NEWARK, N.J. – State regulators on Friday temporarily suspended the medical license of a doctor who health officials suspect is linked to a hepatitis B outbreak.
Nearly 3,000 of Dr. Parvez Dara's patients have been warned to get tested after five cancer patients tested positive for the disease, which is transmitted through exposure to infected blood and can cause serious liver damage.
On Friday, the state presented evidence about the conditions at the oncologist's Toms River office. Investigators said they found blood on the floor of a room where chemotherapy was administered, blood in a bin where blood vials were stored, open medication vials and unsterile saline and gauze.
Inspectors also cited problems with cross-contamination of pens, refrigerators and countertops; use of contaminated gloves; and misuse of antiseptics, among other health code violations.
"This was not a one-time episode," Deputy Attorney General Siobhen Krier told regulators. "This is a case of egregious, bad medical judgment displayed over a long period of time."
A special committee of the state Board of Medical Examiners issued the suspension, effective immediately, on an emergency basis. The full board will consider whether to continue the suspension on Wednesday.
During the hearing Friday, Krier said Dara had a history of health code violations dating to 2002 and posed "a clear and imminent danger to the public."
Since 2002, Dara has paid nearly $56,000 in fines for infection control health code violations, court records show.
Dara said he only used sterile supplies and equipment and took steps correct the violations. He questioned whether the patients may have contracted the disease some other way, such as from a hospital or from surgery, and suggested some may have been latent carriers — meaning they had the virus but it was dormant — until they began receiving chemotherapy, which can suppress the body's immune system.
"It's not that rare," Dara said.
In making its decision, the committee said Dara showed "a significant and gross deficiency in judgment" and that that could not be remedied by changing office practices.
"Dr. Dara's own testimony has not persuaded the committee that he has an appreciation for the gravity of multiple breaches of basic infection control practices," the committee said in its order to suspend Dara's license.
Dara did express sympathy for his patients: "This is hurting them so much more than it's hurting me."
A March 28 letter was sent to his patients warning them of the risk and suggesting they be tested for the liver diseases hepatitis B and hepatitis C and for HIV, the virus that causes AIDS.
Dara, originally from Pakistan, has been practicing at his Toms River office for 23 years. He estimated that he sees between 45 and 60 patients a day, with about a dozen receiving chemotherapy each day.
His attorney, Robert Conroy, argued to the board that there was no direct evidence the hepatitis cases were linked to Dara's office. He characterized the state's investigation as sloppy and said the fact that the outbreak investigation is ongoing should have precluded regulators from drawing any conclusions.
Conroy said Dara plans to immediately appeal the decision.
Minggu, 05 April 2009
Doctor in hepatitis B case has license suspended
Kraft Foods offers salmonella timeline
FRESNO, Calif. – Kraft Foods Inc., the company whose testing led to the nationwide pistachio recall, said Friday it first heard there was salmonella in its trail mix in late 2007, but could not trace the possible source to tainted nuts from California until two weeks ago.
Workers at one of Kraft's manufacturers in Illinois turned up a contaminated batch of fruits and nuts in December 2007. Then, in September of last year, another positive sample appeared.
Only after thousands of tests could the company pinpoint the source for the second positive test as California-based Setton Pistachio of Terra Bella, Inc., said Kraft spokeswoman Susan Davison.
Last week, the food products giant recalled or destroyed all suspect foods, and notified its suppliers and the Food and Drug Administration, which on Monday issued a sweeping national warning against eating the nuts.
"If we did detect salmonella, of course we would never ship our products," Davison said. "We conducted extensive testing of all our food, and we were just unable to zero in until March that pistachios were the root cause."
On Friday, Lee Cohen, a production manager for Setton's sister company in New York, said Kraft did not tell Setton until recently that they had detected salmonella-tainted pistachios last year. The company later retracted his statement without explanation.
Setton, the second-largest pistachio processor in the nation, sells its nuts to Kraft and 35 other wholesalers across the country, which use them in everything from ice cream to cake mixes. As FDA officials scour its records and swab its factory, the plant has temporarily shut down after recalling more than 2 million pounds of nuts.
No pistachio-related illnesses have been reported.
Also Friday, the FDA sent out a letter to the pistachio industry reminding nut processors to follow good manufacturing practices to protect consumers, something food safety experts called welcome guidance.
Dr. David Acheson, FDA's assistant commissioner for food safety, said Kraft first told the administration about the problems last week.
Neither federal nor state laws require food manufacturers to test the safety of their products or to report any findings of contamination, though many do if they plan to recall a product, Acheson said.
"If they find problems in a product prior to shipment, they'll pull it back and destroy it," Acheson said. "I wouldn't call that a good manufacturing practice, but that is clearly a good public health practice."
Kraft finally determined pistachios caused last year's problem in March, when their manufacturer in Illinois detected salmonella for the third time — this time in the nuts, the only common ingredient between the second and third batch of trail mix, Davison said. Kraft has not traced the source for the first positive salmonella test in 2007.
Salmonella, the most common cause of food-borne illness, causes diarrhea, fever and cramps. Most people recover, but the infection can be life-threatening for children, the elderly and people with weakened immune systems.
Roasting is supposed to kill the bacteria in nuts, but problems can occur if the roasting is not done correctly or if roasted nuts are re-contaminated. That can happen if mice, rats or birds get into the facility.
Setton Pistachio officials suspect the roasted pistachios sold to Kraft Foods may have become mixed at the plant with raw nuts that could have contained traces of the bacteria.
Cohen, the production official at Setton International Foods Inc. in Commack, N.Y., said Friday that Setton Pistacio's internal tests had detected salmonella on some of its raw pistachios in the past, but said all tainted pistachios were later roasted. He did not specify when those tests were performed.
"We have found salmonella on raw pistachios, but that doesn't mean anything because those nuts are coming straight from the orchards where you could have had a very small localized contamination from birds," Cohen said. "Those nuts never hit the marketplace."
More than a dozen other companies that got their nuts from the California plant have recalled their pistachio products this week for fear of possible contamination. On Friday, Setton International announced it was also voluntarily recalling about 118,000 pounds of pistachio products.
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CDC: Rocket fuel chemical found in baby formula
ATLANTA – Traces of a chemical used in rocket fuel were found in samples of powdered baby formula, and could exceed what's considered a safe dose for adults if mixed with water also contaminated with the ingredient, a government study has found.
The study by scientists at the U.S. Centers for Disease Control and Prevention looked for the chemical, perchlorate, in different brands of powdered baby formula. It was published last month, but the Environmental Working Group — a Washington, D.C.-based advocacy organization — issued a press release Thursday drawing attention to it.
The chemical has turned up in several cities' drinking water supplies. It can occur naturally, but most perchlorate contamination has been tied to defense and aerospace sites.
No tests have ever shown the chemical caused health problems, but scientists have said significant amounts of perchlorate can affect thyroid function. The thyroid helps set the body's metabolism. Thyroid problems can impact fetal and infant brain development.
However, the extent of the risk is hard to assess. The government requires that formula contain iodine, which counteracts perchlorate's effects. The size of the infant and how much formula they consume are other factors that can influence risk.
The U.S. Food and Drug Administration, aware of the debate over perchlorate in food and water, has not recommended that people alter their diet or eating habits because of the chemical.
The study itself sheds little light on how dangerous the perchlorate in baby formula is. "This wasn't a study of health effects," said Dr. Joshua Schier, one of the authors.
The largest amounts of the chemical were in formulas derived from cow's milk, the study said.
The researchers would not disclose the brands of formula they studied. Only a few samples were studied, so it's hard to know if the perchlorate levels would be found in all containers of those brands, a CDC spokesman said.
"This study provides no data on potential health effects of perchlorate. Health authorities continue to emphasize that infant formula is safe," said Haley Curtis Stevens of the International Formula Council, which represent formula manufacturers.
Earlier this year, the U.S. Environmental Protection Agency said it was considering setting new limits on the amount of perchlorate that would be acceptable in drinking water. A few states have already set their own limits.
The agency issued a statement Friday saying perchlorate exposure is a serious issue and "a top priority" for EPA Administrator Lisa Jackson. EPA officials expect to announce a decision soon about future steps in dealing with the chemical.
The EPA has checked nearly 4,000 public water supplies serving 10,000 people or more. About 160 of the water systems had detectable levels of perchlorate, and 31 had levels high enough to exceed a new safety level the EPA is considering.
___
CDC: http://www.cdc.gov/
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Kamis, 02 April 2009
NJ warns nearly 3,000 to get tested for hep B
TRENTON, N.J. – New Jersey officials have advised nearly 3,000 people who share a doctor to get tested after five cancer patients who visited the physician were found to have hepatitis B.
Two cases of hepatitis B were confirmed in late February as connected with the office of Dr. Parvez Dara, an oncologist with offices in Toms River and Manchester, near the Jersey Shore, Marilyn Riley, spokeswoman for the state Health Department, said Thursday.
Health officials recently learned of three more cases, all in Toms River, in which the patients were also under Dara's care.
"These were older adults who didn't have other risk factors, so that is what raised a red flag," Riley said.
Ocean County decided to send a letter to all Dara's patients dating to 2002. The March 28 letter warns them of the risk and suggests they be tested for the liver diseases hepatitis B and hepatitis C and for HIV, the virus that causes AIDS.
Linda Bradford of Bayville said she's worried about her husband's health after hearing news of the outbreak.
"The first thing I did was call my husband," Bradford told WCBS-TV. "I was terrified. Oh my God, what's going on here?"
Hepatitis B is transmitted through exposure to infected blood, often by sexual contact or infected needles. Dara's office treats patients with blood disorders and cancer, some of whom receive chemotherapy there.
"The evidence that's available suggests the infections could be linked to the method the clinical staff used to administer injectable medications," such as chemotherapy, Riley said. "There's no evidence to suggest the medications were a problem."
Dara faces suspension of his medical license in connection with the outbreak and for other alleged health code violations. A hearing is scheduled for Friday before the state Board of Medical Examiners.
Until then, he is performing only patient consultations, not procedures, said his lawyer, Robert Conroy. Neither of Dara's offices were open Thursday.
According to a report by the state epidemiology division, Dara has infection control violations dating to 2002, including violations of standards of the federal Occupational Safety and Health Administration.
Conroy said that there is no proof the patients got the disease from Dara's office and that other factors aren't being considered. All five patients were also seen at Community Medical Center in Toms River, he said.
Health officials said they ruled the hospital out as a possible source of the infection.
Hepatitis B is transmitted through exposure to infected blood, often by sexual contact or infected needles.
Conroy said three patients were found to have dormant hepatitis infections that might have been noticed only after they started cancer treatments, which can suppress the body's immune system.
Because the patients live in the same area, he said, there could be another possible source.
"Absent any evidence, it is just as likely that those patients were infected (at) ... a common eatery," he wrote in a letter to the Medical Examiners Board.
Meanwhile, Conroy said Dara has received only support from his patients.
"The doctor has never felt more appreciated by his patients than he does right now," he said.
Ocean County Health Department spokesman Edward Rumen said no new cases have been reported since the alert was issued.
___
Associated Press writer Bruce Shipkowski in Toms River contributed to this report.
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..read more...House approves FDA regulation of tobacco products
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WASHINGTON – Anti-smoking forces won a long-awaited victory Thursday as the House passed legislation that would give the federal government key controls over the tobacco industry for the first time.
The measure, passed 298-112, gives the Food and Drug Administration authority to regulate — but not ban — cigarettes and other tobacco products.
The Senate could take up its version of the bill later this month, and supporters are confident they can overcome opposition from tobacco-state senators. The White House supports the legislation, a shift from the Bush administration which threatened to veto a House-passed measure last year.
President Barack Obama has spoken publicly about his own struggles to kick a smoking habit.
"This is truly a historic day in the fight against tobacco, and I am proud that we have taken such decisive action," said Energy and Commerce Committee Chairman Henry Waxman, D-Calif., the bill's sponsor. "Today we have moved to place the regulation of tobacco under FDA in order to protect the public health, and now we all can breathe a little easier."
Waxman and his Senate counterpart, Sen. Edward Kennedy, D-Mass., have promoted legislation giving the FDA regulatory powers over tobacco products since the Supreme Court in 2000 ruled that the agency did not have that authority.
That ruling came after years of lawsuits and debate on the issue, including Waxman's memorable 1994 hearing where the heads of big tobacco companies testified that nicotine was not addictive.
Waxman's Family Smoking Prevention and Tobacco Control Act wouldn't let the FDA ban nicotine or tobacco outright, but the agency would be able to regulate the contents of tobacco products, make their ingredients public, prohibit flavoring, require much larger warning labels and strictly control or prohibit marketing campaigns, especially those geared toward children.
Kennedy plans to introduce his version of the bill after Congress returns from its April recess. Sen. Richard Burr, R-N.C., is expected to lead the opposition, but supporters are confident they can clear the 60-vote threshold needed to break a filibuster.
"FDA regulation of cigarettes — the most lethal of all consumer products — is long overdue," Kennedy said Thursday. "I am confident that the Senate will approve it expeditiously."
Opponents from tobacco-growing states such as top-producing North Carolina argued that the FDA had proven through food safety failures that it's not up to the job. They also said that instead of unrealistically trying to get smokers to quit or prevent them from starting, lawmakers should ensure they have other options, like smokeless tobacco.
That was the aim of an alternate bill offered by Rep. Steve Buyer, R-Ind., who would leave the FDA out and create a different agency within the Health and Human Services Department. His proposal failed on a 284-142 vote.
"Effectively giving FDA stamp of approval on cigarettes will improperly lead people to believe that these products are safe, and they really aren't," Buyer said. "We want to move people from smoking down the continuum of risk to eventually quitting."
Major public health groups, including the American Lung Association and the American Medical Association, wrote to lawmakers asking them to oppose Buyer's bill, contending it would leave tobacco companies without meaningful regulation and able to make untested claims about the health effects of their products.
Buyer pointed out that Waxman's bill is supported by the nation's largest tobacco company, Marlboro maker Philip Morris USA. Officials at rival tobacco companies contend the Waxman bill could cement Philip Morris' market advantage.
Lorillard Tobacco Co. said in a statement that among other problems, Waxman's bill "leads to an industry monopoly by locking in the huge market share of our largest competitor while eliminating our ability to communicate with our adult smokers."
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The bill is H.R. 1256.
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Congress: http://thomas.loc.gov/
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NY county ban on baby bottle chemical is official
NEW YORK – A suburban New York county has adopted the nation's first ban on the chemical found in plastic baby bottles and sippy cups.
The measure banning the sale of baby bottles containing BPA was signed by Suffolk County Executive Steve Levy on Thursday after county legislators passed it last month.
Several states including California, Oregon and Hawaii are considering bans the chemical formally known as bisphenol A, but Suffolk County, on Long Island, is the first place in the nation to enact one.
Canada announced in October it was banning BPA in baby bottles, becoming the first country to restrict sale of the chemical, which is commonly used in the lining of food cans, eyeglass lenses and hundreds of household items.
The Suffolk County ban will take effect within 90 days of being filed with New York's secretary of state and applies to empty beverage containers used by children ages 3 and younger.
Baby bottles frequently contain BPA, which is used to harden plastic and make it shatterproof.
Some scientists believe that long-term exposure to BPA is harmful to humans, but the European Union and the U.S. Food and Drug Administration say the chemical is safe.
"While the U.S. Food and Drug Administration stands by, Suffolk County is taking measures to protect their most vulnerable population from the potential harm of BPA exposure," said Urvashi Rangan, a senior scientist and policy analyst at Consumers Union, the nonprofit that publishes Consumer Reports magazine.
Levy, the Suffolk County executive, said children's exposure to potentially harmful products should be minimized.
"Of all the things a parent must worry about," he said, "whether or not their child is being harmed by a baby bottle should not be one of them."
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..read more...1 in 5 Medicare patients readmitted within month
NEW YORK – One in five Medicare patients end up back in the hospital within a month of discharge, a large study found, and that practice costs billions of dollars a year. The findings suggest patients aren't told enough about how to take care of themselves and stay healthy before they go home, the researchers said. A few simple things — like making a doctor's appointment for departing patients — can help, they said.
The study found that a surprising half of the non-surgery patients who returned within a month hadn't even seen a doctor between hospital stays.
"Hospitals put more effort into the admission process than they do into the discharge process," said Dr. Eric Coleman, one of the study's authors from the University of Colorado in Denver.
Coleman, who runs a program to improve "hand-offs" between health care systems, said patients often have a honeymoon notion about how things will be once they're home. Then when they become confused about how to take their medicine or run into other problems, they head back to the hospital because they don't know where to turn, he said.
The issue of hospital readmissions and their cost has come under scrutiny in recent years. And it's getting attention now because President Barack Obama's budget calls for reducing spending on Medicare readmissions to pay for health care reform.
For their study, reported in Thursday's New England Journal of Medicine, the researchers looked at Medicare records from late 2003 through 2004. They found that about 20 percent of 11.9 million patients were readmitted to the hospital within a month of discharge; about a third were back in the hospital within three months.
About half of the patients hospitalized for ailments didn't see a doctor before they landed back in the hospital within a month.
Patients with heart failure and pneumonia had the most readmissions overall; among surgical procedures, heart stents and major hip and knee surgery had the highest returns.
About 10 percent of all readmissions were probably planned, such as putting in a stent, the researchers said. They estimated that the cost of unplanned return visits in 2004 was $17.4 billion.
"It's a big hunk of money and it's a big hunk of misery," said another study author, Dr. Stephen Jencks, an independent consultant who worked for the Centers for Medicare and Medicaid Services.
Besides making follow-up doctor appointments, Jencks said hospitals should give patients a list of all their medications, explain what to do at home and where to call if they run into problems. He said the hospitals should also call the patient within two days and make sure that the patient's doctor knows they were in the hospital.
He said the goal is to keep patients from getting really sick again, not to keep them out of the hospital if they do.
The differences in readmission rates among states suggests that improvements can be made, he said. Iowa had the lowest rate with 13 percent, while Washington, D.C., had the highest at 23 percent.
Dr. Brian Jack at Boston Medical Center tells the story of a patient who didn't understand that the blood pressure medicine that the hospital told her to take was the same as the one she had at home — just with different names. She took both and returned to the hospital with kidney failure. Jack and his colleagues tested a new checklist that nurses used when they sent patients home. The patients who used the checklist had 30 percent fewer visits to the emergency room or return hospital stays over the next month, compared to patients who didn't use it, they found.
"There are not too many things that improve health and save money," said Jack, who was not involved in the new research.
In 2007, a panel that advises Congress on Medicare suggested ways to cut hospital readmissions. One recommendation was to change how Medicare pays hospitals and to cut payments to those with high rates — an approach included in Obama's budget proposal.
Currently, hospitals get the same payment for each hospital stay and critics say there's no incentive to reduce readmissions.
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On the Net:
New England Journal: http://www.nejm.org
Care Transitions: http://www.caretransitions.org/
Project Red: http://www.bu.edu/fammed/projectred
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..read more...Selasa, 31 Maret 2009
Pistachio warning could signal food safety shift
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TERRA BELLA, Calif. – It could take weeks before health officials know exactly which pistachio products may be tainted with salmonella, but they've already issued a sweeping warning to avoid eating the nuts or foods containing them.
The move appears to indicate a shift in how the government handles food safety issues — from waiting until contaminated foods surface one-by-one and risking that more people fall ill to jumping on the problem right away, even if the message is vague.
Officials wouldn't say if the approach was in response to any perceived mishandling of the massive peanut recall that started last year, only that they're trying to keep people from getting sick as new details surface about the California plant at the center of the pistachio scare.
"What's different here is that we are being very proactive and are putting out a broad message with the goal of trying to minimize the likelihood of consumer exposure," said Dr. David Acheson, FDA's assistant commissioner for food safety. "The only logical advice to consumers is to say 'OK consumers, put pistachios on hold while we work this out. We don't want you exposed, we don't want you getting salmonella.'"
Dr. Joshua Sharfstein, the president's new acting commissioner who started Monday, made it clear staff needed to move quickly, Acheson said.
The agency announced Monday that Setton Pistachio of Terra Bella Inc., the second-largest pistachio processor in the nation, recalled more than 2 million pounds of its roasted pistachios.
Suspect nuts were shipped as far away as Norway and Mexico, Acheson said Tuesday. One week after authorities first learned of the problem, they still had little idea what products were at risk, he said.
As federal health inspectors take swabs inside the plant to try to identify a salmonella source, a whole range of products from nut bars to ice cream and cake mixes remain in limbo on grocery shelves.
Company officials said Tuesday they suspected their roasted pistachios may have been contaminated by salmonella-tainted raw nuts they were processed with at the hulking facility.
Roasting is supposed to kill the bacteria in nuts. But problems can occur if the roasting is not done correctly or if roasted nuts are re-exposed to bacteria.
The firm sells its California-grown pistachios to giants of the food industry such as Kraft Foods Inc., as well as 36 wholesalers across the country.
"We care about our business and our customers greatly," said Lee Cohen, the production manager for Setton International Foods Inc., a sister company to Setton Pistachios. "We've never had an illness complaint before but obviously this affects the whole industry. It's not good."
California supplies 99.99 percent of the U.S. pistachio market, according to the California Pistachio Board.
"What's scary is that it's after the nuts have been processed that this stuff is getting into it, so it really makes you wonder," said Marcia Rowland, an avid pistachio eater in Apopka, Fla.
The FDA learned about the problem March 24, when Kraft notified the agency that routine product testing had detected salmonella in roasted pistachios. Kraft and the Georgia Nut Co. recalled their Back to Nature Nantucket Blend trail mix the next day and expanded the recall to include any Planters and Back to Nature products that contain pistachios Tuesday.
Kraft spokeswoman Laurie Guzzinati said her company's auditors visited the plant early last week, and "observed employee practices where raw and roasted nuts were not adequately segregated and that could explain the sporadic contamination."
She said she didn't know specifically what they saw.
Federal inspectors last visited the plant in 2003, and the California Department of Public Health was there last year, Acheson said. Federal officials made note of several problems — an open door into one of the nut rooms, and an employee wearing street clothes that weren't adequately covered — but nothing that posed a food safety threat, he said.
Acheson said management corrected the problems that day, and said he did not have access to California inspectors' records.
Cohen said the plant had never had an illness complaint, followed industry health guidelines and had its huge metal silos and warehouse inspected regularly, but refused to provide additional details or records. Several plaques on the firm's office walls showed the firm won industry awards for food safety excellence.
No illness have been tied to contaminated pistachios. Two people called the FDA complaining of gastrointestinal illness that could be associated with the nuts, but the link hasn't been confirmed, Acheson said.
While consumer advocates praised the government's swift action, they said the pistachio recall illustrated that more oversight was needed.
"It is encouraging that this response was so quick, but we need to move to a system that focuses on prevention through the entire food production process," said Jeff Levi, executive director of Trust for America's Health.
Two California legislators introduced a bill Tuesday that would require periodic testing of food at food processing facilities and mandate processors to report to state authorities within 24 hours any positive test result for a dangerous contaminant.
"We shouldn't be reacting to the next crisis, we should be preventing the next crisis," said Assemblyman Mike Feuer, D-Los Angeles.
___
Associated Press writers Tracie Cone in Fresno and Samantha Young in Sacramento contributed to this report.
___
On the Net:
http://us.rd.yahoo.com/dailynews/ap/ap_on_re_us/storytext/salmonella_pistachios/31503103/SIG=10s3n7kvf/*http://www.settonfarms.com
http://www.fda.gov/
FDA cracks down on unapproved narcotic painkillers
WASHINGTON – The government ordered 14 unapproved narcotic painkillers off the market Tuesday, prescription versions of potent morphine, hydromorphone and oxycodone. The Food and Drug Administration told nine manufacturers to quit distributing the drugs within 90 days — but insisted there are plenty of legal versions of the painkillers being sold for patients who need relief.
"There will be no shortage for consumers," said Deborah Autor, director of FDA's drug compliance office.
The move is part of the FDA's years-long attempt to weed out thousands of prescription drugs that sell despite never being formally approved by the health regulatory agency. Many entered the market decades ago, before federal law required such approval. The FDA estimates that unapproved drugs account for 2 percent of all prescriptions filled.
Tuesday, the FDA targeted unapproved versions of high-concentrate liquid morphine sulfate and unapproved immediate-release tablets containing morphine sulfate, hydromorphone and oxycodone. Most are generic.
To help consumers tell if they have an approved or unapproved version, the FDA posted both lists on its Web site: http://www.fda.gov/cder/drug/unapproved_drugs/narcoticsQA.htm.
Manufacturers receiving warning letters Tuesday are: Boehringer Ingelheim Roxane Inc. of Columbus, Ohio; Cody Laboratories Inc. of Cody, Wyo.; Glenmark Pharmaceuticals Inc. of Mahwah, N.J.; Lannett Co. Inc. of Philadelphia; Lehigh Valley Technologies Inc. of Allentown, Pa.; Mallinckrodt Inc. Pharmaceuticals Group of St. Louis; Physicians Total Care inc. of Tulsa; Roxane Laboratories Inc. of Columbus, Ohio; and Xanodyne Pharmaceutical Inc. of Newport, Ky.
The largest, Boehringer, didn't immediately return a call seeking comment.
Even FDA-approved versions of these painkillers pose a risk of serious side effects, but the unapproved products add an extra problem: Regulators haven't checked that those versions work as well and are as pure as their approved competitors.
Companies that don't heed the FDA's deadline could face big penalties: The government once seized $24 million worth of unapproved drugs from a company that ignored a stop-selling order, Autor noted.
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..read more...St. Louis hospital to study birth defect
ST. LOUIS – A top children's hospital wants to improve the survival rate of infants born with a birth defect that many families have never heard of until their child is diagnosed.
Dr. Brad Warner, surgeon-in-chief of St. Louis Children's Hospital, said Tuesday that he and others plan research to better understand the condition, known as CDH, or Congenital Diaphragmatic Hernia. One in 2,000 babies is diagnosed with the disease, doctors say. Half of those don't live to their first birthday.
The condition occurs when the diaphragm, which separates the chest cavity from the abdomen, does not completely form in the womb. The contents of the belly migrate to the chest, which keeps the lungs from developing properly.
Eight babies at the St. Louis hospital died last year from the condition.
Doctors at St. Louis Children's Hospital say they're part of a national database registry to collect and track information on children with the condition. They plan to recruit faculty candidates that are able to explore fetal surgery intervention and are working to collect DNA for analysis.
Treatment for the birth defect varies.
Many are stillborn. Babies who die from the birth defect usually have insufficient lung tissue to survive, or develop hypertension in the blood vessels of the lungs. Medications to lower blood pressure in the lungs lower the baby's overall blood pressure, which can be problematic.
Of those who live, some are in distress from the moment the umbilical cord is clamped; others are OK for their initial hours of life, then get worse. A third group, which is the most uncommon, initially looks good, but later exhibits signs, such as bowel sounds in the chest, that reveal the condition.
In some cases, doctors have performed surgery on pregnant women and their fetuses to try to address problems before a baby is born, but those procedures have risks. Children with CDH can grow up to be healthy adults.
Doctors say they hope to better understand predictors of good and bad outcomes for babies with the condition, as well as how to address the many complications that can arise.
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On the Net:
Breath of Hope: http://www.breathofhopeinc.com/
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..read more...Study: Plavix plus aspirin helps prevent strokes
ORLANDO, Fla. – Taking the blood thinner Plavix along with aspirin helped prevent strokes and heart attacks in people with a common heartbeat abnormality that puts them at high risk of these problems, doctors reported Tuesday.
The treatment is for atrial fibrillation, a rhythm disorder that 2.2 million Americans have. It occurs when the upper parts of the heart quiver instead of beating properly. This allows blood to pool and form clots that can travel to the brain, causing a stroke.
The usual treatment is the blood thinner warfarin, sold as Coumadin and in generic form. But finding the right dose is tricky — too little and patients can have a stroke; too much and they can have life-threatening bleeding. Patients on the drug must go to the doctor often for blood tests to monitor their dose.
For these reasons, as many as half of patients take aspirin instead of warfarin, even though aspirin is much less effective at preventing strokes.
Dr. Stuart Connolly of McMaster University in Hamilton, Ontario, led a study testing whether adding clopidogrel, sold as Plavix by French-based Sanofi-Aventis SA, could help.
The study involved 7,554 patients in the United States and 32 other countries who were not able or chose not to take warfarin. All were treated with aspirin; half also were given Plavix.
After nearly four years of followup, the dual drug treatment lowered a combined measure — heart attacks, heart-related deaths, strokes and blood clots — by 11 percent. There were 924 of these problems in patients on aspirin alone but only 832 in those also getting Plavix.
However, the combination treatment raised the risk of serious bleeding — 251 cases versus 162 for those on aspirin alone.
Doing the math, patients still come out ahead on the combination, Connolly said. For every 1,000 patients treated for three years, it would prevent 28 strokes and six heart attacks, and lead to 20 bleeding cases. Bleeding often is treated with transfusions and is not as likely to prove fatal.
"For the first time in 20 years, there's a new treatment for atrial fibrillation," Connolly said.
Results were presented Tuesday at an American College of Cardiology conference and published online by the New England Journal of Medicine.
The study was sponsored by Sanofi, and Connolly and other authors have consulted for the company. Plavix costs about $4 a day.
"Warfarin was, and remains, first-line therapy — this does not change that," said Dr. Richard Page, cardiology chief at the University of Washington School of Medicine in Seattle and an American Heart Association spokesman.
But for those who can't tolerate it, the Plavix-aspirin combo gives a better option than aspirin alone, he said. Page has consulted for Sanofi in the past.
On Saturday, other doctors at the cardiology conference reported on another potential treatment for atrial fibrillation — an experimental heart device called the Watchman aimed at preventing clots from reaching the brain. A federal Food and Drug Administration panel meets to consider it on April 23.
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On the Net:
Cardiology meeting: http://www.acc.org
Medical journal: http://www.nejm.org
news source of www.news.yahoo.com
..read more...Stop-smoking lines flooded as tobacco tax rises
WASHINGTON – Calling your state stop-smoking hot line for help kicking the habit? Expect a wait: Smokers are flooding the lines in a panic over an increase in the tobacco tax.
Denver-based National Jewish Health received triple the usual number of calls Monday for a March day to quit lines it runs in six states: Colorado, Idaho, Iowa, Montana, New Mexico and Ohio.
The calls — 2,317 on Monday — had steadily increased all month as smokers began dealing with a big price hit in a sour economy. Not only does the per-pack federal tax climb from 39 cents to $1.01 on Wednesday, but the major cigarette makers raised prices several weeks ago in anticipation.
Quit lines around the country are feeling the surge, according to an informal survey by the Campaign for Tobacco-Free Kids that found a missed opportunity as cash-strapped states struggled to meet demand.
Michigan's quit line itself had to quit — working, that is. It ran out of money in mid-March after logging more than 65,000 callers in five days. Besides counseling and tips, Michigan's hot line offered free nicotine patches, gum or lozenges. The giveaway program in 2008 generated only about 20,000 calls in six weeks, the campaign noted.
Arkansas quit general advertising of the quit line to keep up with calls that rose from about 500 a week in January to more than 2,000 a week in mid-March, the campaign said. And Indiana and Oklahoma were receiving record-level weekly calls.
Price surges typically spur would-be quitters to take the plunge. Not all will be successful. The tobacco-free kids group estimates that about 1 million adults will quit as a result of the tax increase.
Consumers can dial 1-800-QUIT-NOW to be directed to their state hot lines.
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Campaign for Tobacco-Free Kids: http://www.tobaccofreekids.org/index.php
news source of www.news.yahoo.com
..read more...
Selasa, 24 Maret 2009
German researchers testing veggie Viagra: reports
BERLIN (AFP) – German researchers are testing an impotency treatment for men made using only natural ingredients that in some cases works better than Viagra, newspapers reported Monday.
"In clinical trials, 50 men had much better sex afterwards, more fun in bed and just generally felt better about themselves," the Sueddeutsche Zeitung daily cited Olaf Schroeder from Berlin's Charite hospital as saying.
"Their libido was even higher than the control group taking Viagra," he said.
The potent cocktail includes tribulus terrestris, a herb already used in alternative medicine, a root vegetable found in the Andes called maca and grape juice extract, newspapers said.
The treatment, dubbed "Plantagrar", is due to be launched in early 2010, the Bild daily said.
But some of those tested had unwelcome side effects.
"Two of the subjects had bad diarrhoea," the Berliner Kurier quoted Schroeder as adding.
news source of www.news.yahoo.com
..read more...Second-Generation Female Condom Approved
WEDNESDAY, March 11 (HealthDay News) -- The Female Health Co.'s FC2 Female Condom has been approved by the U.S. Food and Drug Administration, the company said Wednesday. The product helps protect women against pregnancy and sexually transmitted diseases.
The second-generation condom is similar in design and performance to the FC1, except that it is made of a synthetic rubber called nitrile and costs about 30 percent less, the company said. The FC1 was approved in 1993.
The FDA approval of the FC2 will allow the U.S. Agency for International Development to distribute the condoms via global HIV/AIDS programs, the Associated Press reported.
The first-generation FC1 has been distributed by United Nations agencies in 142 countries, the wire service said.
More information
To learn more about female condoms, visit the U.S. National Library of Medicine.
news source of www.news.yahoo.com
..read more...Suriname starts free circumcision project
PARAMARIBO (AFP) – Suriname has launched a three-month pilot project offering free circumcisions in a bid to cut sexually transmitted diseases, Health Minister Celsius Waterberg said Friday.
Circumcision "could also minimize the risk of HIV infection", he said, adding the project would run in the capital city, Paramaribo.
Some two percent of the Suriname population is HIV-infected, about 10,000 people, and the project aims to carry out the operations on 100 men aged between four and 21 years old over the next three months.
If successful then the project will spread nationwide, Waterberg said.
news source of www.news.yahoo.com
..read more...
