8 Is Plenty: Mother Gives Birth to Octuplets
“We were fortunate that this patient was extremely strong, very courageous and able to handle these births,” said Dr. Karen E. Maples, who is chief of service for obstetrics and gynecology at Kaiser Permanente Bellflower Medical Center and delivered Baby No. 8.
No pictures of the children were released, and at the mothers request doctors declined to reveal her name, any information about her family or whether she took fertility drugs before becoming pregnant, though outside experts said it is almost certain she did.
The chances of delivering eight babies naturally are “unbelievably rare,” said Dr. Richard Paulson, director of the fertility program at the University of Southern California.
The babies have not been named yet, and the staff assigned them letters A through H in the meantime. They were expected to remain hospitalized for several weeks and could face serious developmental problems later on because of their small size.
“They are doing amazingly well at this time,” said Dr. Mandhir Gupta, a neonatologist who was part of the team of 46 doctors, nurses and others who took part in the cesarean section delivery. But he added: “I wont be able to comment on chances of survival because weve never had eight babies born at 30 weeks before.”
The odds of survival drop off dramatically in multiple births, particularly if there are more than three babies. The risks include breathing and eating difficulties and growth problems because their lungs and other systems are often underdeveloped. They also may have hearing or vision problems and learning disabilities as they mature.
In fact, the risks in multiple births are so high that when a woman is pregnant with more than three babies, doctors routinely recommend “selective reduction,” or aborting some of them. But Dr. Harold M. Henry, director of maternal-fetal medicine for the hospital, would not discuss what took place in this case.
The babies were still in incubators and their mother had not been able to hold them yet. Three had oxygen tubes up their noses to help them breathe. The first four were expected to begin taking milk sometime Tuesday, with the others shortly after that.
“Thats the biggest test,” Gupta said. “We want to make sure that they start tolerating and digesting the milk.”
The woman and her doctors were actually expecting seven children, not eight. The delivery team was thinking the hard work was over after that seventh baby was removed from the womb, when another physician spotted another little hand, Maples said.
The mother reacted calmly to the news, said Dr. Jalil Riazi, an anesthesiologist. “Her question was, Really, an eighth baby? How did we miss that baby?” he said.
As word of the births spread people began to call with offers of cribs, strollers, baby clothes and other items, said hospital spokeswoman Carmen Gonzalez.
“Were compiling a list of things that people want to donate,” she said, adding the mother will review the list and decide what she needs.
The worlds first live octuplets were born in 1967 in Mexico City, but all died within 14 hours, according to Encyclopedia Britannica.
The United States first live octuplets were born in Houston in 1998, three months premature. The tiniest died a week after the birth. The surviving siblings turned 10 in December and were reported to be doing well by their mother.
“Its wonderful watching them be together. They are happy to have each other. Theyre doing their homework right now,” Nkem Chukwu said Monday.
Source: dctms
In Peanut Checks, Gaps For Salmonella to Sneak By
As health officials scramble to limit the effects of the latest outbreak, food safety advocates have renewed calls for increased testing at peanut processing plants. Its a costly and time-consuming proposition for an inspection process that, as an Associated Press review of state and federal procedures shows, already suffers from a lack of manpower and transparency, and from uncertainty over how much testing is enough.
Peanut butter had long been considered a relatively low risk for salmonella because roasting the peanuts properly kills the bacteria, and because peanut butters low moisture content makes it a less fertile breeding ground for the virus than other foods, such as poultry or lunch meats.
There is no federal law that mandates the number of inspections that must be carried out each year at peanut processing facilities. The Food and Drug Administration contracts with states to perform inspections but allows them broad discretion when it comes to how they do them. The agency asks the states to base the frequency and nature of inspections on how risky a food is considered, giving priority to high-risk foods.
The states, in turn, rely on the companies to police themselves between infrequent visits from state inspectors. And a number of leading peanut butter companies wont specify what they do to keep their products from being contaminated.
Jif maker J.M. Smucker Co., Skippy manufacturer Unilever and ConAgra Foods Inc., which makes Peter Pan, all said they have stringent food safety and quality control standards. But neither Unilever or ConAgra responded to the APs questions about how often the plants test their finished product for foodborne illnesses or other contamination. Smuckers said it couldnt answer those questions for proprietary reasons.
None of those manufacturers is implicated in the current salmonella outbreak.
Authorities reassessed peanut butters risk level in 2007, when salmonella was found in Peter Pan and Great Value peanut butters made at a plant operated by ConAgra in south Georgia. ConAgra officials later said jars were contaminated when moisture from a roof leak during a rainstorm and a malfunctioning sprinkler system mixed with dormant salmonella bacteria in the plant.
The FDA still considers peanut butter a low-risk food, though after the ConAgra outbreak, Georgia Agriculture Commissioner Tommy Irvin ordered state inspectors to start routinely testing peanut butter for salmonella.
This month, a facility in Blakely, a rural Georgia town that calls itself the “Peanut Capital of the World” and is an hour or so drive from the ConAgra plant, found itself at the center of the investigation into the deadly salmonella outbreak. Virginia-based Peanut Corp. of America, which owns the Blakely plant, distributes peanut butter to institutions such as hospitals and nursing homes. It also provides peanut paste to food companies, which use the product in cookies, cakes and other products available on supermarket shelves.
On Tuesday, federal officials said Peanut Corp. failed to tell inspectors that after samples sent to a contract lab for testing in 2007 and 2008 tested positive for salmonella, the company got a second opinion from another lab and sold the food after the secondary tests came back negative.
“Under the current regulations and laws, they are not required to share those records with state regulatory authorities or even with the FDA,” said Oscar Garrison, Georgias assistant agriculture commissioner, who oversees the consumer protection division.
In a news release issued after federal officials discussed the positive tests, Peanut Corp. said the company has fully cooperated with the FDA during its current salmonella investigation.
“We have shared with them every record that they have asked for that is in our possession and we will continue to do so,” the release stated.
The Georgia Department of Agriculture performed two inspections last year at the Blakely plant, including one in October – a month after the first people fell ill with salmonella. They found relatively low-level violations, such as equipment that wasnt properly covered and dust buildup, but did not check for salmonella during either inspection, according to department reports obtained by the AP through an open records request.
Regulators in Georgia, Arkansas and Kentucky, where the three top commercial peanut butter brands are produced, said state employees carry out routine inspections at peanut butter plants at least once or twice a year. Officials in Arkansas and Kentucky – where Skippy and Jif are produced, respectively – review records kept by the companies. Samples of the finished product are not taken during routine walkthroughs unless inspectors have reason to believe there might be a violation.
Agriculture officials in Georgia, whose inspections are comparable to Arkansas and Kentuckys, said last week that manpower and funding shortages limit the number and extent of inspections they can do. The state has 60 inspectors responsible for examining 15,000 sites, or about 250 food sources per inspector, ranging from individual ice machines to sprawling factories.
Source: dctms
Medicare Expands Coverage For Cancer Drugs
“In some instances … the medical community may have scientific evidence that supports using a drug to treat a disease even if the drugs FDA-approved label does not include those clinical conditions,” Medicare explained in a June 5 news release describing the policy.
The policy change was first reported Tuesday by The New York Times.
Medicares decision could prove controversial, however. It deals with so-called “off-label” prescribing, a gray area in medical practice and government policy. While the FDA approves medications for specific uses, the agency is not allowed to dictate to doctors how they will practice medicine or prescribe drugs. For example, a doctor can write a prescription for a brain cancer drug and use it to treat kidney tumors.
That nuance may mean the difference between life and death for some patients. Its also worth billions to drug companies, although they are forbidden from promoting their medications for off-label uses.
Cancer doctors strongly supported Medicares decision. Off-label prescribing has long been standard practice in their field.
“Basically what this means is that there will be faster coverage of evidence-based and appropriate cancer medications for patients,” said Dr. Joseph Bailes, a spokesman for the American Society of Clinical Oncology. “It will reduce the hassle factor.”
But some consumer advocates said Medicare should take a second look at its new policy.
“Im not sure I would say its a bad thing, but I think it was ill-advised and needs to be re-evaluated,” said Steven Findlay, a health policy analyst for Consumers Union, publishers of Consumer Reports. “We think its better to be cautious. Evidence shows that some of these drugs extend life by a very small amount and at great cost.”
Medicares policy change essentially allows its billing contractors to use a broader range of pharmaceutical reference materials in deciding whether or not to approve payment for cancer drug treatment.
These reference materials list uses not approved by the FDA for several medications. The editors of the reference collections base their decisions mainly on reviews of scientific articles about medications. But many of the studies reported in those articles are financed by pharmaceutical companies seeking broader uses for their medications.
Medicare spokesman Peter Ashkenaz said the decision was not a concession to the drug industry, but a routine update of reference materials. Some of the reference books that Medicare previously relied on were no longer being published.
Source: dctms
Fda Reviews Benefits Of Plavix In Certain Patients
In both cases, FDA said patients may have trouble metabolizing Plavix, reducing its ability to prevent deadly blood clots.
Plavix had global sales of $7.3 billion in 2007. The drug is marketed by Bristol-Myers Squibb Co. and Sanofi-Aventis SA and has been prescribed to more than 90 million patients around the world.
In November, researchers found that taking Plavix with popular prescription heartburn drugs like AstraZeneca PLCs Nexium significantly increased patients chances of being hospitalized for a heart attack, stroke or chest pain. The researchers suggested that the heartburn drugs might interfere with a liver enzyme needed to metabolize Plavix.
However, some heart experts were skeptical of the findings. They noted that patients taking heartburn drugs may already have health problems that skew their risk for heart attack and other problems.
Doctors prescribe so-called proton pump inhibitor drugs to treat heartburn, in which painful stomach acids come back up the esophagus. Because Plavix, known generically as clopidogrel, can upset the stomach, it is often prescribed with the acid-blocking drugs, which include Wyeths Protonix.
FDA said in a statement it is important to determine how the drugs interact because “decreases in the effectiveness of clopidogrel might be avoided, in part, by using other drugs … that do not interfere with its metabolism.”
FDA said there is no evidence that the “H2 blocker” family of heartburn drugs counteract Plavix. Those drugs include Johnson & Johnsons Pepcid, Boehringer Ingelheims Zantac and GlaxoSmithKlines Tagamet HB.
Sanofi-Aventis and Bristol-Myers Squibb said they are conducting studies of whether genetic factors or heartburn drugs can interfere with Plavix.
“Individuals do not all respond to the same degree to a specific drug,” said Sanofi spokeswoman Elizabeth Baxter. “Many studies are currently ongoing, including studies of clopidogrel, to explore what is responsible for this phenomenon.”
The studies will take several months to complete, according to FDA, which said it would issue recommendations after reviewing them.
Until more information is available, the FDA says patients should continue taking Plavix. However, doctors should be cautious when prescribing the heartburn drugs to patients already taking Plavix.
Shares of Paris-based Sanofi-Aventis rose 23 cents Monday to $30.60 in midday trading. Shares of New York-based Bristol-Myers Squibb Co. dipped 1 cent to $22.38.
Source: dctms
Woman Gives Birth to Octuplets In Socal Hospital
“My eyes were wide,” Dr. Karen Maples said, explaining her reaction to the last birth.
Doctors said the babies were born nine weeks premature but are in stable condition. Two newborns were placed on ventilators and a third needs oxygen.
Hospital officials would not release any information about the mother, including her name, condition or whether she used fertility drugs. They did, however, say she planned to breast feed all of them.
“Shes a very strong woman, so she probably will be able to handle all eight babies,” said Dr. Mandhir Gupta, a neo-natologist who cared for the infants.
The mother checked into the hospital in her 23rd week of pregnancy and gave birth seven weeks later. All eight babies will probably remain in the hospital for at least two months and the mother should be released in a week, Maples said.
The worlds first live octuplets were born in March 1967 in Mexico City, but all the babies died within 14 hours, according to Encyclopedia Britanica.
The United States first live octuplets were born in Houston in December 1998. They were three months premature and their weights at birth ranged from 11 ounces to 1 pound, 11 ounces. The tiniest infant died of heart and lung failure a week after being born. The surviving siblings – girls Ebuka, Gorom, Chidi, Chima and Echerem, and their brothers Ikem and Jioke – turned 10 in December.
Their mother and father, Nkem Chukwu and Iyke Louis Udobi, said they are astonished and grateful their children have grown up to be healthy and active. Chukwu is even happier to hear another mother successfully accomplished the same feat.
“Its a blessing, truly a blessing,” Chukwu told The Associated Press. “Well keep praying for them.”
Forty-six hospital staff and four delivery rooms were used for the latest octuplets births. After one baby was born, staff rushed the newborn into another room and waited for the next, the hospital said. But despite weeks of preparation, doctors did not expect the eighth child.
“It is quite easy to miss a baby when youre anticipating seven babies,” said Dr. Harold Henry, chief of maternal and fetal medicine at the hospital. “Ultrasound doesnt show you everything.”
“When the first baby came out, he was crying and kicking,” Gupta said. “That eased the tension in the operating room because the first one came out healthy.”
Dr. Richard Paulson, director of the fertility program at the University of Southern California, said octuplets born premature could face serious health risks, including breathing problems and neurological damage. The mother also has an increased risk of hemorrhage, Paulson said.
“Its a risky decision to try to have all eight babies,” said Paulson, who had no role in the delivery. “I would not recommend it under any circumstances, but I respect a parents decision.”
For people who use fertility drugs, the vast majority of births – 80 percent – are single babies. Among multiple births, the most common are twins, Paulson said.
Paulson said the latest births likely resulted from the use of fertility drugs and not in vitro fertilization.
Source: dctms
Worlds Highest Drug Levels Entering India Stream
Those Indian factories produce drugs for much of the world, including many Americans. The result: Some of Indias poor are unwittingly consuming an array of chemicals that may be harmful, and could lead to the proliferation of drug-resistant bacteria.
“If you take a bath there, then you have all the antibiotics you need for treatment,” said chemist Klaus Kuemmerer at the University of Freiburg Medical Center in Germany, an expert on drug resistance in the environment who did not participate in the research. “If you just swallow a few gasps of water, youre treated for everything. The question is for how long?”
Last year, The Associated Press reported that trace concentrations of pharmaceuticals had been found in drinking water provided to at least 46 million Americans. But the wastewater downstream from the Indian plants contained 150 times the highest levels detected in the U.S.
At first, Joakim Larsson, an environmental scientist at the University of Gothenburg in Sweden, questioned whether 100 pounds a day of ciprofloxacin could really be running into the stream. The researcher was so baffled by the unprecedented results he sent the samples to a second lab for independent analysis.
When those reports came back with similarly record-high levels, Larsson knew he was looking at a potentially serious situation. After all, some villagers fish in the streams tributaries, while others drink from wells nearby. Livestock also depend on these watering holes.
Some locals long believed drugs were seeping into their drinking water, and new data from Larssons study presented at a U.S. scientific conference in November confirmed their suspicions. Ciprofloxacin, the antibiotic, and the popular antihistamine cetirizine had the highest levels in the wells of six villages tested. Both drugs measured far below a human dose, but the results were still alarming.
“We dont have any other source, so were drinking it,” said R. Durgamma, a mother of four, sitting on the steps of her crude mud home in a bright flowered sari a few miles downstream from the treatment plant. High drug concentrations were recently found in her well water. “When the local leaders come, we offer them water and they wont take it.”
Pharmaceutical contamination is an emerging concern worldwide. In its series of articles, AP documented the commonplace presence of minute concentrations of pharmaceuticals in U.S. drinking water supplies. The AP also found that trace concentrations of pharmaceuticals were almost ubiquitous in rivers, lakes and streams.
The medicines are excreted without being fully metabolized by people who take them, while hospitals and long-term care facilities annually flush millions of pounds of unused pills down the drain. Until Larssons research, there had been widespread consensus among researchers that drug makers were not a source.
The consequences of the India studies are worrisome.
As the AP reported last year, researchers are finding that human cells fail to grow normally in the laboratory when exposed to trace concentrations of certain pharmaceuticals. Some waterborne drugs also promote antibiotic-resistant germs, especially when – as in India – they are mixed with bacteria in human sewage. Even extremely diluted concentrations of drug residues harm the reproductive systems of fish, frogs and other aquatic species in the wild.
The discovery of this contamination raises two key issues for researchers and policy makers: the amount of pollution and its source. Experts say one of the biggest concerns for humans is whether the discharge from the wastewater treatment facility is spawning drug resistance.
“Not only is there the danger of antibiotic-resistant bacteria evolving; the entire biological food web could be affected,” said Stan Cox, senior scientist at the Land Institute, a nonprofit agriculture research center in Salina, Kan. Cox has studied and written about pharmaceutical pollution in Patancheru. “If Cipro is so widespread, it is likely that other drugs are out in the environment and getting into peoples bodies.”
Before Larssons team tested the water at Patancheru Enviro Tech Ltd. plant, researchers largely attributed the source of drugs in water to their use, rather than their manufacture.
In the U.S., the EPA says there are “well defined and controlled” limits to the amount of pharmaceutical waste emitted by drug makers.
Indias environmental protections are being met at Patancheru, says Rajeshwar Tiwari, who heads the areas pollution control board. And while he says regulations have tightened since Larssons initial research, screening for pharmaceutical residue at the end of the treatment process is not required.
Source: tnjac
Merck: New Pill May Work For Ms
Patients on cladribine had up to a 60 percent reduced chance of having a relapse compared to patients on placebo. The study was paid for by Merck.
“This is promising news,” said Dr. Lee Dunster, head of research for the Multiple Sclerosis Society in the United Kingdom. Dunster was not linked to the Merck study. He said cladribine appeared to be twice as effective as current primary treatments for MS.
Multiple sclerosis is the most common neurological condition affecting young adults. It is the result of damage to myelin, the protective coating on nerve fibers of the central nervous system. When myelin is damaged, that interrupts the brains messaging system to other parts of the body.
Patients with MS often suffer from fatigue, muscle spams, problems with vision, speech, coordination, and the bladder. Relapses are often unpredictable and there is no known cure.
Current treatments for MS must be given by injections and have varying success rates.
Cladribine is already used to treat leukemia, but only for short periods of time. Doctors said more information was needed about the potential side effects from taking the drug in the long term, since multiple sclerosis is a lifelong condition.
Known side effects from cladribine include fatigue, an increased chance of infections, and anemia.
Merck has already asked American and European drug regulators to fast-track the drug to the market. In their press statement, Merck said they will submit cladribine for registration in the U.S. and Europe later this year.
Swiss pharmaceutical giant Novartis AG is also working on a pill to treat MS.
Though Mercks study showed that cladribine reduced the relapse rate, Dunster said the real question was whether the drug slowed the diseases progression. He expected that data to be released in the next few months.
“Relapses are not very nice things to have, but we are really looking to slow down the disease,” Dunster said. “For patients, its all about whether or not they will be able to kick around the ball with their kids in a few years.”
Source: iledw
European Union Wants to Double Cancer Screenings
“Investing in cancer-screening programs will pay long-term dividends,” said European Health Commissioner Androulla Vassiliou.
Every year about 3.2 million of some 500 million Europeans are diagnosed with cancer. In 2006, 90,000 women died of breast cancer, 15,000 of cervical cancer and 68,000 of colorectal cancer. That same year 78,000 men died of colorectal cancer.
EU countries that have implemented large-scale screening programs have seen reductions of breast cancer mortality of up to 35 percent and reductions of the incidence of cervical cancer of up to 80 percent. Such screening for colorectal cancer is still comparatively new, but pilot programs in Britain and Finland are ongoing.
The report calls on the 27 member countries to improve large-scale screening programs for target groups regardless of their symptoms. Twenty-two member states have such programs for breast cancer, 15 for cervical cancer and 12 for colorectal cancer.
Source: iledw