Category: News

Getting to school the old-fashioned way

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Those seem like unremarkable statements, but they’re not. Today only 12 percent of all children walk or bike to school, according to U.S. government studies, down from 48 percent when I was traipsing up and down the hill to Barnard Elementary in the late 1960s.

These days, we have to hold a nationwide street fair like Oct. 6′s International Walk and Bike to School Day, with giveaways of helmets, water bottles and breakfast bars to get kids out of cars and onto bikes, scooters and their own two feet. Meanwhile, as you doubtlessly know by now, childhood obesity is epidemic and the rise of Type 2 diabetes in kids is staggering.

No study has yet proved cause and effect. But it’s a pretty safe bet there’s some connection.

It’s easy to see how this happened, especially in the suburbs and exurbs of places like Washington. The “neighborhood school” is now much more likely to be too far away to make walking or riding feasible for most young children. Vehicular traffic is way up. The percentage of families with a parent available to usher kids to school in the morning and back in the afternoon is way down. And, true or not, the perception that our streets are much more dangerous than when we were young has taken hold and is not going away.

“It’s inertia. People are used to [driving kids to school] and they accept it,” says Tim Blumenthal, president of the Bikes Belong Coalition, the administrative home of the Safe Routes to School National Partnership. In 2005, Congress allocated 2 million for Safe Routes to School, which works to get more kids to school under their own power.

None of my three children has ever walked or biked to school in the 10 years we have lived in an affluent Montgomery County suburb. The high school and middle school are too far from my home. The elementary school is a bit of a hike, but it would mean crossing two heavily trafficked streets at the tail end of the morning rush hour. No way. My kids take the school bus or carpool.

In the early 1970s, before I could drive, I would hitchhike two or three miles to high school. Often, I’d be picked up by an older kid with a car, but sometimes an adult stranger would take pity and pull over. No one worried about it too much.

Today I would chop off my children’s thumbs before I let them hitchhike down the block.

Poorer communities, with larger minority populations, tend to have higher obesity rates than middle-class neighborhoods. Many are in the city and closer-in suburbs, making the schools more “walkable.” At Whittier Education Campus in Northwest Washington, for example, a study by Safe Routes to School shows that 83 percent of the children live within one mile, close enough to walk, bike, skateboard or scooter to school, but only 45 percent do, says Terri Rhoulac-Smith, a school liaison for the organization.

On a chilly morning on Oct. 6, as the sun intermittently pushed through a lid of gray clouds, the atmosphere on a small patch of grass in front of Whittier was festive. Balloons were tied to the fence. The Rails-to-Trails Conservancy was there, handing out some terrific bike and skateboard helmets free. Kaiser Permanente provided water bottles, breakfast bars and stickers. Kids and parents, almost all of them black or Latino, lined up for the giveaways.

The school tries to encourage walking and educate drivers about sharing the road with bikes. For example, it is trying to discourage three-point turns in the drop-off area.

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Wash Post Health

First patient treated in stem cell study

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The patient was treated Friday at the Shepherd Center, a 132-bed hospital in Atlanta that specializes in spinal cord and brain injuries, according to announcement by the hospital and Geron Corp. of Menlo Park, Calif., which is sponsoring the research.

The hospital is one of seven sites participating in the study, which is primarily aimed at testing whether the therapy is safe. Doctors will also conduct tests to see whether the treatment restores sensation or enables the patient to regain movement. No additional information about the first patient was released.

The milestone was welcomed by scientists eager to finally move the research from the laboratory to the clinic, as well as by advocates for patients and by patients hoping for cures. Although the cells have been tested in animals, and some clinics around the world claim to offer therapies using human embryonic stem cells, the trial is the first to have been vetted by a government entity and aimed at carefully evaluating the strategy. After repeated delays, the Food and Drug Administration gave the go-ahead in July.

But the move was criticized by those with moral objections to any research using cells from human embryos, and it is raising concern even among many proponents. Some argue that the experiments are premature, others question whether they are ethical, and many fear that the trials risk disaster for the field if anything goes awry.

“Without knowing more clinical detail, there’s little I can say,” said Steve Goldman, chairman of the department of neurology at the University of Rochester in New York. “In more general terms . . . I remain concerned about the long-term safety of unpurified grafts of embryonic stem cell derivatives. Time will tell.”

David Prentice, senior fellow for life sciences at the Family Research Council, said: “Geron is helping their stock price, not science and especially not patients. It will be years before there is hard evidence about safety or effectiveness. Adult stem cells have published evidence documenting effective treatment of spinal cord injury.”

Supporters of the privately funded research are confident that it has been exhaustively vetted. The FDA has demanded extensive experiments in the laboratory and on animals to provide evidence that the cells hold promise and are safe enough to test in people.

“Initiating the . . . clinical trial is a milestone for the field of human embryonic stem cell-based therapies,” said Thomas B. Okarma, Geron’s president and chief executive, in a statement. “This accomplishment results from extensive research and development and a succession of inventive steps.”

Donald Peck Leslie, Shepherd’s medical director, said: “We are pleased to have our patients participating in this exciting research. Our medical staff will evaluate the patients’ progress as part of this study. We look forward to participating in clinical trials that may help people with spinal cord injury.”

But some scientists worry that if patients are hurt by the cells – or even if there’s no hint that the cells help – it could be a devastating blow to the field. They cite the case of Jesse Gelsinger, whose 1999 death from a gene therapy experiment set that once-highly touted field back years.

Safety worries – most prominently fears that the cells could cause tumors – prompted the FDA to repeatedly demand additional data from Geron, including, most recently, assurance that cysts that developed in mice injected with the cells posed no threat.

Although Geron eventually hopes to test the cells for many different medical problems, the first trial will involve 10 patients who were partially paralyzed by a spinal cord injury in the previous one to two weeks. Surgeons injected the first patient with about 2 million “oligodendrocyte progenitor cells,” created from embryonic stem cells, in the hopes that the cells will form a restorative coating around the damaged spinal cord. In tests in hundreds of rats, partially paralyzed animals walked.

Spinal cord injuries, however, are highly unpredictable. Patients often improve on their own, for example, making it difficult to evaluate whether the cells had any effect. Some wonder whether trauma victims who have so recently suffered a life-altering injury will agree to the experiments out of desperation without fully grasping the risks. There is also concern that the therapy risks worsening the patients’ conditions, perhaps making them fully paralyzed.

But company officials said they are confident. Even if problems occur, research shows that the cells do not leave the site of the injury, indicating that patients would not suffer any ill effects, Okarma said. Extra precautions, including assigning each subject an independent advocate, will guarantee that volunteers fully understand their decisions, he said.

In the meantime, officials at Advanced Cell Technology of Santa Monica, Calif., are hoping for the FDA’s go-ahead to start injecting 50,000 to 200,000 cells into the eyes of 12 patients with Stargardt’s macular dystrophy. “Retinal pigmented epithelial cells,” also made from human embryonic stem cells, should replace those ravaged by the progressive loss of eyesight, which usually begins in childhood. Studies in rats found that the cells helped prevent further vision loss and even restored some sight. The company hopes that the approach will work for many conditions, including macular degeneration, the leading cause of blindness among the elderly.

The announcement comes as the future of federal funding for embryonic stem cell research remains in doubt. A federal judge ruled in August that the Obama administration’s more permissive policy for funding the research violated a federal law prohibiting taxpayer money being used for research that involves the destruction of human embryos. The Justice Department is appealing the decision.

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Wash Post Health

Mental health providers grapple with Medicaid expansion

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The federal government handed them an opportunity to save million over four years by expanding Medicaid this summer and they jumped at it. They switched 35,000 low-income residents from the city -funded D.C. Health Care Alliance insurance plan to a Medicaid plan and reaped the reward.

It looked like a win-win: The city got some financial relief and the new Medicaid beneficiaries got mental health coverage, which was not part of the Alliance plan. But it creates a problem for the city’s mental health-care providers, who said this week that they are faced with serving thousands of new clients they are not prepared to manage.

“We support expanding Medicaid eligibility, but you have to have the provider capacity to do it,” said Shannon Hall, executive director of the D.C. Behavioral Health Association, an advocate for providers. “If you do one without the other, you’re going to have a bad experience for the people who need care.”

The complaint by Hall and local mental health providers echoes general concerns about the health-care overhaul raised by hospitals, doctors, nurses and their advocates nationwide who say the mammoth program is being built on a network that cannot support it.

Officials at the D.C. Health Care Finance office, which was in charge of the changeover, said there is no evidence that the local mental health-care network will be overwhelmed.

And Sharon Baskerville, executive director of the D.C. Primary Health Care Association, an advocate for comprehensive insurance coverage, said the complaints are speculative.

“Advocacy is great . . . but it’s not to be always about crying,” said Baskerville, who noted that children are already being treated for less severe mental health problems under the plan. “It’s also about working out solutions.”

Mental health screening and treatment as part of primary care is important, experts say, because problems such as depression, anxiety, post-traumatic stress disorder and attention deficit disorders often go undiagnosed until they are severe, and patients show up in hospital emergency rooms, which increases health-care costs.

Between 11 and 36 percent of primary-care patients have a psychiatric problem, according to estimates in studies cited by the American Academy of Family Physicians.

“If you talk to [emergency room] doctors, they’ll say they’re overflowing with people suffering from a mental health crisis,” said Ron Honberg, legal director for the National Alliance on Mental Illness. “They don’t have space to put these people.”

Federal officials hope to reduce emergency room visits with the overhaul. The Department of Health and Human Services announced last month that it will offer a grant package that includes million to help providers incorporate mental health services into primary care.

Despite arguments for expanding mental health care, and grants to implement it, mental health providers have their share of sympathizers because of the enormous task they face.

According to the Centers for Medicare and Medicaid Services, only Connecticut and the District took advantage of the government’s offer to expand Medicaid for Americans who earn 133 percent of the federal poverty level – ,400 for an individual and ,300 for a family of four, a category that included more than 13 million uninsured adults in 2008, 17 percent of whom had a fair, poor or chronic mental health condition, according to a report by the Kaiser Family Foundation.

The health-care law requires all states to expand Medicaid when changes are fully implemented in 2014. As states prepare to expand their managed-care programs under Medicaid, many have cut Medicaid fee-for-service reimbursements to doctors who deal primarily with chronic health conditions such as HIV, substance abuse and various mental disorders.

In the District, one clinic, Mary’s Center, said it experienced a 70 percent increase in screenings for depression after beneficiaries were switched to Medicaid under the expansion.

The center was already stretched thin to care for patients with severe and chronic forms of mental illness such as schizophrenia, dementia and bipolar disorder under a contract with the Department of Mental Health. Joan Yengo, vice president of programs for the center, which treats 17,000 patients a year, said one solution would be to hire a few managers so that the center can deliver services more efficiently.

“But if they’re cutting rates, [care] will be hard to sustain,” Yengo said. “We’re a federally qualified health center and we can’t turn people away. You have this demand on your staff, but you’re not getting more resources to increase your staff.”

In Southern California, Los Angeles County is bracing for the impact that expanded Medicaid will have on its mental health services. County facilities traditionally have cared for residents with illnesses such as schizophrenia, dementia and bipolar disorder.

“We already have a workforce challenge, a capacity challenge,” said William Arroyo, regional medical director of the Los Angeles County Department of Mental Health. “We’re going to have to absorb people with less serious conditions. This will force the public mental health system to manage more efficiently than it has.”

In the District, city health officials downplayed concerns over the proposed rate cut, saying that it offered doctor reimbursements of only 50 percent of Medicare just two years ago. Health Care Finance raised the rate to 100 percent at that time before proposing to cut it back to 80 percent recently because of budget shortfalls.

“Our proposed changes allow us to not have to cut coverage or benefits for residents who need health insurance, and this puts our rates still ahead of what most other states pay,” Julie Hudman, director of the finance office, said in a statement.

Federal and city health officials are not overburdening mental health providers, Honberg said.

“D.C. has spent more for mental health than just about any jurisdiction in the country,” Honberg said. “I sympathize with providers who have to worry about rate cuts, but they just might have to absorb some of the impact.

“In the long run, this creates the potential for positive change. In the short run, some significant adjustments have to be made.”

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Wash Post Health

Nurse practitioner explains why she refuses to endorse routine mammography

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In her office, I filled out a comprehensive health history, deposited a urine sample and waited for what I hoped would be a swift and straightforward consultation. But no, my nurse practitioner wanted to talk about my health in general.

“When was your last mammogram?” she asked, scanning the form I’d filled out.

“Two years ago, I think. But I’ve decided not to do them anymore.”

Silence.

“I don’t believe they save lives,” I added defensively.

Her eyes dropped from my face to my family health history, then moved back up to me.

“Ah, I understand,” she said compassionately. “Your sister died of breast cancer and you’re still dealing with that.” She went on for a while, using words like anger and fear.

“No,” I resisted. “I don’t believe early detection guarantees successful treatment or extends life.”

“I understand,” she consoled me. “You’re not ready. But you really need to start getting your mammograms again. Your sister’s cancer puts you at higher risk.”

I left the office with the prescription I needed and recovered quickly from the bladder infection, but I couldn’t put the encounter out of my mind. I thought of all the things I wished I’d said.

Maybe this: You’re wrong about the anger and fear. My sister’s cancer, discovered in her early 40s during the course of a routine physical exam, sent me into the medical literature with an insatiable hunger for information. It’s this search for answers and 20 years of experience caring for women – many of whom bore physical or emotional scars acquired in the aftermath of suspicious or inconclusive mammograms – that led me to decide that I could no longer endorse the tests as routine screening measures for me or any other woman.

I didn’t realize it at the time, but at age 56, I had had what would be my last yearly mammogram.

Questions

I can’t remember just when my confidence in screening mammograms started to slip. Maybe it was after reading an early edition of “Dr. Susan Love’s Breast Book,” which I’d bought with the intention of passing it on to my sister the year she had her mastectomy.

I was impressed by how plainly and intelligently Love, a breast surgeon, presented the research findings about mammography. I began to go through research studies online and in the medical library. I studied the wordings of my patients’ and my own mammogram results. They were almost never reported as normal, but as “benign findings” or “no evidence of malignancy at this time.” Keep coming back, they seemed to predict, and we’ll find it.

In my practice and personal life, I saw how women embraced the well-intentioned but relentless messages from medical, workplace and women’s groups to “take the test, not the chance.” Mammograms save lives, we were reminded. You owe it to yourself and your family.

Then a few research reports began to filter into the media with a different point of view. They verified the benefit of mammography screening – for a few women, at a significant cost in unnecessary follow-up and treatment for hundreds of others.

But minds that were made up didn’t take in this new information. The whole engine of breast cancer awareness was – and still is -simply too big, too powerful and too well funded to gear down.

Compelling data

I shock friends when I admit that I’m no longer a member of the mammogram club. Unless asked, though, I don’t elaborate on the compelling data that have informed my own decision. I discovered early on that facts alone would sway no one. So I simply listen respectfully to other women when they tell me that, thanks to early detection and surgery – often followed by grueling courses of chemo and radiation – they or their best friend, sister or mother are here today as survivors with many healthy years ahead of them.

They don’t consider whether the outcome would have been different without early detection or extensive treatment. And if the many healthy years do not materialize, it is seldom remarked on. The sad truth is that, despite excruciatingly slow advances in treatment, there is still no way of knowing with certainty whether the surgery, chemo or radiation “got it all.”

These days, on the rare occasions when someone really wants to know why I don’t get mammograms, I’m glad to be able to share the information from a particularly well-sourced pamphlet, published online in 2008 by the Nordic Cochrane Center in Denmark, that describes what studies have actually found.

The center describes itself as “an independent research and information centre that is part of The Cochrane Collaboration, an international network of individuals and institutions committed to preparing, maintaining, and disseminating systematic reviews of the effects of health care.” (Its Web site is www.cochrane.dk.) The information it provides is also available elsewhere, but I like the clarity of the pamplet as well as its list of solid scientific references.

“If 2,000 women are screened regularly for ten years, one will benefit from the screening, as she will avoid dying from breast cancer,” the pamphlet says. “At the same time, ten healthy women will . . . become cancer patients and will be treated unnecessarily. These women will have either a part of their breast or the whole breast removed, and they will often receive radiotherapy, and sometimes chemotherapy. Furthermore, about 200 healthy women will experience a false alarm. The psychological strain until one knows whether or not it was cancer, and even afterward, can be severe.”

Another important fact from the pamphlet that I noted: It has not been shown that women who undergo regular screening live longer than those who don’t.

Discord in the ranks

A Post headline late in 2009, “Fierce debate raging over new cancer test guidelines,” came as no surprise to me. The U.S. Preventive Services Task Force had recommended that women in their 40s, as well as those older than 75, talk to their doctor about how often they should be screened, rather than automatically opting for an annual mammogram. What’s more, the task force, an independent panel of experts in prevention and primary care that evaluated numerous studies, recommended a screening mammogram every two years, instead of annually, for women ages 50 to 74.

It also didn’t surprise me that after the recommendations were released and a heated debate began, government officials were quick to backpedal from the task force’s recommendations.

And the general public, including most health professionals, clung to the belief that early detection saves lives. The “routine” mammogram has become part of the cycle of the year for many women.

If you are the one in 2,000 whose life is extended, that’s all that counts.

If you are somehow harmed as a result of annual mammograms, that’s the price you pay for access to a test that is considered the gold standard in breast cancer detection.

My perspective

Metastatic breast cancer is terrible, no question. But I agree with a January 2010 commentary in the Journal of the American Medical Association that breast cancer is just as treatable and just as deadly regardless of screening. For that reason, I’ve opted out of routine screening.

I might accept the statistical evidence that because I have a first-degree relative who had breast cancer, my own risk is increased, perhaps even doubled. But that fact doesn’t make screening any more valuable to me than it would be to another woman – unless I believe that early detection will guarantee a better outcome for me. I don’t.

I don’t do breast self-exams. There’s no evidence to support their effectiveness. But that’s not to say I don’t pay attention to my body. If I should happen to discover a lump in my breast, I’ll have it evaluated. I’m not opposed to having a diagnostic mammogram.

If I’m told a lump is cancerous, I’ll seek other opinions. The interpretation of cell changes can be subjective. I want two – or three – expert pathologists to concur on any changes in mine to avoid what a recent New York Times article reported was much “outright error” in diagnosing breast cancer in its earliest stages.

I won’t rush into treatment, because I know that cancers don’t develop or spread overnight. Any cancerous lump I find has probably been growing for years. (Of course, I understand that there are exceptions.)

If there are research breakthroughs that dramatically increase the value of early detection, I’ll change my attitude toward screening accordingly. I accept that sooner or later, I’ll die of something. It could be breast cancer. It’s also possible that I’ll die with cancerous changes in my breast (or some other location) that never progressed enough to cause harm.

I’m grateful for the gift of good health, recognizing that that’s what it is: a gift. I will always mourn my sister’s untimely death, which took place three years after her diagnosis despite state-of-the-art treatment. If it were in my power, I’d honor her by redirecting the billion this country spends each year on screening mammography to the study of how breast cancer starts and what we can do to treat it more effectively.

In the meantime, it’s been 10 years since my last mammogram.

Masson is a nurse practitioner and writer living in Washington. Her most recent book is a collection of poetry, “Clinician’s Guide to the Soul.” This essay was excerpted from October’s edition of Health Affairs magazine. It can be read in full at www.healthaffairs.org.

Here’s the link: http://content.healthaffairs.org/cgi/content/full/29/10/1958

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Wash Post Health

New ‘superbugs’ raising concerns worldwide

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The gene, NDM-1, which is apparently widespread in parts of India, has been identified in just three U.S. patients, all of whom had received treatment in India and recovered. But the gene’s ability to affect different bacteria and make them resistant to many medications marks a worrying development in the fight against infectious diseases, which can mutate to defeat humans’ antibiotic arsenal.

“The problem thus far seems fairly small, but the potential is enormous. This is in some ways our worst nightmare,” said Brad Spellberg, an infectious-disease specialist at LA Biomed (the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center) and author of “Rising Plague,” a book about antibiotic resistance. “You take very common bacteria that live in all of us and can travel from person to person, and you introduce into it some of the nastiest antibiotic-resistance mechanisms there are.”

The bacteria, which include previously unseen strains of E. coli and other common pathogens, appear to have evolved in India, where poor sanitation combines with cheap, widely available antibiotics to create a fertile environment for breeding new microorganisms.

The infections were then carried to the United States, Britain and more than a half-dozen other countries, often through “medical tourism,” which involves foreigners seeking less expensive, more easily accessible surgery overseas.

“We need to be vigilant about this,” said Arjun Srinivasan, a medical epidemiologist at the Centers for Disease Control and Prevention, which has been monitoring the spread of the microbes. “This should not be a call to panic, but it should be a call to action. There are effective strategies we can take that will prevent the spread of these organisms.”

Experts fear the germs will follow the path of other multi-drug-resistant bugs and become a common scourge in medical centers and perhaps even among otherwise healthy people.

“It’s an acute example of how bacteria can outwit people,” said Stuart Levy, a professor of molecular biology at Tufts University School of Medicine and president of the Alliance for Prudent Use of Antibiotics.

So far, the highly resistant gene has not jumped into bugs spread by coughing or sneezing, and the three U.S. patients did not transmit their infections to anyone else. But the microbes can spread readily through other common ways, including contaminated sewage, water and medical equipment and lax personal hygiene such as inadequate hand-washing. Many patients eventually recover, but it remains unclear how many people have died and what the mortality rate is.

Indian roots?

The origin of the microbes is politically sensitive. The Indian government has condemned the reports saying the bugs arose in that country, arguing that the tale was concocted by Western pharmaceutical companies and others to discredit India’s burgeoning medical tourism industry, which is attracting more than 450,000 patients a year and could generate annual revenues of .4 billion by 2012, according to some estimates.

“They say it’s found in patients who visit India and Pakistan,” said India’s health minister, Ghulam Nabi Azad. “It was nowhere mentioned if the bacteria are found even before those persons visited India.”

The resistance gene – NDM-1 stands for New Delhi metallo-B-lactamase 1 – was first identified in 2008 in bacteria in a Swedish patient who had been hospitalized in New Delhi. The gene produces an enzyme that destroys most antibiotics, including so-called carbopenems, which are usually used in last-ditch efforts to save patients whose infections fail to respond to standard antibiotics.

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Wash Post Health

Weight-loss drug withdrawal latest blow to obesity fight

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Despite millions of dollars in research by scientists and drug companies, only a handful of government-approved weight-loss drugs remain on the market. Only one can be used long term, and none is considered very effective.

“It’s been very frustrating,” said Jennifer Lovejoy, incoming president of the Obesity Society, a research and advocacy group. “We desperately need safe new drugs so we can begin to have something effective against this public health epidemic.”

The search for a weight loss cure, once dismissed as a cosmetic luxury, has intensified as more than two-thirds of Americans have become overweight, including one-third who are obese, boosting their risk for a host of health problems.

Experts stress that the best way to be healthy is to eat well and exercise regularly and to avoid gaining weight in the first place – and the failure to produce a pharmaceutical magic bullet makes the importance of that ever clearer. Doctors recommend that people always try to improve their eating habits and increase their physical activity to lose weight. But diets and exercise regimens often fail, and many people are unable to shed significant numbers of pounds or keep them off, so they resort to drugs or even surgery.

The effort to develop safe and effective weight-loss drugs, however, has suffered one setback after another. Part of the problem has been scientific, experts say. The body’s hunger, fat storage and energy-burning system has turned out to be far more complex than originally thought.

“It’s got lots of fail-safes and mechanisms in it,” said Donna H. Ryan of the Pennington Biomedical Research Center in Baton Rouge. “Our biology is really designed to promote food intake and prevent weight loss. Our genes evolved to defend against starvation.”

But some experts argue that obesity drugs are held to too high a standard and should be treated like medications for other chronic diseases, such as diabetes, and approved and allowed to remain on the market even if they have some risks.

“The criteria seem to be more strenuous to get a drug approved for obesity than it does for other chronic conditions,” said George Blackburn, director of the division of nutrition at Harvard Medical School. “It’s a real hardship for millions of Americans who are asked to live in an environment which is very difficult for them to restrain their eating.”

Part of that, some experts argue, is because of a bias against obese people.

“The attitude is all people have to do is eat less and exercise more and that’s going to be the solution to the problem,” Ryan said. “That’s a failure to understand the complex nature of what is essentially a complex disease.”

The most stunning disappointment came 13 years ago, when the widely popular “fen-phen” two-drug combination was pulled off the market after being linked to heart-valve damage and to a rare but potentially deadly lung disease. Since then, a parade of major drug companies has abandoned once-promising diet drugs, most notably Sanofi-Aventis, which finally gave up on Acomplia after it was linked to depression.

In recent weeks, a panel of Food and Drug Administration advisers recommended against approval of two experimental weight-loss drugs, lorcaserin made by Arena Pharmaceuticals Inc. and Qnexa from Vivus Inc.

The last diet drug to win FDA approval was Orlistat in 1999, which was authorized for over-the-counter use in 2007 at a lower dose. But it is not very effective and can cause unpleasant side effects, most notably diarrhea.

Meridia, or sibutramine, was approved in November 1997 based on studies that showed the drug could help people lose at least 5 percent of their weight compared with people who took a placebo and relied on diet and exercise alone. But safety advocates have long called for the drug’s withdrawal, citing concerns that it raised blood pressure.

Those concerns spiked earlier this year with the results of a European study that found Meridia increased by 16 percent the risk of serious heart problems, including heart attacks, strokes and death. The drug led only to a small weight loss, the study found.

Abbott Laboratories withdrew Meridia for sale in the United States at the request of the FDA, which concluded that the drug’s power to help people lose a small amount of weight was far outweighed by new data showing it carried significant risks. Canadian drug officials announced a similar withdrawal.

About 100,000 Americans take Meridia, the FDA estimated. All should immediately stop and doctors should cease prescribing it, the agency said. Patients who have taken the drug in the past should no longer face increased risk after they discontinue the medication, officials said.

Drug safety advocates welcomed Meridia’s withdrawal, arguing that it should have come far sooner and that the lag illustrated the FDA’s lax enforcement of drug safety, especially compared with European regulators. Meridia was taken off the market in Europe in January.

Sidney Wolfe of Public Citizen’s Health Research Group, which had petitioned the FDA to remove Meridia, noted that while European regulators recently pulled two other drugs – the pain pill Darvon and the long-controversial diabetes drug Avandia – both remain available in the United States.

“Both of these unacceptably dangerous drugs remain on the market in this country, predictably injuring or killing many people, who, unlike their European counterparts, do not have the government protecting them from drugs with no unique benefits but significant, unique risks,” Wolfe said.

Meanwhile, in yet more bad news for people trying to lose weight, the FDA also warned Friday against using “Slimming Beauty Bitter Orange Slimming Capsules,” an herbal product sold over the Internet, because tests found it contains sibutramine.

Several experts said that the solution will probably come from developing a cocktail of drugs, similar to how cancer and AIDS are treated.

“The solution to the problem is going to be multiple drugs that produce some weight loss, which would enable us to combine them together,” Ryan said.

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Wash Post Health

HHS awards $727 million to nation’s community health centers

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Officials from the Health and Human Services Department said the 7 million to 143 clinics will bring more health care to 745,000 underserved patients as part of the health-care overhaul. The nation’s 1,100 rural and urban health centers last year served 19 million people, about 40 percent of whom had no insurance.

Virginia clinics received most of the awards in the Washington area, about million. The District got slightly more than million and Maryland was awarded slightly more than million. California clinics received more than million.

“There is no question that the economic downturn has made it harder for some Americans to get health care and important preventive services,” HHS Secretary Kathleen Sebelius said in a statement. “Community Health Centers provide quality healthcare services to Americans across the country but are a life line for those who have lost coverage or are between jobs.”

The awards build on the more than billion already invested in health centers from stimulus funds, Sebelius said. The health overhaul will provide billion more for the operation, expansion and construction of the nation’s community health centers.

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Foes of health care law lose key court ruling

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The ruling came in a lawsuit filed in Michigan by a Christian legal group and four people who claimed lawmakers exceeded their power under the Constitution’s commerce clause, which authorizes Congress to regulate trade.

But Judge George Caram Steeh in Detroit said the mandate to get insurance by 2014 and the financial penalty for skipping coverage are legal. He said Congress was trying to lower the overall cost of insurance by requiring participation.

“Without the minimum coverage provision, there would be an incentive for some individuals to wait to purchase health insurance until they needed care, knowing that insurance would be available at all times,” the judge said.

“As a result, the most costly individuals would be in the insurance system and the least costly would be outside it,” Steeh said. “In turn, this would aggravate current problems with cost-shifting and lead to even higher premiums.”

Julian Davis Mortenson, a University of Michigan law professor and former U.S. Supreme Court law clerk, said the decision affects only the parties in the lawsuit and is not binding on any other federal judges hearing challenges to the law.

Nonetheless, the Justice Department hailed Steeh’s opinion as the first time a “court has considered the merits of any challenge to this law.”

“The court found that the minimum coverage provision of the statute was a reasonable means for Congress to take in reforming our health care system,” spokeswoman Tracy Schmaler said. “The department will continue to vigorously defend this law in ongoing litigation.”

Robert Muise of the Thomas More Law Center in Ann Arbor, Mich., which filed the case, said he would take it to a federal appeals court in Cincinnati.

The four individual plaintiffs said they do not have private insurance and object to being forced to buy it. They also fear that any financial penalty paid to the government would be used to pay for abortions.

In Florida, a federal judge is overseeing a lawsuit filed by 20 states. They, too, say the law is unconstitutional and claim it would force states to absorb higher Medicaid costs.

A decision on whether to dismiss the case is expected by Oct. 14, though the judge said last month that he would probably dismiss only parts of the complaint while letting others go to trial.

There is also a lawsuit pending in Virginia.

Randy Barnett, who teaches constitutional law at Georgetown University, said Steeh’s ruling could be cited by lawyers trying to persuade other judges.

“This is one judge’s opinion. They’ll read it,” Barnett said. Steeh “accepted the government’s argument, the same argument that’s being made in front of other judges.”

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Hungary town evacuated, fears of new sludge flood

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AJKA, Hungary — The Hungarian town of Kolontar near the toxic red sludge reservoir that flooded the area and killed at least seven people was evacuated Saturday over fears of a new leak of the dangerous heavy metal waste, officials said.





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CDC: More American adults hobbled by arthritis

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About 22 percent of U.S. adults have been told by a doctor that they have arthritis, the Centers for Disease Control and Prevention reported. The statistic comes from national telephone polling of tens of thousands of adults in 2007 through 2009.

That translates to nearly 50 million people with the joint disease. It’s also roughly the same percentage with arthritis as reported in a 2003-2005 study.

But there was a significant jump in adults who said their joint pain or other arthritis symptoms limited their usual activities, to 9.4 percent from 8.3 percent. That means more than 21 million adults have trouble climbing stairs, dressing, gardening or doing other things, up from less than 19 million only a few years before, the CDC researchers estimated.

That jump was “more than we would have expected,” said Dr. John Klippel, president of the Atlanta-based Arthritis Foundation.

Klippel said the increase probably was due mainly to baby boomers, who are at an age when they are more likely to suffer osteoarthritis, the most common form of arthritis. It breaks down cartilage and causes pain and joint stiffness.

He added that a complicating factor is high rates of baby boomers who are overweight and obese. Extra weight puts more pressure on arthritic joints, making the problem worse, he said.

The percentage of people who were hobbled was more than twice as high in obese people as those who were normal weight or were underweight, the CDC researchers found. Obesity can lead to or worsen osteoarthritis in the knees, the researchers wrote.

The study is published in a CDC publication, Morbidity and Mortality Weekly Report.

—

Online:

CDC report:http://www.cdc.gov/mmwr

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