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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.”

Cervical cancer vaccine: key questions

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Cervical cancer vaccine: key questions

Cervical cancer is malignant neoplasm of the cervix uteri or cervical area. It may present with vaginal bleeding but symptoms may be absent until the cancer is in its advanced stages. Treatment consists of surgery (including local excision) in early stages and chemotherapy and radiotherapy in advanced stages of the disease.

Pap smear screening can identify potentially precancerous changes. Treatment of high grade changes can prevent the development of cancer. In developed countries, the widespread use of cervical screening programs has reduced the incidence of invasive cervical cancer by 50% or more.

The initial post mortem said was “most unlikely” the vaccine was the cause of death. It could have been nothing more than a coincidence, although one scenario that has been presented is she had a very rare severe allegric reaction to the vaccine, known as anaphylaxsis, which can be fatal.

Signs and symptoms

The early stages of cervical cancer may be completely asymptomatic. Vaginal bleeding, contact bleeding or (rarely) a vaginal mass may indicate the presence of malignancy. Also, moderate pain during sexual intercourse and vaginal discharge are symptoms of cervical cancer. In advanced disease, metastases may be present in the abdomen, lungs or elsewhere.

Symptoms of advanced cervical cancer may include: loss of appetite, weight loss, fatigue, pelvic pain, back pain, leg pain, single swollen leg, heavy bleeding from the vagina, leaking of urine or faeces from the vagina, and bone fractures.

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High street pharmacy offers cervical cancer vaccine for £405

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High street pharmacy offers cervical cancer vaccine for £405

The Cervarix vaccine which protects against the two strains of humanpapilloma virus responsible for the majority of cases of cervical cancer is available to girls aged between 12 and 18 on the NHS as part of a national vaccination programme.

However older women have been requesting the vaccine from their GPs only to be turned down in most cases. Cervarix and its rival Gardasil are available privately.

Government scientists advised that young girls be offered the vaccine as the virus is transmitted through intimate contact and sex and is less effective in women who have already been exposed to the virus.

Fears have also been raised that women may be given a false sense of security through having had the vaccine and not attend for cervical smear tests in future.

Boots the chemist is offering the service to women aged between 18 and 54 in 134 of its stores in England and Wales following successful pilots in ten stores in London which began in November last year.

Lloydspharmacy also offers the vaccine in almost 300 of its stores.

Women will not be tested to establish if they have already been infected with the HPV strains 16 and 18 which are included in the vaccine and so cannot be sure whether it will offer them substantial benefit.

Evidence considered by the Government advisers on the Joint Committee on Vaccination and Immunisation showed that one in ten women aged between 20 and 29 were already infected with HPV strain 16.

In recommending that girls aged 12 be routinely vaccinated with a catchup campaign offering it to all girls aged up to 18, a statement from the JCVI said: “Vaccination of girls above this age was not cost-effective given the assumed cost of vaccine and administration, and the increase in prevalence of previous infection in this age group.”

Sarah Woolnough, Cancer Research UK’s head of policy, said: “The best way that older women can protect themselves against cervical cancer is through the free NHS cervical screening programme, which has saved 100,000 lives since its introduction in 1988.

“We strongly advise all women to attend cervical screening when invited, even if they have had the HPV vaccination.

“We don’t yet know how effective the vaccine is in women who have already come into contact with HPV.”

However Dr Anne Szarewski, clinical consultant at Cancer Research UK’s centre for epidemiology at the Wolfson Institute of Preventive Medicine, is backing the Boots programme.

She said the chances of having contracted both strain 16 and 18 were just five per cent.

Dr Szarewski said: “And, even if you do catch HPV then a lot of people – around 50 per cent – will clear it from their bodies and not be immune.

“Even if you have an antibody response, this does not mean you are protected in the future.

“There is no reason why an individual woman should not have this vaccine.”

Dr Graham Marshall, Boots Medical Director, said: “As this vaccination is only available on the NHS through the schools’ vaccination programme, most women above the age of 18 will not be aware that they could benefit from the vaccination. Pharmacists are well placed to offer this service with convenient high street locations and a welcoming, familiar atmosphere.

“Boots pharmacists have undergone comprehensive training – written and agreed by an independent panel of experts – to provide this innovative, patient-led service. The consultation includes advice on sexual health and the importance of regular cervical screening.”

A Department of Health spokesman said: “The NHS runs a free HPV vaccination programme for girls from 12-18 years of age which will save the lives of up to 400 women each year.

“We strongly encourage all women over 25 to be regularly screened to help protect them from cervical cancer.

“Careful consideration was given to vaccinating older women. However, the national HPV vaccine programme aims to protect girls and young women before they are exposed to the human papillomavirus, where research shows that vaccination is most effective. The programme has been a great success with over three quarters of girls aged 12-13 years already having received all three doses of the vaccine.”

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