Bacteriatainted syringes sicken dozens
Wed, 19 Dec 2007 02:10:12 GMTBy LINDSEY TANNER, AP Medical Writer
CHICAGO - Federal health officials said Tuesday they are investigating dozens of blood infections in at least two states that have been linked to medical syringes contaminated with bacteria.
About 40 people have been sickened in Illinois and Texas, including 20 outpatients from Rush University Medical Center in Chicago. No deaths were reported.
Rush doctors traced the infections earlier this month to heparin-filled syringes the patients used during home treatment for cancer and other ailments. Heparin is a blood thinner, and the syringes are used to clear out catheters and intravenous lines.
The infections were caused by bacteria called Serratia marcescens , found in a single batch of heparin-filled syringes made in Angier, N.C., by a company called Sierra Pre-Filled.
Syringes from that batch also were sent to Colorado, Florida and Pennsylvania but infections so far have turned up only in Illinois and Texas, said Dr. Arjun Srinivasan of the federal Centers for Disease Control and Prevention.
The infections can cause fever and chills. They can be serious but generally respond well to antibiotics.
There have been no known deaths, Srinivasan said. Of the 20 Rush outpatients who fell ill, 14 required hospitalization. All responded quickly to antibiotic treatment and only one remained hospitalized Tuesday, said Dr. John Segreti, hospital epidemiologist.
The president of Sierra Pre-Filled, Dushyant Patel, said the company is working with the CDC and the Food and Drug Administration and has voluntarily recalled the implicated lot. "There's nothing out there anymore," Patel said.
The affected lot is 070926H, Srinivasan said. He said the CDC is working to make sure doctors are alerted about the contamination and that more cases could surface.
"Our highest priority is to ensure that all of those cases that occur are identified," he said.
Patients who think they used affected syringes should contact their doctors, Srinivasan said.
He said bacteria were found in fluid from the pre-filled syringes but it is uncertain if the original contamination was in the heparin, the saline used to dilute the drug, or the syringes themselves.
"We'll be working to perform genetic fingerprinting on the bacteria to confirm a link between bacteria in the syringes and the case patients," Srinivasan said.
Heparin is the same drug linked to overdoses accidentally given to actor Dennis Quaid's newborn twins. In that case the heparin was made by Deerfield, Ill.-based Baxter Healthcare Corp. The twins appeared to be doing well, a lawyer for the Quaids said earlier this month.
Patel said the heparin in his company's pre-filled syringes comes from a different company.
___
On the Net:
CDC: http://www.cdc.gov/
Adoptive Mo. dads obesity tale trashed
Wed, 19 Dec 2007 00:00:44 GMTBy MARIA SUDEKUM FISHER, Associated Press Writer
KANSAS CITY, Mo. - A man who gained national media attention by claiming he was not allowed to adopt a baby because of his weight was awarded temporary custody of the child, but the judge chided him and his wife, saying they knew the primary reason the boy had been removed from their home had nothing to do with obesity.
Gary and Cindy Stocklaufer had violated adoption law when they failed to obtain some required paperwork when the baby was moved into Missouri from another state, Jackson County Circuit Judge John R. O'Malley said in his order, which he made public Tuesday.
After their petition to adopt the baby, Max, was denied in July by another judge, the couple publicly said it had been because Gary Stocklaufer weighed 550 pounds at the time. The 35-year-old underwent gastric bypass surgery for free from a Dallas clinic in August after the publicity and has lost about 200 pounds.
"He seeks to extort a favorable result by his accusations," O'Malley said. "Fortunately, Missouri courts base decisions on the weight of the evidence, not the weight of the litigants."
The judge said he took the unusual step of making his order public because of the publicity surrounding the case. He likened the attention to a "parade that would embarrass P.T. Barnum."
O'Malley said the Stocklaufers took advantage of the confidentiality of court proceedings in adoption cases. "Knowing the other parties could not respond, Mr. Stocklaufer made his physical condition an ersatz issue," he said.
Under Missouri law, it is a felony to bring a child into the state for adoption without getting a court order first. The Stocklaufers failed to do that, O'Malley said, but the judge still agreed to award them temporary custody.
"In spite of their unlawful actions at the start of this process, they did care enough to step forward and are responsible for bringing into the state and their home," O'Malley said. He added that the Stocklaufer home has a "loving, close environment."
Max, who has been cared for by a family in Missouri, is to be transferred to the Stocklaufers by Dec. 31.
Cindy Stocklaufer, 34, would not comment on the judge's remarks.
"I'm very excited," Stocklaufer said by phone from her home in Independence. "We're very excited. We're just waiting for him to come home. That's all that matters."
She referred all other questions about the case to the couple's attorney, Gerald McGonagle.
McGonagle, who was not the Stocklaufers' attorney during the first hearing, agreed that the earlier ruling denying custody was "not totally" based on Gary Stocklaufer's weight. He added that the couple never intended to break the law.
McGonagle said Gary Stocklaufer had gone to the media "to bring attention to what he thought was an injustice."
"What I'm concerned about is that the court made what I think is the appropriate decision in the case," the lawyer said.
O'Malley's order is for statutory adoptive custody with a new hearing in six months to finalize the adoption, McGonagle said.
Angie Flores, director of patient relations for the Renaissance Hospital in Dallas, which performed Stocklaufer's surgery, said she is "ecstatic" for the Stocklaufers.
"Everything I saw had to do with his weight," Flores said. "I actually got to see the documents and how they talked about his weight." The documents she was referring to were from the guardian ad ltem in the case, not the court.
The Stocklaufers have been married 15 years and have an 8-year-old son they also adopted.
Lawmakers craft reprieve for medical pay
Wed, 19 Dec 2007 00:00:49 GMTBy KEVIN FREKING, Associated Press Writer
WASHINGTON - Physicians will get a six-month reprieve from a 10 percent rate cut when treating Medicare patients under legislation that passed the Senate on Tuesday.
The pay cut for doctors had been scheduled to take effect Jan. 1. Doctors had warned that a cut in reimbursement rates would lead to physicians taking on fewer new Medicare patients. Instead, they'll get a 0.5 percent raise when they treat the elderly and disabled.
The legislation, crafted by leaders of the Senate Finance Committee and approved on a voice vote, also would extend funding for a popular children's health insurance program through March 2009.
Large majorities in both chambers supported spending an additional $35 billion on the State Children's Health Insurance Program, bringing total spending to $60 billion over five years. President Bush twice vetoed expansions of the program; supporters were unable to muster enough support in the House to overcome the first veto. Supporters will try to override the second veto when they return in January.
Some advocacy groups, such as the AARP, described the Medicare legislation that passed the Senate as woefully inadequate. They had hoped that Congress would substantially lower payments to private insurers serving Medicare beneficiaries. The savings from those cuts would be used to pay for other programs that they wanted, such as increasing the number of people eligible for the low-income subsidy in the Medicare drug benefit.
"The influence of the insurance lobby once again ruled the day," said Barbara B. Kennelly, president and CEO of The National Committee to Preserve Social Security and Medicare.
Insurers argued that any cut in their reimbursement rates would result in benefit cuts for many of the 8 million elderly getting their health coverage through managed care.
Officials with the American Medical Association said that a six-month fix creates great uncertainty for Medicare patients and physicians. The trade group for doctors urged lawmakers to shelve the funding formula that has annually caused lawmakers to pass legislation avoiding a Medicare pay cut.
Under the compromise, lawmakers would trim $1.5 billion from a fund established for certain insurers that entered previously unserved regions. But that's a far cry from the tens of billions of dollars that Democrats proposed trimming.
The higher reimbursement rates for doctors is expected to cost about $6 billion.
Lawmakers would offset that cost primarily by freezing payments for inpatient rehabilitation care and for prescription drugs delivered by physicians through Medicare Part B.
Inpatient rehabilitation facilities commonly treat patients suffering from stroke, arthritis and spinal cord or brain injuries. The medicines delivered by physicians are the kind routinely provided at a doctor's office, such as injections to treat cancer or anemia.
Sen. Charles Grassley, R-Iowa, said the extension of the children's health program gives states more certainty about funding levels for the program. The states will get enough money to maintain their current enrollment of more than 6 million people. A one-year extension would have made the topic another hot-button issue for lawmakers to deal with before the general election.
Grassley acknowledged that the Medicare package fell far short of what many lawmakers wanted.
"This is a disappointment for many of us," he said. "The purpose of moving forward with a six-month package now is to provide the opportunity for the Finance Committee to address these priorities next year."
Some states not planning for flu season
Wed, 19 Dec 2007 00:01:34 GMTBy KEVIN FREKING, Associated Press Writer
WASHINGTON - Seven states have yet to participate in a federal program to buy antivirals for a potential influenza pandemic. Thirteen states do not have adequate plans to distribute vaccines and medical supplies from the Strategic National Stockpile.
Those findings and others are part of a new report on how well states have prepared for public health emergencies. The report concluded that states have made significant progress since the terrorist and anthrax attacks in 2001. However, critical gaps remain.
Seven states performed adequately in each of the 10 categories that were measured, which earned them a score of 10 from the Trust for America's Health, a research group. The top scores went to Illinois, Kentucky, Nebraska, New Jersey, Pennsylvania, Tennessee and Virginia.
The states that got the lowest score were Arkansas, Iowa, Mississippi, Nevada, Wisconsin and Wyoming.
The federal government has had a difficult time measuring progress when it comes to the billions of dollars it has sent states over the past six years to improve preparedness. The money went to upgrade laboratories, buy medical supplies and conduct training exercises.
The Bush administration has encouraged states to stock up on antivirals in the event of an influenza pandemic. Under one program, the federal government will pay for a quarter of the cost of buying Tamiflu or Relenza, and states pay the remainder for a combined investment of about $680 million. Antivirals reduce the severity of influenza.
Seven states have so far declined to purchase any antivirals, according to the report: Colorado, Connecticut, Florida, Massachusetts, Mississippi, North Dakota and Rhode Island. Several more have bought only a fraction of what they're entitled to under the federal program.
"If a significant number of states don't pick up their share of responsibility, then the country as a whole is less protected," said Jeffrey Levi, executive director of Trust for America's Health.
A spokesman for the Department of Health and Human Services said that states have until June 2008 to get their orders in. All states have told the federal government they plan on participating, he said. However, many have only ordered part of the medicine that's available to them.
"States that are not buying the full amount of antivirals we have allocated under this program are putting their own citizens at risk," said HHS Spokesman Bill Hall.
The report also highlighted the need for nearly half the states to update their "Good Samaritan" laws. Such laws create liability shields for those who come to the aid of another at the scene of an emergency. The trust said states need shield laws that can cover days or even weeks of voluntary work, such as a shield law tied to a declared emergency by a governor.
The report also warned that a decrease in federal funding could offset many of the improvements that states have made since 2001.
Dr. Irwin Redlener, associate dean for public health preparedness at Columbia University, said he's concerned that federal funding levels for hospital preparedness, now at about $400 million annually, are inadequate. He said the hospitals need an initial investment of $5 billion just to cover existing personnel and equipment needs, plus $1 billion a year thereafter. He said the money is needed for additional beds, ventilators, medicine and personnel.
"This has been a situation going in reverse," Redlener said.
The trade association representing state health officials said that money for emergency preparedness has also been divvied up among more entities in recent years, which don't coordinate their work. They want the money for preparedness to be distributed through the states.
"It's important that we knit together all these different entities getting federal funding," said Dr. Paul Jarris, executive director of the Association of State and Territorial Health Officials.
Among the other categories measured, the report said
• Flu vaccination rates for the elderly dropped in 11 states.
• Six states cut their public health department budgets last year.
• All 50 states and the District of Columbia held emergency drills with their health department and state National Guard.
• Twenty-one states do not have key liability protections for health care volunteers who respond to emergencies.
____
On the Net: Trust for America's Health: http://healthyamericans.org/
FDA to add HIV warning to contraceptive products
Tue, 18 Dec 2007 21:04:10 GMTWASHINGTON - U.S. regulators on Tuesday finalized a rule requiring makers of certain contraceptive gels, foams, films and inserts to carry a warning that the products do not protect against sexually transmitted diseases, including AIDS.
The U.S. Food and Drug Administration will require the warning on over-the-counter products containing nonoxynol 9, used in many stand-alone spermicides.
&;FDA is issuing this final rule to correct the misconceptions that the chemical N9 in these widely available stand-alone contraceptive products protects against sexually transmitted diseases,&; Janet Woodcock, FDA's deputy commissioner for scientific and medical programs, said in a statement.
The FDA proposed the warning in 2003, after results from a large study in Africa and Thailand found women using a contraceptive gel were not protected against HIV and other sexually transmitted diseases and were at a higher risk of HIV than those on a placebo.
The new FDA warning states that because the products can irritate the vagina and rectum, they may boost the risk of acquiring HIV/AIDS. A skin irritation may boost the chance of infection as the virus has more ways to invade the body.
Many kids may not outgrow cow39s milk allergy
Tue, 18 Dec 2007 23:09:17 GMTBy Joene Hendry
NEW YORK - Cow's milk allergy persists longer than previously reported, and the majority of children may retain the sensitivity into school age, study findings suggest.
&;The old data saying that most milk allergy will be easily outgrown, usually by the age of 3 years, is most likely wrong,&; Dr. Robert A. Wood, at Johns Hopkins University School of Medicine, told Reuters Health.
He and colleagues found that just 19 percent of children allergic to cow's milk outgrew their allergy by age 4.
Moreover, Wood added, &;some children will outgrow their allergy into their teenage years, which was previously thought to be unlikely.&; His team found that by the ages of 8, 12, and 16 years, 42 percent, 64 percent, and 79 percent, respectively, had outgrown their milk allergy.
Wood and colleagues reviewed the clinical history of 807 children who were treated at a pediatric allergy clinic for milk allergy. Children were considered to have acquired tolerance if they passed a skin prick test, reported drinking milk without a reaction for the last years and had cow's milk associated immunoglobulin E antibody levels less than 3 kU/L.
&;The higher the level of immunoglobulin-E antibody, the stronger the allergy,&; Wood said. &;Therefore, higher levels not only confirm the allergy but make it less likely that the allergy will be outgrown, or at least that it will take longer to outgrow,&; he added.
They also found that children with asthma and allergic rhinitis had a decreased likelihood of developing tolerance to milk products.
In this population of highly allergic children, 91 percent had at least one other food allergy, most commonly to eggs and peanut.
The most common symptom of milk allergy was skin-related reactions, affecting 85 percent, followed by vomiting, diarrhea or another gastrointestinal reaction in 46 percent; wheezing, cough or difficulty breathing occurred in14 percent; and nasal congestion or other upper respiratory symptoms were seen in 6 percent, the investigators note in the Journal of Allergy and Clinical Immunology.
Wood and colleagues suggest their findings be corroborated through similar studies in a more general population of children with milk allergies.
SOURCE: Journal of Allergy and Clinical Immunology, November 2007.
