Category Archives: Pulmonary Diseases and Sleep Medicine

Have You Had Your Pertussis Vaccine?

As the North Pacific Pediatric Society’s annual meeting got underway recently, organizers invited Dr. Maxine Hayes of the Washington State Department of Health to the podium to deliver a special – and urgent – message.

Dr. Maxine Hayes (Sherry Boschert/IMNG Medical Media)

Her plea to pediatricians: Make sure that you, all of your staff, and your patients have been immunized against pertussis. Not only was the Society meeting during National Infant Immunization Week, but Washington State had just recorded its 1,000th case of pertussis in 2012, with 61% of cases in school-age children, she reported.

“It’s the worst we’ve seen in six decades,” Dr. Hayes said. “If infections continue at this rate, we’ll have more than 3,000 cases by the end of the year.”

Washington State had 1,008 reported cases of pertussis by April 21, 2012 – nearly 10 times more than the 110 cases reported during the same period in 2011, according to the U.S. Centers for Disease Control and Prevention. There are more pertussis cases in the state already for 2012 than there were in all of 2011 (965 cases) or all of 2010 (608 cases).

The Washington epidemic follows on the heals of a 2010 outbreak of 9,143 cases in California – the most in 63 years – that killed at least 10 infants.

My colleagues at IMNG Medical Media have been following the story, with multiple reports. The California epidemic probably was due to the waning immunity of the tetanus-diphtheria-acellular pertussis (Tdap) vaccine. Tdap vaccine is recommended for all health care workers.

And it’s not just for kids, health care workers, and medical office staff. If you’re a physician who treats adults, you should know that older adults need the Tdap vaccine too. Even pregnant women should be vaccinated.

When Dr. Michael E. Pichichero randomly asked 10 pediatricians if they’d had the Tdap vaccine, 8 of them said no, with some pretty weak excuses, if you ask me.

“I know that there are people in this room who have not had their Tdaps,” Dr. Hayes said with an accusing smile. “I also know that in busy practices, you have people in and out every day that have not had their Tdap. I’m calling on you to really get on it.” Make sure that your emergency rooms have Tdap in stock, too, she added.

“And if you’re not in Washington, don’t be smug about this, because you could be next,” Dr. Hayes said. Her public health colleagues in Oregon State are taking this so seriously that they’re planning to open pertussis booster clinics, she noted.

–Sherry Boschert (@sherryboschert on Twitter)

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Will the UK Win Gold in Public Health Preparedness?

In all likelihood, there will be no large-scale public health crises during the London 2012 Olympics. But Dr. Brian McCloskey has to prepare, just in case. That’s his job as the London director of the UK’s Health Protection Agency (HPA), the UK-government-funded yet independent public body charged since 2004 with protecting the health of the country’s population from all threats, including those from infectious disease, chemicals, violence, and anything else that may arise. The HPA also collaborates with the World Health Organization on “emergency preparedness for Mass Gatherings and High Consequence, High Visibility events,” Dr. McCloskey explained at the 22nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), sponsored by the European Society of Clinical Microbiology and Infectious Diseases.

Dr. Brian McCloskey/Photo by Miriam E. Tucker

“Mass gatherings” are nothing new for London, which has routinely hosted large music and sporting events against a backdrop of ongoing terrorist threats. However, the Olympics represents one of the largest public health challenges yet, in terms of sheer scale and international media scrutiny, noted Dr. McCloskey, who has been with HPA since its inception and was director of public health with the U.K.’s National Health Service for 14 years prior to that.

The Olympics officially begins July 27 and ends 12 Aug. 12, followed by the Paralympics 29 Aug. 29 to Sept 9. In addition, London will also host the Olympic torch relay, Queen Elizabeth’s Diamond Jubilee beginning in May, Wimbledon in June, possibly the largest-ever gay pride festival in late June-early July, and the Notting Hill Carnival in August. “In other words, there will be one long party in London from May through September,” he commented.

In all, the Olympics will comprise 26 sports in 34 venues, with 10,500 athletes, 17,000 people living in the Olympic Village, 21,000 media and broadcasters, and approximately 180,000 spectators per day in the Olympic Park. The challenge, he said, is to plan to respond to anything that can happen without disrupting life for Londoners.

Dr. McCloskey and his colleagues have been studying experiences at previous Olympics, as well as published literature on mass gatherings such as the yearly Islamic pilgrimage, or “Hajj,” to Mecca. Indeed, “mass gatherings” is an emerging area of medicine that was explored in depth earlier this year in a series of six articles in The Lancet. There is also a WHO advisory group on mass gatherings, and even a specialty curriculum being developed, he said in an interview.

Judging by previous experience, “The most likely thing to happen is nothing at all. Most Olympic Games go off without any problems, with only minor impact on the public health service and on public health. But, we do need to think about all the things that could happen.”

Mass gatherings have been associated with both food/waterborne and airborne/respiratory infectious diseases. Yet, less than 1% of healthcare visits in Sydney during the 2000 Olympics were for infectious diseases. In the 2006 winter Olympics in Torino, Italy, surveillance for acute gastroenteritis, flulike illness, measles, and other health-related events turned up nothing unusual as compared with non-Olympics time periods.

London Underground Billboard/Photo by Miriam E. Tucker

During the 2012 Olympics, the HPA will deliver a “Situation Report” each morning to Olympics organizers, describing the state of public health in England and highlighting any potential issues. Managing rumors will also be important, he noted.

Laboratory surveillance, clinical case reporting, and syndromic surveillance—based on patient complaints—will all be enhanced during the Games, with the help of primary care providers and hospitals around the U.K. Any triggers will be followed up, with a much lower threshold and greater speed than usual. In fact, most of these surveillance systems have been in place for at least a year now. “So we’re feeling very comfortable,” Dr. McCloskey said.

And these measures will last beyond the Games. “We will have at least two new surveillance systems in the U.K. as a legacy afterwards…What you get is improved public health systems but also better recognition of the importance of public health and better working relationships…Every country I’ve talked to who’s hosted the Games says we can expect that legacy. Provided nothing goes wrong. But of course, it’s not going to go wrong, it’s all in place, so come and enjoy it.”

–Miriam E. Tucker (@MiriamETucker on Twitter)

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Should Physicians Prescribe Positivity?

Scott Jordan Harris  is a U.K.-based blogger, editor, book author, movie critic, and sports writer. Remarkable, considering that he spends most of his time in bed. His primary diagnosis is myalgic encephalomyelitis (ME), also known as chronic fatigue syndrome.

In a piece he wrote last week for the BBC’s website, Mr. Harris said that keeping a diary in which he focuses on the positive aspects of his life — at the suggestion of a doctor – keeps him “sane.”

©froglegs/Fotolia.com

“My depression told me my existence was filthy and barren…. After a few months of storing up the previously unrecorded richness of my life, my diary simply disproved that. I knew from re-reading the pages I’d written that I was doing interesting things — and I began to ensure I kept doing them simply to have something to write about. The diary was better than therapy; it pushed me forward through mental pain that had been holding me back.”

He added, “Doctors unaware of the realities of the lives of the chronically ill often suggest we waste what little energy we have noting down exactly how unwell we feel each day, how much we sleep and how little we do, so that they may study the results. These doctors are to be smiled at, and nodded to, and instantly ignored.”

So should physicians advise patients with chronic conditions to keep positive diaries?  I asked two experts.  Dr. Daniel Clauw, a rheumatologist who directs the University of Michigan’s Chronic Pain and Fatigue Research Center, referred me to his associate, Afton Hassett, Psy.D.

“That was a compelling story in the BBC and it actually does reflect my clinical and research experience as a pain psychologist,” Dr. Hassett told me.

Negative and positive affect (emotions) have been well-studied  in health in general and chronic and acute pain states in particular. There are numerous studies suggesting that positive affect plays an important role in pain outcomes. While few formal studies have evaluated the effectiveness of the exact intervention Mr. Harris described, there are studies   supporting the efficacy of similar positive psychology interventions for depression, Dr. Hassett said.

“Enhancing positive affect is likely a good thing for one’s mental and physical health. Sometimes just keeping a gratitude journal like the BBC article writer noted is all it takes. I always tell people to write down three different things each day for which you are grateful. After the first week or so you really start looking for the small wonders in your life: a great cup of coffee, a kind gesture from a complete stranger, the first tiny yellow flowers of spring.”

Courtesy Wikimedia Commons/4028mdk09/Creative Commons License

But Dr. David Spiegel, a psychiatrist who heads the Stanford University Center on Stress and Health, urges caution regarding positive psychology.   “I think the drumbeat for upbeat can be a little overwhelming… I agree with [Mr. Harris] that just focusing on how bad you feel you can dig yourself into a pit, but at the same time you can’t deny your feelings. The worst thing you can do to a depressed person is to tell them to cheer up.”

However, Dr. Spiegel, who works with breast cancer patients, noted that “you can help them by saying let’s give dimension to what’s bothering you, but also put that in perspective, and see other things that are good, that are positive. So it’s not one or the other…Happiness is not the absence of sadness.”

Dr. Spiegel said that advising patients with chronic conditions to keep a diary in general is an “interesting idea,” and that there is a literature base  for the medical benefits of journaling.

He advised that physicians suggest to their patients, “See if it helps you to have a daily journal of your journey through this illness, what your problems were and what your little victories were, and what you did that helped you deal with it and get beyond it.”

—Miriam E. Tucker (@MiriamETucker on Twitter)

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New Questions on Lung Cancer Screening

Would you allow patients to self-refer for a CT lung cancer screening? Would you screen a never-smoker? What size nodule would trigger a follow-up exam? What is your lower age limit and lower pack-year limit for screening?

These are just a few of the questions tackled during an interactive lung cancer screening session at the recent Radiological Society of North America meeting, and that highlight the uncharted waters physicians face in the wake of the pivotal National Lung Screening Trial.

The NLST demonstrated a 20% reduction in lung cancer mortality when low-dose CT screening was used, compared to chest X-ray, among 53,000 asymptomatic current or former heavy smokers. However, CT produced more than three times the number of positive results and a higher false-positive rate than radiography.

Without a clear plan to manage abnormal findings or a firm handle on cost, policymakers and payors are hesitant to back reimbursement for widespread lung cancer screening. Results of the ongoing NLST cost-effectiveness analysis are expected early next year. Based on already published data, however, a crude back-of-the-envelope estimate puts the incremental cost-effectiveness ratio at $38,000 per life-year gained, NLST investigator Dr. William Black told attendees.

“That actually is a pretty good deal compared to a lot of things we do in medicine, and in fact most people would put the threshold for acceptability somewhere between $50,000 to $100,000 per life-year gained,” he said. “So it certainly is feasible”

Dr. Black pointed out that low-dose CT saved one lung cancer death per 346 persons screened in NLST, which again is very favorable compared to the rate of 1 per 2,000 patients for mammography.

Although the session provided just a small snapshot in time, audience responses suggest there is much work ahead. A full 77% of attendees were not using low-dose CT to screen for lung cancer and 72% reported not being familiar with the recently published National Comprehensive Cancer Network guidelines for lung cancer screening.

One-quarter of the audience had no lower age limit for screening, and 34% said they did not provide either decision support or obtain informed consent.

Dr. Caroline Chiles. Image by Patrice Wendling/Elsevier Global Medical News

Radiologist and NLST collaborator Dr. Caroline Chiles said informed consent in NLST helped prepare patients for the potential risks of a screen, the likelihood of a positive result and that a positive result didn’t mean they had lung cancer.

“It made a huge difference once they got that letter saying they had a positive screen, because at that point you don’t want everyone rushing out to a surgeon to get that nodule resected,” she added.

What attendees and panelists could agree on is the need for smoking cessation to be included in any future lung cancer CT screening program, with 60% of attendees saying they already do so.

Dr. Chiles pointed out that 16.6% of participants in the NELSON lung screening trial quit smoking compared with 3%-7% in the general public, but that participants were less likely to stay non-smokers. She also cited a recent MMWR that found 70% of adult smokers want to quit smoking, but only about half had been advised by a health professional to quit.

“We really have to think of lung cancer screening as being a teachable moment,” she said.

She suggested physicians visit www.smokefree.gov for help in guiding their patients. Dr. Black also noted that the NLST team is working on a lung cancer screening fact sheet for physicians and patients that will be ready in a few weeks and made available on the Internet.

—Patrice Wendling

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Step Aside, Pink

Courtesy Wikimedia Commons/Jason Meredith/Creative Commons

Raise your hand if you’ve never seen a pink ribbon or don’t know what it means.

No one?

The tremendous success of the pink ribbon breast cancer awareness campaign is a great fundraising and awareness lesson for any charitable organization.  There are no clear numbers on research funds raised by pink ribbons, in part because there are so many sources for pink ribbon items. Still, those ribbons and the public awareness they’ve raised have made a huge difference in breast cancer research and survival. For example, the 5-year breast cancer relative survival rate in 1975-1977 was 75%. In the most recent data from the American Cancer Society’s Cancer Statistics 2011 (table 12), the 5-year breast cancer relative survival rate in 1999-2006 was 90%.

According to the NCI Snapshot of Breast Cancer: “In the United States, breast cancer is the most common non-skin cancer and the second-leading cause of cancer-related death in women. Each year, a small number of men are also diagnosed with or die from breast cancer. Although the rate of diagnosis of breast cancer increased in the 1990s, it has decreased since 2000, and the overall breast cancer death rate has dropped steadily.” In 2008, the incidence rate for breast cancer in white women and African American women is just a tad less than 130 breast cancers per 100,000 women in each group.

The point is this: we’re had incredible success in raising money, awareness and survival for breast cancer. Maybe it’s time to put the same effort into defeating other cancers.

For example, the 5-year relative survival rate for lung/bronchus cancer — represented by a white ribbon, by the way — in 1975-1977 was 13%; in 1999-2006 that rate had increased only to 16%.  Worse still: the 5-year relative survival rate for pancreatic cancer (purple ribbon)  in 1975-1977 was 3%; in 1999-2006 that rate was 6%.

According to the NCI Snapshot of Lung Cancer, lung cancer is the second most common cancer and is the primary cause of cancer-related death in both men and women in the United States. The overall mortality rate for lung and bronchus cancers rose steadily through the 1980s and peaked around 1993. Mortality rates are highest among African-American males, followed by white males.

The button I wear to support my dad's battle against lung cancer. Kerri Wachter/Elsevier Global Medical News

In 2008, the incidence rate of lung cancer among African American men was roughly 100 per 100,000 men; for white men the rate was about 70 per 100,000 men.  Remember though that the 5-year relative lung cancer survival rate in 2006 was estimated at 16%.  That’s a lot of people dying…and that’s just lung cancer. By the way November is the awareness month for lung cancer and stomach cancer (periwinkle ribbon).

The point is, maybe it’s time that the White Ribbon (or purple or gray or … ) became the new Pink Ribbon.
Kerri Wachter

Special thanks to David Sampson, director of medical & scientific communications for the American Cancer Society, for his help with data.

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Approved or not Approved? That is a Good Question.

In a move last month that apparently took at least two device manufacturers completely by surprise, one center of the Food and Drug Administration recommended against an intended use of their products, despite the products’ approval and licensure by another FDA center.

PharmaJet's Stratis is used to vaccinate a Cambodian child against measles. Photo courtesy of Heather Potters.

Recent jet injector models, including Bioject’s ZetaJet and Biojector 2000 and PharmaJet’s Stratis, were approved and licensed by the FDA’s Center for Devices and Radiological Health (CDRH) as needle-free alternatives for injecting vaccines and injectable medications. Both companies had been marketing their devices for influenza immunization in the current flu season.

On October 26th, the FDA’s Center for Biologics Evaluation and Research (CBER) issued a notice  advising healthcare professionals that inactivated influenza vaccines should be administered only with a sterile needle and syringe. The reason: “Safety and effectiveness information that would support labeling inactivated influenza vaccines for delivery by jet injector have not been submitted to FDA.” However, CBER said, individuals who have already received a flu vaccine with a jet injector do not need to be revaccinated.

Currently, only the measles-mumps-rubella vaccine is approved and specifically labeled for administration by jet injector.

So what’s the concern with influenza vaccine? “A jet injector subjects the vaccine to a different pressure than it would receive during administration by sterile needle and syringe and as a result the effectiveness and the safety profile of the injected vaccine may be altered,” according to the CBER document.

Evidently this information had not been previously communicated to the manufacturers. “We were provided no notice by FDA of any concerns about Jet Injectors or FDA’s statement. To our knowledge, no other needle-free injection manufacturer received notice or an opportunity to discuss this matter with FDA,” PharmaJet said in a statement.

Bioject’s President and CEO Ralph Makar was similarly taken aback by the FDA notice. “The FDA communication on the use of jet injectors with influenza vaccines was surprising given that Bioject’s Needle-Free Injection Devices…are both FDA 510(k) cleared with indications for use that describe their use in delivery of subcutaneous or intramuscular injections of vaccines and other injectable drugs,” he said in a statement.

In a public comment at the October meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, PharmaJet Inc’s chairman Heather Potters said, “Last year we scaled up to provide several hundred thousand syringes, and this season we were expecting to sell several million. Now, our domestic sales have virtually stopped, except for [investigational trials].”

The companies are expected to meet with the FDA in early January to work this out. According to Mr. Makar, “We are looking into the matter to better understand the situation and the FDA’s concerns. A number of Bioject’s Needle-Free Injection devices have been on the market for many years and we are committed to resolving this matter with the FDA in a timely manner.”

-Miriam E. Tucker (@MiriamETucker on Twitter)

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A Win For Big Tobacco

A federal judge has just handed the tobacco industry one of its more salient victories in recent years, having decided that the Food and Drug Administration’s plan to require graphic warnings on cigarette packs violated the manufacturers’ right to free speech.

Image of proposed warning courtesy the Food and Drug Adminstration

Richard J. Leon of the U.S. District Court for the District of Columbia issued an order that prohibits the FDA from moving ahead until at least 15 months after he has rendered a final decision.

It’s a firm rebuke to the agency, which had trumpeted the warnings as a crucial means of dissuading Americans from smoking.  In June, the FDA shared nine cigarette package prototypes and issued a final rule that ordered manufacturers to comply with the new packaging by Sept. 2012.

A few months later, R.J. Reynolds Tobacco Co., Lorillard Tobacco Co., Commonwealth Brands, Liggett Group, and Santa Fe Natural Tobacco Co. sued the agency. And it’s not just big tobacco that is fighting the regulation. Tobacco marketing is big business.

Not surprisingly, the Association of National Advertisers and the American Advertising Federation filed a friend of the court brief in September.  The brief excoriated the government for overreaching.  And, the advertising groups likened the effort to a thinly-veiled propaganda attempt.

“If the government can deputize tobacco companies through their product packaging and advertisements to deliver its message, there is no reason it could not do so for other things — and history shows it will not hesitate to do so,” said the brief.

Judge Leon was persuaded, at least in some way, to weigh these First Amendment arguments. According to the New York Times, in his 29-page opinion (which has not been made available online yet), he lambasted the government’s “obvious anti-smoking agenda!”

But activists and others who fought for many years to find a way to regulate tobacco expressed dismay over his stay.

Rep. Henry Waxman (D-Calif.) called the Judge’s ruling “extremely regrettable.” He says that Congress already worked out all the First Amendment issues “to ensure the FDA could act as it has proposed….”

Sen. Tom Harkin (D-Iowa), who in 1998 introduced the first bill to give FDA the power to regulate tobacco products, said that graphic warnings were necessary. “This decision must be appealed so that implementation of the warning label requirement can go forward without delay,” he said, in a statement.

In January, a U.S. District Court Judge in Kentucky upheld FDA’s authority to require warnings in a similar lawsuit. That case is now on appeal.

It may now be years before the legal wrangling is settled.

—Alicia Ault (on Twitter @aliciaault)

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