Category Archives: Epidemiology

Can HPV Vaccination Be Simplified?

The human papillomavirus vaccine was recommended for routine use in 11-12 year old girls in 2007. But by 2010, the most recent year for which data are available, less than half had received one dose of the three-dose series and fewer than a third had received all three. The inconvenience of the need for three separate office visits along with the vaccine’s price – about $130 per Gardasil dose, as of July 2011 – have certainly contributed to the low uptake.

©BVDC/Fotolia.com

Now, some parts of the world – including Mexico, Switzerland, and parts of Canada have moved to either a two-dose schedule, or a so-called “extended dose” schedule, in which the third dose is delayed until 5 years after the second one. (In the current U.S. three-dose schedule, doses two and three are given at 2 and 6 months, respectively, after dose one.)

“There has been emerging interest in HPV vaccine schedules with fewer than three doses, for a variety of reasons. These schedules could facilitate implementation, they may be more convenient for providers, parents, and vaccinees, and of course they would be cost-saving,” said Dr. Lauri Markowitz, of the Centers for Disease Control and Prevention, at a recent meeting of the CDC’s Advisory Committee on Immunization Practices.

No data on the efficacy of fewer than three doses have been published by either Merck or GlaxoSmithKline from their pivotal trials of Gardasil and Cervarix, respectively. But some other data are available for both vaccines. A nonrandomized study in Costa Rica that included more than 1,100 women who had received just one or two doses of Cervarix suggested that two doses or maybe even just one – could be as protective as three doses against infection at 4 years.

And in an as-yet unpublished study done in Canada, immune responses against both HPV 16 and 18 at 3 years were similar between two doses of Gardasil given at age 9-13 years and three doses given at age 16-26 years. But, there are limited efficacy data and no long-term data, Dr. Markowitz said.

Electron micrograph of human papillomavirus (HPV) / Courtesy of the National Cancer Institute

In an e-mail, Deb Wambold of Merck Vaccines said that, while the company does support studies of alternative dosing schedules for HPV vaccination including two-dose regimens, so far those studies are “interesting preliminary explorations in select subpopulations of vaccinees,” and “It is important to note that there are no data on the clinical efficacy or durability of effectiveness with two doses of either of the HPV vaccines, as we have for the recommended three-dose vaccination regimen.”

Dr. Joseph A. Bocchini Jr., who chairs the ACIP HPV vaccine working group, concurred. In an interview at the ACIP meeting, he noted that the long-term efficacy of two doses is “worth looking at,” as is the varying of three-dose schedules. “But, at this point, there are too few data to apply this to recommendations in the United States.”

More data from ongoing trials will be available in the next few years, Dr. Markowitz said.

-Miriam E. Tucker (@MiriamETucker on Twitter)

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“Turning the Tide” on HIV/AIDS

In advance of the upcoming XIX International AIDS Conference, the International AIDS Society and the University of California, San Francisco, have issued the “Washington D.C. Declaration,” a nine-point action plan aimed at broadening global support for “Turning the Tide” of the AIDS epidemic.

Everyone is urged to sign the Declaration.

It calls for:

1) An increase in targeted new investments;
2) Evidence-based HIV prevention, treatment, and care in accord with the human rights of those at greatest risk and in greatest need;
3) An end to stigma, discrimination, legal sanctions, and human rights abuses against those living with and at risk for HIV;
4) Marked increases in HIV testing, counseling, and linkages to services;
5) Treatment for all pregnant and nursing women living with HIV and an end to perinatal transmission;
6) Expanded access to antiretroviral treatment for all in need;
7) Identification, diagnosis, and treatment of tuberculosis;
8) Accelerated research on new tools for HIV prevention, treatment, vaccines, and a cure;
9) Mobilization and meaningful involvement of affected communities.

Turning the Tide is the theme of this year’s biennial conference, which will take place July 22-27 in Washington.  It is expected to draw 25,000 attendees, including HIV professionals, activists, politicians, and celebrities. Sir Elton John will open the conference and Bill Clinton will close it. A large delegation of U.S. members of Congress will participate, and Bill Gates will moderate a session. An enormous “Global Village” outside the D.C. Convention Center will be open to the public. “If you haven’t been, it’s a conference like no other,” conference cochair Dr. Diane V. Havlir said at a press briefing.

The recent optimism regarding HIV/AIDS stems from major advances in knowledge regarding prevention of partner transmission with early patient treatment, pre-exposure prophylaxis, and male circumcision as HIV infection prevention (new data will be released at the meeting), all of which are viewed as breakthroughs  in the fight against HIV/AIDS. “So we have now in our hands the tools. The question is how do we combine those tools together, and how do we roll them out,” said Dr. Havlir, professor of medicine at the University of California, San Francisco, and chief of the HIV/AIDS division at San Francisco General Hospital.

Dr. Diane V. Havlir / Photo by Miriam E. Tucker

Monday’s plenary session will include an address from Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, on “Ending the HIV Epidemic: From Scientific Advances to Public Health Implementation.” Other plenary topics during the week will include viral eradication, vaccines, TB and HIV, and HIV/AIDS in specific populations including minorities, women, youth, and men who have sex with men. On Friday, there will be a plenary talk that may be of particular interest to the primary care community, “The Intersection of Noncommunicable Diseases and Aging in HIV.”

Plenaries and other conference sessions will be webcast at http://globalhealth.kff.org/aids2012.

-Miriam E. Tucker (@MiriamETucker on Twitter)

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The U.S. Obesity Epidemic and Surging Liver Cancer

If there is one truism that trumps everything else these days about U.S. health, it’s that America is a chubby country that keeps getting fatter.

The consequences seep into every corner of the nation’s medical state, including the surprising fact that obesity and the type 2 diabetes it causes are likely pushing up the incidence of liver cancer—hepatocellular carcinoma—to unprecedented heights.

courtesy Wikimedia Commons

When I covered Digestive Disease Week in San Diego recently, one of the biggest stories I heard was that U.S. liver-cancer rates tripled from 1975-2007, and that the numbers continued to rise from the mid to the late 2000s. (My full report on this is here).

Granted, factors other than just obesity play into the liver cancer surge, notably the sizable number of Americans infected with either hepatitis B or C virus, and the fact that as they age their risk for developing hepatocellular carcinoma rises.

But new U.S. infections by hepatitis B and C are largely under control these days (although people infected elsewhere continue to emigrate to the United States). The part of the booming liver-cancer story that is by no means under control is the obesity part.

Every time I see a new CDC map for U.S. obesity prevalence, the colors on it keep getting redder and darker (the CDC’s code for higher prevalence rates).

courtesy CDC

courtesy CDC

Earlier this year, the CDC reported a 36% obesity prevalence rate for the entire U.S. population–and still on the rise–and just a few weeks ago we heard that obesity among children and adolescents had hit a new high of 17%. With obesity seemingly on an unchanging upward trajectory, one can only wonder what rates of liver cancer it might produce in the future. Obesity carries a special relationship with the liver, and it’s not pretty. Just consider any goose headed to a foie-gras future.

Until now, the evidence linking obesity and liver cancer, and type 2 diabetes and liver cancer has been epidemiologic. Compelling, but just an association. At DDW, a new study provided more observational data on the diabetes-liver cancer link, and while still circumstantial it further supports the notion and also carries an intriguing punchline.

The study, done in Taiwan, examined 97,000 hepatocellular carcinoma patients and 195,000 matched controls. The analysis showed that people with diabetes had a two-fold increased risk for liver cancer compared with those without diabetes. Even more striking, the analysis also showed that people with diabetes treated with the oral hypoglycemic drug metformin had their risk for liver cancer cut in half compared with those not on metformin, and those with diabetes treated with a glitazone drug (such as pioglitazone–Actos) had their risk cut nearly in half.

The best solution would be if people avoided obesity and type 2 diabetes all together. Both conditions cause a lot of medical problems, and this new evidence indicates more strongly than ever before that liver cancer is one of them.

—Mitchel Zoler (on Twitter @mitchelzoler)

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Adolescent Misuse of Prescription Pain Medicine Starts Early

In stark contrast to most research that suggests senior year in high school or later is the peak time for misuse of prescription pain relievers, it is younger 16-year-olds who are the mostly likely to report their first use of these agents outside their intended prescription within the previous year, a new study finds.

Courtesy Wikimedia Creative Commons/Kandy Talbot

The time for physicians to identify risk and intervene is the young to middle teenage years, Elizabeth A. Meier, Ph.D., and her associates at Michigan State University in East Lansing reported.

“With peak risk at age 16 years and a notable acceleration in risk between ages 13 and 14 years, any strict focus on college students or 12th graders might be an example of too little too late in the clinical practice sector and in public health work,” they wrote in the Archives of Pediatrics & Adolescent Medicine, published online May 7, 2012.

“We suspect that many physicians, other prescribing clinicians, and public health professionals will share our surprise that for youth in the United States, the peak risk of starting extramedical use of prescription pain relievers occurs before the final year of high school [and] not during the post-secondary school years,” the authors wrote.

Another reason to screen your young adolescent patients is the risk of hazardous consequences associated with prescription pain misuse, which is greatest during early adolescence, Dr. Meier and her colleagues noted.

They assessed self-reported extramedical prescription pain reliever use among 119,877 U.S. teens and young adults (ages 12-21 years) using 2004-2008 data from the National Survey on Drug Use and Health (NSDUH).

They calculated the highest risk estimate, 2.8%, at 16 years of age. This is an increase from 0.5% at 12 years; 0.7% at 13 years; 1.6% at 14 years; and 2.2% at 15 years. After the peak in mid-adolescence, risk dropped steadily by 0.3% or 0.4% each year, down to 1.1% among 21-year-olds.

Reliance on self-reported misuse of prescription pain killers is a limitation of the study. A strong point of the research, however, was including adolescents and young adults regardless of whether they were still in school.

Earlier and stronger school-based prevention and outreach programs are warranted, according to the researchers. There also is a distinct role and reason for pediatricians, dentists, and other clinicians to work toward misuse prevention in their practices, they added: roughly 15% of the youths surveyed were not in school during the peak time of risk.

–Damian McNamara

@MedReporter 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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Seeking Global Accord on Allergy

Four major professional allergy organizations have launched a new effort to raise worldwide awareness of allergic diseases.

The International Collaboration on Asthma, Allergy, and Immunology (iCAALL) is a project of the American Academy of Allergy, Asthma & Immunology (AAAAI), the American College of Allergy, Asthma & Immunology (ACAAI), the European Academy of Allergy and Clinical Immunology (EAACI), and the World Allergy Organization (WAO). The leaders of each group announced the new initiative at a press briefing held during the AAAAI’s annual meeting in Orlando. An editorial introducing the initiative is online and will be published in the April issue of the Journalof Allergy and Clinical Immunology.

“The world has experienced a tremendous increase in the prevalence of allergic diseases and asthma over the last 50 years,” EAACI president Dr. Cezmi Akdis said, noting that asthma currently affects 8%-12% of the developed world, and allergic rhinitis, approximately 20%-25%. Asthma care costs more than 20 billion Euros today and is expected to jump to 200 billion Euros in 2050. Yet, current research funding is only about 2%-3% of that devoted to diseases such as cancer and HIV/AIDS.

“We need better treatments and tailored care. We need more and more research … I am confident that iCAALL will result in a greater awareness about allergies, asthma, and immunologic diseases all around the world, resulting in prevention, cure, and better patient care, which is only possible by increased allocation of resources for research,” Dr. Akdis said.

According to WAO president Dr. Ruby Pawankar, “Allergies and asthma are no longer diseases of just the developed world … It’s a huge problem in the industrializing and the developing world.” She pointed out that allergic disease has been absent from the recent World Health Organization/United Nations focus on noncommunicable diseases (NCDs), highlighted by a high-level meeting last September.

“The WHO and UN have made efforts toward giving more attention to NCDs. However, the area of allergy and asthma and clinical immunologic diseases needs to get to the stage to be represented at the WHO and UN.” To that end, WAO has issued a White Book on allergic disease with reports from 62 member countries, Dr. Pawankar said.

Dr. Wesley Burks described the iCAALL centerpiece initiative, a series of International Consensus (ICON) reports. The first ICON, on food allergy, is already online. It includes breastfeeding in the first 4-6 months as a key recommendation for reducing the risk for allergic disease. Food allergy is rising worldwide; in China, for example, food allergy has almost doubled from 3.9% 10 years ago to 7.7% today. “In a country thought not to have a lot of food allergy, that’s a significant change,” said Dr. Burks, president-elect of AAAAI.

Dr. Stanley Fineman, ACAAI president, outlined the plans for dissemination of upcoming ICONs: One on pediatric asthma is to be released at the EAACI Congress  in June in Geneva; the next, on angioedema, at the ACAAI meeting in November in Anaheim, Calif.; and then one on eosinophilic disorders at the WAO’s International Scientific Conference in December in Hyderabad, India.

Dr. Dennis K. Ledford, outgoing AAAAI president and iCAALL chair, said that other initiatives will incorporate additional means for disseminating research and increasing support for research. “It’s an evolving collaborative, happening as we speak.”

-Miriam E. Tucker (@MiriamETucker on Twitter)

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BP to Pay Spill-Related Health Claims

Gulf Coast residents who may have been made sick — or who may become sick in the future — as a result of the April 2010 Deepwater Horizon oil spill may now be able to make a claim against BP. The oil giant announced on March 2 that it had reached an agreement in principle for a settlement with the attorneys representing the thousands of plaintiffs in the massive case.

Overall, the company says it will make almost $8 billion available — about $5 billion will go toward health claims.

Photo by Alicia Ault/IMNG Medical Media

In a sense, it is opportunity No. 2 for the fisherman, shrimpers, restaurant and hotel owners, and hundreds of thousands of others who make their living or just live in the areas affected by the spill. BP had already set aside $20 billion — in June 2010 — to pay mostly economic damage and other direct economic claims.

At that time, there was an outcry about the lack of any dedicated funds to cover mental health issues or physical illnesses that might arise out of the oil spill. I blogged about that here, in an earlier post.

In the almost 2 years since the disaster, BP says it has paid “approximately $6.1 billion to resolve more than 220,000 claims from individuals and businesses” through the trust fund, known as the Gulf Coast Claims Facility. It has been administered by Kenneth Feinberg, not coincidentally, the man who also oversaw the claims process for the Sept. 11 Victim Compensation Fund.

According to lengthy article in the New Orleans Times-Picayune on the proposed settlement, Mr. Heisenberg is now stepping down and another special master will take over administration of the Trust Fund.

The proposed settlement — which will come out of the $20 billion Trust Fund — has one agreement to address economic loss claims and another for medical claims. For those who have a qualifying medical claim, there is essentially a 21-year statute of limitations. It’s likely taking into account that some conditions — such as cancer — may take that long to show up in clean-up workers or others exposed to either the oil or the chemicals used to mitigate the disaster.

BP is also making $105 million available “to improve the availability, scope, and quality of health care in Gulf communities.” The money will cover an expansion of primary care, mental health services, and access to environmental health specialists, according to the company.

If the agreement in principle goes into effect, the plaintiffs who eventually get paid will release BP from future liability claims.

Alicia Ault

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