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More to know about COPD: Disputing the myths about an underdiagnosed disease

December 31, 2007 on 9:14 pm | In Uncategorized | Comments Off It's a slow and surreptitious process within the lung tissue. At first, few patients notice the subtle changes -- the shallow, uneven breathing; the trapped air; the uncomfortable suffocation. Even when they do, they rationalize: "I'm getting older," they say, or "I need to lose some weight."

Without intervention, the devastation continues -- sometimes a result of cigarette smoke or inhaled toxins, sometimes for no known reason. Over time, the alveoli appear almost moth-eaten, unable to do their jobs. The silhouette of the heart shrinks because of hyperinflated lungs, the diaphragm flattens and the bronchi become floppy and narrow. Other symptoms -- the chronic cough, the mucus, the shortness of breath, the difficulty blowing air out, the inability to do physical activities -- become more pronounced.

Often, more than half of lung functioning is lost before a diagnosis of chronic obstructive pulmonary disease is made. Partly because the condition's patient profile has changed -- it's no longer considered a disease of old men -- and partly because it is fraught with other misconceptions, COPD remains overlooked, even though it is the fourth leading U.S. cause of death.

More than 12 million people are diagnosed with COPD, but at least 12 million more unknowingly have it. "It's absolutely not on anybody's front burner," says Barbara Yawn, MD, a family physician who directs research at Olmstead Medical Center in Rochester, Minn. She also co-chairs the U.S. COPD Coalition, a nonprofit network of organizations dedicated to public education and research. "The primary care physician is focusing on two or three other chronic conditions, and they don't get around to questions of COPD."

Thus, the National Institutes of Health's National Heart, Lung and Blood Institute launched in early 2007 the Learn More, Breathe Better Campaign in an attempt to raise awareness and communicate a key message of early detection. "We are updating attitudes and concepts. We now have more tools to diagnose and treat," says James P. Kiley, PhD, director of the NHLBI's division of lung diseases. "The awareness program is a wake-up call. This disease is on the rise, and we need to get our hands on it. There is a role for primary care physicians, and spirometry is key."

Nonetheless, as Dr. Yawn explains, doctors still ask why they should test for a disease they can't help. "Our first job is to let doctors know this is not hopeless, and if we diagnose earlier we can help patients return to work and to normal activities," she says. "We need to show this is worth identifying. Treating this condition can give doctors, patients and families the same satisfaction and hope that treating other chronic diseases can, especially if we find it earlier when treatments make more difference."

MYTH: Spirometry is cumbersome

"We found that almost 40% of COPD is missed by primary care physicians," says Frederic D. Seifer, MD, clinical associate professor at East Tennessee University Quillen College of Medicine and director of the Erlanger Center for Better Health in Chattanooga. "How can you help these patients without identifying them?"

Two of the biggest reasons COPD gets missed in the primary care setting, Dr. Seifer says, are that most physicians believe it can be diagnosed clinically without spirometry and that it primarily affects men older than 65. "Wrong sex and wrong age," he says, adding that spirometry is essential.

More than 12 million people have chronic obstructive pulmonary disease.

But primary care doctors often recall the expensive, cumbersome, hard-to-calibrate equipment of their medical school days. As a result, barely 20% of their offices have spirometers. "Of 20,000 newly diagnosed COPD patients," says Aaron Milstone, MD, the director of the lung transplant program at Vanderbilt University in Nashville, Tenn., "less than 2% had testing."

Today, spirometers cost less than $1,000. They're small, about the size of a smart phone; they are easy to use; and they are reimbursable. "It's much easier than an EKG," says Stephen Rennard, MD, professor of internal medicine at the University of Nebraska Medical Center in Omaha. "It's like measuring blood pressure."

These newer machines generate a computer report, and Dr. Seifer has been teaching local physicians how to interpret the results. "Physicians are intelligent, and they want to be able to read the reports," he says. "They are less likely to use it if they can't read it."

Additionally, the COPD Foundation sponsors a mobile spirometry unit. "Since Jan. 14, [2007], we've been in 21 cities and tested almost 10,152 [people]" says John Walsh, founder and president, who himself has the alpha-1 form of COPD.

MYTH: Alpha-1 COPD is untreatable

Since she was a child, Melissa Biggs was chronically ill with colds, sore throats and upper respiratory conditions. But it wasn't until the 34-year-old former "Bay Watch" actress had her second bout of pneumonia that she went to an allergy specialist for help.

"She drew nine vials of blood, did scratch tests," Biggs says. "She said I was severely allergic and diagnosed me as a stoic asthmatic." Weeks later, after further testing, the allergist diagnosed Biggs with an alpha-1 antitrypsin deficiency, the only known genetic cause of COPD.

Almost 40% of COPD is missed by primary care physicians.

Biggs was referred to a critical care specialist. "He said, 'I don't know much, but what I do know [is that] it is rare and it is fatal. I give you two years.'" Biggs, a single mother, says she went into a depression, but she also found out more. "I learned that my doctor was grossly misinformed. It's treatable and it's not rare. It's rarely diagnosed."

The average alpha-1 deficient patient has symptoms for 7.2 years and sees three different doctors before getting a correct diagnosis, says D. Kyle Hogarth, MD, assistant professor of medicine at the University of Chicago Medical Center. He also directs its Alpha-1 Antitrypsin Deficiency Clinical Resource Center.

Alpha-1 antitrypsin is an anti-inflammatory protein that shields the lung's delicate tissues by binding to neutrophil elastase -- a normal lung enzyme that digests bacteria and other foreign substances. Without alpha-1, this digestion goes unchecked, eventually damaging healthy lung tissue. According to a study by the Respiratory & Allergic Disease Foundation, alpha-1 is estimated to affect up to 100,000 Americans, but nearly 95% are undiagnosed or misdiagnosed.

Knowing whom to screen appears to be one of the missing links.

"Our surveillance study found that physicians cannot depend on typical patient profiles to assess whether AAT deficiency screening is necessary," says Dr. Hogarth, the lead author of a study presented at the annual meeting of the American College of Chest Physicians in October 2007. A number of patients who normally would not be screened based on suggested guidelines turned out to be positive for AAT deficiency. "In the real-world setting, this suggests that thousands of patients who have been diagnosed with COPD or severe asthma may actually have alpha-1."

Study findings suggest that all patients with moderate or severe persistent asthma and/or COPD should be tested for AAT deficiency, says Gary Rachelefsky, MD, one of the investigators and a professor of allergy and immunology and director of the Executive Care Center for Asthma, Allergy and Respiratory Diseases at California's UCLA School of Medicine. "It is imperative that clinicians become more vigilant about alpha-1 testing."

MYTH: It's a hopeless condition

It's the "pumpkin pie" talk that helps his COPD patients grasp what they are facing, Dr. Seifer explains.

He draws a circle on the back of the patient's spirometry reading. If the patient has lost one-third of his or her lung function, that's a one-third sized slice of the pie. "This much of your pie is gone. You'll never get it back," he tells them. "We're going to help you quit smoking, because you can't take any more bites out of this pie. For the first time they say they understand their disease."

COPD is the 4th leading cause of death in the U.S.

Understanding is an important part of the treatment equation, as is pulmonary rehabilitation, nutrition and exercise. "This improves quality of life," Nebraska's Dr. Rennard says.

Long-acting bronchodilators and inhaled corticosteroids added to bronchodilators are helping and, in some cases, slowing progression, he said. In the TORCH (TOward a Revolution in COPD Health) study, presented at the American Thoracic Society meeting in May, patients treated with salmeterol/fluticasone propionate had a slower rate of lung function decline over three years compared with patients receiving a placebo. In addition, advances in smoking cessation give primary care physicians new tools.

A previous therapy -- lung volume reduction surgery, originally used in the 1950s -- has re-emerged for patients with upper lobe damage. Surgeons remove the most damaged portion, hoping to restore lung elasticity. And it seems a small umbrella might hold an answer for some patients. Known as the IBV Valve System, these one-way devices are placed inside the lung's upper lobe to redirect airflow to healthier portions of the lung.

"This is just the tip of the iceberg," Dr. Milstone says.

The Global Initiative for Chronic Obstructive Lung Disease, an initiative of NHLBI and the World Health Organization, has developed evidence-based guidelines for COPD management and staging criteria from spirometry. Yet, on average, physicians estimate that only 12% of their patients have COPD. And although 55% of doctors are aware of major COPD guidelines, only 25% use them to guide decision-making.

"We are in a Columbus-like era for the treatment of COPD. We are going forward with great impact," Dr. Milstone says. "We now need to focus on primary care physicians and internists, to let our colleagues know the future is really quite bright, that we have great optimism."

Health experts seek more awareness about Chagas

December 31, 2007 on 9:14 pm | In Uncategorized | Comments Off A parasite that is the leading cause of heart failure in Latin American countries appears to be far more common here than previously thought. Public health officials and physicians are now struggling to devise strategies for detecting, treating and preventing transmission, according to a series of papers published over the past year and symposiums at recent infectious disease meetings.

"This is really a neglected disease, but Chagas is more and more on the radar screen in the U.S.," said Caryn Bern, MD, MPH, medical epidemiologist at the Centers for Disease Control and Prevention's division of parasitic diseases.

Chagas disease, caused by the Trypanosoma cruzi parasite and carried by the triatomine or "kissing bug," has always been here in a very limited way. Many mammals are infected. The first indigenous human case was noted more than a half century ago in the Oct. 15, 1955, Journal of the American Medical Association, but its incidence in humans has been considered rare.

Widespread testing of the blood supply as of January 2007 triggered by cases of transmission through transplanted organs and transfused blood -- in some cases causing death -- has enabled the detection of many more infections. Most are in people who have spent significant time in Latin America or, because this parasite can be transmitted to a fetus, are children of immigrants from endemic regions. A handful of cases, though, seem to have been contracted on this side of the border.

Data from the American Red Cross presented at the American Society of Tropical Medicine and Hygiene meeting in Philadelphia in November 2007 show that one in 30,000 donors tested positive for the parasite. This number is much higher in some regions of the country with large numbers of Latin American immigrants.

Not everyone who tests positive on the initial screen will actually carry it, but at least 317 people in 30 states were confirmed as infected last year by AABB, an association which represents organizations that collect about 65% of the U.S. blood supply. Experts say more than 100,000 people may have Chagas without knowing it.

More than 100,000 people may have Chagas without knowing it.

"We're just seeing the tip of the iceberg," said Patricia Dorn, PhD, associate professor of biological sciences at Loyola University New Orleans. She was the lead author on a paper in the April 2007 Emerging Infectious Diseases that documented the first locally acquired case of Chagas in Louisiana.

In order to facilitate treatment, JAMA published a review of data by leading experts in this field. In addition, the first U.S. clinic devoted to it, the Center of Excellence for the Diagnosis and Treatment of Chagas Disease at Olive View-UCLA Medical Center in Los Angeles, opened last month.

"We want to treat these patients, and we want to follow them long term because this has not been looked at before in the U.S.," said Sheba Meymandi, MD, center director and associate professor of medicine at UCLA.

But with all this activity comes a growing awareness of the complexity of dealing with Chagas.

Experts urge physicians to test those who may be infected, but determining who that may be is difficult. Dr. Meymandi is running a trial to evaluate the effectiveness of screening all Latin American patients with heart conduction abnormalities and unexplained cardiomyopathy. She is also testing close relatives of those known to carry the parasite.

Until the results are available, the categories of those who potentially carry this -- including those who have spent significant time in Latin America -- are too broad to allow targeted testing. This infection is also, for the most part, asymptomatic for decades until heart or gastrointestinal trouble appears.

Not all infants born to mothers infected with Chagas will acquire the disease.

"The most important thing for physicians is to keep Chagas disease on the differential," said Dr. Bern.

There's also not yet an easy way to detect this parasite. Two different tests, at minimum, are needed, and even those whose results are negative may still be infected.

"There is not one single test that is considered the gold standard, and we may be missing some people," Dr. Bern said.

And then there's the question of what to do with a positive result. Drug treatment is most effective in those who are newly infected and those who are younger than 18.

Limited evidence suggests that treating those who are older can have some benefit, and one of the more contentious debates is whether adults should be given these medications. They can be hard to take, and they're not always effective.

Moreover, the majority of those infected will never develop the major heart or gastrointestinal problems that drug treatment seeks to prevent. The estimated 20% to 30% of patients who do can be monitored and managed symptomatically.

"The bottom line is that there are no properly structured, double-blinded trials that demonstrate that giving a full course of the drug to those with long-standing infection is beneficial," said Louis V. Kirchhoff, MD, MPH, professor in the division of infectious diseases at the University of Iowa. Dr. Kirchhoff has been studying Chagas disease for more than 20 years.

A randomized clinical trial that may answer this question of drug treatment for long-term infections is under way, but there is also the challenge of getting patients access to treatment. The drugs are not approved by the Food and Drug Administration, even though they have been used in Latin America for decades. They are only available in the United States from the CDC, which provides them at no charge.

Despite these challenges, experts hope that all this testing will not only protect the blood and organ supply, but also ensure that more babies who contract the parasite congenitally will be treated.

Not all infants born to mothers who are infected will acquire Chagas. But some will -- and treatment is most effective in this group soon after birth.

Salt limits urged for processed foods, restaurant meals

December 17, 2007 on 9:00 pm | In Uncategorized | Comments Off Washington -- Reducing the amount of salt in America's diet would go a long way toward lowering our collective blood pressure, according to AMA testimony before a Nov. 29 hearing of the Food and Drug Administration.

The Association joined with others in asking the agency to set strict limits on the levels of salt in processed foods and restaurant meals and to remove salt from the list of foods that generally are considered to be safe.

The consumption of excessive amounts of sodium is one of the main causes for the rise in blood pressure that accompanies aging, said Stephen Havas, MD, MPH, the AMA's vice president for Science, Quality and Public Health. The progressive rise leads to a 90% lifetime probability of developing hypertension and its accompanying risks for heart attacks and strokes, he added.

Dr. Havas testified for the AMA in support of a petition brought to the FDA by the Center for Science in the Public Interest, a Washington, D.C.-based nutrition and public health advocacy group that has been trying for decades to draw the FDA's attention to the risks of too much salt.

Most of the abundance of sodium, which now totals two to three times what is considered appropriate, in the average American's diet does not come from overused salt shakers in home kitchens. Rather, it comes from food manufacturers and restaurants putting it there, Dr. Havas said.

To eliminate this health threat, the AMA recommended a 50% reduction in the sodium content of processed foods, fast food and restaurant meals over the next decade. Improved labeling, it said, also could help consumers make healthier choices.

The average American's diet contains 2 to 3 times the recommended amount of salt.

"The AMA is confident the implementation of these recommendations would reduce sodium intake, result in a better educated consumer, and eventually lower the incidence of hypertension and cardiovascular disease in this country, saving countless lives," Dr. Havas said.

Other nations are far ahead of the U.S. in addressing this issue, he noted. Finland began a major campaign more than 30 years ago using warning labels for foods high in sodium. Since then, Finnish sodium consumption has decreased by 40%, and average blood pressure has dropped by more than 8 mm Hg -- "a huge decrease for a population," Dr. Havas said. Also, age-adjusted cardiovascular disease mortality rates in Finland are down more than 80%.

The United Kingdom began a campaign about five years ago aimed at the food industry and the public to reduce sodium intake, he said. Many U.K. companies voluntarily adopted a red-yellow-green traffic light system on the fronts of packages indicating the amount of sodium in a product.

Dr. Havas said there is no evidence the safety or quality of food in those countries has been adversely affected by the lowered sodium content.

“Whole patient” approach needed in diabetes care

December 17, 2007 on 9:00 pm | In Uncategorized | Comments Off Washington -- Diabetes by itself is hard enough to manage effectively, but try adding another one, two or three chronic diseases, and the complexities escalate.

Plus, ineffective management of some of these other diseases may be standing in the way of good diabetes control. Researchers in a recent study recommended physicians consider the "whole patient" when devising treatments and advise patients that their chronic conditions may, in fact, be related.

The study, which is in the December Journal of General Internal Medicine, found that 92% of 1,900 older patients queried had at least one other chronic disease in addition to their diabetes, and half had three or more additional diseases. One researcher also speculated that those high numbers are probably underestimates.

The study concluded that patients may neglect their diabetes care and increase their risk for stroke because of the competing demands posed by these simultaneous chronic diseases. The likelihood of this scenario went up with the number and severity of co-existing diseases.

The findings underscore the need to treat the whole patient, because successfully managing one chronic disease, in this case diabetes, could depend on how effectively a patient is managing another. If a patient had arthritis, for example, he or she can continue to exercise, researchers said.

Determining how best to meet these overlapping needs was a driving force behind the research, said the principal investigator, Eve Kerr, MD, MPH, associate director for the VA Ann Arbor Health Services Research and Development Center for Clinical Management Research and associate professor of internal medicine at the University of Michigan Medical School in Ann Arbor.

The study is an extension of the challenges in her practice.

"Many of my older patients are dealing with these same issues. They are patients who have multiple chronic conditions, and they look to me to help them prioritize and figure out how to improve their quality of life."

Helping with self-care

But how to do this in the limited time available in an office visit remains a puzzle. Dr. Kerr believes that most primary care physicians are trying to deliver comprehensive care that touches on their patients' needs, but time -- with a 15-minute visit -- isn't on their side. "So one of the things that I believe the health care system needs to think about is developing systems, mechanisms and methods to help patients to focus on their own self-care needs."

One step toward better self-care could be to help patients understand their diseases are often related. For example, patients may not know their diabetes puts them at higher risk for heart disease and stroke. That lack of awareness may mean they don't put as much emphasis on controlling their blood pressure or cholesterol as they should. Patients need to perceive diabetes as a multisystem disease, Dr. Kerr said.

Using data from the national Health and Retirement Study, which surveys 22,000 older Americans every two years, the researchers were able to focus on diabetes. However, they noted that these findings may apply to other chronic diseases as well.

The research shows how complex patients' health issues have become as life spans have increased, noted Jacqueline A. Pugh, MD, professor of medicine at the University of Texas Health Science Center in San Antonio, in an editorial in the same journal issue. "Clinical practice guidelines, as currently designed in a disease-specific manner, are woefully inadequate for dealing with the intersection of comorbidities and prioritizing among treatments."

"The work reminds us," Dr. Pugh wrote, "that we need to take care of the whole person, not just their heart, knee or pancreas, and to truly let that person be the decision-maker with the care team providing information and support."

FDA eyes “behind the counter” drug category with greater clinical role for pharmacists

December 10, 2007 on 3:07 pm | In Uncategorized | Comments Off The Food and Drug Administration is contemplating the establishment of a class of medications that would be available only after counseling from a pharmacist but without a physician's prescription. Physicians widely oppose the development, arguing that it could disrupt continuity of care and put patients at risk.

"We're concerned about patient safety," said Rebecca J. Patchin, MD, an American Medical Association trustee. "If a medication requires oversight, it should be available by prescription, and a physician should be involved in prescribing it and monitoring the patient." The AMA testified in opposition to this action at the FDA's Nov. 14 hearing on the subject.

Known as "behind the counter," this category exists in many other countries in various forms. The FDA is considering the possibility for the fourth time since the 1970s because agency officials feel the emergence of the Internet means that consumers are more informed than ever and the time may be right to make this change in the United States.

"Given that new technology, it seems like an appropriate time to ask now whether or not there are ways of improving public health through increased access by behind-the-counter availability," said Randall Lutter, PhD, the FDA Deputy Commissioner for Policy.

It is unknown what drugs might fall into the BTC category or how dispensing them might work, although two examples currently exist. Emergency contraception is behind the counter because of the need for age verification. Over-the-counter medicines with pseudoephedrine also are handled in this manner in an effort to reduce their diversion to the manufacture of methamphetamine. These two examples, however, are not what pharmacists, who tend to support this step, have in mind.

"This class should not be used to enforce age or quantity-based limits on certain medications or otherwise restrict access," Mary Ann Wagner, RPh, senior vice president of policy and pharmacy regulatory affairs at the National Assn. of Chain Drug Stores, said during the hearing.

Rather, if created, the category would allow pharmacists to perform a clinical evaluation of a patient before deciding to dispense a drug or refer that patient to a physician. Those who support the creation of this third category argue that it would increase access, improve patient compliance, reduce health care costs and allow for more postmarketing surveillance.

"This does have a lot of merit. There are many prescription drugs that have been around long enough to be used without as much medical supervision but still need a little bit more supervision than over the counter would allow," said Stephen Giroux, PD, president of the National Community Pharmacists Assn. "Many times a patient can see a pharmacist far more frequently than a physician, and pharmacists can keep the physician informed so that they have better information when they do see the patient."

Lining up in opposition

While pharmacists tend to be most in favor of the BTC category, physicians argue it would make an already fragmented health care system even more so. They also say the need to see a doctor first is not the most significant barrier to patients getting needed care.

"Patients need a medical home. They don't just need a medication," said Jim King, MD, president of the American Academy of Family Physicians. "What's limiting access is the cost of medications, not access to a physician. And there may be a good reason why patients should not be able to get some medications."

Concerns about a third class of drugs focus on other themes, too. First, many argue that it would not reduce costs and improve access. Medications that otherwise would be sold over the counter could end up behind it, making them less available to consumers. In addition, pharmacists are calling for the establishment of mechanisms that would allow them to bill for clinical services on top of charging for the drug, thereby making it possible that a BTC category wouldn't so much save money as move it around. Also, another cost burden for patients could result if some third-party payers, many of which do not pay for OTC medications, decide not to pay for those that shift from prescription to BTC.

"This may decrease access because patients may not have enough resources to pay for a medication no longer covered by insurance," Dr. Patchin said.

In addition, questions arise as to whether the FDA has authority to make this change without congressional action, and many are unconvinced patients are better educated.

"Just because people have more information doesn't mean people are better informed. They have more access to misinformation as well," said Bruce Bouts, MD, RPh, an internist and chair of the Pharmacy and Therapeutics Committee at Blanchard Valley Medical Associates in Findlay, Ohio.

And while the category exists elsewhere in the world, an August 1995 Government Accountability Office report -- considered to be the most definitive on this subject -- concluded that there was little evidence BTC had any public health benefit or had increased access.

The FDA is considering all input and is expected to reach a conclusion soon.