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Australia reports first Tamiflu-resistant H1N1 case

Australia reports first Tamiflu-resistant H1N1 case

The first Australian case of swine flu resistant to Roche Holding AG’s antiviral drug Tamiflu was confirmed by the Western Australia state government on Friday.

“The 38-year-old Perth man, who has a weakened immune system, initially responded to the drug but developed a resistant strain of the virus when his illness relapsed,” the state’s Department of Health said in a statement.

There have been 13 cases of Tamiflu-resistant infections around the world, the statement said.

A Roche executive said on Monday that isolated cases of Tamiflu-resistant H1N1 pandemic flu were to be expected, in line with what has been seen in clinical studies.

“There is no evidence that the virus has spread to other people. None of the patient’s family or hospital staff caring for him have contracted the virus, and he has not been in contact with the wider community,” said the state’s Chief Health Officer Tarun Weeramanthri, adding that the case was a rare and isolated one.

The man remained in a critical condition in intensive care.

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Why Patients Aren’t Getting the Shingles Vaccine

Four years ago at age 78, R., a retired professional known as much for her small-town Minnesotan resilience as her commitment to public service, developed a fleeting rash over her left chest. The rash, which turned out to be shingles, or herpes zoster, was hardly noticeable.

But the complications were unforgettable.

For close to a year afterward, R. wrestled with the searing and relentless pain in the area where the rash had been. “It was ghastly, the worst possible pain anyone could have,” R. said recently, recalling the sleepless nights and fruitless search for relief. “I’ve had babies and that hurts a lot, but at least it goes away. This pain never let up. I felt like I was losing my mind for just a few minutes of peace.”

Shingles and its painful complication, called postherpetic neuralgia, result from reactivation of the chicken pox virus, which remains in the body after a childhood bout and is usually dormant in the adult. Up to a third of all adults who have had chicken pox will eventually develop one or both of these conditions, becoming debilitated for anywhere from a week to several years. That percentage translates into about one million Americans affected each year, with older adults, whose immune systems are less robust, being most vulnerable. Once the rash and its painful sequel appear, treatment options are limited at best and carry their own set of complications.

While the search for relief costs Americans over $500 million each year, the worst news until recently has been that shingles and its painful complication could happen to any one of us. There were no preventive measures available.

But in 2006, the Food and Drug Administration approved a new vaccine against shingles. Clinical trials on the vaccine revealed that it could, with relatively few side effects, reduce the risk of developing shingles by more than half and the risk of post-herpetic neuralgia by over two-thirds. In 2008, a national panel of experts on immunizations at the Centers for Disease Control and Prevention went on to recommend the vaccine to all adults age 60 and older.

At the time, the shingles vaccine seemed to embody the best of medicine, both old school and new. Its advent was contemporary medicine’s elegant response to a once intractable, age-old problem. It didn’t necessarily put an end to the spread of disease, in this case chicken pox; but it dramatically reduced the burden of illness for the affected individual. And, most notably, its utter simplicity was a metaphoric shot-in-the-arm for old-fashioned doctoring values. Among the increasingly complex and convoluted suggestions for health care reform that were brewing at that moment, here was a powerful intervention that relied on only three things: a needle, a syringe and a patient-doctor relationship rooted in promoting wellness.

Not.

In the two years since the vaccine became available, fewer than 10 percent of all eligible patients have received it. Despite the best intentions of patients and doctors (and no shortage of needles and syringes), the shingles vaccine has failed to take hold, in large part because of the most modern of obstacles. What should have been a widely successful and simple wellness intervention between doctors and their patients became a 21st century Rube Goldberg-esque nightmare.

Last month in The Annals of Internal Medicine, researchers from the University of Colorado in Denver and the C.D.C. surveyed almost 600 primary care physicians and found that fewer than half strongly recommended the shingles vaccine. Doctors were not worried about safety — a report in the same issue of the journal confirmed that the vaccine has few side effects; rather, they were concerned about patient cost.

Although only one dose is required, the vaccination costs $160 to $195 per dose, 10 times more than other commonly prescribed adult vaccines; and insurance carriers vary in the amount they will cover. Thus, while the overwhelming majority of doctors in the study did not hesitate to strongly recommend immunizations against influenza and pneumonia, they could not do the same with the shingles vaccine.

“It’s just a shot, not a pap smear or a colonoscopy,” said Dr. Laura P. Hurley, lead author and assistant professor of medicine at the University of Colorado in Denver. “But the fact is that it is an expensive burden for all patients, even those with private insurance and Medicare because it is not always fully reimbursed.”

Moreover, many private insurers require patients to pay out of pocket first and apply for reimbursement afterward. And because the shingles vaccine is the only vaccine more commonly given to seniors that has been treated as a prescription drug, eligible Medicare patients must also first pay out of pocket then submit the necessary paperwork in order to receive the vaccine in their doctor’s office. It’s a complicated reimbursement process that stands in stark contrast to the automatic, seamless and fully covered one that Medicare has for flu and pneumonia vaccines.

Despite this payment maze, some physicians have tried to stock and administer the vaccine in their offices; many, however, eventually stop because they can no longer afford to provide the immunizations. “If you have one out of 10 people who doesn’t pay for the vaccine, your office loses money,” said Dr. Allan Crimm, the managing partner of Ninth Street Internal Medicine, a primary care practice in Philadelphia. Over time, Dr. Crimm’s practice lost thousands of dollars on the shingles vaccine. “It’s indicative of how there are perverse incentives that make it difficult to accomplish what everybody agrees should happen.”

Even bypassing direct reimbursement is fraught with complications for doctors and patients. A third of the physicians surveyed in the University of Colorado study resorted to “brown bagging,” a term more frequently used to describe insurers who have patients carry chemotherapy drugs from a cheaper supplier to their oncologists’ offices. In the case of the shingles vaccine, the study doctors began writing prescriptions for patients to pick up the vaccine at the pharmacy and then return to have it administered in their offices. However, the shingles vaccine must be frozen until a few minutes before administration, and a transit time greater than 30 minutes between office and pharmacy can diminish the vaccine’s effectiveness.

Dr. Crimm and the physicians in his office finally resorted to what another third of the physicians in the study did: they gave patients prescriptions to have the vaccine administered at pharmacies that offered immunization clinics. But when faced with the added hassles of taking additional time off from work and making a separate trip to the pharmacy, not all patients followed through. “Probably about 60 percent of our patients finally did get the vaccine at the pharmacy,” Dr. Crimm estimated. “This is as opposed to 98 percent of our patients getting the pneumonia and influenza vaccines, immunizations where they just have to go down the hall because we stock it, roll up their sleeves then walk out the door.”

With all of these barriers, it comes as no surprise that in the end only 2 percent to 7 percent of patients are immunized against shingles. “There’s just so much that primary care practices must take care of with chronic diseases like obesity and diabetes and heart disease,” Dr. Hurley noted. “If a treatment isn’t easy to administer, then sometimes it just falls to the bottom of the list of things for people to do.”

“Shingles vaccination has become a disparity issue,” Dr. Hurley added. “It’s great that this vaccine was developed and could potentially prevent a very severe disease. But we have to have a reimbursement process that coincides with these interventions. Just making these vaccines doesn’t mean that they will have a public health impact.”

pregnancy

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Whether bipolar pregnant women should stop taking medication depends on each individual case, expert says.

As recently as 10 years ago, doctors advised women with bipolar disorder not to have children. While that thinking is now dated, bipolar women often face tough decisions about how to handle their medication during pregnancy.

Most drugs prescribed for bipolar disorder carry some risk of birth defects, yet women who discontinue medication risk relapsing into a manic or depressive episode; during the postpartum phase the relapse rate is as high as 50 percent to 70 percent, by some estimates.

Even more alarming, bipolar women are 100 times more likely than other women to experience postpartum psychosis, a severe mood disorder that, at its very worst, can result in infanticide.

Sally Martini, 38, started taking lithium after a severe manic episode eight years ago. She eventually switched to other drugs, but in 2007 she stopped her medication altogether when she learned that she was pregnant.

The pregnancy was uneventful. Her daughter, Stella, did arrive six weeks early, but after 21 days in the hospital Stella was finally at home and thriving.

Martini, meanwhile, was falling apart.

“I was extremely hyperactive,” she says. “I was going a million miles an hour.” Everyone had told her, “When the baby sleeps, you sleep” — but she couldn’t rest. While Stella napped, Sally would clean her Jackson, N.J., home yet again, wiping down doorknobs and light switches. She baked blueberry cobbler at 6 a.m. and pulled weeds into the night.

Though she had restarted her meds the day she gave birth to Stella, after a string of sleepless nights several months later Martini finally realized that lithium was the only thing that would bring her back to her senses. And it did.

Yet Martini continued to have doubts that she was strong enough to be a mother. These are doubts that many women with bipolar disorder share.

Say no to drugs?

Meredith, 27, of Dix Hills, N.Y., was diagnosed with bipolar disorder in 2007 and began taking lithium. Two years later, as she was planning her wedding, she took a cocktail of mood stabilizers, antidepressants, and antipsychotics: lithium, Abilify, propranolol (Inderal), and escitalopram (Lexapro).

“I was grateful for the lithium at first,” says Meredith, who did not want her last name used. “But then I was like, ‘There go all my options for having kids.'”

When it was first approved by the FDA in 1970, lithium was believed to cause heart-valve defects in an extremely high percentage of infants born to mothers who were on the drug (about 1 in 50). Decades later, new research has downgraded the risk, to about 1 in 1,000 to 2,000.

Bipolar medications aren’t considered as risky during pregnancy as they once were, but they aren’t exactly harmless either. According to the FDA’s letter-grade system for drug safety during pregnancy, most psychotropic drugs pose a potential risk to the fetus. Studies have found that the anticonvulsants valproic acid (Depakote) and carbemazepine (Tegretol) can cause birth defects ranging from physical deformities to spina bifida, for instance, while some research suggests that another anticonvulsant, lamotrigine, may carry an increased risk of cleft palate.

The risk of birth defects is small, yet the decision to stop taking medication is common, even among women with severe psychiatric illness. In 2008, after she got engaged, and after consulting her psychiatrist, Meredith decided to start tapering off lithium. “I, personally, would like to not be on any medication,” she says, when considering a future pregnancy. “I just don’t want to take any chances.”

Should bipolar women discontinue their medication? According to reproductive psychiatrist Catherine Birndorf, MD, the founding director of the Payne Whitney Women’s Program at New York Presbyterian Hospital, “There’s not just one answer.” The severity of bipolar disorder varies widely from person to person, and for this reason it’s difficult to standardize care for pregnant women with the disorder, Birndorf explains. “Each case must be considered on an individual basis,” she says.

But what many of Bindorf’s patients do not initially realize is that untreated illness — and not just medication — can be risky. According to a 2007 study in the American Journal of Psychiatry, women who discontinued mood stabilizers during pregnancy spent over 40 percent of their pregnancy in an “illness episode.” And research suggests that the effects of maternal depression on the fetus can lead to complications both during and after pregnancy.

Still, many bipolar women believe they have to stop taking all of their medications for the sake of their child — and often psychiatrists or OB/GYNs steer women away from medication, according to Margaret Spinelli, MD, director of the Women’s Program in Psychiatry at Columbia University.

“I hope that women will come to a perinatal psychiatrist to get an evaluation,” says Dr. Spinelli. “Because they can become so ill. And the problem is that if they become really ill during the pregnancy off the medication, it may take a lot more medication to stabilize them.”

Postpartum planning

A complication-free pregnancy with or without medication doesn’t mean a woman is in the clear. For any bipolar mother, the trickiest time is not the pregnancy itself but the postpartum period.

Postpartum difficulties are not limited to bipolar women, of course. Many women experience the crying episodes known as the “baby blues,” and an estimated 10% of women go through a more severe postpartum depression. Women with bipolar disorder are at much higher risk, however; postpartum psychosis — which is believed to be a form of bipolar disorder — occurs in as many as 25 percent to 50 percent of deliveries.

While postpartum psychosis is a serious risk, it’s a risk that can be treated, and often prevented, with medication. It’s extremely important for a woman with bipolar disorder to have a plan in place with her family and her doctors in the event that she does become psychotic, says Spinelli. Due to the high risk of psychosis, bipolar women should “really start medicines at least before they deliver,” she adds.

As the field of perinatal psychiatry grows, many bipolar women are choosing to stay on medications to avoid any chance of postpartum psychosis or manic episodes. “I’d heard so many horror stories of people harming the baby,” says Michele Noll, 38, of Atlanta, who has delivered two healthy babies while taking mood stabilizers.

“I did not have mood swings,” Noll says of her pregnancy and postpartum period. “Nobody even knew I was bipolar.”

Breast-feeding presents another challenge. Even though some medications are safe while nursing, feeding a baby requires waking up often throughout the night. And in people with bipolar disorder, sleep deprivation can trigger a manic episode.

Shanun Carey, 26, of Manchester, N.H., became so manic while breast-feeding that she was “bouncing off the walls,” eventually volunteering to clean her neighbors’ apartments to burn off excess energy. When her daughter was six months old, Carey realized she had to stop breast-feeding to get healthy again; she switched to formula so she could resume her medications and a regular sleep schedule.

Formula isn’t the only solution. Rachael Bender, 31, of Naples, Florida, who writes a blog called My Bipolar Pregnancy, realized that losing sleep would be a huge challenge in trying to breast-feed. But she did want to try, so she and her husband worked out a system when her daughter was an infant.

To save Bender from getting the baby up and back to sleep, her husband slept in the guest room, next to the bassinet, and brought the baby in to Bender when the baby was hungry. “The hardest thing about the whole pregnancy,” Bender says, “was the sleep after she was born.”

The next generation

Martini, who lapsed into depression after the lithium got her mania under control, still struggles with the ups and downs of bipolar disorder. Because she is committed to being a great parent to Stella, she has made what she says is the most difficult decision of her life.

“Absolutely, I will not have another baby,” Martini says, acknowledging that no matter how many times her healthy daughter kisses her, or her husband tells her she’s a wonderful mother, she still has doubts related to her bipolar disorder and the amount of attention it requires. “I want to be the best mother I can be, and if I had two children I’d worry that I was spreading myself too thin,” she says.

Meredith knows that pregnancy will be “a difficult time,” and people have already questioned her decision to have children; a family friend even told her that it would be a “heartache” for her if she did have a child with bipolar disorder. Bipolar disorder does tend to run in families: Studies show that a person is 10 times more likely to develop the disorder if a parent is bipolar.

None of this has swayed Meredith’s desire to be a mother.

“I’m not going to not have a child because I’m afraid they’re going to be bipolar,” says Meredith. “I’ve seen so many wonderful things and I’ve done so many wonderful things, and I plan to do a lot more. My kid will have a better life than a lot of kids out there. This isn’t going to stop me.”