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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.”

Cancer drug crosses key hurdle in brain: study

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Cancer drug crosses key hurdle in brain: study

An experimental drug appears to cross a protective barrier in the brain that screens out most chemicals, offering potentially better ways to treat brain tumors, U.S. researchers said on Sunday.

The drug, made by privately held Angiochem Inc of Montreal was safe and showed evidence it could shrink tumors in two separate early phase studies totaling more than 100 people with a brain cancer called glioblastoma.

It also worked among people whose cancers had spread or metastasized to the brain, the researchers reported at the annual meeting of the Society for Neuroscience in Chicago.

In both studies, tumors shrank in patients who got a higher dose of the drug, called ANG1005. The drug also showed signs of working in patients whose cancers resisted the chemotherapy drug taxane.

“It is highly encouraging to see that ANG1005 has shown the potential to be effective in metastatic brain cancers and against drug-resistant tumors,” Dr. Jan Drappatz of Dana-Farber Cancer Institute and Brigham and Women’s Hospital in Boston, who is studying the drug, said in a statement.

Drappatz said tumors shrank significantly in some patients and some neurological problems were reversed in several.

Studies of brain tumor samples showed concentrations of the drug in the tumors, proving it successfully crossed the blood-brain barrier and accumulated.

Made up of a network of blood vessels, the blood-brain barrier prevents 95 percent of all chemicals from leaving the bloodstream and entering the brain.

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Modern Cataract Surgery

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Modern Cataract Surgery

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Cataract surgery is the removal of the natural lens of the eye (also called “crystalline lens”) that has developed an opacification, which is referred to as a cataract. Metabolic changes of the crystalline lens fibers over the time lead to the development of the cataract and loss of transparency, causing impairment or loss of vision. During cataract surgery, a patient’s cloudy natural lens is removed and replaced with a synthetic lens to restore the lens’s transparency. 

Following surgical removal of the natural lens, an artificial intraocular lens implant is inserted (eye surgeons say that the lens is “implanted”). Cataract surgery is generally performed by an ophthalmologist (eye surgeon) in an ambulatory (rather than inpatient) setting, in a surgical center or hospital, using local anesthesia (either topical, peribulbar, or retrobulbar), usually causing little or no discomfort to the patient. Well over 90% of operations are successful in restoring useful vision, with a low complication rate. Day care, high volume, minimally invasive, small incision phacoemulsification with quick post-op recovery has become the standard of care in cataract surgery all over the world.

Types of surgery

Extracapsular cataract extraction involves the removal of almost the entire natural lens while the elastic lens capsule (posterior capsule) is left intact to allow implantation of an intraocular lens. There are two main types of cataract surgery:

Phacoemulsification (Phaco) is the preferred method in most cases. It involves the use of a machine with an ultrasonic handpiece equipped with a titanium or steel tip. The tip vibrates at ultrasonic frequency (40,000 Hz) and the lens material is emulsified. A second fine instrument (sometimes called a cracker or chopper) may be used from a side port to facilitate cracking or chopping of the nucleus into smaller pieces. Fragmentation into smaller pieces makes emulsification easier, as well as the aspiration of cortical material (soft part of the lens around the nucleus). After phacoemulsification of the lens nucleus and cortical material is completed, a dual irrigation-aspiration (I-A) probe or a bimanual I-A system is used to aspirate out the remaining peripheral cortical material.

Conventional extracapsular cataract extraction (ECCE): It involves manual expression of the lens through a large (usually 10–12 mm) incision made in the cornea or sclera. Although it requires a larger incision and the use of stitches, the conventional method may be indicated for patients with very hard cataracts or other situations in which phacoemulsification is problematic. Microincision cataract surgery involves a technique by which a cataract can be reached through an incision of 1.5 millimeters or less.

Cryoextraction is a form of ICCE that freezes the lens with a cryogenic substance such as liquid nitrogen[4]. In this technique, the cataract is extracted through use of a cryoextractor — a cryoprobe whose refrigerated tip adheres to and freezes tissue of the lens, permitting its removal. Although it is now used primarily for the removal of subluxated lenses, it was the favored form of cataract extraction from the late 1960s to the early 1980s

Intraocular lenses

Intraocular lens implantation: After the removal of the cataract, an intraocular lens (IOL) is usually implanted into the eye, either through a small incision (1.8 mm to 2.8 mm) using a foldable IOL, or through an enlarged incision, using a PMMA (polymethylmethacrylate) lens. The foldable IOL, made of silicone or acrylic material of appropriate power is folded either using a holder/folder, or a proprietary insertion device provided along with the IOL. The lens implanted is inserted through the incision into the capsular bag within the posterior chamber (in-the-bag implantation). Sometimes, a sulcus implantation (in front or on top of the capsular bag but behind the iris) may be required because of posterior capsular tears or because of zonulodialysis. Implantation of posterior-chamber IOL (PC-IOL) in patients below 1 to 2 years of age is relatively contraindicated due to rapid ocular growth at this age and the excessive amount of inflammation, which may be very difficult to control. Optical correction in these patients without intraocular lens (aphakic) is usually managed with either special contact lenses or glasses. Secondary implantation of IOL (placement of a lens implant as a second operation) may be considered after 2 years of age. New designs of multi-focal intra-ocular lens are now available. These lenses allow focusing of rays from distant as well as near objects, working much like bifocal or trifocal eyeglasses. Pre-operative patient selection and good counselling is extremely important to avoid unrealistic expectations and post-operative patient dissatisfaction. Acceptability for these lenses has become better and studies have shown good results in selected patients. Brands in the market include: ReSTOR (R), Rezoom (R) and Technis MF (R).

Preoperative evaluation

An eye examination or pre-operative evaluation by an eye surgeon is necessary to confirm the presence of a cataract and to determine if the patient is a suitable candidate for surgery. The patient must fulfill certain requirements such as:The degree of reduction of vision due, at least in large part, to the cataract should be evaluated. While the existence of other sight-threatening diseases, such as age-related macular degeneration or glaucoma, does not preclude cataract surgery, less improvement may be expected than in their absence.

The eyes should have a normal pressure, or any pre-existing glaucoma should be adequately controlled on medications. In cases of uncontrolled glaucoma, a combined cataract-glaucoma procedure (Phaco-trabeculectomy) can be planned and performed.

The pupil should be adequately dilated using eyedrops; if pharmacologic pupil dilation is inadequate, procedures for mechanical pupillary dilatation may be needed during the surgery.

Operation procedures

The surgical procedure in phacoemulsification for removal of cataract involves a number of steps. Each step must be carefully and skillfully performed in order to achieve the desired result. The steps may be described as follows:

Anaesthesia,

Exposure of the eyeball using a lid speculum,

Entry into the eye through a minimal incision (corneal or scleral)

Viscoelastic injection to stabilize the anterior chamber and to help maintain the eye pressurization

Capsulorhexis

Hydrodissection pie

Hydro-delineation

Ultrasonic destruction or emulsification of the cataract after nuclear cracking or chopping (if needed), cortical aspiration of the remanescent lens, capsular polishing (if needed)

Implantation of the artificial IOL

Entration of IOL (usually foldable)

Viscoelastic removal

Wound sealing / hydration (if needed).

The pupil is dilated using drops (if the IOL is to be placed behind the iris) to help better visualise the cataract. Pupil constricting drops are reserved for secondary implantation of the IOL in front of the iris (if the cataract has already been removed without primary IOL implantation). Anesthesia may be placed topically (eyedrops) or via injection next to (peribulbar) or behind (retrobulbar) the eye. Oral or intravenous sedation may also be used to reduce anxiety. General anesthesia is rarely necessary, but may be employed for children and adults with particular medical or psychiatric issues. The operation may occur on a stretcher or a reclining examination chair. The eyelids and surrounding skin will be swabbed with disinfectant. The face is covered with a cloth or sheet, with an opening for the operative eye. The eyelid is held open with a speculum to minimize blinking during surgery. Pain is usually minimal in properly anesthetised eyes, though a pressure sensation and discomfort from the bright operating microscope light is common. The ocular surface is kept moist using sterile saline eyedrops or methylcellulose viscoelatic. The discission into the lens of the eye is performed at or near where the cornea and sclera meet (limbus = corneoscleral junction). Advantages of the smaller incision include use of few or no stitches and shortened recovery time. . A capsulotomy (rarely known as cystotomy) is a procedure to open a portion of the lens capsule, using an instrument called a cystotome. An anterior capsulotomy refers to the opening of the front portion of the lens capsule, whereas a posterior capsulotomy refers to the opening of the back portion of the lens capsule. In phacoemulsification, the surgeon performs an anterior continuous curvilinear capsulorhexis, to create a round and smooth opening through which the lens nucleus can be emulsified and the intraocular lens implant inserted.

Complications

Complications after cataract surgery are relatively uncommon.

Some people can develop a posterior capsular opacification (also called an after-cataract). As a physiological change expected after cataract surgery, the posterior capsular cells undergo hyperplasia and cellular migration, showing up as a thickening, opacification and clouding of the posterior lens capsule (which is left behind when the cataract was removed, for placement of the IOL). This may compromise visual acuity and the ophthalmologist can use a device to correct this situation. It can be safely and painlessly corrected using a laser device to make small holes in the posterior lens capsule of the crystalline. It usually is a quick outpatient procedure that uses a Nd-YAG laserposterior capsulotomy). This creates a clear central visual axis for improving visual acuity. . In very thick opacified posterior capsules, a surgical (manual) capsulectomy is the surgical procedure performed. (neodymium-yttrium-aluminum-garnet) to disrupt and clear the central portion of the opacified posterior lens capsule (

Posterior capsular tear may be a complication during cataract surgery. The rate of posterior capsular tear among skilled surgeons is around 2% to 5%. It refers to a rupture of the posterior capsule of the natural lens. Surgical management may involve anterior vitrectomy and, occasionally, alternative planning for implanting the intraocular lens, either in the ciliary sulcus, in the anterior chamber (in front of the iris), or, less commonly, sutured to the sclera.

Retinal detachment is an uncommon complication of cataract surgery, which may occur weeks, months, or even years later.

Toxic Anterior Segment Syndrome or TASS is a non-infectious inflammatory condition that may occur following cataract surgery. It is usually treated with topical corticosteroids in high dosage and frequency.

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