth. And investigative documents indicate that more than 1,000 people may have been injected with it, many unaware they weren't given federally approved Botox.
The company accused of selling the unapproved toxin and marketing it as a Botox substitute goes on trial next month in federal court in Fort Lauderdale, Fla.
"We don't know how dangerous it is, it's not as well controlled as the commercially available product," said Dr. Thomas Rohrer, a Boston dermatologic surgeon who has written extensively about botulinum, which he describes as more powerful than cyanide.
Tucson, Ariz.-based Toxin Research International and owners Chad Livdahl and Zarah Karim, who are jailed awaiting the trial, are accused of defrauding people who thought they were getting a safe, approved Botox treatment.
No one is known to have been hurt by TRI's toxin; the four paralyzed people were injected with a toxin bought straight from the manufacturer that supplied TRI, not from the company itself.
Eric and Bonnie Kaplan were allegedly injected by Dr. Bach McComb, who also injected himself and his girlfriend, Alma Hall. Federal prosecutors say McComb worked as a consultant for TRI.
Lawyers in the case say McComb injected himself and the others with the wrong dose. They have all partially recovered.
But last December, when McComb, Hall and the Kaplans lay paralyzed on ventilators and unable to swallow or see, investigators searching the clinic where McComb worked found marketing materials from TRI.
Although TRI hasn't been directly linked to the paralysis case, authorities say the Arizona company told other doctors its product was safe and on its way to being approved for people.
According to case documents, at least 180 doctors -— plastic surgeons, dermatologists, naturopaths -— ordered Botulinum Toxin Type A from TRI. A five-dose vial would cost $1,250, compared to about $2,000 for Botox.
TRI's lawyer Ben England said "we disagree" that TRI was acting fraudulently, and declined to elaborate.
Most doctors who bought the toxin haven't been publicly named, and officials say many patients don't know they got the unapproved toxin.
In Salem, Ore., Dr. Jerome Lentini is one the few who has been criminally charged, accused of injecting a TRI toxin into hundreds of patients, many of whom signed a consent form that implied they were getting FDA-approved Botox.
All charges against TRI involve misleading patients.
Some doctors and clinics say that's because the toxin is basically the same as what's used to make Botox.
The unapproved material "is a naturally occurring neurotoxin that ... appears to be identical," said Scott Hopes, an epidemiologist who also represents a north Florida surgery center where a doctor's license was suspended for buying the unapproved toxin.
Dr. Dale Abadir of New York City said she used it on herself and her husband. "I was interested in getting it and seeing if it worked," she said. "From what I could see it seemed to work as well as" Botox.
"Those people should think themselves very lucky," countered Dr. John Agwunobi, a U.S. Department of Health and Human Services official and former Florida health secretary.
Agwunobi and others said just because no one was injured yet, doesn't mean it won't happen in the future.
"The physicians who are buying it are just plain stupid," said Dr. Sue Ellen Cox, a dermatologic surgeon in Chapel Hill, N.C. "You could be injecting God knows what."
Expert Tips Make Raking Up Safer
Raking the leaves can provide good exercise and a chance to enjoy the autumn weather, but it can also result in back strain and sore muscles.
The Canadian Physiotherapy Association offers the following tips to keep raking risk-free:
If you have a heart condition or other medical problems, talk to your doctor before raking.
Wear well-fitting shoes with good soles that will prevent slipping.
Do stretches and warm-up exercises before you start raking.
When raking, hold the rake handle close to your body to help maintain good posture. Keep one hand near the top of the rake handle for better leverage. Use your arms and legs more than your spine when raking. Ergonomic rakes can help reduce the strain on your body.
Change sides frequently while raking and avoid twisting at the waist.
Pace yourself and take frequent breaks and/or change to a different activity.
When bagging leaves, lift manageable loads and keep your back straight and use your legs to do the lifting. If you have to stoop to pick up leaves, face the pile of leaves and don't twist as you lift.
Don't pile too many leaves into one bag -- especially if they're wet.
When you finish for the day, do cool-down exercises.
Food Fact:
Nothing fishy.
Follow a few savvy shopping tips, and seafood will be as good for your taste buds as it is for your heart. Here's what to know: Fresh fish smells good, like sea air, so walk away from a strong fishy smell or an off odor; fish fillets and steaks should look moist, with no gaps between the segments; scrub mussels and clams with a stiff-bristled brush under running water, and discard any that don't close when tapped.
Fitness Tip of the day:
Brain check.
Physical exercise may mean as much for your mind as it does for your body. Research shows exercise can relieve anxiety and depression, increase your energy levels, enhance your self-image, help release tension, and may improve sleeping patterns. Exercise also reduces your overall risk of dying prematurely and helps you control your weight.
FAQ of the day:
Can tomatoes and lycopene prevent breast cancer?
Tomatoes and lycopene probably can't protect against breast cancer, they are still a good nutritional choice for women because they'e so rich in antioxidants and vitamins. There is evidence that tomatoes may help protect men against prostate cancer.
Residents of an isolated Amish community appear divided on what to do after doctors diagnosed four cases of the polio virus in their children. Some have decided on vaccinations to ward off future polio cases, while others prefer leaving the matter in God's hands.
About two dozen Amish households dot the hillsides in central Minnesota's rolling farm country. On Thursday, state health officials announced the four polio infections -— the first known cases in the United States in five years.
The Amish community -— it has no official name -— has seen a flurry of visitors from the state Health Department after three siblings under 16 were diagnosed. Two weeks earlier, an infant from the community had been diagnosed with polio, and state doctors expect more cases to turn up.
None of the four have developed symptoms, and health officials say most polio cases do not result in paralysis. But they have urged members of the community to be immunized as soon as possible to reduce the chances the virus will spread. Only unvaccinated people are at risk.
"The doctors were here to talk to us," said Susie Borntreger, a young Amish mother who was hunting down snakes with a hoe in her yard Friday. "They talked with my husband. They told us we should think about the vaccine."
The Borntregers decided to vaccinate their two sons, aged 2 and 1. But that decision is not universal. Some Amish families here don't trust vaccinations. Borntreger was vague when asked to explain her family's thinking, saying the decision was made by her husband.
"Some people are very open, some people want to think about it, some people just say no," said Harry Hull, the state epidemiologist.
After consulting with Amish community leaders, state and county officials decided to approach families separately about vaccinations to avoid social pressures in the extremely close-knit community.
Unlike other Amish communities that cater to tourists, this small, conservative settlement in sparsely populated Todd County has little interaction with modern society. The closest town, Clarissa, has hitching posts outside stores on Main Street, but residents say their Amish neighbors keep to themselves.
"They come to town to shop," said Diane Hanson, a drug store clerk. "They're nice, friendly, but they never stick around long. I don't know any of them, and I don't know many people who do."
Many of the Amish settled here in the last five years or so, migrating from communities in Wisconsin in search of inexpensive farmland. They raise turkeys, cows and pigs and cultivate corn and wheat.
On Friday, a group of Amish men and boys were building an addition to one family's home. They declined requests to talk, expressing fears that a public airing of concerns over the polio cases could drive a wedge between neighbors.
Seventeen-year-old Alma Miller said her mother was spending the weekend at the Minneapolis hospital where the infant was staying so its parents could come home and care for their other children.
"The mothers are taking turns going down there," said Miller, who became upset when a camera was pointed toward her.
Miller said she herself had not been vaccinated and was waiting to see what her parents decide.
The last reported cases of paralytic polio in the United States were three in 1999, and three the year before that. There was a significant outbreak in 1979 in Amish communities in Iowa, Wisconsin, Missouri and Pennsylvania.
Many Amish people were vaccinated after that outbreak, said Jane Seward, chief of the viral-vaccine preventable disease unit at the Centers for Disease Control.
Until 2000, the United States used a live virus vaccine for polio -— which caused about eight cases of paralytic polio a year. The United States and Canada now use an injected vaccine made from the killed virus, but some Amish still fear that a vaccination could inadvertently infect their children with polio.
State doctors don't know the source of the recent infection. Hull said it appears to be a mutated version of a live polio vaccine, which is still used in some countries.
Health officials consider polio eliminated in the Western Hemisphere. It persists in other parts of the world, including India, Nigeria, Yemen and Pakistan, according to the World Health Organization.
Deadly bird flu confirmed in Romania's Danube delta
Laboratory tests showed on Saturday that the same deadly H5N1 strain of bird flu as that found in Turkey and Asia had infected ducks in Romania, confirming the virus had reached mainland Europe.
A British laboratory testing Romanian samples established that three birds found dead in the Danube delta last week contained the H5N1 strain, which has killed more than 60 people and caused the death of millions of birds in Asia since 2003.
The World Health Organization's top influenza expert, echoing previous warnings, said the virus could mutate into a form that could kill thousands or millions of people around the world and urged governments to prepare for such a pandemic.
But encouraging news came from China, where state media said a new, improved vaccine for birds had been developed, a low-cost spray that could protect them from the H5N1 strain of avian flu.
The spread of the virus in Asia has been blamed on backyard farms and open-air markets where humans and birds mingle in often unsanitary conditions, and authorities have been unable to wipe it out despite large-scale culling and vaccination.
In Turkey, the state Anatolian news agency reported that nearly 1,000 chickens had died in the east, near the Iranian border, after being transported from the west of the country. It said samples had been sent for tests for possible bird flu, but did not say where exactly the birds had been moved from.
A Turkish Health Ministry official said earlier that nine people under observation in hospital for possible bird flu had been allowed to go home as tests showed they were not infected.
Turkish officials also said the incubation period for the avian flu found on a farm in the northwest was over, and the danger to humans had passed.
The EU Commission in Brussels confirmed that the H5N1 strain found in Romanian ducks was exactly the same as that detected in Turkish birds. "The link has now been confirmed," Health and Consumer Protection Commissioner Markos Kyprianou said in a statement.
Kyprianou said the European Union had already banned poultry and live bird imports from Romania, so no further measures were needed. EU veterinary experts will meet on Thursday to review the situation, he added.
"TERRIBLE PANDEMIC"
Klaus Stoehr, director of the WHO influenza program, said "the virus has the potential to change and mutate and thus spark a terrible pandemic," echoing the fear of other experts that H5N1 may change into a form that spreads easily among humans.
"We don't know whether a pandemic will break out in the coming weeks, months or only in years," he told German NDR radio. "But there's no question that if such a pandemic occurs we'll be looking at hundreds of thousands or even millions of deaths worldwide."
Countries so far unaffected must assume the virus will spread further, Stoehr said. "It's not about speculating, it's about actually getting ready for an outbreak to occur, even in Europe."
In Romania, pharmacies ran out of regular flu vaccine and local media reported that worried citizens had bought up to 2 million doses of the vaccine in the past few days.
Flu vaccine protects people only against the latest strain of regular flu. Only if H5N1 mutates into a form that passes easily between humans will pharmaceutical firms be able to develop a vaccine specifically against that strain.
In Romania's southeast Danube delta area, six counties were cordoned off. Vehicles leaving the area were being disinfected at checkpoints and residents were being given antiviral drugs, officials said.
Television footage showed masked and gloved veterinarians gassing poultry and disinfecting farms in the delta village of Ceamurlia de Jos, part of a cull of more than 60,000 birds aimed at stopping the virus from spreading.
The Danube delta contains Europe's largest wetlands and is a major resting place for migratory wild birds -- the carriers of the virus -- coming from Russia, Scandinavia, Poland and Germany and heading for North Africa for winter.
Poland, responding to European Commission calls, said all poultry must be kept indoors from Monday to keep it away from migratory wild birds.
"The situation means quite a large danger for poultry in Poland, so I decided to impose some restrictions ... including a ban on keeping poultry in open spaces," Farm Minister Jerzy Pilarczyk told a news conference.
Hundreds May Have Used Botox Knockoff
Plastic surgeon Frederic Corbin was intrigued last year when he saw an ad for a product that offered the same protein used in the wildly popular wrinkle treatment Botox -— only much, much, cheaper.
"My initial reaction was, 'Hmm, Botox now has some competition,'" recalled Corbin, who practices in Beverly Hills, Calif.
But when he received a vial of the botulinum toxin in the mail, he was puzzled by the warning: "For Research Purposes Only. Not for Human Use."
He says he returned it and more or less forgot about it until he heard about four people last December whose mysterious paralysis was linked to the use of a Botox knockoff.
Authorities have found that dozens of doctors around the country bought unapproved botulinum, which in its raw form is one of the most potent neurotoxins on Earth. And investigative documents indicate that more than 1,000 people may have been injected with it, many unaware they weren't given federally approved Botox.
The company accused of selling the unapproved toxin and marketing it as a Botox substitute goes on trial next month in federal court in Fort Lauderdale, Fla.
"We don't know how dangerous it is, it's not as well controlled as the commercially available product," said Dr. Thomas Rohrer, a Boston dermatologic surgeon who has written extensively about botulinum, which he describes as more powerful than cyanide.
Tucson, Ariz.-based Toxin Research International and owners Chad Livdahl and Zarah Karim, who are jailed awaiting the trial, are accused of defrauding people who thought they were getting a safe, approved Botox treatment.
No one is known to have been hurt by TRI's toxin; the four paralyzed people were injected with a toxin bought straight from the manufacturer that supplied TRI, not from the company itself.
Eric and Bonnie Kaplan were allegedly injected by Dr. Bach McComb, who also injected himself and his girlfriend, Alma Hall. Federal prosecutors say McComb worked as a consultant for TRI.
Lawyers in the case say McComb injected himself and the others with the wrong dose. They have all partially recovered.
But last December, when McComb, Hall and the Kaplans lay paralyzed on ventilators and unable to swallow or see, investigators searching the clinic where McComb worked found marketing materials from TRI.
Although TRI hasn't been directly linked to the paralysis case, authorities say the Arizona company told other doctors its product was safe and on its way to being approved for people.
According to case documents, at least 180 doctors -— plastic surgeons, dermatologists, naturopaths -— ordered Botulinum Toxin Type A from TRI. A five-dose vial would cost $1,250, compared to about $2,000 for Botox.
TRI's lawyer Ben England said "we disagree" that TRI was acting fraudulently, and declined to elaborate.
Most doctors who bought the toxin haven't been publicly named, and officials say many patients don't know they got the unapproved toxin.
In Salem, Ore., Dr. Jerome Lentini is one the few who has been criminally charged, accused of injecting a TRI toxin into hundreds of patients, many of whom signed a consent form that implied they were getting FDA-approved Botox.
All charges against TRI involve misleading patients.
Some doctors and clinics say that's because the toxin is basically the same as what's used to make Botox.
The unapproved material "is a naturally occurring neurotoxin that ... appears to be identical," said Scott Hopes, an epidemiologist who also represents a north Florida surgery center where a doctor's license was suspended for buying the unapproved toxin.
Dr. Dale Abadir of New York City said she used it on herself and her husband. "I was interested in getting it and seeing if it worked," she said. "From what I could see it seemed to work as well as" Botox.
"Those people should think themselves very lucky," countered Dr. John Agwunobi, a U.S. Department of Health and Human Services official and former Florida health secretary.
Agwunobi and others said just because no one was injured yet, doesn't mean it won't happen in the future.
"The physicians who are buying it are just plain stupid," said Dr. Sue Ellen Cox, a dermatologic surgeon in Chapel Hill, N.C. "You could be injecting God knows what."
Expert Tips Make Raking Up Safer
Raking the leaves can provide good exercise and a chance to enjoy the autumn weather, but it can also result in back strain and sore muscles.
The Canadian Physiotherapy Association offers the following tips to keep raking risk-free:
If you have a heart condition or other medical problems, talk to your doctor before raking.
Wear well-fitting shoes with good soles that will prevent slipping.
Do stretches and warm-up exercises before you start raking.
When raking, hold the rake handle close to your body to help maintain good posture. Keep one hand near the top of the rake handle for better leverage. Use your arms and legs more than your spine when raking. Ergonomic rakes can help reduce the strain on your body.
Change sides frequently while raking and avoid twisting at the waist.
Pace yourself and take frequent breaks and/or change to a different activity.
When bagging leaves, lift manageable loads and keep your back straight and use your legs to do the lifting. If you have to stoop to pick up leaves, face the pile of leaves and don't twist as you lift.
Don't pile too many leaves into one bag -- especially if they're wet.
When you finish for the day, do cool-down exercises.
Food Fact:
Nothing fishy.
Follow a few savvy shopping tips, and seafood will be as good for your taste buds as it is for your heart. Here's what to know: Fresh fish smells good, like sea air, so walk away from a strong fishy smell or an off odor; fish fillets and steaks should look moist, with no gaps between the segments; scrub mussels and clams with a stiff-bristled brush under running water, and discard any that don't close when tapped.
Fitness Tip of the day:
Brain check.
Physical exercise may mean as much for your mind as it does for your body. Research shows exercise can relieve anxiety and depression, increase your energy levels, enhance your self-image, help release tension, and may improve sleeping patterns. Exercise also reduces your overall risk of dying prematurely and helps you control your weight.
FAQ of the day:
Can tomatoes and lycopene prevent breast cancer?
Tomatoes and lycopene probably can't protect against breast cancer, they are still a good nutritional choice for women because they'e so rich in antioxidants and vitamins. There is evidence that tomatoes may help protect men against prostate cancer.
Saturday, October 15, 2005
Halloween Safety Tips
I'd like to remind everyone that Halloween is just weeks away. And while children are thinking about costumes, candy gathering and fun with their friends - adults must focus on making Halloween safe for them.
Parents are encouraged to accompany their children as they go trick or treating and only go to homes of friends and family. It is always recommended to check your child's treat bag and candy before allowing your child to eat the treats collected during the evening. Throw away homemade or non-wrapped treats.
The most common cause of injuries on Halloween night are due to falls from tripping on the hems of costumes, as well as steps, curbs or unseen objects.
Parents can help their children enjoy a safe Halloween by following these tips. In fact, it is recommended that parents go over these safety procedures with their children ahead of time.
􀂙 Make sure costumes fit properly and are short enough to avoid tripping over them.
􀂙 Use face paint or make up instead of masks that can obstruct vision.
􀂙 If using a mask, cut eye holes large enough to allow full vision.
􀂙 Wear shoes that fit well and are easy to walk in.
􀂙 Decorate costumes and treat bags with reflective tape to help make trick or treaters more visible to motorists.
􀂙 Have an adult or older child accompany youngsters.
􀂙 Buy costumes and wigs labeled flame resistant.
􀂙 Stay in your own neighborhood.
􀂙 Trick or treat at homes you know with porch lights on.
􀂙 Never go to a stranger's house.
􀂙 Stop and look both ways before crossing the street, and always cross at corners.
􀂙 Use a flashlight to ensure safe walking and to be more visible.
􀂙 Have parents inspect all treats before they are eaten.
􀂙 Discard any unwrapped treats.
􀂙 Offer a healthy alternative to candy such as individually wrapped raisins or trail mix.
􀂙 Keep small candies and peanuts away from younger children. They may choke on the small pieces.
􀂙 Drive slowly through neighborhoods and be especially careful on side streets.
Parents are encouraged to accompany their children as they go trick or treating and only go to homes of friends and family. It is always recommended to check your child's treat bag and candy before allowing your child to eat the treats collected during the evening. Throw away homemade or non-wrapped treats.
The most common cause of injuries on Halloween night are due to falls from tripping on the hems of costumes, as well as steps, curbs or unseen objects.
Parents can help their children enjoy a safe Halloween by following these tips. In fact, it is recommended that parents go over these safety procedures with their children ahead of time.
􀂙 Make sure costumes fit properly and are short enough to avoid tripping over them.
􀂙 Use face paint or make up instead of masks that can obstruct vision.
􀂙 If using a mask, cut eye holes large enough to allow full vision.
􀂙 Wear shoes that fit well and are easy to walk in.
􀂙 Decorate costumes and treat bags with reflective tape to help make trick or treaters more visible to motorists.
􀂙 Have an adult or older child accompany youngsters.
􀂙 Buy costumes and wigs labeled flame resistant.
􀂙 Stay in your own neighborhood.
􀂙 Trick or treat at homes you know with porch lights on.
􀂙 Never go to a stranger's house.
􀂙 Stop and look both ways before crossing the street, and always cross at corners.
􀂙 Use a flashlight to ensure safe walking and to be more visible.
􀂙 Have parents inspect all treats before they are eaten.
􀂙 Discard any unwrapped treats.
􀂙 Offer a healthy alternative to candy such as individually wrapped raisins or trail mix.
􀂙 Keep small candies and peanuts away from younger children. They may choke on the small pieces.
􀂙 Drive slowly through neighborhoods and be especially careful on side streets.
Health Headlines - October 15
Patients Complain About Medicare Changes
Officially, former tug boat captain Lawrence Michalski died of cardio-respiratory disease last month at his Seminole, Fla., home. Unofficially, his wife and some doctors say the 67-year-old man died in part because changes in Medicare funding left him scrambling to find a particular drug treatment that many health care providers say they can no longer afford to give needy patients.
The case has become a flashpoint in an argument over thousands of Medicare patients suffering from rare immune disorders and other illnesses that can be treated with intravenous immune globulin, or IVIG.
Immune globulin is a mixture of antibodies, infection-fighting proteins that healthy people normally have in their bloodstreams. Given intravenously, it is used mainly by the 50,000 Americans who suffer primary immunodeficiency, 7,000 of whom receive Medicare.
IVIG has also been given to multiple sclerosis or nerve damage patients for whom other treatments have been unsuccessful. It has recently been studied as a possible treatment for Alzheimer's disease.
Until recently, most patients could get monthly IVIG treatments at their doctors' offices. IVIG restores the strength of patients whose immune systems are so weak they would otherwise be vulnerable to many infections or illnesses.
At the start of the year, after Medicare cut the IVIG reimbursements for doctors from $66 per gram to $39 a gram for powdered brands, many stopped providing the treatment. Michalski and his wife Angelina scrambled to get IVIG from local hospitals, who are slated to get a similar cut next year.
Angelina Michalski said a four-week delay in her husband's IVIG treatment is partly responsible for his death.
"I had to fight every month to get the medicine, and everyone was saying they can't afford to get it for us," said Angelina. "It started with a scratch on his hand, and then he had a fever, and then he needed surgery."
Michalski died Sept. 15.
Now, doctors who treat such patients are warning that another scheduled cut in IVIG reimbursements, one that would apply to hospitals starting in January, will result in even fewer Medicare patients receiving effective treatment.
"If that happens, a lot of patients aren't going to be able to get IVIG at all, and that will essentially kill some patients," said Dr. Mark Davis-Lorton, director of Clinical Immunology at Winthrop-University Hospital in Mineola, N.Y.
Health advocates first raised alarms in the spring when doctors stopped offering the treatments, arguing they were seeing dangerous shortages.
The Department of Health and Human Services investigated the complaints, and declared in August that there was no shortage. Medicare officials still insist the payment changes have not led to a lack of treatment or scarcity of the drug.
"There are a variety of factors going on in the marketplace, so I don't think you can say the Medicare change in pricing is in itself creating a single reason why individuals say they are not getting their treatment," said Herb Kuhn, director of the Center for Medicare Management.
Part of the problem, Kuhn said, is that IVIG is being used to treat all sorts of health disorders, and that may be siphoning supply away from those who need it most.
Kuhn also said hospitals would not stop offering IVIG treatment once the reduced reimbursement rate goes into effect.
"Manufacturers are working very hard to make sure they're getting the product into the hands of suppliers," said Kuhn, adding that the recent problems with IVIG were a matter of "the market being out of equilibrium," and adding that equilibrium is now being restored.
Rep. Steve Israel, D-N.Y., blamed "an absolutely appalling lack of priorities" in government.
"If we don't stop cutting these Medicare reimbursements, the only people who will be able to afford these treatments will be wealthy people," said Israel, who is trying to rally support in Congress for IVIG patients.
Shirley Peters, a 71-year-old in Palm Beach Gardens, Fla., receives regular IVIG treatments at a hospital for her immunodeficiency, but fears fewer hospitals will offer the treatment next year.
"It's disgusting. What do they expect us to do?" she said. "Are we supposed to just get sicker and sicker until we pass away?"
Health Official Warns of Bird Flu Pandemic
Health and Human Services Secretary Mike Leavitt finished up a four-country tour of Southeast Asia a week after officials from 80 countries met in Washington to discuss how to prevent and contain a potential global health threat.
After watching chickens and ducks being gutted and cleaned on the sidewalk, Leavitt said it would be difficult to change behavior that is a regular part of people's lives.
"It's evident to me that part of the dilemma here is the cultural momentum because it's happened for hundreds of years, and the chances of changing it anytime soon are very low," he said while walking through the open-air market. "It adds obviously to the equation and to the possibility that you will see an outbreak at some point."
During Leavitt's Southeast Asian trip, which also included stops in Thailand, Cambodia and Laos, he has repeatedly warned of a potential flu pandemic and the importance of all countries rallying together to quickly come up with preparedness plans. The deadly H5N1 bird flu virus was confirmed in birds in Turkey this week.
The disease has hit Vietnam harder than any other country, killing 43 people and 45 million birds, decimating the flocks of poor farmers.
Health experts have warned that the world is due for the next pandemic and fear that the H5N1 virus could mutate into a form that is easily passed among people.
Leavitt on Saturday compared the spread of a pandemic to a brush fire, and said the "chances are not good" of being able to monitor the "spark" when a virus mutates and then quickly contain it.
"There is a spark where every fire starts, and if you're able to be there at the moment it occurs it's possible to simply stamp it out," he said. "If you allow it to burn for an hour, often it will gain enough momentum that it's uncontainable and begins to start other fires."
The U.S. has committed $25 million to address the threat in Asia, and Vietnam will receive more than $6 million for preparedness.
Leavitt was traveling with U.S. Centers for Disease Control and Prevention Director Dr. Julie Gerberding, U.S. National Institute of Allergy and Infectious Diseases Director Dr. Anthony S. Fauci, and Margaret Chan, the World Health Organization's top official in charge of monitoring avian influenza.
Fauci said the potential severity of a bird flu pandemic remains "extraordinarily variable."
"We as public health officials ... must assume the worst-case scenario, and H5N1 now is giving us a lot of signs that it is becoming a little bit more worrisome, if not a lot more worrisome, because of the events that are going on," he said.
Two of the last three global pandemics, all in the 20th century, originated in Asia.
The Asian flu of 1957-58 and the Hong Kong flu of 1968-69 each killed more than 1 million people. Neither compared to the Spanish flu of 1918-19, which killed up to 40 million people and sickened an estimated 20 percent to 40 percent of the world's population.
So far, most human cases have been linked to contact with birds. More than 60 people have died from the virus in Southeast Asia since the disease began ravaging poultry stocks in the region two years ago.
Adult Obesity May Trace to Infancy
Big babies who grow quickly in the first two years of life risk being obese in childhood and adulthood, British researchers report.
As obesity reaches epidemic proportions in the United States -- 30 percent of adults are obese and 65 percent are obese or overweight -- researchers are looking for keys to prevent it. Those efforts may need to begin in childhood, the researchers said.
"Levels of obesity are increasing in the population, and halting the rising prevalence of obesity is a public health priority," said study lead author Dr. Janis Baird, a research fellow at the MRC Epidemiology Resource Centre at the University of Southampton.
"It is not clear how early prevention can begin," she added.
To determine whether obesity may begin in infancy, Baird and her colleagues looked at 24 studies that found a relationship between infant size or growth during the first two years of life and obesity later in life.
They found that the heaviest infants and those who gained weight rapidly during the first and second year of life faced a nine-fold greater risk of obesity in childhood, adolescence, and adulthood.
"These findings suggest that factors in infant growth are probably influencing the risk of later obesity," Baird said. "There are many factors that do influence infant growth. What's needed now are much more detailed studies to look at how infants grow and what the predictors of their growth are."
The study findings appear in the Oct. 14 online edition of the British Medical Journal.
One expert believes that nurture, more than nature, is responsible for the rise in obesity among children.
"If people take this too seriously, people may start calorie-restricting their infants, which is a bad thing," said Dr. Dennis Woo, chairman of the pediatrics department at Santa Monica-UCLA Medical Center, in California.
According to Woo, children regulate their own calorie intake.
"A lot of kids eat what they want to eat, and they do a pretty good job of regulating their weight and height balance. There are some kids who grow rapidly in the first year, but then they go through a phase where they become picky as far as their eating goes," added Woo, who's also an assistant clinical professor of pediatrics at the University of California, Los Angeles David Geffen School of Medicine.
Woo advises parents to let infants eat what they want to eat and not force them to eat during the time they are picky about eating. "We are fighting the cultural belief that fat babies are healthy babies," Woo said. "So people like to fatten their kids up."
Many parents also believe fat babies are fine because they slim down when they are older, Woo said. "That doesn't always happen. People use that as a rationale for really stuffing their kids."
"There is nothing wrong with a baby being heavy as an infant as long as he's regulating his own eating," Woo said. "There will come a time when he will not be growing and he will cut down on his eating. Most of the time, those are the big babies who then slim down."
Woo believes healthy eating habits begin in infancy.
"We want to teach all kids healthy eating habits right from the very beginning," he said. "We need to shape how people look at eating. Because infants don't have the psychological cues that adults have, they respond to their biological needs. We could actually learn from infants about how to eat."
Interferon-Linked Protein Key to HIV Vaccine
Scientists say a newly discovered cellular pathway could pave the way for a new type of vaccine against HIV, the virus that causes AIDS.
According to background information, disease progression after HIV infection is associated with the decreased presence of plasmacytoid dendritic cells (pDCs), major producers of an immune protein called type 1 interferon. According to researchers at New York University (NYU), high numbers of pDCs are related to successful control of HIV, the virus that causes AIDS.
The new study, published in the Oct. 13 online issue of the Journal of Clinical Investigation, outlines the mechanisms by which HIV-1 activates human pDCs. This activation requires at least two interactions between the HIV and pDCs, the NYU team explains.
The study noted that a decrease of blood pDC is frequently observed in chronic infections suffered by people with HIV. This decrease of blood pDC correlates with high viral load, reduced CD4 counts and susceptibility to opportunistic infections.
By identifying the active component of HIV-1 that stimulates pDC function, the researchers believe they have pinpointed an important pathway that may prove a useful target in the development of HIV vaccines or immunotherapies.
Food Fact:
Fish: Good fat vs. bad.
In seafood, it's key to know which fat can help your heart -- and which can hurt it. The fat in seafood is the kind you want to eat -- even in a low-fat diet. A "fatty" fish still has less fat than the "leanest" red meat. Better yet, the fat in fish helps prevent heart attacks. For maximum benefit, resist the urge to cook your seafood in butter, or ordering it fried out -- almost all oils used for commercial frying contain artery-clogging fats. Cook seafood at home with small amounts of canola or olive oil -- or no added fat.
Fitness Tip of the day:
Make a cardio-commute.
You're going to work anyway -- be creative, and you can squeeze in a little effortless exercise on the way. In the morning, walk or ride your bike to the train station or bus stop, or hop off the bus a few blocks from your normal stop and walk the rest of the way. At work, try talking the talk as you walk the walk. Suggest to your boss that you take your brainstorming sessions outside for a walk around the block or a stroll through the halls.
FAQ of the day:
Are fish-oil pills better for me than eating fish?
While fish-oil pills contain the same heart-healthy omega-3 fatty acids as seafood, they also add fat and calories to your diet, which may defeat the purpose. When you eat fish or shellfish, it often means you're not eating high-fat foods, such as burgers, you might otherwise have chosen at that meal. If you can't stand fish and want to explore taking a fish-oil supplement, check with your doctor first.
Officially, former tug boat captain Lawrence Michalski died of cardio-respiratory disease last month at his Seminole, Fla., home. Unofficially, his wife and some doctors say the 67-year-old man died in part because changes in Medicare funding left him scrambling to find a particular drug treatment that many health care providers say they can no longer afford to give needy patients.
The case has become a flashpoint in an argument over thousands of Medicare patients suffering from rare immune disorders and other illnesses that can be treated with intravenous immune globulin, or IVIG.
Immune globulin is a mixture of antibodies, infection-fighting proteins that healthy people normally have in their bloodstreams. Given intravenously, it is used mainly by the 50,000 Americans who suffer primary immunodeficiency, 7,000 of whom receive Medicare.
IVIG has also been given to multiple sclerosis or nerve damage patients for whom other treatments have been unsuccessful. It has recently been studied as a possible treatment for Alzheimer's disease.
Until recently, most patients could get monthly IVIG treatments at their doctors' offices. IVIG restores the strength of patients whose immune systems are so weak they would otherwise be vulnerable to many infections or illnesses.
At the start of the year, after Medicare cut the IVIG reimbursements for doctors from $66 per gram to $39 a gram for powdered brands, many stopped providing the treatment. Michalski and his wife Angelina scrambled to get IVIG from local hospitals, who are slated to get a similar cut next year.
Angelina Michalski said a four-week delay in her husband's IVIG treatment is partly responsible for his death.
"I had to fight every month to get the medicine, and everyone was saying they can't afford to get it for us," said Angelina. "It started with a scratch on his hand, and then he had a fever, and then he needed surgery."
Michalski died Sept. 15.
Now, doctors who treat such patients are warning that another scheduled cut in IVIG reimbursements, one that would apply to hospitals starting in January, will result in even fewer Medicare patients receiving effective treatment.
"If that happens, a lot of patients aren't going to be able to get IVIG at all, and that will essentially kill some patients," said Dr. Mark Davis-Lorton, director of Clinical Immunology at Winthrop-University Hospital in Mineola, N.Y.
Health advocates first raised alarms in the spring when doctors stopped offering the treatments, arguing they were seeing dangerous shortages.
The Department of Health and Human Services investigated the complaints, and declared in August that there was no shortage. Medicare officials still insist the payment changes have not led to a lack of treatment or scarcity of the drug.
"There are a variety of factors going on in the marketplace, so I don't think you can say the Medicare change in pricing is in itself creating a single reason why individuals say they are not getting their treatment," said Herb Kuhn, director of the Center for Medicare Management.
Part of the problem, Kuhn said, is that IVIG is being used to treat all sorts of health disorders, and that may be siphoning supply away from those who need it most.
Kuhn also said hospitals would not stop offering IVIG treatment once the reduced reimbursement rate goes into effect.
"Manufacturers are working very hard to make sure they're getting the product into the hands of suppliers," said Kuhn, adding that the recent problems with IVIG were a matter of "the market being out of equilibrium," and adding that equilibrium is now being restored.
Rep. Steve Israel, D-N.Y., blamed "an absolutely appalling lack of priorities" in government.
"If we don't stop cutting these Medicare reimbursements, the only people who will be able to afford these treatments will be wealthy people," said Israel, who is trying to rally support in Congress for IVIG patients.
Shirley Peters, a 71-year-old in Palm Beach Gardens, Fla., receives regular IVIG treatments at a hospital for her immunodeficiency, but fears fewer hospitals will offer the treatment next year.
"It's disgusting. What do they expect us to do?" she said. "Are we supposed to just get sicker and sicker until we pass away?"
Health Official Warns of Bird Flu Pandemic
Health and Human Services Secretary Mike Leavitt finished up a four-country tour of Southeast Asia a week after officials from 80 countries met in Washington to discuss how to prevent and contain a potential global health threat.
After watching chickens and ducks being gutted and cleaned on the sidewalk, Leavitt said it would be difficult to change behavior that is a regular part of people's lives.
"It's evident to me that part of the dilemma here is the cultural momentum because it's happened for hundreds of years, and the chances of changing it anytime soon are very low," he said while walking through the open-air market. "It adds obviously to the equation and to the possibility that you will see an outbreak at some point."
During Leavitt's Southeast Asian trip, which also included stops in Thailand, Cambodia and Laos, he has repeatedly warned of a potential flu pandemic and the importance of all countries rallying together to quickly come up with preparedness plans. The deadly H5N1 bird flu virus was confirmed in birds in Turkey this week.
The disease has hit Vietnam harder than any other country, killing 43 people and 45 million birds, decimating the flocks of poor farmers.
Health experts have warned that the world is due for the next pandemic and fear that the H5N1 virus could mutate into a form that is easily passed among people.
Leavitt on Saturday compared the spread of a pandemic to a brush fire, and said the "chances are not good" of being able to monitor the "spark" when a virus mutates and then quickly contain it.
"There is a spark where every fire starts, and if you're able to be there at the moment it occurs it's possible to simply stamp it out," he said. "If you allow it to burn for an hour, often it will gain enough momentum that it's uncontainable and begins to start other fires."
The U.S. has committed $25 million to address the threat in Asia, and Vietnam will receive more than $6 million for preparedness.
Leavitt was traveling with U.S. Centers for Disease Control and Prevention Director Dr. Julie Gerberding, U.S. National Institute of Allergy and Infectious Diseases Director Dr. Anthony S. Fauci, and Margaret Chan, the World Health Organization's top official in charge of monitoring avian influenza.
Fauci said the potential severity of a bird flu pandemic remains "extraordinarily variable."
"We as public health officials ... must assume the worst-case scenario, and H5N1 now is giving us a lot of signs that it is becoming a little bit more worrisome, if not a lot more worrisome, because of the events that are going on," he said.
Two of the last three global pandemics, all in the 20th century, originated in Asia.
The Asian flu of 1957-58 and the Hong Kong flu of 1968-69 each killed more than 1 million people. Neither compared to the Spanish flu of 1918-19, which killed up to 40 million people and sickened an estimated 20 percent to 40 percent of the world's population.
So far, most human cases have been linked to contact with birds. More than 60 people have died from the virus in Southeast Asia since the disease began ravaging poultry stocks in the region two years ago.
Adult Obesity May Trace to Infancy
Big babies who grow quickly in the first two years of life risk being obese in childhood and adulthood, British researchers report.
As obesity reaches epidemic proportions in the United States -- 30 percent of adults are obese and 65 percent are obese or overweight -- researchers are looking for keys to prevent it. Those efforts may need to begin in childhood, the researchers said.
"Levels of obesity are increasing in the population, and halting the rising prevalence of obesity is a public health priority," said study lead author Dr. Janis Baird, a research fellow at the MRC Epidemiology Resource Centre at the University of Southampton.
"It is not clear how early prevention can begin," she added.
To determine whether obesity may begin in infancy, Baird and her colleagues looked at 24 studies that found a relationship between infant size or growth during the first two years of life and obesity later in life.
They found that the heaviest infants and those who gained weight rapidly during the first and second year of life faced a nine-fold greater risk of obesity in childhood, adolescence, and adulthood.
"These findings suggest that factors in infant growth are probably influencing the risk of later obesity," Baird said. "There are many factors that do influence infant growth. What's needed now are much more detailed studies to look at how infants grow and what the predictors of their growth are."
The study findings appear in the Oct. 14 online edition of the British Medical Journal.
One expert believes that nurture, more than nature, is responsible for the rise in obesity among children.
"If people take this too seriously, people may start calorie-restricting their infants, which is a bad thing," said Dr. Dennis Woo, chairman of the pediatrics department at Santa Monica-UCLA Medical Center, in California.
According to Woo, children regulate their own calorie intake.
"A lot of kids eat what they want to eat, and they do a pretty good job of regulating their weight and height balance. There are some kids who grow rapidly in the first year, but then they go through a phase where they become picky as far as their eating goes," added Woo, who's also an assistant clinical professor of pediatrics at the University of California, Los Angeles David Geffen School of Medicine.
Woo advises parents to let infants eat what they want to eat and not force them to eat during the time they are picky about eating. "We are fighting the cultural belief that fat babies are healthy babies," Woo said. "So people like to fatten their kids up."
Many parents also believe fat babies are fine because they slim down when they are older, Woo said. "That doesn't always happen. People use that as a rationale for really stuffing their kids."
"There is nothing wrong with a baby being heavy as an infant as long as he's regulating his own eating," Woo said. "There will come a time when he will not be growing and he will cut down on his eating. Most of the time, those are the big babies who then slim down."
Woo believes healthy eating habits begin in infancy.
"We want to teach all kids healthy eating habits right from the very beginning," he said. "We need to shape how people look at eating. Because infants don't have the psychological cues that adults have, they respond to their biological needs. We could actually learn from infants about how to eat."
Interferon-Linked Protein Key to HIV Vaccine
Scientists say a newly discovered cellular pathway could pave the way for a new type of vaccine against HIV, the virus that causes AIDS.
According to background information, disease progression after HIV infection is associated with the decreased presence of plasmacytoid dendritic cells (pDCs), major producers of an immune protein called type 1 interferon. According to researchers at New York University (NYU), high numbers of pDCs are related to successful control of HIV, the virus that causes AIDS.
The new study, published in the Oct. 13 online issue of the Journal of Clinical Investigation, outlines the mechanisms by which HIV-1 activates human pDCs. This activation requires at least two interactions between the HIV and pDCs, the NYU team explains.
The study noted that a decrease of blood pDC is frequently observed in chronic infections suffered by people with HIV. This decrease of blood pDC correlates with high viral load, reduced CD4 counts and susceptibility to opportunistic infections.
By identifying the active component of HIV-1 that stimulates pDC function, the researchers believe they have pinpointed an important pathway that may prove a useful target in the development of HIV vaccines or immunotherapies.
Food Fact:
Fish: Good fat vs. bad.
In seafood, it's key to know which fat can help your heart -- and which can hurt it. The fat in seafood is the kind you want to eat -- even in a low-fat diet. A "fatty" fish still has less fat than the "leanest" red meat. Better yet, the fat in fish helps prevent heart attacks. For maximum benefit, resist the urge to cook your seafood in butter, or ordering it fried out -- almost all oils used for commercial frying contain artery-clogging fats. Cook seafood at home with small amounts of canola or olive oil -- or no added fat.
Fitness Tip of the day:
Make a cardio-commute.
You're going to work anyway -- be creative, and you can squeeze in a little effortless exercise on the way. In the morning, walk or ride your bike to the train station or bus stop, or hop off the bus a few blocks from your normal stop and walk the rest of the way. At work, try talking the talk as you walk the walk. Suggest to your boss that you take your brainstorming sessions outside for a walk around the block or a stroll through the halls.
FAQ of the day:
Are fish-oil pills better for me than eating fish?
While fish-oil pills contain the same heart-healthy omega-3 fatty acids as seafood, they also add fat and calories to your diet, which may defeat the purpose. When you eat fish or shellfish, it often means you're not eating high-fat foods, such as burgers, you might otherwise have chosen at that meal. If you can't stand fish and want to explore taking a fish-oil supplement, check with your doctor first.
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