30 September 2010

Wound Care The New Way

Hyperbaric chamber immerses patients in pure oxygen

An innovative method for wound care places patients in a tube-like chamber filled with pure oxygen. The new treatment approach is cutting edge and highly effective for healing all types wounds.

A case of a patient suffering from ulcers on his legs, associated with venous insufficiency, proves the chamber's wound healing worthiness. The patient's skin is vulnerable to ulceration, and the soreness caused by any sort of friction takes a long time to heal. Starting mid-Summer, he began regular treatment at his local wound healing facility. The center opened in early June and utilizes a hyperbaric oxygen chamber to treat chronic and highly sensitive wounds.

In a matter of few session in the chamber, the patient realized drastic improvements. "The wounds themselves have reduced significantly," he said. "And what's most encouraging is that no new ulcers have developed."

The chamber is making its way into hospitals all throughout Michigan. From the Macomb County Wound Care Center located just north of Detroit, to the neighboring Medical Center of Wound Care in Oakland county MI, the application and popularity of pure oxygen treatment is emerging.

The physicians operating the facility are drawn to the chamber's wonders. "The hyperbaric oxygen therapy Macomb County has to offer is the new way of wound treatment." said a southwest Michigan wound care specialist. "Many patients who have struggled to heal after months of traditional treatment methods are experienced promising results after just a few therapy sessions in the Macomb County hyperbaric chamber."

Hyperbaric oxygen therapy can be applied to treat a wide range of issues. Such wounds include diabetic wounds, slow-to-heal injuries and compromised grafts, among other skin-related conditions. Before beginning the therapy, a prospective patient must have a "chronic" wound — a wound that has not displayed signs of healing in 30 days of treatment.

Among other medical centers in the southwest Michigan area that have been witnessing similar results is the Lapeer County Wound Care Center.

After a traumatic car accident, a young patient had problems healing a critical leg abrasion. The injury was very slow to heal using tradition approaches to treatment, which entailed minimal surgical intervention and ointments to help heal the skin. The boy started hyperbaric oxygen therapy in Lapeer County, and in a matter of days, his skin showed signs of clearing and the soreness was greatly alleviated.

The chamber treatment requires a serious time commitment. For up to six weeks, patients must immerse themselves in the pure oxygen chamber for 90 minutes to two hours, five days a week. Weekly photographs of the wounds are taken to analyze signs of healing tissue as well as to evaluate the overall healing schedule.

Most chambers are constructed with glass, so the see-through tank allows patients to watch a TV mounted on the outside. Many patients of hyperbaric oxygen therapy in Lapeer county Michigan's medical center have claimed the treatment process to be peaceful and relaxing.

"The abundance of oxygen is rejuvenating!" as described by one patient after experiencing the chamber for the first time. "Not only do I feel better, but I can already sense the treatment is speeding my wound's healing process." she added.

A similar case occurred in a hyperbaric chamber at Oakland County Michigan's Crittenton Hospital. A patient with a severe case of diabetes - a common candidate for the chamber - noticed drastic healing in puncture wound after a week of the treatment. He claimed that the pain was very persistent, and becuase he was diabetic, the recovery process was long and enduring. After completing a month of hyperbaric oxygen therapy at the Oakland county facility, his pain was "barely noticeable".

The hyperbaric chamber is pressurized to the equivalent of about 60 feet of sea water, said one of the doctors who helps wound care patients. The chamber has enabled diabetic patients to avoid amputation for foot-related issues, the doctor added.

In case of the medical center in Lapeer county Michigan, as well as most other providers, patients go through an extensive evaluation before they are admitted for treatment in the Lapeer County hyperbaric chamber. This allows nurses and physicians to fully understand the effectiveness of the chamber with respect to each unique case as well as its infancy in wound care treatment.

At the end of a week-4 session in the chamber, the patient suffering from ulcers on his leg claimed his discomfort decreased to an "astonishing" level. As more and more patients seek the hyperbaric chamber for wound care, the proven effectiveness of the pure oxygen treatment grows even more valid and accepted around the nation.

1 in 10 Teens using Sunless Tanning Products

USA Today

About one in 10 U.S. teens slather on sunless tanning products, and those who do are more likely to get sunburns and engage in other skin-damaging behaviors such as indoor tanning, a new study finds.

Looking into the use of sunless tanning lotions and sprays among 1,600 U.S. adolescents aged 11 to 18, researchers found that 10.8% of them had tried the products in the past year. Those who did so tended to be older and female, to have a parent or caregiver who also used such products, and — not surprisingly — to view a tanned appearance as desirable.

The researchers also found that the use of sunless tanning products by teens was associated with higher frequency of sunburn and the use of indoor tanning beds, which have been found to expose users to harmful levels of ultraviolet radiation.

Ultraviolet radiation exposure was recently upgraded to the highest cancer risk category and is also the most common preventable cause of skin cancer, according to background information in the studies.

"Our findings are that in adolescents, use of sunless tanning products appears independently correlated with risky UVR exposure behaviors (indoor tanning and having sunburns in the previous summer) but not with routine use of sunscreen," wrote Vilma E. Cokkinides, of the American Cancer Society, and colleagues, in a news release.

Adolescents, therefore, must be educated about these products and the importance of avoiding indoor tanning and practicing sun-protective behaviors," they added.

The study appears in the September issue of the Archives of Dermatology.

Another study in the same issue of the journal found that adult women sunbathers who were encouraged to use sunless tanning products sunbathed less often, had fewer sunburns, and wore more sun-protective clothing than those who didn't use the products.

"These findings have implications for public health and clinical efforts to prevent skin cancer. Promoting sunless tanning to sunbathers in the context of a skin cancer prevention public health message may be helpful in reducing sunbathing and sunburns and in promoting the use of protective clothing," wrote Sherry L. Pagoto, of the University of Massachusetts Medical School, and colleagues.

"Further research should determine how to further convince tanners to switch to sunless tanning," she added.

Most sunless tanning lotions and sprays contain a chemical called dihydroxyacetone, which combines with amino acids in the skin to produce a tanned color.

29 September 2010

Health-care Overhaul Supports Research on Breast Cancer in Young Women

The Washington Post

Breast cancer is extremely rare in young women. But when it does happen, it can be serious, even deadly. A little-noticed section in the health-care overhaul aims to raise awareness among young women and their doctors about the risk of breast cancer between the ages of 15 and 44.

The law directs the Centers for Disease Control and Prevention to create education campaigns that will focus on breast cancer and young women, and encourage healthful habits that promote prevention and early detection of the disease.

The law also provides grants to groups that support young women with breast cancer. And it directs the National Institutes of Health to develop new screening tests and other methods to prevent breast cancer in young women and improve early detection. The law provides $9 million annually between 2010 and 2014 for these efforts.

Only about 10 percent of the roughly 250,000 women who receive diagnoses of breast cancer in a given year are younger than 45, according to the American Cancer Society . Family history, ethnicity and genetics can all increase a woman's risk.

When young women do get breast cancer, it tends to be more aggressive. The five-year survival rate for women given the diagnosis before age 40 is 83 percent, compared with 90 percent for other women, according to the American Cancer Society.

Advocates say younger women's lower survival rates also may be due in part to later diagnoses. With the likelihood of cancer remote, young women and their doctors sometimes take a wait-and-see approach when they discover a lump or other breast change.

When Robyn Haines found a lump under her arm last summer, she wasn't overly concerned, and she waited a few months before checking it out. The 28-year-old television newscaster eventually visited her gynecologist near her home in Cadillac, Mich., and her doctor said it was probably nothing but referred her for a mammogram and ultrasound, just to be safe. The results were inconclusive. The doctor then sent Haines to a general surgeon, who wasn't particularly concerned, either. But he said that if the lump was uncomfortable, he could remove it.

Haines decided to go ahead with that surgery and says she was "extremely shocked" to learn last October that she had an aggressive form of breast cancer. Haines underwent a bilateral mastectomy and chemotherapy, continuing her morning anchor duties in a wig after her hair, eyebrows and eyelashes fell out. She's still undergoing breast reconstruction.

Haines says some of her concerns are different than they would be if she were older. Fertility, for example, is a big unknown at this point. "I did what I could to preserve it, but it could be an issue down the road," says Haines, who received a series of shots during chemotherapy intended to minimize effects on her ovaries.

Experts agree that there are no easy solutions for screening women younger than 40. Given the low incidence of breast cancer in this group, widespread screening with mammograms wouldn't be cost-effective, and young women's breast tissue is often too dense to be effectively evaluated by a breast X-ray.

In the absence of cost-effective, high-tech tools, an advocacy group recommends that young women speak up quickly if they notice a change in their breasts. "Be familiar with the look, feel and shape of your breasts, so that if something develops you're aware of it," says Stacy Lewis, vice president of programming for the Young Survival Coalition. "If you see a change, go see a doctor, and if you're told that it's probably nothing, go to another provider."

Although encouraging young women to learn more about breast cancer may be good advice, some experts caution that knowledge isn't always power.

"It's all a balance," says H. Gilbert Welch, a professor and researcher at the Dartmouth Institute for Health Policy and Clinical Practice. "You want people to be aware without making them feel more vulnerable to disease than they are."

Experts say that the new law's most significant provisions relevant to breast cancer in younger women may be those that encourage further research.

Since screening women before age 40 isn't practical, identifying young women who are at risk becomes all the more important, says Dr. Therese Bevers, medical director of the cancer prevention center at the MD Anderson Cancer Center at the University of Texas in Houston. "We've got to have a way of picking out the right young women," she says. "Otherwise we'll miss cases."

Feds Reopen Probe into Medical Scanner Approvals

Associated Press

Federal inspectors have reopened an investigation into complaints by Food and Drug Administration scientists who say they were pressured by their managers to approve high-tech medical scanners that could pose harm to patients.

The lead inspector overseeing the matter told The Associated Press on Tuesday that the inquiry into the allegations, which were dismissed in February, is being revisited to look at manager misconduct.

"The original intent of the investigation was to look at criminal matters and our agents did that," said Gerald Roy, deputy inspector general for investigations in the Department of Health and Human Services. "But I point toward broader issues that really compelled me to take a second look at this and reopen it from an administrative perspective."

The HHS office of inspector general, which oversees the FDA, closed the case in February after finding there was "no violation of law."

But the whistleblowers have repeatedly stressed that their grievances involve mismanagement and violations of regulations - which don't fall under criminal law.

Nine FDA medical device reviewers alleged in 2008 that agency management overruled their opinions without supporting evidence and tried to intimidate them when they went public with their concerns.

At issue are CT scanners, MRI machines and other medical devices that use radiation to detect or treat diseases. Many of the devices allow lifelike pictures of the human anatomy, but carry a higher risk from radiation than older scans such as X-rays.

In recent years, hundreds of radiation overdoses have been reported with imaging devices used by hospitals across the country. The whistleblowers say these problems underscore the concerns they raised about such devices.

The new probe comes after prodding from lawmakers and nonprofit watchdog groups, including the Project for Government Oversight. In a letter to the inspector general Tuesday, the group calls the previous investigation a "sham."

"If these allegations are true, the FDA is failing in its primary mission of keeping people safe," said Danielle Brian, the group's executive director.

An agency spokeswoman said she could not immediately provide comment Tuesday.

Since the FDA whistleblowers went public with their concerns - in letters to Congress and the Obama administration in 2008 and 2009 - at least two scientists have been let go and another has quit after alleged intimidation.

Interviews with the staffers and internal e-mails obtained by The Associated Press provide new details of alleged mismanagement in the FDA's device division.

Central to the scientists' complaints is an FDA pathway to approval that allows speedy clearance if a device appears comparable to others already on the market.

Former FDA reviewer Dr. Gamal Akabani repeatedly recommended against clearing radiation-emitting devices used to treat cancer under the accelerated system, saying the devices needed to undergo actual testing to prove their safety and effectiveness. Between 2007 and 2008, Akabani said he was frequently pressured by supervisors to change his opinion, he said in an interview with The Associated Press.

In the final incident, Akabani's manager asked about the health of his wife, who has cancer, and his son, who was born severely handicapped. According to Akabani, the manager suggested his job - and health insurance for his family - would be safe as long as he cooperated with his supervisors.

"It shook me to the core because I realized that he was coercing me," said Akabani, who resigned from the FDA and currently teaches nuclear physics at Texas A&M University.

Akabani and other whistleblowers say a key problem at the agency is that managers - who have often spent decades in government - have far less expertise and up-to-date training than the medical reviewers they oversee. Akabani was recruited to the FDA after a decade in the radiology department at Duke University Medical Center.

The whistleblowers also point out that FDA managers are evaluated, in part, on their ability to get speedy reviews of devices, causing them to pressure and sometimes overrule scientists who slow down the process.

In another case of alleged retaliation, an Oxford-trained medical specialist's contract was not renewed after he repeatedly opposed approving a CT scanner for routine colon cancer screening. Dr. Julian Nicholas said that he objected to exposing otherwise healthy patients to the cancer risks of radiation. He says he was ridiculed by agency managers for "raising the bugaboo of radiation."

"They conspired against me because I refused to change my expert medical opinion to conform with their desired regulatory outcome," Nicholas wrote in an e-mail to FDA Commissioner Margaret Hamburg after his termination late last year.

Both Akabani and Nicholas say they were never contacted by the office of inspector general, which they say makes the inspectors' original report flawed and incomplete.

The inspector general's office issued a memo to FDA leadership in February when it concluded there had been no criminal violations.

The whistleblowers complain that FDA officials have used the four-page memo to try to dissuade members of Congress from looking into their allegations.

Robert Smith, a former radiology division reviewer who left the agency in July, said FDA leadership assured the whistleblowers that the investigation would be comprehensive.

"It was the FDA's responsibility to make sure the investigation they requested was properly conducted and reported," Smith said, "And it was the responsibility of the inspector general to conduct a legitimate investigation - which they know they did not."

How to Widen the Hunt for Targeted Cancer Therapy

Associated Press

Cancer is a tale of two sets of genetic code, your own and your tumor's - and tracing the unique areas of damage makes for a way to target treatment.

Fifty years after the discovery of the first direct genetic link to cancer, scientists are assessing the state of so-called targeted therapy - with nearly 30 treatments on the market and a dozen or so more under study.

"We're still not using the 'C' word, 'cure,'" cautioned personalized medicine director Jeff Boyd of Fox Chase Cancer Center, who helped organized a meeting in Philadelphia on Tuesday to mark the anniversary and examine the future of targeted therapy.

But, he added, "there is real potential to transform many cancers into chronic diseases."

One next challenge is how to expand the number of targets to attack, in part by answering what the new chief of the National Cancer Institute calls the "big questions" about what makes this disease so intractable.

Questions like: What makes a tumor metastasize, or spread through the body? Metastasis is what kills, yet scientists don't know why some tumors spread and others don't, and what programs those tumor cells to invade, say, the liver instead of the bone or the lung - factors that undoubtedly could be new treatment targets.

Starting in October, Dr. Harold Varmus, the NCI's director, will begin quizzing top researchers from around the country about which of oncology's underlying mysteries should be part of his "Big Questions Initiative," a new focus of government cancer research.

Answering those questions "would get you over a roadblock that keeps us from making better progress," Varmus told a meeting of his scientific advisers earlier this month.

For Dr. Otis Brawley of the American Cancer Society, such a project might finally offer clues to a huge problem facing patients today: How to tell who needs the most aggressive treatment, and who would be OK skipping the big guns.

A domino effect of genetic alterations is required to cause any of the 200 diseases collectively called cancer. Some occur in the person, making them more prone to illness. But tumors also have their own genetic signature - four to seven genetic changes that are critical to turning, say, a normal breast or colon or liver cell into a cancerous one, and a pattern of activity that signals how aggressive that malignancy will be. Those unique patterns also offer targets for treatment, drugs that zero in on the particular genetic pathways fueling the person's cancer - and even vaccine-like therapies, a fledgling field that aims to train patients' immune systems to recognize and fight their tumors.

It all started with the 1960 publication of what was dubbed the Philadelphia chromosome, a funny-looking chromosome that two scientists - one from the University of Pennsylvania, one from Fox Chase - spotted only in patients with a specific kind of leukemia. Fast-forward to the 2001 approval of the groundbreaking drug Gleevec, which has turned chronic myeloid leukemia from a fast killer into a disease that many patients today manage with a daily pill. It works by targeting the cancer-causing protein produced by the Philadelphia chromosome.

Gleevec wasn't the first genetic targeted therapy for cancer - the decades of research sparked by that discovery actually paid off for some other cancers first.

Boyd predicts there will be more than 100 targeted therapies available within several more years, and the real quest is for targets that prove as crucial to holding cancer in check as Gleevec's did.,

Generating particular excitement now are possible new drugs for hard-to-treat breast cancer, compounds called PARP inhibitors that block enzymes needed for cell growth. Also on the radar are earlier-stage experiments with drugs for melanoma and St. Louis lung cancer treatment that target different genetic pathways involved in spurring cancer growth.

The biggest threat: Funding for cancer research isn't keeping up with the discovery of possible new targets, said the cancer society's Brawley. The NCI's budget has held at around $5 billion for several years, but federal scientists are bracing for possible cuts in 2012.

And because these targeted therapies work differently - shrinking a tumor or slowing its growth - than the tumor-destroying approaches of chemotherapy and radiation, it's harder to prove a benefit.

But Allison Frey, whose aggressive form of thyroid cancer spread to her liver in inoperable patches, says that approach has made her cancer an illness she can manage much like a diabetic manages insulin. For nearly five years, the Lanoka Harbor, N.J., woman has swallowed an experimental pill called Axitinib that shrank those patches and kept them from growing back, working through a pathway that targets a tumor's blood supply.

"Honestly, to me it's just like any other chronic illness," said Frey, who's part of a study at Fox Chase. "I show up for work every day and live life ... with minimal issues."

28 September 2010

U.S. Can Continue Stem-Cell Funding, Court Says

Bloomberg / BusinessWeek

The U.S. government can continue funding embryonic stem-cell research while it seeks to reverse a lower-court order that barred support to scientists who use the cells, an appeals court said.

The ruling by U.S. Court of Appeals in Washington today puts on hold an order cutting off funding by U.S. District Judge Royce Lamberth, which the government argued would cause irreparable harm to researchers, taxpayers, and scientific progress while the case is appealed.

The government’s lawyers “have satisfied the standards required for a stay pending appeal,” the judges wrote in a one- page order that said the appeal will be expedited and the parties would later be informed the briefing and oral arguments schedule.

Lifting the ban allows the government to temporarily continue funneling tens of millions of dollars to scientists seeking cures for diseases such as Parkinson’s, spinal cord injuries, and genetic conditions. Embryonic stem cells can grow into any kind of tissue and may have the potential to accelerate a range of research.

The decision, coming after oral arguments yesterday, was made by Judith Rogers, appointed by former President Bill Clinton, and Thomas Griffith and Brett Kavanaugh, both appointed by former President George W. Bush.

Geren Corp., which was cleared in July to proceed with the first human test on an embryonic stem-cell therapy aimed at patients with a spinal cord injury, rose 5 percent in after hours trading.

Representaives from the U.S. Justice Department and Thomas Hungar, an attorney for the opponents of the funding, didn’t immediately return calls seeking comment.

Halt in Funding

Lamberth on Aug. 23 issued an order temporarily stopping the Health and Human Services Department and the National Institutes of Health from funding or conducting the studies. On Sept. 7, Lamberth denied a U.S. request to reconsider his ruling. The court of appeals then allowed funding to resume pending today’s decision.

The judge cited the still-in-force 1996 Dickey-Wicker Amendment in his ruling, saying that Congress prohibited funding any research in which a human embryo was destroyed. By implication, that included all stem-cell research, Lamberth said.

In March 2009, President Barrack Obama reversed an executive order of Bush’s to allow research on cells derived from embryos that would otherwise be disposed of after in vitro fertilization procedures.

Under Bush’s order in August 2001, Dickey-Wicker was interpreted to allow research on lines of stem cells that already had been created using human embryos. Bush limited federal funding for such research to about 20 existing lines of embryonic cells and banned funding on any additional lines.

Lamberth’s order prevented the National Institutes of Health from acting on grant applications that have been reviewed, and from considering dozens of other applications that are in the review process, the U.S. wrote in its appeal. It may take as long as eight months to reinitiate the review process for grant applications, the U.S. claimed.

27 September 2010

Blue Cross to refund $156 million in N.C.

USA Today

Health insurance regulators in North Carolina have identified nearly $156 million in refunds owed to Blue Cross policyholders because of changes coming under the nation's new health law.

Consumers with policies at other companies across the nation also may deserve refunds, says North Carolina Insurance Commissioner Wayne Goodwin. He plans to urge other states to probe potential overcharging for a type of reserve fund.

The health care law will dramatically change how health policies are sold in 2014, and many plans in effect now will cease to exist that year in their current form. Yet state regulators who scrutinized a recent rate increase request by Blue Cross and Blue Shield of North Carolina say they discovered the insurer was collecting reserves to pay claims beyond 2014.

Discovering this took "heavy lifting" by financial experts at the department, Goodwin said, adding: "Since the passage of the federal health reform law we've ramped up our interactions with the insurance companies we regulate."

The result: Blue Cross has agreed by year's end to send refunds to more than 215,000 North Carolina policyholders with individual plans in force on March 23 — the date the new health law was enacted. The refunds announced Monday will vary depending on premiums paid, but will be worth about a month and a half's premiums. For an average policy holder, that's $690, said Brad Wilson, the insurer's president and CEO.

Wilson said the reserves being refunded are portions of consumers' premiums that the insurer set aside in the early years of a policy to keep monthly payments more stable over the life of the policy, as the person's medical expenses increased. "Blue Cross maintained this money on behalf of our customers and now it is time to release it," he said.

Blue Cross' group policies didn't use this kind of reserve, company spokesman Lew Borman said.

It's unclear what percentage of health policies nationwide use similar "active life reserves" formulas in setting rates and whether policyholders in other states also deserve refunds. Several industry groups and insurers contacted by USA TODAY, including America's Health Insurance Plans, either didn't know or didn't respond to interview requests. Brett Lieberman, spokesman for the Blue Cross and Blue Shield Association, which represents 39 independent companies, said: "We're not aware of this being a broader issue."

Steve Larsen, who heads insurance oversight at the U.S. Department of Health and Human Services, said there may be others. "I really do think there may be a bigger issue at work here," he said.

Cartilage Regeneration Builds a new Knee, From the Inside

USA Today

Dara Torres says life was "kind of depressing" — and she is not one to be depressed.

A year ago, the Olympic swimmer could not walk up stairs without limping or pick up her baby girl because her knee hurt so much.

Now, after undergoing a highly specialized surgery, Torres is picking up her toddler and her training for the 2012 London Olympics. She became the first U.S. swimmer to compete in five Olympics, winning three silver medals at the 2008 Beijing Games at age 41. "When you train like this at my age, it takes its toll on your body," she says.

Before Beijing, she had left knee pain, and afterward, it got much worse. A series of X-rays taken during several months revealed quickly deteriorating cartilage. "My doctor told me it was one of the worst knees he's ever seen."

She opted to delay knee replacement and instead had orthopedic surgeon Thomas Minas perform knee cartilage regeneration surgery on Oct. 20.

Autologous chondrocyte implantation (ACI) requires two operations, followed by a lengthy recovery and physical therapy. Torres says it's the toughest rehab she has ever faced, but "I was diligent about listening to the doctor (and) pacing myself."

For 12 to 18 months, the new cartilage cells need to heal and harden. Patients wear a leg brace and use crutches for several months. They can run after a year and pivot several months later. Exertion or twisting too early could cause irreversible damage.

Torres' knee "was a mess," Minas says. "Now she walks normally, climbs stairs and has no pain."

Minas, director of the Cartilage Repair Center at Brigham and Women's Hospital in Chestnut Hill, Mass., performed the first ACIs in the USA in 1995 and has done more than 600. He says his patients, average age 39, have had a 92% success rate. "This will delay a small group of patients who need knee replacements," he says. "But we will always need replacements, unless we find some ... breakthrough halting the progression of osteoarthritis and severe knee pain."

Torres says she is on track for London and just started "easing back into kicking." She hopes to keep motivating others to pursue dreams, no matter what age: "I hear people say what I'm doing inspires them to do things they put off because of age or thought they couldn't do."

$93,000 Cancer Drug: How Much are a few Months of Life Worth?

USA Today

Cancer patients, brace yourselves. Many new drug treatments cost nearly $100,000 a year, sparking fresh debate about how much a few months more of life is worth.

The latest is Provenge, a first-of-a-kind therapy approved in April. It costs $93,000 and adds four months' survival, on average, for men with incurable prostate tumors. Bob Svensson is honest about why he got it: insurance paid.

"I would not spend that money," because the benefit doesn't seem worth it, says Svensson, 80, a former corporate finance officer from Bedford, Mass.

His supplemental Medicare plan is paying while the government decides whether basic Medicare will cover Provenge and for whom. The tab for taxpayers could be huge — prostate is the most common cancer in American men. Most of those who have it will be eligible for Medicare, and Provenge will be an option for many late-stage cases. A meeting to consider Medicare coverage is set for Nov. 17.

"I don't know how they're going to deal with that kind of issue," said Svensson, who was treated at the Lahey Clinic Medical Center in suburban Boston. "I feel very lucky."

For the last decade, new cancer-fighting drugs have been topping $5,000 a month. Only a few of these keep cancer in remission so long that they are, in effect, cures. For most people, the drugs may buy a few months or years. Insurers usually pay if Medicare pays. But some people have lifetime caps and more people are uninsured because of job layoffs in the recession. The nation's new health care law eliminates these lifetime limits for plans that were issued or renewed on Sept. 23 or later.

Celgene Corp.'s Revlimid pill for multiple myeloma, a type of blood cancer, can run as much as $10,000 a month; so can Genentech's Avastin for certain cancers. Now Dendreon Corp.'s Provenge rockets price into a new orbit.

Unlike drugs that people can try for a month or two and keep using only if they keep responding, Provenge is an all-or-nothing $93,000 gamble. It's a one-time treatment to train the immune system to fight prostate tumors, the first so-called "cancer vaccine."

It's also in short supply, forcing the first rationing of a cancer drug since Taxol and Taxotere were approved 15 years ago. At the University of Texas M.D. Anderson Cancer Center, doctors plan a modified lottery to decide which of its 150 or so eligible patients will be among the two a month it can treat with Provenge. An insurance pre-check is part of the process to ensure they financially qualify for treatment.

"I'm fearful that this will become a drug for people with more resources and less available for people with less resources," said M.D. Anderson's prostate cancer research chief, Dr. Christopher Logothetis.

For other patients on other drugs, money already is affecting care:

—Job losses have led some people to stop taking Gleevec, a $4,500-a-month drug by Novartis AG that keeps certain leukemias and stomach cancers in remission. Three such cases were recently described in the New England Journal of Medicine, and all those patients suffered relapses.

—Retirements are being delayed to preserve insurance coverage of cancer drugs. Holly Reid, 58, an accountant in Novato, Calif., hoped to retire early until she tried cutting back on Gleevec and her cancer recurred. "I'm convinced now I have to take this drug for the rest of my life" and will have to work until eligible for Medicare, she said.

—Lifetime caps on insurance benefits are hitting many patients, and laws are being pushed in dozens of states to get wider coverage of cancer drugs. In Quincy, Mass., 30-year-old grad student Thea Showstack testified for one such law after pharmacists said her first cancer prescription exceeded her student insurance limit. "They said 'OK, that will be $1,900,'" she said. "I was absolutely panicked." The federal health care law forbids such caps on plans issued or renewed Sept. 23 or later.

—Tens of thousands of people are seeking help from drug companies and charities that provide free medicines or cover copays for low-income patients. Genentech's aid to patients has risen in each of the last three years and the company says nearly 85% of Americans earn less than $100,000, making them potentially eligible for help if no other programs like Medicaid will pay.

—Doctors and insurers increasingly are doing the cruel math that many cancer patients want to avoid, and questioning how much small improvements in survival are worth. A recent editorial in a medical journal asked whether the extra 11 weeks that Genentech's Herceptin buys for stomach cancer patients justified the $21,500 cost.

Doctors also have questioned the value of Genentech's Tarceva for pancreatic cancer. The $4,000-a-month drug won approval by boosting median survival by a mere 12 days. Here's how to think about this cost: People who added Tarceva to standard chemotherapy lived nearly 6 1/2 months, versus 6 months for those on chemo alone. So the Tarceva folks spent more than $24,000 to get those extra 12 days.

When is a drug considered cost-effective?

The most widely quoted figure is $50,000 for a year of life, "though it has been that for decades — never really adjusted — and not written in stone," said Dr. Harlan Krumholz, a Yale University expert on health care costs.

Many cancer drugs are way over that mark. Estimates of the cost of a year of life gained for lung cancer patients on Erbitux range from $300,000 to as much as $800,000, said Dr. Len Lichtenfeld, the American Cancer Society's deputy chief medical officer.

Higher costs seem to be more accepted for cancer care than for other illnesses, but there's no rule on how much is too much, he said.

Insurers usually are the ones to decide, and they typically pay if Medicare pays. Medicare usually pays if the federal Food and Drug Administration has approved the use.

"Insurance sort of isolates you from the cost of health care," and if people lose coverage, they often discover they can't afford their medicines, said Dr. Alan Venook, a cancer specialist at the University of California, San Francisco. He wrote in the New England Journal in August about three of his patients who stopped taking or cut back on Gleevec because of economic hardship.

Two of the three now are getting the drug from its maker, Novartis AG, which like most pharmaceutical companies has a program for low-income patients. About 5,000 patients got help for Gleevec last year, said Novartis spokesman Geoffrey Cook.

"We have seen a steady increase in requests over the past few years" as the economy worsened, he said.

Showstack, whose leukemia was diagnosed last year, gets Gleevec from Novartis. The dose she's on now would cost $50,000 a year.

"I'm not actually sure that I know anyone who could afford it," she said.

Gleevec's cost is easier to justify, many say, because it keeps people alive indefinitely — a virtual cure. About 2,300 Americans died each year of Showstack's form of leukemia before Gleevec came on the market; only 470 did last year.

"I don't think we quibble with a drug that buys people magical quality of life for years," Venook said.

It's unclear whether Provenge will ever do that — it needs to be tested in men with earlier stages of prostate cancer, doctors say. So far, it has only been tried and approved for men with incurable disease who have stopped responding to hormone therapy. On average, it gave them four months more, though for some it extended survival by a year or more.

Until it shows wider promise, enthusiasm will be tepid, said Dr. Elizabeth Plimack a prostate specialist at the Fox Chase Cancer Center in Philadelphia.

"I've not had any patient ask for it," she said. "They ask about it. Based on the information, they think the cost is tremendous, and they think the benefit is very small."

Logothetis, at M.D. Anderson, said Provenge and other experimental cancer vaccines in development need "a national investment" to sort out their potential, starting with Medicare coverage.

"It's no longer a fringe science. This is working," he said. "We need to get it in the door so we can evolve it."

26 September 2010

Poll: Repeal? Many Wish Health Law Went Further

USA Today

President Obama's health care overhaul has divided the nation, and Republicans believe their call for repeal will help them win elections in November. But the picture's not that clear cut.

A new AP poll finds that Americans who think the law should have done more outnumber those who think the government should stay out of health care by 2-to-1.

"I was disappointed that it didn't provide universal coverage," said Bronwyn Bleakley, 35, a biology professor from Easton, Mass.

More than 30 million people would gain coverage in 2019 when the law is fully phased in, but another 20 million or so would remain uninsured. Bleakley, who was uninsured early in her career, views the overhaul as a work in progress.

The poll found that about four in 10 adults think the new law did not go far enough to change the health care system, regardless of whether they support the law, oppose it or remain neutral. On the other side, about one in five say they oppose the law because they think the federal government should not be involved in health care at all.

The AP poll was conducted by Stanford University with the Robert Wood Johnson Foundation. Overall, 30% favored the legislation, while 40% opposed it, and another 30% remained neutral.

Those numbers are no endorsement for Obama's plan, but the survey also found a deep-seated desire for change that could pose a problem for Republicans. Only 25% in the poll said minimal tinkering would suffice for the health care system.

Brian Braley, 49, a tech industry worker from Mesa, Ariz., wants Washington to keep its hands off. "I think it's a Trojan horse," Braley said of the health care law. "It's a communist, socialist scheme. All the other countries that have tried this, they're billions in debt, and they admit this doesn't work."

It may well satisfy people who share Braley's outlook if Republicans succeed in tearing out what they dismiss as "Obamacare" by the roots. But GOP leaders would still find themselves in a quandary.

Republicans "are going to have to contend with the 75% who want substantial changes in the system," said Stanford political science professor Jon Krosnick, who directed the university's participation.

"Republican legislators' passion to repeal the legislation is understandable if they are paying attention to members of their own party," Krosnick added. "But if they want to be responsive to all Americans, there are more Democrats and independents than there are Republicans."

The poll did find some agreement among people who think the law should do more and those who think government should get out.

Broad majorities of both the "get-outs" and "do-mores" said medical care, health insurance and prescription drugs cost too much. And most said the system should aim to increase the number of people with insurance and enable Americans to get the care they need, while improving quality.

The differences emerge when it comes to the means:

—Only 25% of the "get-outs" favor requiring health insurance companies to sell coverage to people regardless of pre-existing medical conditions, while 54% of the "do-mores" support it. The law requires insurers to cover children regardless of health problems starting this year, and that protection is extended to people of all ages in 2014.

—Among those who want a law that does more, 68% favor requiring medium to large companies to provide insurance to their workers or pay a fine; that stands at 28% among those who want the government out. The law does not require employers to offer coverage, but it hits companies that have 50 or more workers with a penalty if any full-time employee gets a government subsidy for health insurance.

—The "get-outs" overwhelmingly reject the health care law's requirement that most Americans carry health insurance starting in 2014. But the "do-mores" are split, with 34% favoring the mandate, 33% opposing it, and 32% neutral.

Tom Gergel, 45, of West Chester, Pa., said he supports the health care law because it moves toward coverage for all and does away with denial of coverage to people in poor health. But he doesn't think it's perfect.

"Is this program going to make it more expensive?" asked Gergel, who sells computer software for engineers. "The jury's still out versus where we are now. We have the best health care in the world for those who can afford to pay for it, but it doesn't work for everyone."

The survey was conducted Aug. 31 to Sept. 7, and involved interviews with 1,251 randomly chosen adults nationwide. It has a margin of sampling error of plus or minus 3.9 percentage points.

The survey was conducted by Knowledge Networks, which first chose people for the study using randomly generated telephone numbers and home addresses. Once people were selected to participate, they were interviewed online. Participants without Internet access were provided it for free.

Stanford University's participation in the project was made possible by a grant from the Robert Wood Johnson Foundation.

3-D Movies Hampered by Vision Problems for Some

USA Today

As people crowd into theaters for the latest wave of 3-D movies, everyone seems to be oohing and ahhing over the visual feast provided by Hollywood's improved 3-D technology.

Well, almost everyone.

"There will be at least one person in the crowd who says, 'What are you talking about? I didn't see anything flying out at me.' Or maybe they will say, 'That movie actually made me a little nauseated,' " said Dominick Maino, a professor at the Illinois College of Optometry and the Illinois Eye Institute.

Three to 9 million people in the USA have vision problems that keep them from enjoying such 3-D movies as Avatar and Toy Story 3, estimates the American Optometric Association. And as many as 56% of people between 18 and 38 years of age suffer from symptoms related to depth-perception problems.

These problems have to do with binocular vision, the ability to align both eyes on a target and combine the visual images from the two eyes into a single, three-dimensional perception.

"We have 3-D because we have two eyes in our head in slightly different places," Maino explained. "When the brain puts two images together, that's when we get the 3-D effect."

"3-D is really our ability to judge distances," he said. "It's a real nice survival trait, so we could tell how far away that saber-toothed tiger is and have him for lunch rather than the other way around."

Movies done in 3-D recreate this effect by feeding different images into each eye, Maino said. In the early days, 3-D glasses would have one red lens and one blue lens, and there would be one red image and one blue image on the screen separated by a little distance. One eye would be able to see only the red and the other only the blue, and the brain would fit them together to form an in-depth perception.

The technology today is more advanced. Now, 3-D is created using polarized lenses that pick up separate images or by timing the images between the two eyes. "One image will be placed on one eye and then very quickly the other image is placed in the other eye," Maino said. "When the brain puts that together, it gives the sense of 3-D."

However, people who are having problems with their binocular vision will either not be able to perceive the illusion of 3-D, or they will find that the movies or TV shows actually give them "visual hangover," said Leonard Press, a spokesman for the American Optometric Association and optometric director of the Vision and Learning Center in Fair Lawn, N.J.

An association poll found that headaches, blurred vision and dizziness are the most common side effects from 3-D movies for people who have binocular vision difficulties. "After the movie, they're a bit dizzy, and it takes them awhile to get back to normal," Press said.

Several different vision disorders could be the cause of the problem, including:

• Amblyopia, or lazy eye, which occurs when one eye does not see as well as the other. "Because of that difference between the two eyes, the ability to see 3-D is greatly reduced or absent," Maino said.

• Strabismus, or crossed eyes, in which the eyes do not line up in the same direction when focusing. Ultimately, a person with strabismus begins to suffer from double vision or loses the ability to see in 3-D.

• Convergence insufficiency, in which the eyes are incapable of turning toward each other to fix on the same distance.

Any of these can be treated by an optometrist or ophthalmologist trained at a college of optometry. In fact, Maino said, the new 3-D movies are giving some people their first clue of a vision problem they may have had for a long time without recognizing it.

The problems, though, can be treated using optometric vision therapy, in which eye patches or special pairs of glasses are utilized to teach the eyes how to work together, Press and Maino said. Some of the techniques already are used to help kids with amblyopia or strabismus.

"It's a form of physical therapy for the eyes," Press said. "The key is helping your eyes work together with your brain. You do different activities that help both eyes work together. It's almost like lifting weights."

By the end of vision therapy, "we should have someone who has single, clear, two-eyed vision," Maino said.

24 September 2010

Some Leery of this Year's Flu Shots

USA Today

In the wake of last year's swine flu pandemic, this year's standard flu shot includes the H1N1 vaccine. That has caused concern for at least some people getting the shots, pharmacists here say.

Manufacturers this year are including the H1N1 antibodies along with those of two other strains in the standard vaccine. Craig Schury, pharmacist for Pemberton Pharmacy in Salisbury, said this has scared some potential customers away.

"People are somewhat leery about it, but it just happens to be one of three strains in this year's shot," he said. "It's made the same way as the regular flu shot was last year."

Schury said there are normally a mixture of strains in the shots and the majority of his customers weren't concerned.

He said even though he tries to let his customers know what they are receiving, vaccine providers aren't required to verbally tell clients they are getting the H1N1 vaccine. But, he said, they are required to provide a written document that lists all the included strains.

Jennifer Berkman, director of student health services for Salisbury University, is having a somewhat different experience. She said students have wanted to know how to get inoculated for the swine flu.

"I think there's confusion because last year there were two separate shots," she said. "Epidemiologists look globally at different strains and try to predict which strains are going to impact the U.S. this season."

Pharmacists said supplies of vaccine were much better this year compared with last year when manufacturers split their vaccine production between the swine flu and regular flu vaccination. Berkman said the experts this year expect swine flu to act as a seasonal outbreak now that the pandemic is over.

"What happened last year was as the virus progressed it got less and less virulent," she said.

She said the school's health department had been doing culturing for flu patients and by the end of last year's season, most of the cultures that were coming back were consistent with swine flu.

Another less well known addition for this year's vaccinations is a high dose option specifically for people age 65 or over. The high-dose contains roughly four times the amount of antibodies as a regular dose and may have a higher risk of negative reaction. But, pharmacists said, this risk is more than balanced by its benefits, as immune systems tend to weaken with age.

"I get a flu shot every single year," said 77-year-old Karen Carney, who chose to get the high-dose option this year.

She said most of her peers take getting the immunization for granted and she had no fears about the inclusion of the H1N1 vaccine.

How College Health Programs are Failing Students

The Wall Street Journal

On Thursday, the first big pieces of the new health-care overhaul took effect. Among other things, the rules mandate that insurance companies offer coverage to adult children until the age of 26 and devote at least 80% of their revenue to health-care costs.

But one major player was notably absent from these new rule changes: colleges. They have managed to sidestep, at least for now, the regulatory clampdown that has sent hospitals, insurers and corporations scrambling.

How'd they pull it off? Since student plans for the 2010-11 school year were negotiated before Sept. 23, they aren't subject to the regulations this year.

And if industry and university groups succeed, the plans will be exempted permanently from many elements of the new law. At a June American College Health Association conference, James Turner, executive director of student health at the University of Virginia and former president of the ACHA, told audience members that Nancy-Ann DeParle, director of the White House Office of Health Reform, had told him during an earlier meeting to "tell me what you want written into the regulations and we'll make it happen."

"The White House denies that Ms. DeParle ever said that," says White House spokesman Nick Papas. "The administration is still working on this issue and is eager to hear from all parties."

The health-care overhaul has major implications for young adults and their parents. For the first time, parents will have the choice of keeping their graduate-student children on their corporate insurance plans or opting for cheaper college plans.

They should think carefully.

There is broad consensus that, as a group, college health-insurance plans rank among the worst in the nation for consumers. Many college plans come with remarkably low benefit ceilings—in some cases as little as $2,500. Others limit areas of coverage, such as preventative services and chemotherapy.

The upshot: Students are often much less insured than they think they are. In extreme cases high-school seniors with health issues might be advised to consider a college's health plan before attending.

"These plans have not been thoroughly scrutinized," says Bryan A. Liang, executive director of the Institute of Health Law Studies at California Western School of Law in San Diego. "In some instances they offer very paltry care."

The college health-care system is a hodgepodge of school plans and private insurance. According to the Government Accountability Office, more than half of the nation's colleges offer school-sponsored plans. All told, about 80% of college students, nearly 7 million people, are covered by private or public health insurance.

Most schools aim to provide the best care for the lowest cost. Students tend to be healthier than the general population, so school plans don't need the safety nets found in adult plans.

Yet these low-cost plans are a big business for insurance companies. All of the major players are active in the college market, with Aetna Inc. and United Healthcare leading the pack. According to a November 2009 study from the Massachusetts Division of Health Care Finance and Policy, profit margins for student health programs in the state were 10%, compared with 2% for other insurance plans.

When colleges fall short, say health-care experts, it is often because their administrators lack the savvy to negotiate with insurers and arrange the best terms for their students.

"Not every podunk university is going to have a health plan official who will look into these plans," says Elizabeth Ritzman, director of Dominican University's student health center in River Forest, Ill.

The health-care overhaul deals with individual and group insurance plans. In an Aug. 12 letter to the White House, the ACHA and other groups argued that school plans shouldn't be considered group or individual plans but rather "short-term limited-duration" insurance policies. Such a designation would likely exempt them from many of the new regulations, experts say.

The letter also warned that certain reforms "could make it impossible for colleges and universities to continue to offer student health plans."

The ACHA "is supporting regulatory clarification that would allow student plans to preserve the grouplike status that is vital to providing lower cost coverage to students," says Jake Baggott, ACHA's advocacy coalition chair. Dr. Turner, ACHA's president until June, says the spirit of his conversation with the White House was that "they would be happy to include in the regulations the necessary language to assure preservation of the plans."

Insurers seem to be confident they will get their way. According to three people familiar with the matter, Aetna has told colleges that they have nothing to worry about because their plans will be exempted.

Aetna says it never conveyed that message to its members. "We expect that all student plans that wish to be credible will comply with minimum coverage requirements as soon as possible," says Ethan Slavin, a spokesman for the insurer.

Good insurance plans are marked by a few elements, among them benefit ceilings of at least $250,000, generous prescription drug plans and emergency room coverage. According to the GAO, more than half of all school plans have ceilings of less than $30,000.

Some schools boast excellent health plans, says Dr. Liang. Take Boston University's program, offered through Aetna. Students pay $1,676 for coverage that includes a $500,000 benefit ceiling and pays 80% of any ambulance expenses.

Another indicator of a good plan is its "medical loss ratio," or the percentage of the premium that the insurance provider pays out in claims. The health-care overhaul limits loss ratios to 80%; a lower ratio means students aren't getting as much for the cost. Brigham Young University, which offers insurance through Deseret Mutual Benefit Administrators, had a loss ratio of 93% last year, meaning that for every $100 in premiums, students received $93 of care.

Other plans, however, are less generous.

Paula Villescaz, a senior at the University of California at Berkeley, says she never looked closely at the Anthem Blue Cross insurance policy she got through her college. The plan has a $400,000 ceiling, but also has some important limitations, as Ms. Villescaz found out recently.

The political-science major had always been healthy—until March, when doctors discovered she had Ewing's Sarcoma, a rare form of cancer. Berkeley's plan didn't cover her first MRI, her PET scan or many blood tests her doctors required, she says.

In between chemotherapy treatments, Ms. Villescaz says she had to battle the insurance company, which refused to cover her last round of chemotherapy, declaring it medically unnecessary. Her chemotherapy has since concluded, but she is now undergoing radiation treatment.

Ms. Villescaz says she owes about $80,000 all told. Before she got sick, she worked two jobs to support herself and help out her single mother. "I'm going to be paying off these bills for the rest of my life," she says.

Both Berkeley and Anthem declined to comment.

Students who don't study the details of a plan before signing up can end up with nasty surprises, as Nia Heard-Garris, a 24-year-old medical student at Howard University Medical School, learned firsthand.

Ms. Heard-Garris in 2007 signed up for Howard's standard health plan, administered by Summit America Corp. The plan, which now costs $476 a year and is mandatory for all students, came with a $5,000 limit per injury and sickness, and didn't cover radiation and chemotherapy—though the plan now offers more coverage. (Howard also offers an enhanced plan that costs $699 a year and has a limit of $200,000 per injury or sickness.)

Last year, Ms. Heard-Garris went to the emergency room complaining of neck pain. She got a CT scan—then found out that her insurance wouldn't cover the $1,600 bill. "I have absolutely no idea how I can pay this," she says. "I think it's kind of ironic that here I am learning how to help people, and I can't even get care covered." She says she is negotiating with Summit to cover her bill.

Howard doesn't comment on specific cases. A spokeswoman says students receive a booklet detailing medical-care protocols, and "the student health center staff will take the appropriate steps to provide [students] with appropriate care." A Summit spokeswoman says, "We're always willing to work with any student to provide clarity."

Some school plans limit their coverage of certain categories, such as mental health. Franklin College in Indiana offers a plan through Markel Insurance Corp. that covers $50 for every mental-health counseling visit—up to $250 per year.

"There's admittedly very little coverage for mental health," says Terri Nigh, coordinator of student health services at Franklin. While negotiating benefits and evaluating the plan each year, school administrators try to meet the needs of the majority of students, she says. "It's a difficult process."

That's been a problem for Katie Todd, a sophomore at Franklin. A pre-med major, Ms. Todd says she has battled depression since she was 12. She says most private insurers considered her depression a pre-existing condition, and that the best quote she has gotten would cost a steep $310 a month.

With no alternative, she signed up for the Franklin plan, but is frustrated by its limitations. "It's really vital for me to get this coverage, and the plan just mostly ignores it," she says.

"The plan's design is based on the specifications of the college, not the insurer," says Mark Nichols, a managing director at Markel.

Parents and students can get the most for their money by carefully examining school plans before signing up. Health-care planning should come long before enrollment, says James A. Boyle, president of the College Parents of America, a Virginia-based nonprofit.

Anyone considering a school plan should ask a number of questions, say experts:

• What is the maximum benefit for the policy?

• Are prescriptions and mental health services included?

• What happens to coverage if you leave school, go abroad or graduate?

• What is the loss ratio?

• Do any on-campus services, such as checkups or flu shots, overlap with existing coverage?

Parents who are considering keeping their child on their personal insurance should ask their benefits representative or insurer about how coverage will be carried over on campus and off—especially at schools far from home. (This also applies to graduate students and to adult children under age 26.) They should also be ready to sign a waiver with the school so they're not charged for automatic enrollment in a campus policy.

If, after getting all these answers, both the employer and school insurance options seem unappealing, parents should consider using a site like eHealthInsurance.com, which allows for comparison browsing among 10,000 plans from 180 carriers. The prices and coverage can vary widely depending on the state, but the site offers free access to licensed agents who don't work on a commission basis and can answer specific questions about plans, says Carrie McLean, a consumer specialist at the company.

The key is to do the legwork now to avoid surprises later. Otherwise, says Aaron Smith, a founder of Young Invincibles, a nonprofit student group that seeks better care for college students, you could wind up "in a dangerous place, with insurance plans that don't cover any real health-care costs."

23 September 2010

Insurance Companies Drop Child-Only Coverage

LA Times

Major health insurance companies in California and other states have decided to stop selling policies for children rather than comply with a new federal healthcare law that bars them from rejecting youngsters with preexisting medical conditions.

Anthem Blue Cross, Aetna Inc. and others will halt new child-only policies in California, Illinois, Florida, Connecticut and elsewhere as early as Thursday when provisions of the nation's new healthcare law take effect, including a requirement that insurers cover children under age 19 regardless of their health histories.

The action will apply only to new coverage sought for children and not to existing child-only plans, family policies or insurance provided to youngsters through their parents' employers. An estimated 80,000 California children currently without insurance — and as many as 500,000 nationwide — would be affected, according to experts.

Insurers said they were acting because the new federal requirement could create huge and unexpected costs for covering children. They said the rule might prompt parents to buy policies only after their kids became sick, producing a glut of ill youngsters to insure. As a result, they said, many companies would flee the marketplace, leaving behind a handful to shoulder a huge financial burden.

The insurers said they now sell relatively few child-only policies, and thus the changes will have a small effect on families.

"Unfortunately, this has created an un-level competitive environment," Anthem Blue Cross, California's largest for-profit insurer, said in a statement declaring its intention to "suspend the sale of child-only policies" on Thursday, six months after the healthcare overhaul was signed.

The change has angered lawmakers, regulators and healthcare advocates, who say it will force more families to enroll in already strained public insurance programs such as Medi-Cal for the poor in California.

The White House weighed in Tuesday, condemning Anthem corporate parent WellPoint Inc. and others that plan to stop selling child-only policies.

"It's obviously very unfortunate that insurance companies continue to make decisions on the backs of children and families that need their help," White House Press Secretary Robert Gibbs said at a news briefing.

The Obama administration had told insurers they could solve the problem by issuing policies only during designated enrollment periods. Some White House officials, however, noted that families who can't find policies might be able to sign up for high-risk pools being set up around the country as part of the new healthcare law.

In California, the stakes may be particularly high for insurers who abandon child-only policies. A bill awaiting Gov. Arnold Schwarzenegger's signature would bar such companies from selling insurance in the lucrative individual market for five years. A Schwarzenegger spokeswoman said the governor had not yet taken a position on the measure.

Assemblyman Mike Feuer (D- Los Angeles), the bill's author, voiced frustration over the insurers' plans and singled out Anthem Blue Cross, whose corporate parent notified brokers nationwide Friday of its decision to exit the child-only business in 10 states, including Colorado, Connecticut, Missouri, Nevada and Georgia as well as California health insurance quotes.

"At a time when we are launching a national approach to ensure that all children have access to healthcare, Anthem's actions represent a step backwards," Feuer said. "By threatening to drop child-only policies in California, the company jeopardizes the health of families and children. I call on Anthem to reconsider its plan."

Other regional and national insurers also plan to stop selling insurance policies exclusively for children. Among the companies is UnitedHealth Group Inc., the nation's largest insurer by revenue. It did not say which states would be affected.

"We continue to believe that regulations can be structured that will enable child-only plans to be offered, and we are working toward that goal," spokesman Tyler Mason said.

Aetna said that effective Oct. 1 it would no longer offer policies in the 32 states where it conducts business, including California, Florida, Illinois, Virginia and Pennsylvania.

Cigna Corp. will halt the policies in 10 states, including California, Arizona, Colorado, Tennessee and Texas.

"We made a decision to stop offering child-only policies to ensure that we can remain competitive in the 10 markets where we sell individual and family plans," Cigna spokeswoman Gwyn Dilday said. "We'll continue to evaluate this policy and could reconsider changing this position as market dynamics change."

The explanations left healthcare advocates fuming. They accused insurers of trying to skirt the law's new requirement to cover children with health problems.

"Insurers need to decide if they are in the business of providing care or denying coverage," said Anthony Wright, executive director of Health Access California, a consumer group. "In California, we hope our insurers come to an equitable compromise that allows access for all children and affordability for those with preexisting conditions."

In Colorado, regulators and insurance carriers are trying to work out such a compromise. The state's insurance commissioner met Friday with several insurers, including Anthem, Cigna and Aetna. The two sides did not reach an agreement, but officials remain hopeful they can broker a deal before Thursday.

"Obviously this deadline looms large," said Jo Donlin, director of external affairs for the Colorado Division of Insurance. "The commissioner wants families to have access to the insurance they need. Both sides of this want to find a solution."

22 September 2010

California Approves Aetna Rate Hike

San Francisco Chronicle

Aetna, Inc. has gotten the green light to raise premiums, making it the last of California's four major insurers to be cleared for rate hikes by state regulators.

The Department of Insurance approved the move Friday, allowing Aetna to raise rates an average of 19 percent for 65,000 policy holders, according to the Los Angeles Times.

Anthem Blue Cross, Blue Shield of California and Health Net Inc. were allowed to proceed with similar increases last month. The four companies control 90 percent of the state's individual policies.

All the hikes take effect Oct. 1.

Aetna had withdrawn a request for the same proposed hikes in June after an independent review discovered errors in the complicated calculations the company used to justify the boost in California health insurance quotes.

21 September 2010

Is it Safe for Students to Play Sports without Heart Exams?

USA Today

Most teenagers think they're invincible, and that goes double for talented teenage athletes. They're young, immortal, at the top of their game, the envy of their friends.

So when news hits that an apparently healthy, high school or college athlete has dropped dead in the midst of playing his or her favorite sport, millions of parents get understandably anxious.

The uppermost question becomes: Should my child be screened before participating in sports? What tests are needed? And how can we be sure that he or she is truly healthy enough to compete?

Everyone agrees that a medical checkup before participating in sports is crucial. But the agreement seems to stop there. At the core of the conflict over further testing is how extensively young athletes' hearts should be tested before they're cleared for athletic participation, say Livonia Heart Doctors.

Everyone should have a doctor who evaluates them, and the doctor should know the child is going to be participating in athletics.

That statement recommends cardiovascular screening for high school and college athletes before they start participating in athletics and at two- to four-year intervals. The screening should include a family history, a personal history and an exam "focused on detecting conditions associated with exercise-related events," according to a Lincoln Park Cardiologists recommendation.

But, there's more: "The AHA does not recommend routine, additional noninvasive testing such as a routine EKG (electrocardiogram, which assesses the heart's electrical rhythms)."

The American Academy of Pediatrics seems to agree. "Every athlete should have a thorough history (taken) from the athlete as well as the athlete's family," explained Dr. Reginald Washington, a pediatric cardiologist and chief medical officer at Rocky Mountain Hospital for Children in Denver and past chairman of the academy's committee on sports medicine and fitness.

The doctor should ask about any chest pain and dizziness, and whether the athlete has ever passed out or experienced a racing or unusual heartbeat, Washington said. The physician should also ask if the athlete's parents have had early heart disease, before age 55 for a man and 65 for a woman. And the physical exam, he said, should be thorough and include listening to the heart, taking blood pressure and feeling the pulse.

"If all of that is normal and the family history is normal, no further tests need to be done," said Washington, echoing the academy's stand.

But others disagree strongly, calling for universal and extensive testing of all young athletes to avert future tragedy.

Melvindale Heart Doctors and other experts contend that both an EKG and an echocardiogram — which is an ultrasound that measures heart size, pumping function and checks for faulty heart valves — are crucial to detect early signs of heart defects in young athletes because neither test alone will catch all potential problems.

In testing 134 high school athletes competing in the Maryland state track and field championships in 2008, for instance, no life-threatening heart defects were found but blood pressure abnormalities that required further testing and monitoring were detected in 36 athletes, some by EKG and some by echocardiogram, the Hopkins doctors reported at an American Heart Association session in late 2009.

Testing in 2009, according to a Hopkins report, found a serious heart valve disease in one track-and-field athlete and another with an undiagnosed heart condition that could require a transplant in the future. Neither athlete had reported any symptoms.

"If you are going to screen, it has to be comprehensive," Dr. Theodore Abraham, an associate professor at Hopkins' School of Medicine and its Heart and Vascular Institute, said in a prepared statement.

Other studies have found pros and cons to extra screening.

For instance, Harvard researchers who looked at 510 college athletes found that screening with a history and physical exam alone has an overall sensitivity of 45.5%, meaning it would find existing problems in about 45 of every 100 athletes screened. But adding an EKG to the screening boosted it to more than 90%.

However, the EKGs were also linked with a false-positive rate — suggesting a problem when none existed — of nearly 17%, according to their report, published March 2 in the Annals of Internal Medicine.

A separate study in that issue, on the cost-effectiveness of such screenings, reported that adding EKGs to screenings of young athletes saves two years of life per every 1,000 athletes, at a per-athlete cost of $89.

Screening policies differ from region to region across the country. In Houston, for instance, athletic trainers at 10 high schools are using laptop systems to give young athletes EKGs, and a doctor in the city has launched a program to provide heart screening to all sixth-graders, eventually hoping to screen all sixth-graders in Texas.

But there are downsides to such universal screening, others say.

"About 10% of kids who get EKGs are thought to have something the matter with them by the EKG," Thompson, the Connecticut doctor, said. "That drives additional testing, and nearly all don't have anything wrong."

The problem, he said, is not just wasted health-care dollars but the anxiety caused by additional testing, for athletes and their parents.

Thompson said he is not oblivious to parental worry or to the sad reality that some athletes die unexpectedly each year.

"Every single one of these deaths is an incredible tragedy," he said, adding that he will do extra testing if parents are very worried. "But when people have looked at this, the death rate in the U.S. is about one in every 250,000 athletes. There is not really conclusive research to show (extensive testing) saves lives."

Also, in mass screenings — where kids line up and are screened quickly — accuracy may suffer, said Detroit heart doctors. "A good, thorough ultrasound should take a half-hour," he said. "If you line up all the kids (at a school or on a team) to have a portable ultrasound, you will miss some of these subtle abnormalities."

But Sharon Bates, a parent who founded the Anthony Bates Foundation after her athlete son, Anthony, died unexpectedly in 2000 and was found to have had an enlarged heart, disagrees with the arguments against mass screenings.

Even if a problem picked up is minor, she said, you have a right to know, and it needs to be addressed.

Bates's son had passed the typical pre-athletic physical at Detroit heart center with flying colors, she said, yet he still had a major cardiac problem.

Her Phoenix-based foundation promotes universal screenings for all youth, not just athletes, she said.

As Abraham said, "What is the price for a single life?"

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