My Health

The never-ending story: Flu vaccine season goes year-round

September 29, 2008 on 11:27 am | In Uncategorized | Comments Off After several rocky seasons, this year's stock of influenza vaccine has been arriving on time, or even before physicians expected it. "This year was good news," said Stuart Sanders, MD, an internist and sports medicine physician in Demorest, Ga. "There was no problem getting our full shipment of flu vaccine."

His 1,350 doses arrived by the end of August, a far cry from previous years when supplies arrived late or not at all. Some 143 million to 146 million doses are expected before the season is done, and all five manufacturers have been shipping since early August.

"This is really quite a technical achievement that [manufacturers] are rising to this challenge and are on a faster timeline than in previous years," said Bruce Innis, MD, vice president for clinical research and development at GlaxoSmithKline.

Medical societies and public health agencies have long been working to stabilize the supply chain. The American Medical Association and the Centers for Disease Control and Prevention, for example, have organized the National Influenza Vaccine Summit, which meets annually and holds conference calls regularly during flu season. The AMA also advocates that physicians serving high-risk populations receive influenza vaccine in a timely and equitable manner.

Improvements in the supply chain are due to these efforts as well as a combination of business changes and scientific advancements that have made the vaccine's journey more efficient.

5 companies are making vaccine for the 2008-09 flu season.

On the business side, more companies are in the game, making a repeat of the 2004-05 season less likely. At that time, one company, Chiron Corp., had sterility problems in its manufacturing facility, and 46 million to 48 million doses -- nearly half of the total expected supply -- were lost. This left Sanofi Pasteur, then Aventis Pasteur, which initially planned to deliver 52 million doses, as the sole manufacturer of injectable vaccine. Production ramped up, and the company delivered about 58 million doses. MedImmune Inc. created 3 million doses of the intranasal version.

This season, five companies are involved. Sanofi Pasteur expects to ship 50 million doses, and CSL Limited is supplying 6 million. Novartis, which purchased Chiron in 2006, will manufacture 40 million shots, and GSK plans to provide 35 million to 38 million. MedImmune will make 12 million doses of the intranasal version.

Science also is speeding the process. Manufacturers increasingly are using reverse genetics to hasten production of seed viruses. They also are working to develop cell culture production, which is expected to increase capacity and make supplies more predictable. Cell culture would be particularly useful to deal with a pandemic in which the virus also affects birds, since chickens produce the eggs required to make the vaccine.

"The key thing is that it takes chickens out of the mix," said Matthew Stober, global head of technical operations for Novartis.

In the research world, investigators also are looking at vaccine formulations that would not need to be changed annually.

Data on a phase I study of a vaccine for all influenza A viruses will be presented at an October joint meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy and the Infectious Diseases Society of America, to be held in Washington, D.C. The findings suggest this vaccine creates a good immune response and is well tolerated.

"[This] has the potential to be a safe, highly effective and much-needed option to prevent seasonal and pandemic influenza," said Christine Turley, MD, the study's primary investigator and director of clinical trials and research at the Sealy Center for Vaccine Development at the University of Texas Medical Branch in Galveston.

This formula does not rely on cell- or egg-based production processes. Instead, vaccine antigens are produced more quickly by combining toll-like receptor-mediated immune enhancers and recombinant bacteria.

Surgeon general urges more vigilance on dangerous clots

September 29, 2008 on 11:27 am | In Uncategorized | Comments Off Washington -- Deep vein thrombosis and pulmonary embolism affect 350,000 to 600,000 Americans each year, but often they are unrecognized at the earliest and most treatable stages.

With an eye toward elevating awareness of these potentially serious medical conditions, acting Surgeon General Steven K. Galson, MD, MPH, issued a "Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism." He introduced the publication Sept. 15 at the second annual meeting of the Venous Disease Coalition in Washington, D.C.

"DVT and PE are often referred to as 'silent' conditions -- they can occur suddenly and without symptoms. In nearly half of the cases, there are no apparent symptoms," he said. Although gains have been made in understanding how these dangerous clots develop and how to prevent, diagnose and treat them, that knowledge is not always applied systematically, he added.

The conditions generally keep a low profile, but they hit the headlines when they strike young, seemingly healthy individuals. NBC journalist David Bloom died in 2003 at age 39 of DVT and PE while covering the Iraq war, where he spent hours crouched in the close confines of a tank. His widow, Melanie, who attended the surgeon general's meeting, has since worked to spread the word about the dangers of DVT.

The two conditions may contribute to as many as 100,000 deaths each year, Dr. Galson said. That number is expected to rise as the population ages because patients older than 50 are at increased risk.

"It is clear that we are dealing with a major health problem," noted Elizabeth Nabel, MD, director of the National Heart Lung and Blood Institute, who spoke at the event.

The call also is intended to spell out certain warning signs to the primary care physician, who is often the first to detect a clot, Dr. Nabel said. Initial symptoms can be subtle.

Mistaken identity

Patients may have swelling or pain in an arm or leg, skin redness or a warm spot on a leg. Physicians first might consider diagnoses of skin infections or muscle strains instead of DVT. In the case of shortness of breath caused by a pulmonary embolism, the patient may be thought simply to be out of shape, Dr. Nabel said.

Le Keisha Ruffin, 32, described several fruitless trips to emergency departments when pain in her side and chest from an undiagnosed PE became so sharp "it felt like someone was literally stabbing me over and over again in the same spot." She was told the pain was from the birth of her daughter by cesarean section.

Patients older than 50 are at increased risk of pulmonary embolism and deep vein thrombosis.

The proper diagnosis was made weeks later after a hot bath at home resulted in massive swelling in her right leg and she was rushed back to the emergency department. A physician told Ruffin that the DVT in her leg had caused one of the largest blood clots the physician had ever seen. Plus, part of the clot had broken off and caused a PE. She was told she might not have lived through the night had she not received help.

To prevent such occurrences and speed recognition of these conditions, the Agency for Healthcare Research and Quality published a 12-page patient guide and a 60-page physician guide on preventing and treating dangerous blood clots, said AHRQ Director Carolyn Clancy, MD. "We know how to prevent many of these dangerous blood clots, and these guides will help patients and clinicians put that knowledge to work to improve care."

The clinician guide, "Preventing Hospital-Acquired Venous Thromboembolism: A Guide for Effective Quality Improvement," is intended to help hospitals and clinicians implement successful processes to prevent dangerous blood clots, Dr. Clancy said. It identifies such clots as the "most common, preventable cause of hospital deaths."

The document also points to additional triggers for DVT that include taking hormones, having a bad bump or bruise, having had a stroke, being obese, or taking a trip of more than an hour in a car, airplane, bus or train. Certain inherited blood disorders also can make clots more likely.

NHLBI also is funding new research on the two conditions. Studies are under way on treatment for damaged veins and valves following DVT and on improving the health and well-being of elderly patients at risk for dangerous blood clots.

The institute also is launching the first multicenter, randomized clinical trial of genotype-guided dosing of warfarin, the most common blood-thinning treatment for those with diagnosed clots. The study will examine whether the use of clinical plus genetic data during warfarin initiation can lead to better and safer treatment.

Meanwhile, the AMA and other groups have developed the brochure "Personalized health care report 2008: Warfarin and genetic testing." It is designed for physicians and other health care providers who commonly prescribe warfarin but who may not have had exposure to pharmacogenomics and genetic testing. It outlines the effects of variations in the genes CYP2C9 and VKORC1 on warfarin metabolism and response, and summarizes the genetic testing available to determine whether a patient carries such gene variations.

Salmonella outbreak appears over; investigation to continue

September 15, 2008 on 11:13 am | In Uncategorized | Comments Off Washington -- The Salmonella outbreak that swept through 43 states plus the District of Columbia this spring and summer appears to be over. But the Centers for Disease Control and Prevention is continuing to watch for any additional cases of the Saintpaul bacteria strain that caused the illnesses.

As of Aug. 25, the CDC had received reports that 1,442 people had been infected -- at least 286 of whom were hospitalized. In addition, the infection may have contributed to two deaths. The outbreak began in late April, and most people were sickened in May and June. It was identified in the CDC's Aug. 29 Morbidity and Mortality Weekly Report as the nation's largest foodborne disease event in the past decade.

Foodborne illnesses are becoming a major public health problem in the United States. In the past few years, Salmonella-laden peanut butter made more than 300 people sick, and spinach contaminated by Escherichia coli caused 206 illnesses, three deaths and more than 100 hospitalizations.

Proper diagnosis of these illnesses are a top concern of doctors and other health care professionals. The AMA, working with other organizations, has developed a primer to increase awareness. Many cases of foodborne ailments are thought to go unrecognized and unreported, MMWR says.

The assessment that the latest Salmonella outbreak had ended was based on several observations, said Robert Tauxe, MD, MPH, deputy director of the CDC's Division of Foodborne, Bacterial and Mycotic Diseases. "The number of reported cases has been dropping since early July and by the beginning of August was down to the number of cases we would expect to see anyway in the absence of a major outbreak," he reported during an Aug. 28 press briefing.

The nation's largest outbreak of foodborne illness was tied to Salmonella Saintpaul.

Although no firm conclusions were reached on the particular food that caused the illnesses, jalapeño peppers from a Mexican farm are considered the prime suspect. Serrano peppers and tomatoes also were grown on the same farm and may have played a role, the MMWR says.

Tomatoes may have been an early source of infection, Dr. Tauxe said. "We recognize that since the specific source of the contamination with Salmonella has not been identified, it's important that we remain vigilant."

Nevertheless, the Food and Drug Administration lifted its advice to avoid eating raw jalapeño and Serrano peppers, said David Acheson, MD, the FDA's associate commissioner for foods. "The FDA is taking this action consistent with the CDC's declarations that the Salmonella Saintpaul outbreak appears to be over."

Several lessons were learned from the outbreak that point to the need for improved follow-up action, Dr. Acheson said. He urged Congress to give the FDA the authority to require the food industry to institute more protections, including using electronic tracking, so a source of contamination can be traced more quickly.

Scurvy rare, but cases still are popping up

September 15, 2008 on 11:13 am | In Uncategorized | Comments Off The 5-year-old with behavioral developmental disorder appeared to be getting worse. Over six weeks, he lost interest in climbing and running. He complained of leg pain. He stopped talking and became lethargic as well as bedbound. He also bruised easily. A battery of tests revealed nothing -- nothing, that is, until his vitamin C levels were checked.

It turned out he had scurvy -- a disease usually associated with long sea journeys of centuries past. "We commented at the time that if this patient had arrived in a schooner we might have made the diagnosis sooner," said James Noble, MD, assistant professor of clinical neurology at Columbia University Medical Center in New York. This child developed it because, unbeknown to his parents and in spite of the fact he had access to foods with vitamin C, he was living on crackers and ice cream.

The details of this case were published in the March 2007 Pediatrics, one of a handful of recent reports indicating that even if scurvy is not common, it happens.

"We should remember the diseases of dietary deficiency. These diseases still occur, even in the U.S.," said Robert Centor, MD, director of the division of general internal medicine at the University of Alabama at Birmingham.

Dr. Centor authored a case report in last month's Journal of General Internal Medicine detailing the story of a 57-year-old man complaining of shortness of breath and a large swollen bruise stretching from thigh to ankle. Divorced and toothless, his diet was composed of processed food but no fresh produce. He, too, had scurvy.

14% of men and 10% of women are deficient in vitamin C.

Another case, published in the August 2007 Journal of the American Academy of Dermatology, documented a scurvy diagnosis traced to psychosis. The 51-year-old male patient was convinced that "the mob" would harm him if he ate anything other than tuna and crackers.

No data are available on scurvy's prevalence, although anecdotal evidence suggests that most physicians will see at least one case in their careers. Some see many more.

"People think it is not a problem at all in this country, but when it occurs, it's huge," said Toby Maurer, MD, lead author of the Journal of the American Academy of Dermatology paper and associate professor of dermatology at the University of California, San Francisco. She sees two or three patients with this problem a year.

According to National Health and Nutrition Examination Survey data, about 14% of men and 10% of women are deficient in vitamin C. Few progress to scurvy, but some do. According to the Centers for Disease Control and Prevention's National Center for Health Statistics compressed mortality file, 57 people died of ascorbic acid deficiency from 1979 to 2005.

Even if these conditions are not widespread, they warrant notice. "We probably don't recognize it nearly as much as we should," Dr. Noble said. "Myself included."

But the quandary of scurvy is that, although it is easy and inexpensive to prevent and treat, its low frequency means that it is often costly to diagnose. The man in the Journal of General Internal Medicine report had a wide array of tests carried out, including a comprehensive metabolic panel, an electrocardiogram, an echocardiogram, several x-rays, and a computed tomography scan. He also was assessed for infections such as HIV. Because he had a history of alcoholism, his liver function was checked. After several weeks of outpatient care, the child in the Pediatrics paper was hospitalized for nine days before his vitamin C levels were checked.

57 people died of vitamin C deficiency from 1979 to 2005.

"What's striking about these case reports is the million-dollar workup that people receive," Dr. Noble said.

For this reason, experts urge more attention to potential nutritional deficiencies among those most at risk.

"This is a pretty rare condition. We're not seeing people with scurvy right and left. But, having said that, this is a significant condition that's easily treated if you make the diagnosis. All doctors need to have a high index of suspicion in certain kinds of patients," said Robert Brodell, MD, professor of internal medicine and dermatology at Northeastern Ohio Universities College of Medicine. He published his own case study in the August 2002 Nutrition in Clinical Practice.

The at-risk patient population includes those who are older, live alone, or are mentally ill. Children with various behavioral and learning disorders also might restrict their diet.

Muscles matter: Physicans advised to tell patients to build up strength

September 8, 2008 on 11:06 am | In Uncategorized | Comments Off Jeff Williamson, MD, a geriatrician at Wake Forest University School of Medicine in North Carolina, can be persuasive about the benefits of building muscle. "I like to say there are really only two reasons why older people end up in a nursing home. One is that their brains stop working, and the other is that their muscles stop working. Especially their leg muscles."

While the loss of skeletal muscle inevitably comes with aging, no one should just sit still and take it. In fact, sitting still would be the worst thing. People in their 40s and 50s need to take prompt action to preserve what strength they still have, said Dr. Williamson, clinical director of the J. Paul Sticht Center on Aging and Rehabilitation at Wake Forest.

Muscle loss probably starts around age 40 for some people and by age 50 for most. But young, sedentary people likely will arrive at later life with less muscle than those who are more physically active, said Roger Fielding, PhD, director of the Nutrition, Exercise Physiology and Sarcopenia Laboratory at Tufts University in Boston. That circumstance could set them up for more disability in later years.

"We are becoming much more aware now than at any time in the past that as people get older, the amount of muscle they have in their body becomes smaller," Fielding said.

It only has been during the past decade or so that imaging techniques have captured this muscle loss, noted Dr. Williamson. These advances have allowed physicians to quantify how much muscle people should have at certain ages and to develop outcome measures to test interventions that are intended to preserve muscle.

Most people have lost muscle mass by age 50.

General consensus surrounds the idea that physical inactivity plays a big role in muscle loss. "We see pretty large declines in strength in people because they don't maintain activity," said Barbara Bushman, PhD, a professor of health, physical education and recreation at Missouri State University. In one study, 40% of women ages 55 to 64 said they couldn't lift 10 pounds.

"We suggest that people get a dog and walk the dog for exercise, but then they can't even lift a 10-pound bag of dog food into their car," she said. The numbers are even worse for women 75 and older -- 65% said they couldn't handle that amount of weight.

"To me, that's pretty frightening," Bushman said. "They couldn't lift a grandchild or respond in an emergency situation."

Lean body mass decreases about 15% between ages 30 and 60, she said. "It comes down to about five to seven pounds of muscle lost each decade."

Although it's probably never too late to try to regain strength, the middle years -- starting at age 40 -- are a key time to pick up the weights.

"It's like saving money. In middle age, you save so you can have a good retirement. But if you save muscle mass, you'll have an even better retirement," Dr. Williamson said.

W. Jack Rejeski, PhD, a behavioral scientist at Wake Forest, warned that difficulty climbing stairs can be the first sign of functional decline. "We've shown in our research that [such problems] are one of the first signs of early disability."

"The one thing people are most fearful of losing is the ability to function independently," said Tony Marsh, PhD, associate professor of exercise science at Wake Forest. "The strength of your muscles is fundamental in maintaining your independence."

Disease fighter

It's not only functional decline that becomes evident with muscle loss. The Centers for Disease Control and Prevention poses the question on its Web site: Why strength training? The agency provides a number of answers.

For example, arthritis pain was reduced by 43% after a group of older men and women completed a 16-week strength training program. Exercise was just as effective, if not more so, than medications, based on the CDC findings.

Lean body mass decreases about 15% between ages 30 and 60.

Strengthening exercises also can improve balance and flexibility, important in reducing the risk of falls and injury. And, the pull of muscle on bone also builds bone density and helps ward off osteoporosis, which is a major problem for post-menopausal women and older men.

There even is good news in glucose control. The CDC materials include a study of Hispanic men and women who demonstrated improved glucose control after 16 weeks of strength training. The results were comparable with those produced by medication.

In another study, weight training helped to lift depression as effectively as did medications. Why this response should occur is not yet known, but speculation centers on the increased self-confidence that people build as their strength improves. Or perhaps the strength training is producing helpful biochemical changes in their brains, the CDC suggests.

Given that muscles are major reservoirs for the body's supply of fuel in the form of amino acids, having more muscle also may mean having more fuel, said C. Jessie Jones, PhD, professor of kinesiology and health science at California State University, Fullerton, and co-director of the university's Center for Successful Aging. "When recovering from an illness, a person relies on amino acids. The less muscle tissue they have, the less of a reservoir there is."

Muscles' metabolic properties also play a role in improving glucose control. More collective muscle could help control the global diabetes epidemic. CDC figures show that in the U.S. alone, more than 14 million people have type 2 diabetes, a 300% increase over the past 40 years.

New guidance

Recent guidelines also underscore the need for muscle strength. The American College of Sports Medicine and the American Heart Assn., for instance, stressed muscle strength importance in last year's joint recommendations for physical activity in older adults.

In addition to 30 minutes a day of moderately intense aerobic activity five days each week, the organizations call for muscle strengthening activity using the major muscles of the body at least twice weekly.

Weight training has been shown to improve glucose control and lessen arthritis pain.

The AHA published a separate statement last year that emphasizes resistance training's benefits for older people, especially women and those with certain heart conditions. These populations were highlighted because often they become unable to function independently.

"The purpose of the [AHA] update was to underscore the importance of the health benefits of resistance training," said Mark Williams, PhD, director of Cardiovascular Disease Prevention and Rehabilitation at the Creighton University School of Medicine in Nebraska.

"In addition, resistance training has now been reported to potentially positively impact body composition with increased muscle mass, and improve various metabolic factors such as blood lipids and blood sugar levels," he added. Williams led the team that wrote the AHA statement.

Several experts in exercise science point to the role physicians can play in persuading patients to get moving. "Research has shown that if a primary care physician is behind something, patients are more likely to respond," Bushman said.

Physicians also may intercede when patients are recovering from illness. "Just being in the hospital for a few days can dramatically affect muscle mass," Dr. Williamson said. "So physicians, in addition to thinking, 'I've successfully treated this person's heart failure or pneumonia,' need to be thinking, 'How can I help restore their muscle mass and function?' "

Assessing a patient's physical functioning should be part of an office visit, Rejeski said.

One way to conduct an assessment of lower extremity function is by the Short Physical Performance Battery, Rejeski said. It takes about 10 minutes to administer and tests balance, gait, strength and endurance. "It's a very simple test, but it has been shown in large studies to be predictive of decline in function."

Action then should be encouraged.

"The sooner you jump on any signs of decline, the better off you are," Rejeski noted. "As you get further down the slope of disability, it's more difficult to recover."