Franck Robichon/European Pressphoto Agency
Train passengers in Tokyo on Monday. Japan was rushing to contain a widening outbreak of swine flu.
By HIROKO TABUCHI and DONALD G. McNEIL Jr.
The New York Times, May 18, 2009, TOKYO – Japan rushed to contain a widening outbreak of swine flu on Monday, as global health ministers met in Geneva to discuss vaccine preparations and other preventative measures against the new flu strain.
Japanese cases of the H1N1 strain of influenza reached 135 after the government confirmed 74 new infections, including in a 5-year-old boy and a man in his 60s, the Health Ministry said late Monday.
The new cases came as health ministers from around the world met in Geneva for the week-long meeting of the annual World Health Assembly, with pandemic preparedness at the top of the agenda.
Britain, Japan and other nations urged the World Health Organization at the meeting’s opening day to change the way it decides to declare a pandemic – saying the agency must consider how deadly the virus is, not just how fast it is spreading. There has been concern that by raising the global alert level to 5 of a possible 6 on April 29, the United Nations health agency had unduly raised alarm.
The director-general, Margaret Chan, said in her opening address to the assembly Monday that the organization would consider the concerns of member countries. But she warned that the disease’s lethality can vary from country to country, and that while the rapidly spreading virus appeared to be more mild than originally feared – in effect handing the world a “grace period” – no one can say “whether this is just the calm before the storm.”
“An influenza pandemic is an extreme expression of the need for solidarity before a shared threat,” Ms. Chan said. “We are fortunate that the outbreaks are causing mainly mild cases of illness in these early days.”
She added: “I strongly urge the international community to use this grace period wisely. I strongly urge you to look closely at anything and everything we can do, collectively, to protect developing countries from, once again, bearing the brunt of a global contagion.”
The W.H.O. raised its tally of global confirmed cases of the disease Monday to 8,829 in 40 countries. There have been 74 deaths, 68 of them in Mexico, the apparent epicenter of the global outbreak.
In Japan, authorities ordered more than 1,000 schools to close in and around Kobe and Osaka, cities in western Japan where the infections have been centered. None of the cases has been life-threatening, and there have been no deaths, according to the Health Ministry.
The bulk of the infections have been found among high school students in the region who have no record of recent overseas travel, signaling the start of a wider outbreak.
A W.H.O. spokesman, Dick Thompson, said there was still insufficient evidence that the disease was spreading in a sustained way among communities outside of North America, which would be required for the organization to raise its pandemic alert level to 6, the highest level.
All of the confirmed cases in Japan, Mr. Thompson said, derived from infection clusters within schools in Kobe and one in Osaka, and from the family members of people infected in those schools. Sustained community-level transmission, he said, requires cases of the virus to begin to erupt spontaneously, with no apparent link to other sufferers, over a period of time.
“We don’t see sustained community spread at this moment,” Mr. Thompson said, referring to the Japanese cases.
Japan is well known in public health circles for being exceptionally nervous about flu; it has an aging population and a national obsession with cleanliness that makes even Switzerland look messy.
Masks are common on subways because it is considered rude to lack one if you are sneezing. Before the outbreak began last month, Japan used about 60 percent of the world’s stock of the antiviral drug Tamiflu.
In Japan over the weekend, officials in white masks scrambled to set up makeshift tents and telephone hotlines to handle the surge in suspected cases. Osaka city said its public schools would remain closed for seven days, while Kobe imposed similar school shutdowns.
Governor Toshizo Ido of Hyogo prefecture, the region surrounding Kobe, said he would ask the central government to grant financial aid to the affected localities, including support for business owners affected in the outbreak.
In Tokyo, Prime Minister Taro Aso called for calm. “Many infected people received the right treatment at an early stage, and have recovered,” Mr. Aso said at a government task force meeting. “I would like everybody in Japan to act calmly.”
Until Friday, Japanese officials thought they had averted the virus after a string of suspected cases among people entering Japan proved negative. Japan has been sending medical examiners to each flight arriving from North America to take the temperatures of those on board.
On Friday, four Japanese returning from Canada were found with the H1N1 strain, and quarantined together with 50 other passengers. But on Saturday, the authorities confirmed that a 17-year-old student in Kobe with no recent overseas travel was infected.
Since then, new cases have been reported in Kobe and neighboring Osaka. There have been no cases in Tokyo.
Still, the rapid spread of the disease has come as a shock to Japan, which drew up an extensive action plan to contain influenza after bird flu appeared in Asia in 2004. Turkey, India and Chile also reported their first swine flu cases over the weekend.
The patient in Turkey was an American heading to Iraq. India’s case was that of a 23-year-old who arrived in Hyderabad from New York. Chilean officials reported that two of its citizens – two women, 25 and 32 years old – were found to have the flu after returning from a trip to the Dominican Republic.
Late Sunday night, Hong Kong confirmed its third case of swine flu, a 23-year-old man from southern China who had been studying in the United States. He arrived in Hong Kong on Saturday evening on Cathay Pacific Flight 831 from New York.
A spokesman for the Hong Kong health department said the man developed a fever during the flight and was spotted by a thermal scanner at the airport when he left the plane. Authorities put him in an isolation ward at Princess Margaret Hospital and issued a call for other passengers on the flight to report for testing. As of Sunday night, the spokesman said, 22 passengers and a crew member had been quarantined at a camp in rural Hong Kong.
Hong Kong’s first case of flu, on May 1, resulted in the quarantine of hundreds of travelers and hotel guests. The second case occurred last week.
Hiroko Tabuchi reported from Tokyo and Donald G. McNeil Jr. from New York. Mark McDonald contributed reporting from Hong Kong and Sharon Otterman from New York.
Address to Sixty-second World Health Assembly
Monday 18 May 2009
Dr Margaret Chan
Director-General of the World Health Organization
Mister President, honorable ministers, excellencies, distinguished delegates, Dr Mahler, ladies and gentlemen,
Over the past three decades, the world has, on average, been growing richer. People have, on average, been enjoying longer and healthier lives.
But these encouraging trends hide a brutal reality. Today, differences in income levels, in opportunities, and in health status, within and between countries, are greater than at any time in recent history.
Our world is dangerously out of balance, and most especially so in matters of health. The current economic downturn will diminish wealth and health, but the impact will be greatest in the developing world.
Human society has always been characterized by inequities. History has long had its robber-barons and its Robin Hoods. The difference today is that these inequities, especially in access to health care, have become so deadly.
The world can be grateful that leaders from 189 countries endorsed the Millennium Declaration and its Goals as a shared responsibility. These Goals are a profoundly important way to introduce greater fairness in this world.
Populations all around the world can be grateful that health officials are recommitting themselves to primary health care. This is the surest route to greater equity in access to health care.
Public health can be grateful for backing from the Commission on Social Determinants of Health. I agree entirely with the findings. The great gaps in health outcomes are not random. Much of the blame for the essentially unfair way our world works rests at the policy level.
Time and time again, health is a peripheral issue when the policies that shape this world are set. When health policies clash with prospects for economic gain, economic interests trump health concerns time and time again. Time and time again, health bears the brunt of short-sighted, narrowly focused policies made in other sectors.
Equity in health matters. It matters in life-and-death ways. The HIV/AIDS epidemic taught us this, in a most visible and measurable way.
We see just how much equity matters when crises arise.
Ladies and gentlemen,
The world is facing multiple crises, on multiple fronts.
Last year, our imperfect world delivered, in short order, a fuel crisis, a food crisis, and a financial crisis. It also delivered compelling evidence that the impact of climate change has been seriously underestimated.
These crises come at a time of radically increased interdependence among nations, their financial markets, economies, and trade systems. All of these crises are global, and all will hit developing countries and vulnerable populations the hardest. All threaten to leave this world even more dangerously out of balance.
All will show the consequences of decades of failure to invest in health systems, decades of failure to consider the importance of equity, and decades of blind faith that mere economic growth is the be-all, end-all, cure-for-all.
It is not.
The consequences of flawed policies show no mercy and make no exceptions on the basis of fair play. As we have seen, the financial crisis has been highly contagious, moving rapidly from one country to another, and from one sector of the economy to many others.
Even countries that managed their economies well, did not purchase toxic assets, and did not take excessive financial risks are suffering the consequences. Likewise, the countries that contributed least to greenhouse gas emissions will be the first and hardest hit by climate change.
And now we have another great global contagion on our doorstep: the prospect of the first influenza pandemic of this century.
Ladies and gentlemen,
For five long years, outbreaks of highly pathogenic H5N1 avian influenza in poultry, and sporadic frequently fatal cases in humans, have conditioned the world to expect an influenza pandemic, and a highly lethal one. As a result of these long years of conditioning, the world is better prepared, and very scared.
As we now know, a new influenza virus with great pandemic potential, the new influenza A (H1N1) strain, has emerged from another source on another side of the world. Unlike the avian virus, the new H1N1 virus spreads very easily from person to person, spreads rapidly within a country once it establishes itself, and is spreading rapidly to new countries. We expect this pattern to continue.
Unlike the avian virus, H1N1 presently causes mainly mild illness, with few deaths, outside the outbreak in Mexico. We hope this pattern continues.
New diseases are, by definition, poorly understood when they emerge, and this is most especially true when the causative agent is an influenza virus.
Influenza viruses are the ultimate moving target. Their behavior is notoriously unpredictable. The behavior of pandemics is as unpredictable as the viruses that cause them. No one can say how the present situation will evolve.
The emergence of the H1N1 virus creates great pressure on governments, ministries of health, and WHO to make the right decisions and take the right actions at a time of great scientific uncertainty.
On 29 April, I raised the level of pandemic influenza alert from phase 4 to phase 5. We remain in phase 5 today.
This virus may have given us a grace period, but we do not know how long this grace period will last. No one can say whether this is just the calm before the storm.
Presence of the virus has now been confirmed in several countries in the southern hemisphere, where epidemics of seasonal influenza will soon be picking up. We have every reason to be concerned about interactions of the new H1N1 virus with other viruses that are currently circulating in humans.
Moreover, we must never forget that the H5N1 avian influenza virus is now firmly established in poultry in several countries. No one can say how this avian virus will behave when pressured by large numbers of people infected with the new H1N1 virus.
Ladies and gentlemen,
The move to phase 5 activated a number of stepped up preparedness measures. Public health services, laboratories, WHO staff, and industry are working around the clock.
A defining characteristic of a pandemic is the almost universal vulnerability of the world’s population to infection. Not all people become infected, but nearly all people are at risk.
Manufacturing capacity for antiviral drugs and influenza vaccines is finite and insufficient for a world with 6.8 billion inhabitants. It is absolutely essential that countries do not squander these precious resources through poorly targeted measures.
As you heard this morning, we are trying to get some answers to a number of questions that will strengthen risk assessment and allow me to issue more precise advice to governments. Ideally, we will have sufficient knowledge soon to advise countries on high-risk groups and recommend that efforts and resources be targeted to these groups.
I have listened very carefully to your comments this morning. As the chief technical officer of this Organization, I will follow your instructions carefully, particularly concerning criteria for a move to phase 6, in discharging my duties and responsibilities to Member States.
While many questions do not have firm answers right now, I can assure you on one point. When WHO receives information of life-saving importance, such as the heightened risk of complications in pregnant women, we alert the international community immediately.
To date, most outbreaks have occurred in countries with good detection and reporting capacities. Let me take this opportunity to thank the governments of these countries for the diligence of their surveillance, their transparency in reporting, and their generosity in sharing information and viruses.
An influenza pandemic is an extreme expression of the need for solidarity before a shared threat. We are fortunate that the outbreaks are causing mainly mild cases of illness in these early days.
I strongly urge the international community to use this grace period wisely. I strongly urge you to look closely at anything and everything we can do, collectively, to protect developing countries from, once again, bearing the brunt of a global contagion.
I have reached out to the manufacturers of antiviral drugs and vaccines. I have reached out to Member States, donor countries, UN agencies, civil society organizations, nongovernmental organizations, and foundations.
I have stressed to them the absolute need to extend preparedness and mitigation measures to the developing world. The United Nations Secretary-General is joining me in these efforts, which are tireless.
Ladies and gentlemen,
As I said, equity in health matters in life-and-death ways. It matters most especially in times of crisis.
The world of today is more vulnerable to the adverse effects of an influenza pandemic than it was in 1968, when the last pandemic of the previous century began.
The speed and volume of international travel have increased to an astonishing degree. As we are seeing right now with H1N1, any city with an international airport is at risk of an imported case. The radically increased interdependence of countries amplifies the potential for economic disruption.
Apart from an absolute moral imperative, trends such as outsourcing and just-in-time production compel the international community to make sure that no part of the world suffers disproportionately. We have to care about equity. We have to care about fair play.
These vulnerabilities, to imported cases, to disrupted economies and businesses, affect all countries. Unfortunately, other vulnerabilities are overwhelmingly concentrated in the developing world.
On current evidence, most cases of severe and fatal infections with the H1N1 virus, outside the outbreak in Mexico, are occurring in people with underlying chronic conditions. In recent years, the burden of chronic diseases has increased dramatically, and shifted dramatically, from rich countries to poorer ones.
Today, around 85% of the burden of chronic diseases is concentrated in low- and middle-income countries. The implications are obvious. The developing world has, by far, the largest pool of people at risk for severe and fatal H1N1 infections.
A striking feature of some of the current outbreaks is the presence of diarrhea or vomiting in as many as 25% of cases. This is unusual.
If virus shedding is detected in fecal matter, this would introduce an additional route of transmission. The significance could be especially great in areas with inadequate sanitation, including crowded urban shantytowns.
The next pandemic will be the first to occur since the emergence of HIV/AIDS and the resurgence of tuberculosis, also in its drug-resistant forms. Today’s world has millions of people whose lives depend on a regular supply of drugs and regular access to health services.
Most of these people live in countries where health systems are already overburdened, understaffed, and poorly funded. The financial crisis is expected to increase that burden further, as more people forego private care and turn to publicly-financed services.
What will happen if sudden surges in the number of people requiring care for influenza push already fragile health services over the brink? What will happen if the world sees the end of an influenza pandemic, only to find itself confronted, say, with an epidemic of extensively drug-resistant tuberculosis?
We have good reason to believe that pregnant women are at heightened risk of severe or fatal infections with the new virus. We have to ask the question. Will spread of the H1N1 virus increase the already totally unacceptable levels of maternal mortality, which are so closely linked to weak health systems?
Ladies and gentlemen,
In the midst of all these uncertainties, one thing is sure. When an infectious agent causes a global public health emergency, health is not a peripheral issue. It moves straight to centre stage.
The world is concerned about the prospect of an influenza pandemic, and rightly so. This Health Assembly has been shortened for a good reason. Health officials are now too important to be away from their home countries for more than a few days.
Much is in our hands. How we manage this situation can be an investment case for public health.
The world will be watching, and one big question is certain to arise. Are the world’s public health services fit-for-purpose under the challenging conditions of this 21st century? Of course not. And I think the consequences will be quickly, highly, and tragically visible. Now comes the second question. Will something finally be done?
At the same time, we cannot, we dare not, let concerns about a pandemic overshadow or interrupt other vital health programs. In fact, many of the issues you will be addressing this week, or have addressed in recent sessions, concern exactly the capacities that will be needed during a pandemic, or any other public health emergency of international concern.
The health sector cannot be blamed for lack of foresight. We have long known what is needed.
An effective public health response depends on strong health systems that are inclusive, offering universal coverage right down to the community level. It depends on adequate numbers of appropriately trained, motivated, and compensated staff.
It depends on fair access to affordable medical products and other interventions. All of these items are on your agenda. I urge you, in particular, to complete work under the item on public health, innovation and intellectual property. We are so very close.
The International Health Regulations, also on your agenda, give the health sector an advantage that financial managers, at the start of last year’s crisis, did not have when faulty policies precipitated a global economic downturn. The International Health Regulations provide a coordinated mechanism of early alert, and an orderly system for risk management that is driven by science, and not by vested interests.
I must remind you. We need to finish the job of polio eradication, as guided by the ongoing independent evaluation. I must also remind you that this job is already providing solid benefits as we reach for the goal of ridding the world of a devastating disease.
Right now, the vast surveillance networks and infrastructure in place for polio eradication are being used to step up surveillance for cases of H1N1 infection, especially in sub-Saharan Africa and the Asian sub-continent.
The proposed program budget is also on your agenda. WHO is prepared to lead the response to a global public health emergency. Our services, in several areas, are strained, but we are coping. We need to be assured that we can continue to function well, especially if the emergency escalates.
Ladies and gentlemen,
I have a final comment to make.
Influenza viruses have the great advantage of surprise on their side. But viruses are not smart. We are.
Preparedness levels, and the technical and scientific know-how that supports them, have advanced enormously since 1968. We have the revised International Health Regulations, and we have tested and robust mechanisms like the Global Outbreak Alert and Response Network.
As I said, an influenza pandemic is an extreme expression of the need for global solidarity. We are all in this together. And we will all get through this, together.
Yoga, Aromatherapy Among New Offerings at Beth Israel Medical Center
Woodson Merrell, MD, and fashion designer Donna Karan with nurses from the Inpatient Cancer Unit at Beth Israel Medical Center in Manhattan.
“We believe integrative medicine can provide more optimal healing than medicine alone”
GoogleNews.com, May 18, 2009, by Susan Meyers — Walking into Beth Israel Medical Center in New York City for the first time, you might notice a few things that appear out of the norm for a traditional hospital setting. People stroll down the hallways with dogs; small groups of musicians carry instruments, stopping at patient rooms to play a short medley of music; you might even catch a glimpse of a patient and nurse in meditation or in a yoga pose.
Integrative medicine therapies have been working their way into the mainstream of traditional medicine at Beth Israel Hospital for the past eight years, and Beth Israel is embracing it.
“This area is being driven by demand from patients and doctors,” says Richard Freeman, executive vice president and chief operation officer at Beth Israel Medical Center. “We believe there are various approaches to provide quality care to our patients. As time goes on, more and more people are choosing alternative medicine therapies in conjunction with traditional medicine. We believe that this can be an important adjunct to care that can enhance the healing process.”
Beth Israel offers integrative medicine therapies to all of its cancer patients, in combination with conventional treatments, in a yearlong pilot program to determine whether therapies such as yoga, relaxation, and breathing techniques can help alleviate common side effects of treatment such as pain, nausea, anxiety, insomnia, constipation, and fatigue. The program is being funded by Donna Karan’s Urban Zen Foundation, which is dedicated to incorporating Eastern healing practices of yoga, meditation, and aromatherapy with Western medicine.
The foundation was created after Karan’s husband and several close friends died of cancer. During his battle with the disease, Karan’s husband used several Eastern techniques that Karan says were helpful in relieving treatment symptoms and providing inner peace. Through this pilot program, which includes a research component, the Urban Zen Foundation hopes to demonstrate that integrative therapies can work effectively in combination with chemotherapy and radiation to reduce common cancer symptoms and promote healing.
“We believe integrative medicine can provide more optimal healing than medicine alone,” says Joanne Heyman, executive director of the Urban Zen Foundation. “It has much broader applications than just treating cancer, but we wanted to focus on this disease first because of Donna’s personal connection.”
The program is providing specialized training to 15 yoga teachers who will become experts in providing therapy to non-terminal cancer patients. It focuses on yoga, aroma therapy, healing touch, nutrition, and awareness of death and dying in hospital and private settings. Training is being provided by Karan’s yoga masters, Rodney Yee and Colleen Saidman Yee, who also will oversee yoga therapy during the pilot study. Nurses on the oncology floor also are being trained in relaxation techniques including meditation, imagery, aromatherapy, and breathing.
The program also funds a nurse navigator who guides the patient and family through the medical system and orients them to services on the unit; a yoga coordinator and assistant to oversee therapies; and a research director to coordinate the research component.
Heyman says Beth Israel was particularly suited for the program because of its long-standing commitment to integrative medicine. The hospital has been offering alternative therapies to patients for many years, primarily through the Continuum Center for Health and Healing, the nation’s largest and most comprehensive academic integrative medical center. The department is headed by Woodson Merrell, MD, who has been specializing in integrative medicine therapies for more than 20 years and is one of the country’s leading experts on holistic medicine. Merrell believes there is significant evidence to validate its usefulness and that using this approach to empower the patient and provide compassionate, relationship-centered, integrative care is critical for transforming the nation’s ailing healthcare system.
Reflecting an increasing interest and growth in holistic medicine, Beth Israel’s integrative medicine center recently was elevated to departmental status, providing it with more autonomy to grow and expand.
Ed Dailey, RN, a registered yoga teacher, is one of 15 yoga instructors receiving specialized training through the Urban Zen Foundation and is a believer in the healing power of alternative medicine. A nurse for 14 years and a yoga instructor for 10 years, Dailey has seen yoga, meditation, and other forms of relaxation and integrative medicine provide inner strength, calmness, and healing to his patients. Since undergoing formal training, Dailey and other therapists have been offering yoga and relaxation therapies to patients on the head and neck surgical floor at Beth Israel Medical Center with positive results. The therapies are provided at the bedside, using a very flexible definition of yoga. Patients are guided through simple yoga movements and postures while never being touched by the therapist.
“It was believed we could be of service to patients prior to the start of the clinical study,” Dailey says. “We’ve provided therapy to up to 500 patients so far, and I’ve seen patients become calmer and more relaxed, sleep better, [and] experience fewer bed sores, less nausea and constipation, and less anxiety.”
For instance, breathing and relaxation techniques recently brought relief to a young father who had been diagnosed with cancer. “The family was extremely anxious and stressed,” Dailey says. “I provided relaxation interventions to him and his wife, which they now practice at home.” Dailey used the body scan relaxation technique, in which he helps the patient focus on areas of the body that have tension. “It really has a calming effect on the mind, body, and nervous system. It can help relieve stress levels, which can interfere with the healing process. They both became calmer, happier, and much less stressed.”
Dailey says the program also targets staff. “Our goal is to put health back into healthcare,” he says. “Nurses can become depleted [by the demands of their jobs]. How can they provide quality healthcare when they are depleted themselves? Our goal is to encourage staff to take short breaks throughout their day and use yoga and other relaxation techniques to reduce stress levels and re-energize.”
The oncology floor also is undergoing physical changes funded by the Urban Zen Foundation to provide a more healing environment that includes larger spaces for quiet and meditation for patients and staff. The meditation room includes banquette seating, a large flat-screen TV for imagery, and personal MP3 players for music and relaxation sessions. A small kitchenette for families also has been upgraded and expanded. In addition, a small reception area was created so when patients enter the floor, they are greeted by a patient navigator who provides floor tours and guides the patient through the care process.
Integrative medicine is a growing trend, and Heyman says she is seeing growing interest among hospitals in developing integrative medicine services. She says she expects that trend to increase as more research is unveiled that demonstrates the positive benefits of integrative medicine in relieving pain and enhancing healing.
Susan Meyer is a freelance writer.
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Whole Cantaloupes Recalled Because Of Possible Health Risk
FOR IMMEDIATE RELEASE — Raleigh, NC — May 18, 2009 – L&M Companies, Inc. of Raleigh, NC is recalling one lot of whole cantaloupes because it has the potential to be contaminated with Salmonella. No illnesses have been reported to date, and we are working with the FDA to inform consumers of this recall.
The whole cantaloupes were sold between May 10-15, 2009 in Walmart Supercenter Stores in North Carolina and South Carolina, and in the Walmart Supercenter Store located at 315 Furr Street in South Hill, Virginia. Consumers who have purchased whole cantaloupes from these Walmart stores during this time period should not consume them, and should destroy the product.
The recall comes after a cantaloupe at a small farm from which L&M Companies sources product tested positive for Salmonella. L&M Companies has ceased shipments from this farm, and the grower continues to investigate the cause of the problem.
Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting, and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis, and arthritis.
“L&M Companies takes food safety seriously and we are committed to the shoppers who buy our products everyday. We are issuing this recall because we want to ensure that even the slightest risk to public health is minimized,” said Mike McGee, Vice President of Production and Grower Development.
Medscape.com, May 18, 2009, by Roxanne Nelson – Virtual colonoscopy using computed tomography (CT) will not be covered by Medicare as an option for colorectal cancer screening in the United States, according to a final decision from the Centers for Medicare and Medicaid Services (CMS). The agency concluded that “the evidence is not sufficient to conclude that screening CT colonography [CTC] improves health benefits for asymptomatic average-risk Medicare beneficiaries.”
This finalized the coverage denial proposed in February, when CMS first announced it they intended to deny Medicare beneficiaries access to virtual colonoscopy. Although the CMS memo described virtual colonoscopy as a “promising technology,” it also pointed out that many questions about the use of CTC need to be answered with well-designed clinical studies that focus on health outcomes for the Medicare population.
Until the evidence is sufficient, “CMS strongly encourages physicians and beneficiaries to participate in [colorectal cancer] screening by selecting 1 of the several [colorectal cancer] screening tests that are currently covered under Medicare,” states the decision memo. These include optical colonoscopy, fecal blood tests, and sigmoidoscopy.
Decision Stirs Debate on Both Sides
The decision has stirred a great deal of debate among professional organizations, medical experts, and advocacy groups. However, during the 30-day comment period following publication of the draft memo, the majority of responses (97%) opposed a blanket denial of coverage. Members of Congress also wrote letters to CMS urging Medicare coverage of the procedure, including 2 letters signed by more than 50 Representatives.
CMS received comments opposing the decision from the American Cancer Society, the American College of Radiology, the American Gastroenterological Association, the Advanced Medical Technology Association, and UnitedHealthcare; letters supporting the decision came from the American College of Gastroenterology, the American College of Preventive Medicine, the American Society for Gastrointestinal Endoscopy, and American’s Health Insurance Plans.
“It is disappointing but not unexpected, given their preliminary decision,” said David J. Vining, MD, professor of diagnostic radiology at the University of Texas MD Anderson Cancer Center in Houston. “But their rationale behind it is difficult to understand.”
Dr. Vining, who performed the first virtual colonoscopy in 1993, told Medscape Oncology that this is going to remain a “hot topic” and is not going to disappear anytime soon. “Congresswoman Kay Granger’s [R-Texas] office has issued a press release that they are going to continue to fight it and try to get CMS to reconsider their decision,” he said. “This is a worthwhile issue that has multiple facets in terms of economics and politics; it may even become a focal point for healthcare reform.”
The Obama administration has emphasized prevention, he pointed out, and unlike mammography and lung cancer screening, colorectal cancer screening can actually prevent cancer by detecting premalignant lesions.
“Everyone needs screening, but not necessarily colonoscopy, and whatever method they take should be supported,” Dr. Vining said. “Even gastroenterologists are seeing the handwriting on the wall.”
Gastroenterologists appear to be split on the issue. Although they were initially opposed to virtual colonoscopy, the Future Trends Committee of the American Gastroenterological Association (AGA) published a report in October 2006 that demonstrated a change in position. The Committee proposed that gastroenterologists should position themselves to play a role in performing and interpreting CTC. The following year, the AGA issued guidelines listing the minimum requirements that a gastroenterologist must satisfy to become certified to read CTC scans.
However, the American College of Gastroenterology (ACG) has spoken out against virtual colonoscopy, and applauded the decision to not have it covered under Medicare. It said that the decision “underscores the lack of sufficient evidence on the test’s potential as an appropriate option for the screening and prevention of colorectal cancer.”
“There is no evidence that any radiographic test, including [CTC], prevents the development of colorectal cancer. Colonoscopy is one of the most powerful preventive tools in clinical medicine because of its excellent sensitivity in detecting polyps and its potential for removing them and breaking the sequence of polyp to cancer in a single diagnostic and therapeutic intervention,” Eamonn Quigley, MD, FACG, president of the ACG, said in a release.
The American Society for Gastrointestinal Endoscopy, which also supported the CMS decision, stated that even though CTC is a promising addition to colorectal cancer screening, it is premature to endorse the technology. “Because of suggested efficacy in identifying cancers and polyps greater than 9 mm, we believe [CTC] is an appropriate consideration as an alternative test for patients who are unable to have a complete optical colonoscopy because of an anatomic blockage or other medical reason,” they wrote in their original comment letter to CMS.
Addition, Not Replacement
Leonard Lichtenfeld, MD, deputy chief medical officer for the American Cancer Society, expressed his disappointment in the decision. “It was an opportunity . . . to start setting the stage on how we can do things the right way in healthcare going forward, which will be a critical part of any reform effort,” he wrote in his blog. “In my opinion, we have failed to meet the challenge.”
“For me, the issue is reasonably straightforward,” he added. “We lose close to 50,000 people every year in this country from colorectal cancer. We could save thousands of lives if we were able to get people screened for this disease. The American Cancer Society believes that we should favor tests that prevent cancer, and has endorsed [CTC] as a reasonable test for this purpose.”
Andrew Spiegel, CEO of the Colon Cancer Alliance, a national patient advocacy organization, also believes that this is a rather straightforward issue. “Less than 60% of the Medicare population – which is the population most likely to develop colon cancer – is screened,” he told Medscape Oncology. “I’m sure that part of reason is fear of anesthesia or bowel perforation associated with colonoscopy, and just discomfort with the procedure itself.”
Many private insurers, including major companies such as Cigna and UnitedHealthcare, already reimburse for CTC, Mr. Spiegel pointed out. Thus, the denial of coverage by Medicare helps reinforce different standards of care for Medicare beneficiaries and for those with private health insurance.
But perhaps most important is the fact that Medicare turned the issue of coverage into a debate about efficacy – pitting optical colonoscopy against virtual colonoscopy. That was a completely wrong way of looking at it, contends Mr. Spiegel, because no one was looking to replace optical colonoscopy with CTC.
“This was about adding another screening option, not replacing the standard,” he said. “It was about offering an additional option that is more effective than some of the screening tests that Medicare already pays for, like fecal blood testing and sigmoidoscopy.”
In their memo, CMS notes that even though private insurers are offering coverage to people younger than 65 years, there is insufficient evidence on test characteristics and performance of screening CTC, and on health outcomes in older Medicare beneficiaries. There also are no published studies on the impact of adding CTC on colorectal cancer screening rates in older individuals, they write.
In his blog, Dr. Lichtenfeld points out that the CMS decision has made it less likely this evidence is going to be obtained any time soon – if ever. The American Cancer Society had asked CMS to explore other options, and proposed that they consider a “coverage with evidence” decision (CED). This would have permitted CMS and other professional organizations to initiate stringent rules and regulations to follow patients who were screened with CTC, allowing essential data to be obtained from this population that could measure the effectiveness of CTC and answer the questions that have been raised.
“CMS said repeatedly they couldn’t do a CED for [CTC] because it is a screening test,” writes Dr. Lichtenfeld. “They do have such a program for PET [positron emission tomography] scans, but that is OK in their opinion because PET scans are used in the diagnosis and treatment of disease. So much for preventing cancer, as opposed to treating it.”
Another issue raised by CMS is the need for a follow-up optical colonoscopy if lesions are detected. This necessitates the patient undergoing a second bowel prep, and adds the cost of an additional test.
“With the higher prevalence of polyps in the older Medicare population, the rate of referral to optical colonoscopy is extremely important, and also unknown at this point,” CMS says in its memo. “If there is a relatively high referral rate, the utility of an intermediate test such as [CTC] is limited.”
However, to solve the problem of double bowel preps, some insurers are arranging to have a follow-up colonoscopy, if one is needed, the same day as the CTC. As an example, Blue Cross/Blue Shield in Delaware is now requiring that the follow-up colonoscopy be performed within 2 hours of the completion of the CTC.
Dr. Vining pointed out that only 10% of patients have a significant polyp that needs to be removed, so the number of cases requiring a second procedure would be quite small.
Most of the small polyps less than 5 mm are benign; the gray area is with polyps 6 to 9 mm, he explained. “Some radiologists advocate following those without removal unless 3 or more polyps of this size are detected during [CTC]. Of course, patients with polyps larger than 10 mm should be referred for follow-up colonoscopy.”
Ultimately, more definitive practice guidelines need to be established on how to manage small polyps, and better discriminating criteria [are needed] to figure out who needs colonoscopic intervention, he added.
Dr. Lichtenfeld agrees with CMS that more data are needed and that there are unanswered questions, such as those concerning radiation dosage, and extracolonic incidental findings.
Although CTC isn’t perfect, it appears to be a very reasonable test, he said. “It is my opinion and the opinion of others that it would expand the opportunity for colorectal cancer prevention and [provide an] early detection strategy to more people throughout the country.”
The Battle for Coverage Will Continue
Even though CMS has issued their final decision, the debate is likely to continue. Congresswoman Granger notes in a release that “virtual colonoscopies are an important tool in the battle against colorectal cancer,” and has sponsored the Colorectal Cancer Prevention, Early Detection, and Treatment Act (H.R. 1189), which would put in place a national colorectal cancer screening and treatment program.
The CTC Working Group, a coalition of physician providers, colon cancer patient advocates, and imaging-equipment manufacturers, has called on CMS to immediately reopen the rule-making process to consider new clinical data.
If CMS will not reconsider its decision, Mr. Siegel said that they will go to Congress to get it reversed and to push through Medicare funding. “We will call upon the 1.2 million people who currently have colon cancer in the [United States] and ask their voices to unite to mandate coverage for virtual colonoscopy.”
HHS.gov, May 18, 2009 — From the U.S. Department of Health and Human Services – HealthBeat.
For overweight heart patients, doing more lengthy exercise than is currently recommended in cardiac rehab programs might pay off.
Dr. Philip Ades of the University of Vermont College of Medicine bases that a study of a daily walking program. It burned many more calories than standard cardiac rehab, so patients lost about 10 more pounds, along with a greater improvement in risk factors such as cholesterol levels and high blood pressure.
[Dr. Philip Ades speaks] “We would strongly recommend that they supplement cardiac rehab that they might do on-site at a rehab program with daily walking, away from the rehab program, because – over the long term – they will not only lower their weight, they will lower their overall cardiac risk.”
The study in Circulation: Journal of the American Heart Association was supported by the National Institutes of Health.
|Add Stretches to Your Walking Routine
Stretch gently after you warm up your muscles with an easy Push
Lean your hands on a wall with your feet about 3 to 4 feet away from the wall. Bend one knee and point it toward the wall. Keep your back leg straight with your foot flat and your toes pointed straight ahead. Hold for 10 seconds and repeat with the other leg.
Lean your back against a wall. Keep your head, hips, and feet in a straight line. Pull one knee to your chest, hold for 10 seconds, then repeat with the other leg.
Pull your right foot to your buttocks with your right hand. Stand straight and keep your knee pointing straight to the ground. Hold for 10 seconds and repeat with your left foot and hand.
Sit on a sturdy bench or hard surface so that your left leg is stretched out on the bench with your toes pointing up. Keep your right foot flat
on the floor. Straighten your back, and if you feel a stretch in the back of your thigh, hold for 10 seconds and repeat with your right leg. [If you do not yet feel a stretch, lean forward from your hips until you do feel a stretch.]
DiscoverMagazine.com, May 17, 2009 — Specialized cells found only on flower petals have the same basic function as nonslip mats that prevent people from slipping in the shower, a new study has determined. The bumpy cells, called conical cells, help bees come in for a landing on the flower petals and find their footing, so they can get down to the important business of pollination.
Conical cells had been something of a botanical mystery, with most researchers assuming they played a visual role. One hypothesis held that by modifying the spectral properties of the petal, the cells enabled the plant to appear brighter to pollinators [The Scientist]. In the study, will be published in a forthcoming issue of Current Biology, researchers showed that the conical cells’ main function is to provide friction, and that bees can detect them by touch. The first experiment used two kinds white snapdragons that looked identical to both human and bee eyes, but one was a mutant with flat cells instead of conical. The bees initially went to both flower types, but after 20 visits they chose the blossoms with conical cells more than 80 percent of the time.
To take it another step, study coauthor Heather Whitney created “biomimetic epoxy casts” that imitated the surface of conical and flat-celled flowers in remarkable detail. These casts allowed her to study the effect of texture, devoid of the confusing influences of color, smell or any other floral cue. After several visits, bees learned to choose the bumpier surface with almost perfect accuracy – strong proof that the feel of a flower’s petal is part of its attraction.
The researchers also investigated how bees responded to two strains of pink snapdragons: one with conical cells and rich magenta flowers, and the other with flat cells that reflect more white light, which therefore has paler pink flowers. Study coauthor Beverley Glover explains that that this visual cue allows bees to avoid the slippery flowers-but they don’t always choose to. When both blossoms were laid out horizontally, bees crawled onto the two types equally often. But when the flowers were presented vertically, the bees visited the magenta flowers significantly more often, suggesting that they only prefer the conical cells when it is difficult to land on the flower. When the flower is vertical, Glover said, it’s not very energetically efficient for bees to feed on the flat-celled flowers. “Their legs are scrambling as they do it, and their wings keep beating…like a mountain climber trying to find a hold on a vertical mountain side” [The Scientist].