August

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We Americans work hard. Weekends are more like workends. We sleep with our smartphones. And we think vacations are for wimps. So we don’t take them. Or take work along with us if we do.

But what if taking vacation not only made you healthier and happier, as a number of studies have shown, but everyone around you? And what if everybody took vacation at the same time? Would life be better, not just for you, but for the entire society?

Yes, argues Terry Hartig, an environmental psychologist at Uppsala University in Sweden. Yes, indeed.

When people go on a relaxing vacation, they tend to return happier and more relaxed. (The operative word here being relaxing, not frenzied whirlwind.) Traffic? A smile and nod instead of flipping the bird. An upset at the office? A deep breath and a focus, not on the drama, but on the task at hand.

And those mellow, good vibes, he said, spread “like a contagion” to everyone you come in contact with. “Even people you don’t know personally,” he said. Send everyone away on vacation at the same time, and that contagion takes off through the population like a viral happiness pandemic.

Hartig calls it “collective restoration.”

To test his theory, Hartig and his colleagues studied monthly anti-depressant prescriptions in Sweden between 1993 and 2005. In a recently published study, they found that the more people took vacations at the same time, the more prescriptions dropped exponentially. That was true for men and women, and for workers as well as retirees.

Summer, by far, was the happiest time – or at least saw the steepest declines in anti-depressant prescriptions. It’s no surprise why: Since 1977, Swedish law has mandated that every worker have five weeks of paid vacation every year. And workers can take four consecutive weeks off in the summer.
“It’s like there’s this national agreement that it’s vacation time, and work will be left aside,” Hartig said. So instead of working and being distracted and busy, people get outside. They do things they like and enjoy. They see friends, play with their children, visit their aging parents, or finally have time for that cup of tea with a friend who’s been blue.

The benefits, Hartig said, are huge. Not only is the society measurably happier, but workers are more rested and productive, relationships are closer and people are healthier. “Depression is a very costly disease,” he said. (Depression costs the U.S. economy an estimated $23 billion a year in lost productivity.)

Europeans, with their 20 and 30 days of paid vacation every year, live longer and spend less on health care than Americans, Hartig said.

But that kind of widespread, vacation-induced health and euphoria is unlikely to hit the United States anytime soon. “Collective restoration,” Hartig said, is only possible if the entire population can coordinate time off. And the only way to do that, he argues, is through national policy.

The US is the only advanced economy with no national vacation policy. (Unless you count Suriname, Nepal and Guyana.) One in four workers, typically in low-wage jobs, have no paid vacation at all. Those that do, get, on average, 10 to 14 days a year.

American workers don’t take all their vacation days, leaving, by some estimates, 577 million unused days on the table every year. And even when they do, many say they take work along with them. (All those unused days add up to $67 billion in lost travel spending and 1.2 million jobs, according to a recent report by Oxford Economics, an economic forecasting group.)
Kathy Simons was one of them. Even though she knew better. Simons directs the Work-Life Center at MIT. She knows almost better than anyone how taking a break from work not only improves your mood, but your health: One long-term study found that men who don’t take vacations are 30 percent more likely to have heart attacks than those who do. For women, it’s 50 percent. Women who fail to take vacation are more likely to suffer from depression.

But for five years, Simons didn’t take a vacation. She loves her work, had some big projects take off, and didn’t feel she could afford to be away from the office. “But I really got pretty exhausted,” she said. It took worried friends to finally push her to get away with her husband to Cape Cod for a few days. They rode bikes, turned off computers, spent time outside and, she said “got transported, and sort of awed by nature again.”

She came back to the office relaxed, while everyone around her looked stressed. So did her happiness wear off on them, as Hartig theorizes?

“I do think my good mood is contagious,” she said. “But honestly, re-entry is hard because you’re so out of sync with what’s going on around you. In so many work environments, co-workers don’t ask where you’re going on vacation. They only want to know when you’re coming back. It would be a heck of a lot easier to take vacation if we didn’t have to do it alone.”

Because while you’re being awed by a sunrise in a kayak, somewhere in the back of your mind, you know your co-workers are getting ready for a busy day, that stuff is piling up on your desk and you almost dread the emails flooding into your inbox.
The closest that Americans may come to collective restoration, Hartig said, is the quiet week between Christmas and New Years, when large swaths of the population leave the office behind.

William Howard Taft didn’t want Americans to have to go on vacation alone. In 1910, he proposed giving American workers two to three months of paid vacation every year. The naturalist John Muir said better than compulsory schooling, the U.S. should consider compulsory vacationing. In 1938, Congress proposed the 40-hour work week, a minimum wage and two weeks of paid vacation. In both instances, the vacation proposals died.

Now, perhaps with dollar signs, not collective restoration in mind, the travel and tourism industry has launched the Vacation Equality Project and, with slick ads and petition drives, is pushing Congress for a guaranteed minimum amount of paid vacation.

John de Graaf, executive director of the Take Back Your Time organization who has been working on the campaign, said it’s a tough sell in the United States, where vacation is seen as an “extraneous luxury” of little benefit to anyone.

“People don’t experience very much vacation in the United States, so they’re inclined not to understand its value,” he said. “In fact, people are in so much debt that, if given the choice of time or money, people will choose money, which is why they unions tell me they won’t fight for time off.”

DeGraaf just finished work on a video for public television that noted that 20 years ago, 80 percent of the families visiting Yosemite National Park stayed overnight. Today, the average visit, usually in the car, frantically snapping pictures out the window, is five hours. Likewise, the U.S. Travel Association notes that family vacations in 1975 typically lasted one week. In 2010, it was 3.8 days.

The one place in America that comes the closest to Hartig’s dream of collective restoration, with everyone taking off at the same time, is, ironically enough, Washington, DC.

President Obama is heading off for 15 days with his family on Martha’s Vineyard. Members of Congress will scatter for August recess, as will many of the staffers who serve them and the lobbyists who buttonhole them. Washington DC will become a veritable ghost town. (In August, there is no traffic!)

So, come September, will our nation’s leaders be basking in the glow of collective restoration? Will calmer, more relaxed Republicans drop their lawsuit against Obama? Will lawmakers’ good moods mean progress on a host of unfinished business?

Or, is that just too much to expect from a few weeks off, even at the same time, when mid-term elections are just around the corner?

Source: Associated Press

A Liberian doctor who received one of the last known doses of an experimental Ebola drug has died, officials said Monday. Separately, Canada said it has yet to send out an untested vaccine that the government is donating.

Ebola has left more than 1,400 people dead across West Africa, underscoring the urgency for developing potential ways to stop and treat the disease. However, health experts warn these drugs and vaccines have not undergone the rigorous testing that usually takes place before they are used.

The experimental vaccines are at still at a Canadian laboratory, said Patrick Gaebel, spokesman for the Public Health Agency of Canada, who declined to speculate how many weeks it could be before those are given to volunteers.

‘‘We are now working with the (World Health Organization) to address complex regulatory, logistical and ethical issues so that the vaccine can be safely and ethically deployed as rapidly as possible,’’ Gaebel said.

Earlier this month, Canada said it would donate 800 to 1,000 doses of an Ebola vaccine that it developed. Likely candidates include health care workers treating Ebola patients.

The experimental drug known as ZMapp has been tried in only six people. Health experts caution that since ZMapp was never tested in humans, it is unclear whether it works. The small supply is now said to be exhausted and it is expected to be months before more can be produced.

Dr. Abraham Borbor, the deputy chief medical doctor at Liberia’s largest hospital, had received ZMapp, along with two other Liberians. He ‘‘was showing signs of improvement but yesterday he took a turn for the worse,’’ and died Sunday, Information Minister Lewis Brown told The Associated Press.

There was no update provided Monday on the other two Liberians who received the drug.

Earlier, it had been given to two Americans aid workers and a Spanish missionary priest, who died after he left Liberia. After receiving rigorous medical care in the U.S., the Americans survived the virus that has killed about half of its victims.

Ebola can cause a grisly death with bleeding from the eyes, mouth and ears. The virus can only be transmitted through direct contact with the bodily fluids of the sick or from touching victims’ bodies, leaving doctors and other health care workers most vulnerable to contracting it.

International relief efforts have included shipments of gloves, gowns, face masks and other protective equipment, although it’s not clear how many have reached health workers struggling to contain the epidemic in West Africa, where even such basics as sterile fluids can be in short supply.

But just getting enough gear isn’t the whole story: Health workers can infect themselves while taking off contaminated equipment if they don’t do it properly, a trio of infectious disease experts wrote Monday in Annals of Internal Medicine.

‘‘The physical exhaustion and emotional fatigue that come with caring for patients infected with Ebola may further increase the chance of an inadvertent exposure to bodily fluids on the outside of the’’ personal protective equipment, wrote Dr. William A. Fisher II of the University of North Carolina, Chapel Hill, along with Drs. Trish Perl and Noreen Hynes of Johns Hopkins University.

‘‘In addition, the impulse to wipe away sweat in the ever-present hot, humid environment’’ after taking off some gear, and before washing up, could be enough, they added.

Meanwhile, the family of 29-year-old William Pooley, the first British citizen confirmed to be infected with Ebola, said he is receiving excellent care at an isolation ward in London’s Royal Free Hospital after being evacuated from the capital of Sierra Leone.

‘‘We could not ask for him to be in a better place,’’ they said in a statement.

Pooley, a volunteer nurse, was flown back to Britain from Sierra Leone where he was working at an Ebola treatment center.

The WHO is also in the process of trying to evacuate a Senegalese doctor who contracted Ebola while working in Sierra Leone, said WHO Assistant Director General, Dr. Keiji Fukada on Monday.

The U.N. on Monday also spoke out against the limitations placed on flights into and out of the affected countries, saying they are slowing aid organizations’ work in sending personnel and equipment and contributing to the countries’ ‘‘economic and diplomatic isolation.’’

‘‘We shouldn’t do anything that stokes fear and stigmatization,’’ Stephane Dujarric, spokesman for the U.N. secretary-general, told reporters.

On Monday, Japan also said it is ready to provide a newly developed anti-influenza drug as a possible treatment Ebola. The drug, with the brand name Avigan, was developed by Fujifilm subsidiary Toyama Chemical Co. to treat new and re-emerging influenza viruses, and has not been proven to be effective against Ebola.

Source: Associated Press

It is estimated that nearly 75% of adults do not adhere to a prescribed pharmacologic regimen, including failure to fill new prescriptions, taking less than the prescribed dose, or discontinuing drug therapy without prior discussion with their physician. Long-term treatments for chronic illnesses often require strict patient medication adherence, yet only 51% of patients in the United States who are prescribed antihypertensive drugs adhere to the prescribed treatment. This number varies from 40–70% for patients taking antidepressants and greatly increases the risk of relapse. Patient nonadherence to a prescribed pharmacologic treatment can not only harm the patient, but also carries a significant financial burden. The total economic burden of medication nonadherence is estimated to be $100–300 billion annually including the cost of hospitalizations and emergency department visits that could have been prevented with proper adherence. In one study, the number of hospitalizations and emergency department visits related to chronic vascular diseases declined with increased adherence and the uptick in pharmacy costs were offset by the healthcare savings.

In addition to contributing to suboptimal treatment outcomes, medication nonadherence can also impact safety and efficacy data in clinical trials for investigational drugs. If a large trial with an outpatient population has variable adherence, the protocol-specified dose may be too low for efficacy or too high and toxic. In 2012, the Food and Drug Administration (FDA) guidance on clinical trials for human drugs and biological products encouraged the use of adherence prompts, alert systems, and counting pills or smart bottles to monitor medication adherence and encourage patient compliance. New technology in the form of smart pills and bottles could help in reducing nonadherence in both clinical trials and individual patient pharmacologic treatment plans.

Pill boxes are an inexpensive tool for improving patient adherence, but visual acuity and cognitive impairment are potential barriers in correctly filling the pill boxes or taking the daily required medications without reminders (particularly in the elderly). Real-time measurement is now possible with pill dispensers containing sensors to monitor adherence, provide reminders, and transmit data to patients, caretakers, and clinicians. One such smart pill bottle was invented by researchers at the University of Alabama in Huntsville and licensed to AdhereTech; it uses a sensor in the bottle to detect if the bottle has been opened and calculates the number of pills or liquid remaining in real-time. This data is then transmitted wirelessly from the bottle to computer servers and is analyzed for any missed doses or errors. If a patient skips a dose, the bottle notifies the patient or other approved individuals via on-bottle lights and chimes and an automated phone call or text message. The use of real-time data analysis can detect lengthy nonadherence and follow-up via a phone call or text message for information on the missed dose or doses. Their responses can be sent directly to live case managers for immediate interventions such as changing the dose or switching the patient to an alternate medication. The bottles are FDA-registered Class I medical devices and the AdhereTech data collection system is HIPAA-compliant. A pilot test is underway at the Walter Reed National Military Medical Center and will be tested in a 12-week randomized trial at Weill Cornell Medical College involving 70 HIV-positive patients with sub-optimal medication adherence.

The same sensor technology integrated into smart pill bottles is also being incorporated on a much smaller scale- the pills themselves. In 2012, Proteus Digital Health received FDA clearance for its ingestible sensor that can be integrated into tablets or capsules during pharmaceutical manufacturing. Less than 1mm square in size and comprised mainly of silicon, the sensor transmits a unique and private digital code to identify the medication, dose, and time of ingestion upon contact with stomach fluid. The stomach fluid acts as a power source to activate the sensor in transmitting the digital code to a battery-operated patch worn on the left side of the body just below the chest. Lastly, the patch sends the information to a Bluetooth-enabled device and a secured centralized database. Using the secure Helius application for smartphones, tablets, and computers, the information can be viewed by the patient or, with permission, to their caregivers or clinicians. The patch may be worn for up to one week; it also can detect and relay information on heart rate, physical activity, and inactivity. In 2010, Proteus announced a collaboration with Novartis to develop and commercialize products with the sensor in the field of organ transplantation with option rights for cardiovascular and oncology product applications, as well as rights to use the technologies in clinical trials for pharmaceutical product development. A 12-week open-label single-arm exploratory study of twenty kidney transplant patients in stable condition after an average of 6.0±5.0 years post-renal transplantation evaluated the sensor and patch accuracy vs. directly observed ingestions (DOI) in medication adherences and timing adherence. The patients were prescribed enteric-coated mycophenolate sodium (ECMPS) that included the sensor technology system. The sensor system reported a 100% detection accuracy rate over 34 directly observed ingestions, 99.4% in ECMPS that included the sensor, and 99.3% in detecting the ingestion of two ECMPS capsules taken simultaneously.

Improving patient medication adherence can be difficult if social and economic factors (age, race, sex, socioeconomic status), patient-related factors (knowledge, attitude, beliefs), condition and treatment-related factors (severity of the symptoms and disease, complexity of the medical regimen, duration of treatment, adverse effects), provider characteristics (communication skills, training, and resources), and settings (drug coverage, cost sharing of medication, and access to medication and clinical care) are barriers to drug therapy. Technology may not improve adherence if one or more of these are significant factors in which real-time monitoring is not the solution. The World Health Organization (WHO) recommendations for patient adherence to long-term treatments, including diet and/or lifestyle changes, include the need for clinicians to assess patient readiness to adhere to a therapeutic plan and provide guidance and support rather than blame if nonadherence occurs.

As the incidence of chronic illnesses continues to climb, medication adherence will become more important than ever in disease control and reducing healthcare-associated costs. Although technology may not resolve all issues linked to patient medication nonadherence, innovations utilizing sensors like the AdhereTech smart pill bottle and the Proteus sensor system could contribute to improved outcomes in pharmacologic treatments seen in clinical trials and patient therapies.

Source: MPR

American doctor Kent Brantly and North Carolina missionary Nancy Writebol, both of whom contracted Ebola while treating infected Liberian patients, have been released from an Atlanta hospital. Writebol was discharged from Emory University Hospital on Tuesday and Brantly was released on Thursday.

“Today is a miraculous day,” Brantly said at an Emory news conference. “I am thrilled to be alive, to be well and to be reunited with my family.”

Both Writebol and Brantly underwent rigorous blood and urine tests to ensure that the virus was no longer present.

“The medical staff is confident that the discharge of both patients from this hospital poses no public health threat,” said Bruce Ribner, medical director of Emory’s Infectious Disease Unit, who led the team that treated both patients.

The Texas doctor appeared near death weeks ago after contracting the disease, which has killed 1,350 people in the four African nations affected by the contagion. He was flown back to the United States from Liberia in a special transport plane that included an isolation unit and arrived at Emory on Aug. 2.

Days later, Writebol, a missionary from Charlotte, N.C., was flown to Atlanta in the same “air ambulance.” Her ride from the airport to Emory University Hospital was covered live by television news helicopters.

In a desperate effort to save them, both patients received an experimental treatment called ZMapp while they were still in Liberia. The unproven treatment appeared to help both patients.

Brantly had traveled to Liberia as part of an aid mission with Samaritan’s Purse, a Christian humanitarian organization that has treated numerous patients in the West African country hardest hit by Ebola’s spread.

“Today I join all of our Samaritan’s Purse team around the world in giving thanks to God as we celebrate Dr. Kent Brantly’s recovery from Ebola and release from the hospital,” Samaritan’s Purse president Franklin Graham said in a statement. “Over the past few weeks I have marveled at Dr. Brantly’s courageous spirit as he has fought this horrible virus with the help of the highly competent and caring staff at Emory University Hospital.”

The organization currently has 350 staff members in Liberia, many of them working to battle the growing outbreak there, the group said.

“Thank you for your prayers,” Brantly wrote in a statement last week. “Please continue to pray for and bring attention to those suffering in the ongoing Ebola crisis in West Africa. Their fight is far from over.”

Writebol was working with her husband at a hospital in Liberia through a different global ministry group, SIM. The couple reunited at Emory earlier this week after David Writebol completed a 21-day observation period.

“Nancy is free of the virus, but the lingering effects of the battle have left her in a significantly weakened condition,” Writebol’s husband, David, said in a statement released through SIM on Thursday. “Thus, we decided it would be best to leave the hospital privately to be able to give her the rest and recuperation she needs at this time.

“During the course of her fight, Nancy recalled the dark hours of fear and loneliness, but also a sense of the deep abiding peace and presence of God, giving her comfort. She was greatly encouraged knowing that there were so many people around the world lifting prayers to God for her return to health. Her departure from the hospital, free of the disease, is powerful testimony to God’s sustaining grace in time of need.”

Currently, there are no approved treatments or vaccine to treat the deadly Ebola disease, which kills 60 to 90 percent of patients who contract it.

Source: Washington Post

Carnivore no more? Doctors are seeing more and more people who have developed allergies to red meat after being bitten by a tick that has become a fixture in the eastern United States.

A bite from the lone star tick can prompt such a severe reaction to meat that people are even landing in the hospital.

“Classically three to six hours after eating red meat [a person with the allergy] can get with hives, swelling and problems breathing,” says Dr. Robert Valet, an assistant professor of allergy and immunology at Vanderbilt University. “They may even have a full anaphylactic reaction in which their airways close.”

Scientists believe the allergy to red meat is caused by a sugar called alpha-gal passed from the lone star tick to its victims during the bite. Once the sugar enters the blood stream, it can be flagged by the immune system as an invader which results in antibodies being formed against it.

The problem is alpha-gal is found in all red meats, including beef, pork and venison. When the sugar is consumed as food, the stomach just breaks it down, explains Dr. Amesh Adalja, an infectious disease specialist at the University of Pittsburgh Medical Center.

“It’s an interesting mechanism,” Adalja says. “It’s really the reverse of what we’re doing when we give allergy shots. When you get a tick bite, it primes the immune system by exposing the blood to this sugar — and that allows the allergy to develop.”

Right now no one knows whether how long the allergy will last, Valet says. “Anecdotally, there are some patients in whom it does resolve,” he adds. “The most important thing you can do if you develop the allergy, along with avoiding red meat, is to avoid more tick bites since the number of antibodies will rise if there are more tick bites.”

As it turns out, meat allergy isn’t the only damage the lone star tick can cause.

They are also known to spread several serious bacterial infections, such as ehrlichiosis and the potentially deadly tularemia.

Symptoms usually appear within 30 days of a bite and can include:

• fatigue
• fever
• headache or muscle pain
• swollen glands
• Circular rash reminiscent of the Lyme rash, although experts believe that the rash is sparked by a different bacterium.

Treatment is typically with oral antibiotics, although it’s unclear whether medication helps recovery, according to the Centers for Disease Control and Prevention.

Ultimately the best advice experts can offer is avoid getting bit by ticks by staying out of brush areas.

“It underscores the importance of checking your body for ticks when you come in from the outdoors,” Adalja says. “And wearing clothing that can protect you from ticks landing on your skin.”

Source: Today Health

Postmenopausal women who in the past four years had undertaken regular physical activity equivalent to at least four hours of walking per week had a lower risk for invasive breast cancer compared with women who exercised less during those four years, according to data published in Cancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research.

But those benefits quickly disappear if regular physical activity stops.

“Twelve MET-h [metabolic equivalent task-hours] per week corresponds to walking four hours per week or cycling or engaging in other sports two hours per week and it is consistent with the World Cancer Research Fund recommendations of walking at least 30 minutes daily,” said Agnès Fournier, PhD, a researcher in the Centre for Research in Epidemiology and Population Health at the Institut Gustave Roussy in Villejuif, France. “So, our study shows that it is not necessary to engage in vigorous or very frequent activities; even walking 30 minutes per day is beneficial.”

Postmenopausal women who in the previous four years had undertaken 12 or more MET-h of physical activity each week had a 10 percent decreased risk of invasive breast cancer compared with women who were less active. Women who undertook this level of physical activity between five and nine years earlier but were less active in the four years prior to the final data collection did not have a decreased risk for invasive breast cancer.

“Physical activity is thought to decrease a woman’s risk for breast cancer after menopause,” said Fournier. “However, it was not clear how rapidly this association is observed after regular physical activity is begun or for how long it lasts after regular exercise stops.

“Our study answers these questions,” Fournier continued. “We found that recreational physical activity, even of modest intensity, seemed to have a rapid impact on breast cancer risk. However, the decreased breast cancer risk we found associated with physical activity was attenuated when activity stopped. As a result, postmenopausal women who exercise should be encouraged to continue and those who do not exercise should consider starting because their risk of breast cancer may decrease rapidly.”

Fournier and colleagues analyzed data obtained from biennial questionnaires completed by 59,308 postmenopausal women who were enrolled in E3N, the French component of the European Prospective Investigation Into Cancer and Nutrition (EPIC) study. The mean duration of follow-up was 8.5 years, during which time, 2,155 of the women were diagnosed with a first primary invasive breast cancer.

The total amount of self-reported recreational physical activity was calculated in MET-h per week. The breast cancer risk-reducing effects of 12 or more MET-h per week of recreational physical activity were independent of body mass index, weight gain, waist circumference, and the level of activity from five to nine years earlier.

Source: American Association for Cancer Research

Immunization helps prevent dangerous and sometimes deadly diseases. To stay protected against serious illnesses like the flu, measles, and tuberculosis, adults need to get their shots – just like kids do.

Immunization is especially important for adults 60 years of age and older and for those who have a chronic condition such as asthma, COPD, diabetes or heart disease.

Immunization is also important for anyone who is in close contact with the very young, the very old, people with weakened immune systems and those who cannot be vaccinated.

Annual flu shots can protect against seasonal influenza. The Center will continue to provide quadrivalent vaccines this flu season to keep our patients healthy all year long.

Sources: National Public Health Information Coalition and  healthfinder.gov

 

A 2-year randomized trial involving close to 32,000 volunteers at more than 100 sites has yielded evidence that a high-dose (HD) influenza vaccine intended for seniors offers significantly more protection in that age-group than the standard-dose (SD) vaccine, according to a New England Journal of Medicine report published today. The researchers concluded that the relative efficacy of the HD vaccine was 24.2% higher than that of the SD vaccine. About 1.4% of the volunteers in the HD group had a confirmed flu case, compared with 1.9% of those in the SD group.

The results, the authors say, suggest that flu cases in vaccinated seniors would drop by about 25% if they all received the HD vaccine instead of an SD vaccine. They also found that the vaccine had a good safety profile. Because the study did not include an unvaccinated group for comparison, the authors could not calculate how much either vaccine lowered the volunteers’ overall risk of contracting flu (absolute efficacy). (Because flu vaccination is recommended for all seniors, doing a trial with an unvaccinated group would be considered unethical.)

FDA required post-marketing trials

The HD vaccine, Fluzone High-Dose, made by Sanofi Pasteur, contains four times as much antigen (active ingredient) as standard vaccines contain—60 milligrams (mg) for each flu strain targeted, instead of 15 mg. The aim is to generate a stronger immune response in elderly people, whose immune systems are weaker than those of younger people. When the US Food and Drug Administration (FDA) approved the vaccine in 2009, the step was based largely on evidence that it increased the immune response in older people; the actual protection afforded by the vaccine had not yet been studied. Accordingly, the FDA stipulated that Sanofi would have to conduct further studies to assess the vaccine’s benefits. The study, sponsored by Sanofi, was conducted during the 2011-12 and 2012-13 flu seasons at 126 sites in the United States and Canada. The investigators recruited 31,989 adults 65 and older who had no moderate or severe acute illnesses. Half of them were randomly assigned to receive the HD vaccine and half the SD product.

The participants were told to report any respiratory symptoms during flu season, and they were contacted at least once a week during that time. The researchers defined a flu-like illness as a respiratory illness with sore throat, cough, sputum production, wheezing, or difficulty breathing, along with any of the following: a temperature above 37.2°C (99°F), chills, fatigue, headaches, or myalgia. Staff members were instructed to collect nasopharyngeal samples within 5 days after onset of illness for testing. In the HD group, 3,745 participants (23.4%) had at least one flu-like illness meeting the above definition, compared with 3,827 (23.9%) in the SD arm.

Low flu incidence in both groups

Overall, 529 volunteers had a lab-confirmed flu case—228 (1.4%) in the HD group and 301 (1.9%) in the SD group. This translated into 24.2% (95% confidence interval [CI], 9.7%-36.5%) higher efficacy in the HD group. This result met a benchmark set in advance by the FDA, the report says. The agency said the HD vaccine would be considered better than the standard one if the lower limit of the 95% CI exceeded 9.1%, because this provided confidence that the risk of confirmed flu was at least 10% higher with the SD vaccine. The researchers also found that the HD vaccine consistently showed better efficacy across different flu types, clinical illness definitions, methods of lab confirmation, and the two flu seasons.

Good safety profile

On the safety side, 1,323 volunteers in the HD group and 1,442 in the SD group had at least one adverse event, which meant that the relative risk for those in the HD group was 0.92 (95% CI, 0.85-0.99). Three people in the HD group had serious events that were deemed related to vaccination, but all three problems resolved before the end of the study. No one in the SD group had a serious event that was considered related to the vaccine. The investigators also found that immune responses as measured by hemagglutination inhibition titers were significantly higher in those who received the HD vaccine. The senior author and coordinating investigator of the study is Keipp Talbott, MD, of Vanderbilt University. “Until this trial came out we didn’t know if it [the HD vaccine] was going to be clinically better or not and now we know it is better,” he said in a Vanderbilt University Medical Center press release. “The overall efficacy of 24.2% against the primary end point [confirmed flu] indicates that about one quarter of all breakthrough influenza illnesses could be prevented” if the HD vaccine were used instead of the standard one, the report states.

The authors write that the vaccine’s absolute efficacy can be inferred only from other studies of the absolute efficacy of SD vaccines in seniors. They cite two previous studies that suggested that SD vaccines like the one used in the current study provided about 50% protection in the elderly. If that is accurate, they suggest, the absolute efficacy of the HD vaccine would be about 62%, which is similar to what has been seen with standard vaccines in younger adults. Another flu vaccine expert, however, questioned that efficacy estimate, saying it’s based on faulty data.

A ‘high-quality study’

Lisa Jackson, MD, MPH, an experienced flu vaccine researcher who was not involved in the study, called it “a high-quality and significant study,” adding, “It is one of the few trials of persons 65+ that used lab-confirmed virus detection as the endpoint.” Jackson, who is a senior investigator with the Group Health Research Institute in Seattle, said the only other similar study she could recall that used lab-confirmed detection of flu in seniors was one that compared vaccines with and without adjuvants. “Like the adjuvanted vaccine trial, we can see that the vaccine of interest performed better than standard vaccine, but we don’t know what level of efficacy was exhibited by the standard vaccine as there was no placebo arm,” she commented. “Given that there is now good data on the high-dose vaccine indicating that, basically, it does something, I think that warrants preferential use in older adults,” she said. She also suggested that its use should be considered in other groups, such as younger adults, HIV patients, and immunocompromised individuals. She added that it would be helpful to see a “number needed to treat” analysis or a cost analysis, since HD vaccine costs more than standard vaccines. A “number needed to treat analysis” would look at how many people would have to receive HD vaccine instead of SD vaccine to prevent one additional case of flu.

However, Jackson voiced a reservation about the authors’ estimate that standard vaccines have 50% absolute efficacy in seniors and that the HD vaccine thus might have 62% efficacy. She said the 50% estimate for the standard vaccine is not based on solid evidence, because both studies the authors cited had flaws.She also remarked that the low flu prevalence reported in the study (less than 2%) “is consistent with other studies and seems to be discrepant with the reportedly high rate of significant outcomes related to flu in this population.”

Source: Center for Infectious Disease Research and Policy

The Center offers high-dose, quadrivalent, preservative-free vaccinations.

The FDA has not reached a decision about the safety and efficacy of spray-on sunscreens, but continues to accumulate information to base an eventual verdict, a skin specialist said here. After manufacturers stated their case, the agency concluded that available information about spray-on sunscreens is insufficient to rule on its safety or whether it works as advertised. With respect to safety, the principal issues relate to the inhalation potential of spray-on sunscreens, according to Henry Lim, MD, of Henry Ford Health System in Detroit, who presented an update on the status of sunscreens during the summer meeting of the American Academy of Dermatology.

“Anyone potentially could inhale the product, children or adults,” Lim told MedPage Today. “It is not yet clear what the potential is or how great a risk it might pose.”

The FDA has been monitoring the situation since June 2011, when the agency issued rules for manufacturer testing to establish the safety and effectiveness and rules that tightened labeling requirements for sunscreens. At the same time, the FDA requested more data from manufacturers and comments from consumers and other interested parties. The rules went into effect in 2012. The FDA has continued to accumulate and review information on sunscreen safety, Lim said, but maintains that information is still insufficient to make definitive decisions on safety and effectiveness. A year ago the agency did issue a consumer safety notice, warning against use of spray-on sunscreens near an open flame. According to the FDA, at least five cases of serious burns had been reported at that time.

Earlier this year, Consumer Reports urged parents not to expose children to spray-on sunscreens until the FDA reaches a decision about the products’ safety. With regard to effectiveness, manufacturers of spray-on sunscreens have yet to demonstrate that the products provide coverage equivalent to that of other formulations, such as oils and lotions. Lim pointed out that spray-on sunscreen coats the skin with small droplets that have equally small spaces in between. Whether that affects the products’ protection against ultraviolet (UV) radiation remains unclear.

During his presentation at the AAD, Lim also addressed alternative formulations of sunscreens in various stages of development. Some of the products have been available without prescription for years, including vitamins C and E. Technically, the oral products are not “sunscreens” but antioxidants, said Lim, who has participated in studies of some of the products. In theory, the products work inside the body to counter the effects of exposure to UV radiation.

One of the most widely studied oral compounds is polypodium leucotomos, an extract of a fern plant indigenous to parts of Central America. Laboratory studies have demonstrated potential antioxidant and anti-inflammatory properties, Lim said.

Small clinical studies dating back almost 20 years have produced evidence suggesting the substance affords protection against phototoxicity, solar urticaria, and polymorphous light eruption. Besides vitamins C and E, other substances evaluated as potential oral photoprotectants include lutein and alpha-melanocyte stimulating hormone (alpha-MSH) analogs. Studies of oral lutein have demonstrated protoprotective potential in humans, and alpha-MSH analogs have been found helpful in management of erythropoietic protoporphyria and solar urticaria, associated with increased tolerance to artificial light and increased melanin content.

As for the long-term potential of oral photoprotection candidates, Lim remained cautious. “The results have been encouraging, but these products are still in early stages of development,” he said. Regardless of the outcome for oral photoprotectants, none of them should be considered a replacement for conventional sunscreens and the longstanding advice regarding limitations on UV exposure and use of protective clothing, broad-brimmed hats, and sunglasses, he added.

Source: MedPage Today

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