Friday, June 22, 2007

U.S. posts hospital death rates for heart ailments

The U.S. government posted mortality data on Thursday for the nation's thousands of hospitals for heart attacks and heart failure, in an effort to shed light on which hospitals provide the best care.

Health care in the United States is notorious for its lack of transparency -- for both the price of goods and services, as well as the quality of care provided by doctors and hospitals.

The new mortality data updates a year-old project by the U.S. Department of Health and Human Services, contrasting prices and experience at the nation's 4,500 acute-care hospitals. The government's Web site compares 31 elective hospital procedures such as heart valve operations, gallbladder removal and hernia operations.

"We don't yet have the Formula One version. We have the go cart version," Secretary Mike Leavitt said during a briefing on the government's efforts to make hospitals -- which get a large portion of their revenue from government health programs -- more accountable.

The new measures track 30-day mortality following a heart attack and heart failure and make risk adjustments for a patient's health, age and other factors.

Hospitals are rated in-line with the national average, above average, or below average for the two heart conditions. Just seven hospitals were rated worse-than-average for death rates following a heart attack, while 17 were rated better-than- average.

In heart failure, 38 hospitals scored a top rating, while 35 scored a worse-than-average for that measure.

The small numbers reflect a conservative approach taken by the consortium, which developed the measures, and included researchers from Harvard and Yale Universities.

During the 1980s, the government tried releasing hospital quality data, but the industry revolted and they were eventually scrapped.
Source :http://www.reuters.com

FDA Issues Dietary Supplement Rules

The U.S. Food and Drug Administration announced Friday that manufacturers of vitamins, herbal pills and other dietary supplements would have to test the ingredients of all their products for safety and purity.

The new standards follow concerns that existing regulations are too weak in that they allow supplements on the market that were contaminated or whose ingredients didn't match claims made on the label.

But while the rules may strengthen enforcement in these areas, some experts say that the real question is the effectiveness of these products.

"This final rule establishes industrywide standards," said Robert Brackett, director of the center for food safety and applied nutrition at the FDA, in a press conference this morning. "Consumers should have increased confidence that the dietary products that they purchase are safe."

Published in an 800-plus page report, the regulations set so-called good manufacturing processes for the 29,000 dietary supplement products currently on the market -- including vitamins, minerals, botanicals, sports nutrition supplements, weight management products and specialty supplements.

The supplement makers will have to test the ingredients of all their products for purity, and accurately report ingredients on their labels.

Before his, supplements fell under the same regulatory guidelines used for food. But according to the FDA, regulating supplements in this way missed some critical problems.

"[The final rule] tries to be more specific about regulating the processes used to make diet supplements, which are quite different from the way you process food," said Vasilios Frankos, division director of the office of dietary supplements at the FDA.

The requirements also apply to imported supplements manufactured outside the U.S. Enforcement of the new guidelines begins Aug. 24.

"The aim is to prevent the wrong ingredients getting into supplements," said Frankos. The regulations also try to prevent contamination of supplements as well as the accidental inclusion of pesticides, glass or heavy metals like lead.

Fable-Free Labels

"These new regulations will at least take the quality issue off the table," says Dr. Brent Bauer, director of the complementary and integrative medicine program at the Mayo Clinic. "If a patient wants to try ginseng, they can be assured that when they purchase a ginseng brand that claims to have 5 percent ginsenosides, they will know that is what they are getting."
Source :http://www.abcnews.go.com

The Brains of the Family?

Given the choice, 9-year-old Carlyle Quinn would spend all day with his microscope, while younger brother Max would opt for the electric guitar.

There's no telling how these brothers living in Brooklyn, N.Y., will grow up. But according to groundbreaking new research, it is very likely Carlyle will have the highest IQ.

The study, published in the current issue of the journal Science, involved more than 240,000 Norwegian men who took intelligence tests when they entered the military. In most families, the scores of the firstborn were three points higher than the second child, and four points higher than a third.

It's not a huge difference, but it might be enough to divide an A student from a B student.

"It is a breakthrough study that is very difficult to dispute methodologically," Frank Sulloway, a University of California psychologist who wrote an accompanying editorial to the study, told ABC News correspondent Bill Weir.

Lead study author Petter Kristensen, an epidemiologist at the University of Oslo, doesn't think the results apply only to Norwegians, but he added that it would be interesting to examine if family patterns are different in some way in Norway.

As for the reasons behind the apparent intelligence gap, Kristensen and other researchers insist it is not due to nature but nurture, with the firstborn enjoying the fruits of undivided attention early in life.

Intelligence Through Teaching

Experts believe that when older children tutor their siblings, it may help their brains grow.

Add to this the fact that in many families, if the eldest is organized and studious, the younger finds more creative ways to get attention.

Sulloway said such differences are not necessarily bad; in fact, such an arrangement might allow younger children to shine in different ways.

"Younger siblings may have three points of something else that doesn't show up on an IQ test," he said.

Exceptions to the Rule

Examine certain sets of famous siblings, and a tantalizing dynamic emerges that seems to support these findings. Studious Prince William and his playful brother Harry, for example. Or Bill and Roger Clinton.
Source :http://www.abcnews.go.com

Monday, June 18, 2007

Health insurers to halt ad effort

Government officials said seven of the country's largest insurers will cease marketing some plans to seniors amid allegations of misleading and aggressive sales practices.

The companies agreeing to the suspension include Humana, WellCare Health Plans and UnitedHealth. Under the voluntary agreement, the companies will not promote their so-called private-fee-for-service plans until Medicare officials certify the companies use accurate and understandable marketing communication.

Medicare is the government-run health benefit that covers 43 million seniors. Roughly 20 percent of those seniors receive their benefits through privately run Medicare Advantage plans.

Last month, state insurance officials told lawmakers they have received hundreds of complaints from seniors who thought they were signing up for the traditional government program, only to learn they had been enrolled in a for-profit corporate plan.

In other cases, agents misled seniors into leaving the government program for a privately run Medicare Advantage plan.

While nearly all the major health insurers offer the plans, nearly half of all patients enrolled are in Humana plans, Medicare officials said.

The plans are popular among seniors -- over 1 million are enrolled -- because of the benefits, which often include dental and vision care. However, they often carry unexpected costs and limited access to physicians.
Source :http://www.suntimes.com

Tuesday, June 12, 2007

Race May Color Heart Doctors' Choices

When you roll into the ER with crushing chest pain, does your skin color determine the care you get?

A new study in this week's Journal of the American Medical Association suggests it very well might, though experts continue to be at odds over the impact of race in heart disease treatment.

Lead study author Dr. Ioana Popescu and colleagues at the University of Iowa Medical School reported on a five-year study of what happened to more than 1 million elderly black and white Medicare patients after they had heart attacks.

What Popescu found was that that black patients were less likely to receive invasive, aggressive treatments following a heart attack -- procedures like bypass surgery or receiving an artery-opening stent.

Though the study did not examine certain other factors that could influence death rates -- such as obesity and smoking -- Popescu cited consistently higher death rates for black patients between one month and one year after their episode.

The importance of the findings was echoed by other cardiologists and heart surgeons not affiliated with the study.

Dr. Carl Pepine, chief of cardiology at the University of Florida, noted, "These are very important findings that emphasize that we have much important work remaining in the battle against heart disease that is not linked simply to insurance status."

Fewer Aggressive Treatments

When dealing with a patient who has suffered heart problems, doctors have an array of options, some more aggressive than others.

A stent is a sort of scaffolding that props a clogged artery open. In a bypass surgery, a nonessential vein (like one from the leg) is cut out and used to reroute blood away from the blocked artery that caused the heart attack.

Both can be done on an emergency basis, or can be scheduled if an artery is dangerously close to closing off.

Heart patients who do not receive these treatments instead take medications, such as beta-blockers and aspirin, to prevent another heart attack.
Source :http://abcnews.go.com

Children with autism get day in court

The parents of 12-year-old Michelle Cedillo asked a federal court Monday to find that their child's autism was caused by common childhood vaccines, a precedent-setting case that could pave the way for thousands of autistic children to receive compensation from a government fund set up to help people injured by the shots.

Wearing noise-canceling headphones, Michelle, of Yuma, Ariz., was brought into the courtroom in a wheelchair at the start of the proceedings before the U.S. Court of Federal Claims. She stayed only a short time.

Her parents, Theresa and Michael Cedillo, allege a preservative called thimerosal that had been used in vaccines weakened their daughter's immune system and prevented her body from clearing the measles virus after she was immunized for the disease at age 15 months.

Today, Michelle suffers from a litany of health problems, including severe autism, inflammatory bowel disease, glaucoma and epilepsy.

"We hope to find out what happened and hopefully get the help she needs," said Theresa Cedillo, who takes care of her daughter full time at home.

Special Master George Hastings Jr. thanked the family for allowing theirs to be the first of nine test cases that will help guide the resolution of some of the nearly 5,000 similar claims lodged with the government.

"Clearly the story of Michelle's life is a tragic one," Hastings said in pledging to listen carefully to the evidence presented during the three-week hearing.

The burden of proof is easier than in a traditional court. Plaintiffs only have to prove that a link between autism and the shots is more likely than not, based on a preponderance of evidence.

Large scientific studies have found no association between autism and vaccines containing thimerosal.

But many parents say their children's symptoms did not show up until after their children received the vaccines, required by many states for admission to school.

"These are families who followed the rules. These are families who brought children in for vaccines. These are families who immunized their children," said the Cedillos' attorney, Thomas Powers.

Powers said that the science regarding a possible vaccine-autism link is in dispute.

Government attorney Vincent Matanoski dismissed much of what the plaintiffs are expected to present as conjecture or speculation.

"You'll find their hypotheses untested or, when tested, have been found false," Matanoski said.

Since 1999, more than 4,800 families have filed claims with the government alleging their children developed autism as a result of routine vaccinations. Most contend that a preservative called thimerosal is to blame for the impaired social interaction typical of the disorder.

The court is being asked to decide whether there is a link between autism and childhood vaccines. If it finds one exists, the families could be eligible for compensation under the Vaccine Injury Compensation Fund, a program established by Congress to ensure an adequate supply of vaccines by safeguarding manufacturers from lawsuits. Under the program, people injured by vaccines receive compensation through a special trust fund.

Autism is characterized by impaired social interaction. Those affected often have trouble communicating, and they exhibit unusual or severely limited activities and interests. Classic symptoms of mercury poisoning include anxiety, fatigue and abnormal irritation, as well as cognitive and motor dysfunction.

Monday's case addresses the theory that the cause of autism is the measles, mumps and rubella vaccine in combination with other vaccines containing thimerosal. The preservative, about 50 percent mercury by weight, is no longer found in routine childhood vaccines but is used in some flu shots.

In July 1999, the U.S. government asked vaccine manufacturers to eliminate or reduce, as expeditiously as possible, the mercury content of their vaccines to avoid any possibility of infants who receive vaccines being exposed to more mercury than is recommended by federal guidelines.
Source :http://www.chron.com

FDA Steps Up Oversight of Body Parts Companies

U.S. health officials said Tuesday that they're stepping up inspections of companies that use cadavers to harvest body parts for tissue transplants.

The increased vigilance comes after scandal shook the transplant industry last year when it was discovered that funeral homes were harvesting body parts and selling them without consent, including body parts from Alistair Cooke, the 90-year-old former host of PBS' Masterpiece Theater.

f not screened properly, transplanted tissues can cause serious infections, including HIV, hepatitis -- even death. Harvested tissues are used in some 1 million medical procedures in the United States each year, many of them for knee and back surgeries. Up to 100 recipients may receive tissue from a single donor, the FDA said.

In response to the scandal, the U.S. Food and Drug Administration formed the Human Tissue Task Force, which issued its first report Tuesday.

"Today's report finds no significant industry-wide problem in the recovery of human tissues," Dr. Celia Witten, director of FDA's Office of Cellular, Tissue and Gene Therapies, said during an afternoon teleconference. "This provides our belief that the risk of disease transmission is very low for patients who receive these products."

Still, the task force is calling for still more inspections. "There is reason to be ever vigilant because the tissue industry is growing," Witten said.

There are more than 2,000 cell and tissue establishments registered with FDA, the agency said.

Originally, the task force recommended targeted inspections -- or a "blitz" -- of U.S. companies that recover human tissues, including tendons, ligaments, bone and other musculoskeletal tissues, said David Elder, director of the FDA's Office of Enforcement, Office of Regulatory Affairs.

To date the FDA has inspected 153 major human tissue recovery firms and plans on inspecting an additional 300 companies, Elder said. "What our investigators found was encouraging for tissue safety," he said during the teleconference. "Although we identified some deviations from regulations, we generally saw no unsafe or deceptive practices that could put tissue recipients at risk for disease."

The biggest company involved in illegally harvesting body parts was Biomedical Tissue Services of New Jersey. The company faces trial, along with a former New York state funeral home director, on charges they stole bodies and dissected them unlawfully, the Associated Press reported.

In addition, seven funeral home directors have already pleaded guilty and tens of thousands of body parts removed by the company have been recalled. About 10,000 people are believed to have received tissues from the company, according to the AP.

The FDA task force is also recommending:

* Increased education and outreach. The FDA should sponsor a workshop on tissue processing and microbiology for industry, surgeons and academics, to develop and share best practices for reducing the risk of disease transmission.
* Research regulations and guidance. In September 2006, the FDA issued a "guidance document" that emphasized responsibilities for ensuring tissue safety between establishments and their contractors. The FDA will issue guidance on "current good tissue practices" to encourage tissue manufacturers to seek the best methods to further reduce the risk of infection transmission.

The FDA's Center for Biologics Evaluation and Research has strengthened its collaboration with the U.S. Centers for Disease Control and Prevention, to oversee tissue-safety surveillance and adverse reaction investigations, according to the report.
Source :http://www.forbes.com

Autism test cases against US begin

Lawyers began arguments yesterday in the first of several test cases that may help decide whether the government should pay millions of dollars to parents of children with autism.

Nearly 5,000 parents say that vaccinations caused their children to develop autism and many of their claims have been pending for five years. The hearing was held at the "federal vaccine court" set up by Congress 20 years ago when a series of vaccine scares nearly crippled the industry.

Every major study and scientific organization examining this issue has found no link between vaccination and autism, but the parents and their advocates have persisted. Their frustration was evident in the opening statement of the parents' lawyer, Thomas Powers of Portland, Ore.

"Numerous obstacles have been placed in the path of the petitioners seeking that fair and generous compensation that they are entitled to," Powers said.

Powers gave his statement with his back to the three judges who will decide the case, addressing instead a few dozen audience members, many of them lawyers.

"I felt it was important to address the families and the public," he said during a break in the hearing.

The vaccine court has gone to unusual lengths to convince parents that it will fairly adjudicate their claims, even setting up a conference call where parents can listen in to the hearings, which are expected to run for three weeks.

At the opening of the hearing, Special Master George Hastings expressed his sympathy to the parents of children with autism.

He pointed to Michelle Cedillo and her parents, Theresa and Michael, whose claim for compensation is serving as the first test case. Hastings said the Cedillos were "the most important people in the courtroom."

"To all such family members, as to the Cedillo family, we special masters pledge to you that we will listen very carefully to the evidence presented at this hearing," Hastings said. "We realize what an important task . . . has been assigned to us in this hearing."

Michelle Cedillo, 12, was brought into the courtroom in a wheelchair at the start of the hearing. She wore hearing protection similar to that worn by heavy-machinery operators. She hit herself repeatedly and made loud grunting noises. Her parents soon took her out of the courtroom.

Many parents who say that vaccines gave their children autism are deeply suspicious of what they see as the government's role in their children's illness. Most have dismissed the many government-sponsored studies and panels that found no link between vaccination and autism. A few have even physically threatened some government scientists.

Parents' lawyers said this case would probably affect only a few of the other claims. A test hearing for the other claims will be heard next year, said Mike Williams, chairman of a committee of parents' lawyers.
Source :http://www.boston.com

Saturday, June 2, 2007

Home-based care program also benefits the insurer

Every year, about 1.5 million Americans are diagnosed with cancer. Every year, they run up a medical tab estimated at $100 billion.

Some of that money is spent on unnecessary hospitalizations and emergency room visits, which is why Blue Shield of California sends a nurse to Pamela Sprott's home in Valencia several days a week.

"I am not in the hospital because she makes sure I am taken care of," Sprott, 56, said of the care coordinator who keeps track of her mind-boggling regimen of chemotherapy treatments and drug prescriptions and the appointments with specialists who treat her leiomyosarcoma, a rare form of cancer that started in her uterus.

Supplying care coordinators is one of Blue Shield's strategies to prevent patients' conditions from worsening while containing the costs of treatment. By vigilantly managing Sprott's treatment, the insurer lowers her risk of developing complications, such as dehydration or anemia, that could land her in an emergency room or hospital bed.

"What we are saying is, let's just keep the bad stuff from happening in the first place," said Andrew Halpert, Blue Shield's senior medical director.

A Blue Shield study published in the American Journal of Managed Care found that patients like Sprott had 30% fewer emergency room visits and 38% fewer hospital admissions than Blue Shield cancer patients who didn't receive the intensive care coordination.

The study, co-authored by Halpert, concluded that the care-coordination program, launched on a trial basis in 2003, saved more than $18,000 per patient on average in an 18-month period. Survival rates remained virtually the same.

Blue Shield, which with 3.2 million members is the third-largest health plan in California, rolled out the patient-centered management program statewide this year to about 800 patients with late-stage cancer and other serious diseases. The insurer hasn't disclosed the cost of the program, but the study concluded that the trial had a return-on-investment ratio of 2 to 1.

Most health plans have call centers with customer service representatives who answer members' questions about their coverage and help them find specialists, among other things. But the service isn't personalized.

At Blue Shield, each coordinator handles no more than two dozen patients, and they are regularly visited at home.

A chief goal of the program is to keep people out of hospitals, and especially emergency rooms. Patients who land in the ER are likely to be seen by a doctor with little or no background in oncology, said Thomas B. Strouse, the director of pain management at the Cedars-Sinai Outpatient Cancer Center in Los Angeles. That is no good for the patient or the insurance company paying most of the bill.

The idea of decreasing hospitalization to rein in healthcare costs isn't new. For a decade, Kaiser Permanente, the state's largest health maintenance organization, has offered intensive home-based treatment to some of its sickest patients, including cancer sufferers.

The end-of-life care saved about half the costs of treating such patients without the program, according to Kaiser, which plans to double the number of Southern California patients who receive care at home to 2,000 this year.

Avoiding costly hospitalizations is increasingly important for insurers, said Michael Burcham, president of ParadigmHealth Inc. of Upper Saddle River, N.J., which specializes in care coordination for complex cases that include cancer, neo-natal and spinal cord patients. The company, whose clients include Blue Shield, has seen its business grow 20% to 25% a year since 2002.

"If you look at the elderly population, hospitalization is a significant piece of the cost," Burcham said. "As the baby boomers age, we will be facing more of these cases."

Beyond that, patients who remain at home tend to feel more comfortable with their treatment regimen than patients in hospitals.

Len Lichtenfeld, deputy chief medical officer for the American Cancer Society, welcomes the trend. But echoing many patients' advocates, he cautions that such decisions should be based on medical evidence, not cost concerns.

Blue Shield executives said their program was designed to avoid unnecessary treatment rather than withhold what's needed.

Health insurers' attempts to cut costs have often met with accusations that the savings come at the expense of care. Denial of requested treatment is one of the most common complaints that clients lodge, according to the California Department of Managed Health Care. The state received 1,080 such complaints last year, 524 of them against San Francisco-based Blue Shield. The nonprofit health plan is also among a handful of California insurers to be sued by patients saying they were dropped once they became ill and accumulated large medical bills. Blue Shield and the others have denied wrongdoing. Sprott, a former teacher who's married to Robert Sprott, a Superior Court judge, is undergoing chemotherapy and trying not to think about her life ending. The couple have a 15-year-old son.

A few years ago, before she learned she had cancer, she was in a serious car accident.

"The car rolled over three times," she said. "I thought I was going to die then. I don't know that I'll die of cancer. It might be something else, but you just have to take one day at a time and enjoy the day."
Source :http://www.latimes.com