Category Archives: Gastroenterology

Counties Pursue Safer Drug Disposal

New programs to make it easier and safer for San Francisco Bay Area residents to get rid of unused medications are some of the first to try this on a large scale, and may serve as models for other cities and counties.

Since May 2012, a pilot program in San Francisco has allowed residents to drop off old medications at 13 pharmacies and 10 police stations (where controlled substances must be brought). San Francisco supervisors initially considered forcing drug companies to fund the program, and instead agreed to accept $110,000 from Genentech and the Pharmaceutical Research and Manufacturers of America to fund the program.

(Photo by J. Troha, courtesy of National Cancer Institute)

On July 24, supervisors in Alameda County (which includes East Bay cities such as Oakland and Berkeley) are likely to approve a Safe Drug Disposal Ordinance that would require drug companies to pay for disposal of their products or face fines of up to $1,000 per day, The Bay Citizen reports. Public agencies currently fund 25 drug disposal sites there, and the cash-strapped county wants the comparatively wealthy pharmaceutical industry to take more financial responsibility for the lifecycle of its products in order to reduce overdoses, accidental poisonings, and water pollution.

As we reported earlier this year, making prescription-drug “recycling” a cultural norm is one of five emerging public policies that could help the medical system keep opioids available while reducing the risk of addiction, abuse and accidental overdose, according to Keith N. Humphreys, Ph.D. Smaller versions have met with success, such as a drug take-back day organized by sheriffs in a small town in Arkansas (population 20,000) that brought in 25,000 pills, said Dr. Humphreys, acting director of the Center for Health Care Evaluation, Veterans Health Administration, Menlo Park, Calif., and a professor of psychiatry at Stanford University. He reports having no financial conflicts of interest on this issue.

Not everyone is happy with the idea. Trade associations for the pharmaceutical industry and biomedical companies argue that there’s no evidence that these programs will reduce poisonings, and they haven’t ruled out the possibility of suing to block the Alameda County ordinance, The Bay Citizen reports. The compromise that San Francisco reached for voluntary instead of mandatory funding from the pharmaceutical industry may be a middle ground.

In an era when government agencies have less and less money for public programs, it’s probably inevitable that they’ll pursue alternative financing for programs like this.

If your community has a drug disposal program, let us know how it’s working. Will these programs succeed, and will they reduce abuse, addiction, and accidental overdoses? We’ll keep an eye on this topic, and keep you posted.

–Sherry Boschert (@sherryboschert 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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New Anti-Inflammatory Drugs Will End Anti-TNF Dominance

Tumor necrosis factor inhibitor drugs began to dominate treatment of inflammatory diseases like rheumatoid arthritis, psoriasis, and the inflammatory bowel diseases ulcerative colitis and Crohn’s disease a little over a decade again. Now, the time when the importance of the anti-TNFs will wane and newer drugs will take their place is clearly visible on the horizon. It hasn’t happened yet, but the era of anti-TNF dominance for treating inflammatory diseases that persisted throughout the 2000s will end in the next 5 years.

The anti-TNF era began in 1998 with the approval of etanercept (Enbrel) for rheumatoid arthritis and infliximab (Remicade) to treat Crohn’s disease. In subsequent years, the list of approved anti-TNFs expanded to include adalimumab (Humira), golimumab (Simponi), and certolizumab (Cimzia), and the approved indications grew to include many inflammatory disease of joints, the GI tract, and skin. The anti-TNFs revolutionized inflammatory disease treatment and made treatment to remission possible for many patients.

tumor necrosis factor (green, purple, black) and TNF receptors (blue)/courtesy Bassil Dahiyat; Science

But reports from just the past month show that new agents are overtaking the anti-TNFs.

In May, I reported from Digestive Disease Week on phase III trial results with vedolizumab, which was compared against placebo for patients with ulcerative colitis. One of the study investigators noted that vedolizumab beat the placebo arm for steroid-free clinical remission by 30 percentage points. “Nothing else is that good,” Dr. William Sandborn, professor of medicine and chief of gastroenterology at the University of California, San Diego, told me, and the benchmark he had in mind was the performance of the anti-TNFs in similar patients.

More recently, at the European Congress of Rheumatology earlier this month I heard a report on a head-to-head comparison of the anti-IL-6 drug tocilizumab (Actemra) and the anti-TNF adalimumab in patients with rheumatoid arthritis. After 24 weeks of monotherapy, patients on tocilizumab had nearly a fourfold higher remission rate than patients on adalimumab. Though the monotherapy trial design did not mimic the way most rheumatoid arthritis patients get treated, the new drug tocilizumab absolutely blew adalimumab out of the water in a rare head-to-head comparison among different classes of anti-inflammatory drugs.

And at the same meeting several talks highlighted another new anti-inflammatory class of agents coming soon to the U.S. market, the Janus kinase (JAK) inhibitors, such as tofacitinib, which is expected to received FDA approval later this summer. Phase III results show that tofacitinib has safety and efficacy that seems at least comparable to anti-TNF drugs, with the advantage of oral dosing.

Vedolizumab, tocilizumab, and tofacitinib are just the tip of new waves of anti-inflammatory drugs that will soon substantially alter a landscape that the anti-TNFs have mostly had to themselves for the past 14 years. For the moment, the anti-TNFs have the advantage of a longer track record for safety, but changing that is only a matter of time.

—Mitchel Zoler (on Twitter “mitchelzoler)

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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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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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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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