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Infant pertussis outbreak emphasizes need to vaccinate health care workers

June 30th, 2008 by ceo
The cases of 11 infants who contracted pertussis from a health care worker have renewed calls to get adolescents and adults vaccinated against the infection, particularly if they work in a hospital or other medical setting.

"We think it's very important that people do everything to prevent pertussis in infants, and this means immunizing teens, adults, parents of infants and people who are taking care of infants. It means immunizing health care workers," said Don Murphey, MD, lead author of the paper outlining the incident published in the June 6 Morbidity and Mortality Weekly Report. He is also the medical director of occupational health at Cook Children's Medical Center in Ft. Worth, Texas. The infants were infected at another hospital in the community.

The outbreak occurred a year before the Food and Drug Administration's 2005 approval of Tdap -- the vaccine that includes the pertussis immunization -- for adults and adolescents. This step was followed by recommendations from the Advisory Committee on Immunization Practices urging that all adolescents and adults receive the preventive, with those working for a medical institution viewed as especially high-priority targets. The American Medical Association encourages health care workers to be immunized for their own protection and to reduce transmission to others. But most experts suspect that many health care professionals remain unimmunized and that the risk that outbreaks will continue remains high.

"Patients should have the right and every expectation that they're not going to get diseases that they didn't have when they went into the exam room or hospital," said Greg Poland, MD, professor of medicine and director of the vaccine research group at Mayo Clinic in Rochester, Minn.

No data have been collected on how many health care workers have received the Tdap vaccine, although numbers pertaining to the general adult population are not encouraging. According to statistics released in January from the Centers for Disease Control and Prevention's National Immunization Survey, 2.1% of 18- to 64-year-olds had received it. Also, a study published in the November 2007 issue of the journal Infection Control and Hospital Epidemiology found that 87% of health care workers were not planning to receive it.

Experts are concerned because health care workers are more likely to get pertussis in the course of their job. They also are more likely to transmit it to those most likely to experience complications.

A 2007 study said 87% of health care workers didn't plan to get vaccinated against pertussis.

"[Pertussis] is clearly a hundred-day cough in adolescents and adults," said Grace Lee, MD, MPH, assistant professor of pediatric infectious diseases at Harvard Medical School in Boston. "Vaccination protects them and their families. It protects the patients." She has published several papers on the cost effectiveness of this vaccine.

Some medical institutions are piggybacking pertussis vaccination efforts onto those for influenza. In some ways, pertussis vaccination is easier because it doesn't have to be given annually or during a narrow window in the fall and winter like flu vaccine, but motivating health care workers to get the shot is challenging. It's fairly new -- some people are not aware of it or that protection from childhood pertussis immunization likely has waned. Also, even though cases of pertussis have increased among adults, it's still viewed as a childhood disease. So the vaccine may not be viewed as vital for adults.

"This does require a whole new kind of paradigm, and we need to educate both the professional staff and others in the hospital about why we're talking about whooping cough," said William Schaffner, MD, president-elect of the National Foundation for Infectious Diseases and chair of the Dept. of Preventive Medicine at Vanderbilt University School of Medicine in Nashville, Tenn.

The price of the vaccine also may be a barrier, although studies have shown that vaccination saves money by reducing disruption and the need for prophylactic antibiotics caused by outbreaks.

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New book aims to provide vaccine answers: AMNews interviews Martin Myers, MD

June 30th, 2008 by ceo
Washington -- Vaccines have long been considered one of public health's greatest and most life-saving achievements, yet they continue to spark controversy. In recent weeks, protesters in Washington, D.C., claimed that childhood vaccines are unsafe, while in Albany, N.Y., others rallied against a mandatory vaccine bill in that state.

Parents attempting to do the right thing for their children are often caught in the cross fire.

Now along comes a new book, Do Vaccines Cause That?! A Guide for Evaluating Vaccine Safety Concerns. It summarizes the research findings on vaccines and presents a method for analyzing that research. The book is by Martin Myers, MD, a pediatrician and executive director of the nonprofit National Network for Immunization Information, based at the University of Texas Medical Branch in Galveston, and NNii science writer Diego Pineda. NNii provides information about vaccines on its Web site (www.immunizationinfo.org). Affiliates include the AMA, the Infectious Diseases Society of America, the American Academy of Pediatrics and the American Academy of Family Physicians, which support its work. NNii does not accept pharmaceutical company funding, Dr. Myers said.

The authors evaluate the long-running controversy linking vaccines with rising rates of autism as well as claims suggesting vaccines' possible association with asthma. The book also delves into the effects of multiple vaccines on a child's immune system.

Although parents are its intended audience, physicians and others in the health care field can benefit from reading it, according to former Health and Human Services Secretary Louis Sullivan, MD, and Samuel Katz, MD, chairman emeritus of pediatrics at Duke University in Durham, N.C. Together they wrote the book's forward.

"One hopes -- anticipates -- that besides a broad lay audience, health care personnel at every level will take advantage of this book to augment their own perspectives so they can discuss vaccines more comfortably and convincingly with the families for whom they are responsible," write Dr. Sullivan and Dr. Katz.

It remains to be seen whether the new book will answer all queries. "You are going to continue to see parents doing their own research and coming up with a lot of questions," said Barbara Loe Fisher, a frequent critic of vaccines and co-founder of the National Vaccine Information Center, a nonprofit, parent-led organization that seeks to change the mass vaccination process to allow more opt-out flexibility regarding immunizations. She said she looks forward to reading the book but wonders if it will address the issue now being raised about the effect on children's health of recent expansion in the recommended vaccine schedule.

"I've seen the number of vaccines double and the number of doses triple," Fisher said. "No matter what is published in that book, it is still an outstanding question until health authorities give us the answer as to why so many highly vaccinated children are so sick."

AMNews recently talked to Dr. Myers about the book.

AMNews: Why did you write this?

Dr. Myers: For a couple of reasons. The first, and maybe the most important, was that readers of our [NNii] Web site asked us to. They liked the essays on our site and asked us to put them together in a book.

The second was when we went to bookstores to see what was available, we could only find anti-vaccine materials and advocacy books. But we couldn't find a book written to help parents sort their way through conflicting information.

It is meant as a tool to help parents understand what they are hearing and how to evaluate it. We do not advocate. Each section of the book was reviewed by technical experts and parents. We had a panel of parents read the book and tell us whether we were clear or not.

One of my favorite anecdotes concerns a parent who acknowledged that the book was informative but also said it was boring and not the kind of thing a parent is going to read. So we went back and started over.

We hope it's helpful for parents who want more evidence and also to those who need help sorting through the evidence.

AMNews: What's in it for physicians?

Dr. Myers: As Dr. Katz and Dr. Sullivan wrote in the forward to the book, we do review the evidence in some detail. We want to have it all there. They noted that it's something that health professionals should read also, since it's the one place where it is compiled.

A number of physicians at meetings said they were anxious to see the book because they thought it would help them talk to parents.

AMNews: Do physicians and researchers have difficulty communicating clearly to lay people?

Dr. Myers: We use words in a different way. We included a table of words in the book and what they mean to vaccine researchers and what they mean in common English. As we started to compile that table, we kept finding more words.

"Bias" is one of the words. "Plausible" is another. "Significant" to the scientist means it is probably not due to chance, but it could be. But when a parent hears the word significant, it means important.

Then there is the phenomenon of the missing information. If it turns out that a safety concern is caused by the vaccine, like it was with intussusceptions and [the first] rotavirus vaccine [which was withdrawn in 1999], it doesn't take very long to prove it. [Two new rotavirus vaccines were licensed in 2006.] But you can never prove a negative. You have to have lots of studies done by different people, and it might take years until the scientific community says, 'OK, the weight of the evidence is so compelling we think we can reject this.' We used a quote from Einstein that Diego found: 'Many experiments will never prove me right, but one experiment can prove me wrong.'

AMNews: How great is the danger posed by unimmunized children?

Dr. Myers: We have a section in the book called 'community immunity' that addresses how important it is for children to be immunized to protect neighbors. It's an important concept for people to understand that when immunization levels go down, outbreaks can occur.

Attacks of misinformation on vaccine safety can cause that breakthrough. We saw it with whooping cough in the 1970s and 1980s. And we saw it with measles and mumps in the United Kingdom just recently.

AMNews:So are the same vaccine safety debates occurring in other countries?

Dr. Myers: The same discussion on vaccines causing autism was held in England and Europe related to the measles vaccine -- that argument has been discredited now. But as a result, parents became confused and didn't immunize their children, and they had an outbreak of measles and an epidemic of mumps which spread to the United States.

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Centers offer ways to bridge language, cultural differences

June 30th, 2008 by ceo
Washington -- The Upper Cardozo Health Center, located in an economically and ethnically diverse section of Washington, D.C., has enrolled more than 17,000 low-income individuals, and most are non-English speakers. These patients, who hail from more than 90 countries, still receive a full range of primary and preventive health services.

Across the river in Virginia, the Community Health Network in Fairfax is providing similar care for a similarly diverse population.

How do they do it?

More physicians than ever would like to know. Encountering patients whose grasp of English is less than proficient is not unusual in medical practices. More than 55 million people in the nation, or nearly 20% of the population, speak a language other than English at home. And more than 24 million residents speak English less than "very well" and may be considered limited English proficient, or LEP, according to Steve Hitov, managing attorney of the National Health Law Program's Washington, D.C., office. He moderated a June 16 briefing on the importance of language services for quality health care.

The National Health Law Program also released a report, "Serving Patients with Limited English Proficiency," that resulted from a 2007 survey of 260 members of the National Assn. of Community Health Centers.

"Eighty-one percent of general internists treat LEP patients frequently -- 54% at least once a day or a few times a week," Hitov said.

54% of internists treat patients with limited English proficiency at least once a day or a few times a week.

Luis Padilla, MD, the medical director of the Upper Cardozo center, which operates under the umbrella of Unity Health Care Inc., and Christina Stevens, program director of the locally funded Fairfax Community Health Network, provided examples of the problems faced by safety net health care centers as well as their solutions.

Both centers recruit bilingual staff members. At the Cardozo Health Center, whose patients speak primarily Spanish or Amharic, an Ethiopian language, 17 of the 19 primary care professionals speak Spanish, Dr. Padilla said. More than 90% of the support staff are bilingual or multilingual. In addition to Spanish and Amharic, the staff speaks French, Chinese, Tagalog, Farsi, Vietnamese and Tigrinya, a language spoken in the African country of Eritrea.

"We have one of the few pharmacies to provide Spanish labels," Dr. Padilla added.

Reading skills count, too

Many of the patients seen at Dr. Padilla's health center also are illiterate in their own languages, and a national community partnership program called Reach Out and Read has been adopted to promote childhood literacy. Literacy promotion is a focus at well-child visits, he said.

The center also has a language line with interpreters available for more than 100 languages and dialects. The service is accessed via speaker phone in exam rooms.

Underlining all this activity is the 2004 D.C. Language Act, which was enacted to provide residents with limited proficiency greater access to services and activities in their own languages. To comply with the law, the health center faces ongoing challenges, Dr. Padilla said. Among them are the continued recruiting of bilingual health care professionals and the development of resources and staff to assess how patients process the information provided and to measure the degree to which it is understood.

The Fairfax safety net program was established to provide primary health care services to low-income, uninsured residents. It was begun as a temporary operation until a federal program came along. But they are still awaiting the feds' arrival, Stevens said.

Eighty percent of their patients are LEP and, although Spanish is the primary language for more than half, there are at least 70 other languages represented at the clinic.

Referrals to specialists who do not offer interpreters was cited as a major problem by Stevens. Another is family members who wish to serve as interpreters but also interfere with the clinical process and insert their own views.

The Fairfax center found similar solutions to those used in in the district. All health care professionals are bilingual, and there are language service lines in all exam and interview rooms, Stevens said.

To guide the way toward a world in which there are more health centers like the two featured in the briefing, the AMA and other organizations developed in 2001 a set of principles for providing health care access to people with limited English proficiency.

They include offering language assistance at no cost at all points of contact and in a timely manner; providing both verbal and written notice of the right to receive language services in a patient's preferred language; and assurances that the language assistance is competent.

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FDA goes digital for faster “Dear Doctor” letters

June 16th, 2008 by ceo
Washington -- Assuming that physicians would rather not be the last to know that a drug or a device they prescribe or use carries previously undetected dangers, the Food and Drug Administration, the AMA, physician specialty groups, drug and device manufacturers and liability insurers are promoting a new early-warning system that moves doctors ahead in the queue.

The online system, called the Health Care Notification Network, is expected to debut next month. Even before its launch, more than 100,000 physicians have signed up, said the network's developers. That number is expected to grow.

HCNN, which is free to physicians, will be funded by drug and device makers. It is designed to convey the same information that has been delivered by the U.S. Postal Service in the form of "Dear Health Care Professional" or "Dear Doctor" letters, but this time the information will be delivered more quickly via e-mail and accessible from any Internet-capable device.

The network's developers estimate that it could cut to a day or two -- from the three to four weeks it now takes -- the time needed for drug and device manufacturers to draft a letter, gain FDA approval, print and mail the communication.

The need for speed in alerting physicians to possible dangers associated with drugs and devices is being called a patient safety issue -- a matter of continuing focus as reports are released calling attention to preventable deaths or questioning prescription drug safety.

Avoiding the longer time frame also cuts the risk that patients will get the news before doctors. "Electronic warnings make sense if for no other reason than to keep yourself on the same electronic footing as patients," noted Nancy W. Dickey, MD, chair of the iHealth Alliance, a nonprofit board that governs the new service.

The alliance will ensure that e-mail addresses of registered physicians are used exclusively for safety alerts and not spam or ads, said Dr. Dickey, a former AMA president and president of the Texas A&M Health Science Center in College Station.

In addition, physicians should expect more FDA communications, she said. "Medicine will only become more complex, and we can expect that updated information from the FDA is going to increase."

Network advocates

The network also has the agency's support. "This is a great opportunity for better protection of medical products in this country," said Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, when the network was first announced in March. Paper alerts will continue to be sent, she said, although the hope is that they will eventually be phased out.

The AMA also supports HCNN and is encouraging physicians to enroll. "This is another route to get the message out to practicing physicians that there may be a significant change in the way medicines are used or that some problem has surfaced in the way devices are used," said Edward L. Langston, MD, then chair of the AMA Board of Trustees.

Other efforts are under way to speed risk communication between the FDA and physicians, noted Dr. Langston. One, which is being conducted by the AMA and about a dozen specialty groups, involves collecting e-mail addresses from members for use by the FDA to convey new data.

Another, MedWatch, which was established by the agency in 1993, plays a similar role. However, MedWatch has not been very popular with physicians. Critics say it inundates participants with information -- much of it irrelevant to their practices. And, despite MedWatch's 15-year life span, only about 90,000 individuals have signed up, an unknown number of whom are physicians.

Why should HCNN expect to do better? For one thing, it will target notifications to the physicians who need them, said Edward Fotsch, MD, the CEO of Medem Inc., a for-profit company founded in 1999 by the AMA and six other medical societies. Medem will operate the network.

MedWatch is a "one-size-fits-all" system, said Dr. Fotsch. The FDA program sends out "tons of stuff," he said, with the risk being that doctors may miss messages that are important to their practices. MedWatch sends one or two or even more notifications each week to all enrollees, he said.

In contrast, HCNN will disseminate the same number of alerts sent by manufacturers, but alerts will be tailored by specialty, so individual doctors will receive about one or two per month, Dr. Fotsch estimates. "For example, a recall of a pacemaker wire wouldn't go to pediatricians."

The network will provide a link to MedWatch, which retains the important function of collecting reports of adverse events. Dr. Dickey hopes that will make it easier for physicians to send a message about a patient's possible reaction to a medication. "If it were easy to click on an icon and send a message to the FDA, the quality of their pharmaceutical evaluations would go up, and we would know a great deal more about medication interactions and reactions than we do now based on minimal responses from a handful of physicians."

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D.C. hospital starts all-inclusive HIV screening

June 16th, 2008 by ceo
Washington -- It's a good thing that Celia Maxwell, MD, assistant vice president for health sciences at Howard University Hospital in Washington, D.C., didn't have a clue about all the obstacles she would need to overcome to implement an HIV screening program throughout the hospital.

Otherwise, she freely admits, when the task fell to her in the fall of 2006, she probably would have run the other way. The hospital's senior vice president had urged her to develop the initiative after the Centers for Disease Control and Prevention issued sweeping guidelines calling for HIV screening of almost everyone in the nation.

Now, thanks to intense planning and some important CDC and city health department aid, Howard's program is up and running. In its first 16 months, about 20,000 people, ages 14 to 84, who arrived at the hospital for emergency or routine care, have been offered the free tests. About 13,000 have agreed to take the 20-minute oral HIV antibody test. So far, about 260 have showed signs of infection.

The hospital's efforts have been praised by D.C.'s HIV/AIDS Administrator Shannon Hader, MD, as well as President and Laura Bush. Mrs. Bush toured the hospital to see the program for herself last year.

Widespread agreement surrounds the importance of screening. The AMA and other medical societies endorse testing in multiple venues. By the end of 2003, an estimated 1 million people in the U.S. were living with HIV or AIDS, according to figures released at a national HIV conference. About a quarter of those infected were unaware of their status, the CDC estimated in 2005.

Catching the infection early means not only that treatment is more effective but also that most people who find they harbor the virus will take steps to guard against infecting others. The latest CDC estimates indicate that at least 40,000 people in the nation become infected each year. By offering the test to everyone, stigma also is largely avoided.

And what better place to implement what is believed to be the nation's first hospital-wide screening program than Howard University Hospital. The facility, which is located on the campus of a historically black college, also serves a largely black population in a city that has the highest AIDS case rate in the United States -- 128.4 cases per 100,000 population compared to 14 cases per 100,000 population in the country as a whole. The black community has been hit hardest by the disease.

Starting from scratch

But where to begin, thought Dr. Maxwell, who also is director of the hospital's Women's Health Institute. "I had no template to work from. This has never been done before so I could not go somewhere and read about it. It was trial and error."

She first had to gain the support of the hospital's division chiefs and chairs who were understandably concerned about the time it would take an already stretched staff to test all patients. And then came little things. The rapid HIV antibody test had to be approved by pathology, and a Clinical Laboratory Improvement Amendments waiver obtained. "I would never have known that," she said.

40,000 people in the U.S. become infected with HIV each year.

She ultimately developed several testing protocols: confidential testing for patients coming to the emergency department and for inpatients; anonymous testing for patients coming to clinics and other outpatient departments. Another anonymous protocol was developed to test hospital employees, whose circumstances presented a dilemma, said Dr. Maxwell, since some of them may not have felt comfortable being tested on site. The city health department helped resolve this issue by parking a medical van on the street where this testing could be done.

But additional hurdles also had to be confronted. The organizers learned the hard way that patients whose initial tests were positive should be given the definitive Western blot test before they left the hospital because they might not return for their follow-up appointment. "We lost about 80 people," Dr. Maxwell said.

That's when the "street team" went into action, visiting neighborhood fast-food restaurants and other venues. About 70 of these missing patients were found.

Patients who are HIV positive are referred immediately to the hospital's Center for Infectious Disease Management and Research, where they receive treatment.

In general, the response from patients has been overwhelmingly positive, a twist that surprised Dr. Maxwell. "My thought was that most patients would decline the test," she said. "But most didn't." Plus, they returned to the hospital with family members and significant others, and some even brought in children for testing. That meant a protocol for adolescents younger than 18 was needed.

Many patients even expressed surprise that their physicians hadn't already tested them for the virus. They say, "You mean I've been coming to the doctor and they've been drawing all this blood but never tested me before?" Dr. Maxwell said.

The District of Columbia has the highest AIDS case rate in the U.S.

She also tailored the program for her particular patients. For example, she decided to tell those whose results on the rapid test indicated exposure to the virus that they were "preliminarily reactive" instead of "positive," since false positive results are not uncommon, and she didn't want to raise unnecessary alarms.

And even though the District of Columbia, unlike many states and localities, doesn't require that people be counseled either pre- or post-test, Dr. Maxwell decided to include counseling. "I wanted patients to be clear that we weren't doing a test without their knowledge. We wanted to give patients a chance to say no."

Although the Howard program has been a trailblazer, the question of sustainability remains. Many insurers don't cover the tests in these settings.

"If I didn't get the [testing] kits from the D.C. Dept. of Health, I could not do it," Dr. Maxwell said. "If I did not get staff that is funded through the CDC, I couldn't do it. There are true barriers."

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