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Controversy Over H5N1 Flu Continues

Just when it seemed like consensus existed on how to handle the hot potato of mammalian-transmissible H5N1 influenza, the public release on Friday afternoon of a letter sent April 12 from the respected influenza and public health researcher Dr. Michael Osterholm to a National Institutes of Health official collapsed the apparent consensus like a house of cards.

To recap: On March 29 and 30, the U.S. government’s National Science Advisory Board for Biosafety (NSABB), organized by the NIH’s Office of Science Policy, met to reconsider the NSABB’s original decision last December that said the paper written by Dr. Yoshihiro Kawaoka and another paper by Dr. Ron Fouchier on their respective efforts to produce and study H5N1 mutants transmissible by air from ferret to ferret should only be published without the methods sections, a way to prevent release of the details on how they developed these potentially dangerous mutant strains. The initial NSABB recommendation to allow publication of only the redacted papers failed to win support from a panel convened by the World Health Organization in February, creating a conflict between the NSABB (and hence the NIH) and the WHO. Claiming that new data first revealed to the WHO group led to the different outcome, Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases — the U.S. agency that sponsored the work of both Dr. Kawaoka and Dr. Fouchier — called on the NSABB to rethink its initial decision, which resulted in the NSABB reversing itself on March 30 and supporting full publication, in a unanimous vote for Dr. Kawaoka’s work, and in a 12-6 vote for Dr. Fouchier’s. So, by early April, the NSABB (and hence, pending official U.S. policy) and the WHO agreed that full H5N1 publication could proceed. Peace reigned across the land.

Dr. Michael Osterholm

Until 2 weeks later, when Dr. Osterholm an NSABB member, upset the tranquility by writing his bombshell letter to Dr. Amy Patterson, NIH’s associate director for Science Policy. In it, Dr. Osterholm took vigorous swipes at how the NIH set up the NSABB’s reconsideration session and detailed his grave concerns about public release of how the H5N1 work was done. Both “Science” and “Nature” received the letter on April 13, and according to a report in “Nature,” Dr. Osterholm said he was not the source for the leak.

“I believe the agenda and speakers for the March 29 and 30 NSABB meeting as determined by the Office of Biotechnology Activities [part of the NIH’s Office of Science Policy] staff and other U.S. government officials was designed to produce the outcome that occurred,” Dr. Osterholm charged in his letter. “It represented a very ‘one-sided’ picture of the risk-benefit of the dissemination of the information in these manuscripts. The agenda was not designed to promote a balanced reconsideration of the manuscripts.”

A major problem, he said, was that the “experts that addressed [the March NSABB session] have a real conflict of interest in that their laboratories are involved in this same type of work and the results of our deliberations directly affect them too.” The same problem occurred at the WHO meeting in February, he added.

Dr. Osterholm tempered his charge by saying he did not “suggest that there was a sinister motive by the U.S. government,” but still leveled a hefty blast, saying “I believe there was a bias toward finding a solution that was a lot less about robust science- and policy-based risk-benefit and more about how to get us out of this difficult situation.”

The upshot was that in the revised decision NSABB, U.S. policy makers, and researchers failed to “come to grips with the very difficult task of managing dual-use research of concern and the dissemination of potentially harmful information to those who might intentionally or unintentionally use that information in a harmful way.” His worry is — if not in this case — “will the Board ever find a bright line for redacting publication” of any future research that could potentially threaten public health?

Dr. Osterholm cited a major danger if details of this research became fully public: “A ferret-to-ferret experiment is expensive and technically demanding, and could only be done by a handful of labs in the world. Once the mutations are public, individuals … in many other labs could generate the mutants in a few weeks given several thousand dollars for gene synthesis,” using reverse genetics.

Finally, Dr. Osterholm questioned the public-health benefit from full release of the methods sections of the two H5N1 papers. “The most important aspect of the results in these two studies on surveillance and control has already been accomplished namely alerting the world to the possibility that H5N1 influenza virus surely can become a mammalian-transmitted virus and poses real pandemic potential.” Publication of more details from the research will not add to that alert, nor would it immediately help in the development or production of countermeasures against a potential H5N1 pandemic, he said.

Despite his concerns over full disclosure of the methods, Dr. Osterholm affirmed his overall support for this H5N1 research in a comment to “Nature” on Friday.  “I have been and continue to be a supporter of this kind of research,” he told the journal.

—Mitchel Zoler (on Twitter @mitchelzoler)

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New Details Further Blunt the H5N1 Flu Danger

Dr. Ron Fouchier, one of the two researchers who developed and studied mutant forms of avian H5N1 influenza that’s transmissible through the air, provided new details of his findings at a conference this morning in Washington. He explained that the mutant virus is not nearly as deadly or transmissible as many people have supposed.

This new information seems to be, at least in part, at the root of the different conclusions recently reached by the U.S. National Science Advisory Board for Biosecurity (NSABB) and by a group organized by the World Health Organization (WHO) on whether detailed methods of the H5N1 mutant research should be released to the public. During the past few days, the National Institutes of Health called on the NSABB to meet again to hear the new data and see if it would change the Board’s decision to keep the methods sections of the papers under wraps, Dr. Anthony Fauci said at today’s meeting.

ferret; courtesy hemmer@fr.wikipedia, Wikimedia Commons

“This virus does not kill ferrets that are sneezed on [by ferrets already infected with mutant H5N1], and if it was released it is unlikely that it would spread like wildfire, and to extrapolate that it would spread like wildfire in humans is really farfetched at this stage,” said Dr. Fouchier, a researcher at Erasmus University in Rotterdam. “This virus does not spread like a pandemic or seasonal influenza virus,” he said in a session that dealt with H5N1 issues during a meeting on Biodefense and Emerging Diseases sponsored by the American Society for Microbiology. He called any notion that the mutant avian H5N1 flu he created could transmit readily in aerosolized form from ferret-to-ferret a “misperception.”

In addition, many people have had a second important misperception of the virus he’s studied: The H5N1 mutant strains he created are not highly lethal.

“It’s very clear that H5N1 is highly lethal in chickens, but in mammals that’s not the case.” The mutant form of the virus will kill a ferret if you place a large dose of the virus—a million virions—directly into the animals lower respiratory tract. That kills the animal in about 3 days, he said. But if a more modest and typical inoculum gets introduced intranasally to a ferret, the animal simply gets a flu-like illness but recovers. “We saw no severe disease in any of the seven animals that received virus by aerosol,” he said.

A third, heartening observation he’s made about how mammalian-transmissible H5N1 behaves is that ferrets exposed to seasonal flu before exposure to the H5N1 mutant “are fully protected against severe disease.” His conclusion from this: “It’s unlikely that humans have no cross protection to H5N1, so very few would develop severe disease. Most [people] would be protected by cross-protective immunity.”

According to Dr. Fauci, director of the National Institute of Allergy and Infectious Disease, these clarifications from Dr. Fouchier first came to light earlier this month during a meeting on H5N1 convened by the WHO in Geneva. These new data, as well as the recommendations made by the WHO group, led Dr. Fauci to ask the NSABB to reconvene.

“The NIH continues to support the NSABB recommendations regarding the original manuscripts [to publish redacted versions of the papers], and supports revision of the manuscripts to include new data and explicit clarifications of old data,” Dr. Fauci said. “There was obviously a disagreement in the recommendations between Geneva and the NSABB. There was a strong feeling to reconvene the NSABB to give them the benefit of the same information and discussion as in Geneva.”

–Mitchel Zoler (on Twitter @mitchelzoler)

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WHO Trumps U.S. Plan for H5N1 Flu

The American plan for dealing with public release of details from the H5N1 influenza research funded by the U.S. government got trumped last Friday by the contrary conclusion of a committee assembled by the World Health Organization.

The WHO assembled a group of 22 researchers and policy makers from 10 countries in Geneva on Feb. 16-17 to discuss H5N1 airborne-transmissibility research, and the group came to three main conclusions, according to a statement they released and comments later in a press conference by Dr. Keiji Fukuda, the WHO’s assistant director general for Health Security and the Environment:

■ Research into H5N1 virus capable of airborne transmission from mammal to mammal is important and should continue.

■ Full public reporting of all details of the research done so far by Dr. Fouchier in Rotterdam and Dr. Kawaoka in Madison, Wis., should occur in the near future.

■ Until WHO crafts a process by which these full reports can be released publicly, they should remain under wraps along with continuation of the self-imposed moratorium on further research on the new H5N1 strains previously pledged by both Dr. Fouchier and Dr. Kawaoka.

WHO headquarters, Geneva/courtesy WHO ©WHO P. Virot

The WHO panel’s decision directly refutes the ruling first made public last December by the U.S. National Science Advisory Board for Biosecurity (NSABB) to redact the methods sections when the papers by Dr. Fouchier and Dr. Kawaoka are published. Science magazine has been holding the Fouchier manuscript, while Nature has the Kawaoka paper, and until late last week both journals intended to publish the redacted versions of their articles in March. Those plans are now on hold.

While the WHO’s Dr. Fukuda repeatedly stressed that consensus had been reached by the panel, news reports with comments from the two U.S. panelists, Dr. Anthony Fauci, director of  the National Institute of Allergy and Infectious Diseases, and Dr. Paul Keim, acting NSABB chairman, suggest something else: Their views got buried.

“I stand by the NSABB recommendations,” said Dr. Fauci, according to a report in Science. During the press conference, Dr. Fukuda admitted that “the representative from NIH pointed out that himself and others from the U.S. on record comply and understand and support the NSABB decision.”

Dr. Keim was blunter in his critique: “I was disappointed in this conclusion [by the WHO panel] as it was one that NSABB worked hard to achieve,” he told Science.

Dr. Bruce Alberts, editor-in-chief of Science, noted in a separate press conference last Friday that the issue had grown too global to be settled by a U.S.-centric group like the NSABB.

“In the long run, an international organization like WHO had to take charge of this… It may be the start of an international version of the NSABB,” Dr. Alberts said.

—Mitchel Zoler (on Twitter @mitchelzoler)

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N.Y. Times Slams Air-Borne H5N1 Research

The New York Times looked at air-borne H5N1 research, and saw it wasn’t good.

The Times devoted it’s lead Sunday editorial in its Jan. 8 edition — the paper’s place for its highest profile editorial pronouncements, usually focused on politics, economics, or international relations — to its official opinion on  controversial research in which two labs, one in Madison, Wis., and one in Rotterdam, made strains of the deadly H5N1 avian influenza that were transmissible in the air from ferret-to-ferret.

H5N1 virus/image courtesy Cynthia Goldsmith, CDC Public Health Image Library

In the editorial, the newspaper declared that “the research should never have been undertaken because the potential harm is so catastrophic and the potential benefits from studying the virus so speculative.” And that “the consequences, should the virus escape, are too devastating to risk.”

These statements were startling not only because the Times rarely takes an editorial stand on the specifics of biomedical research, but also because, as the editorial itself admitted, “we nearly always champion unfettered scientific research and open publication of the results.” So why the uncharacteristic stand?

The editorial cited two major reasons: the underlying danger from the new virus that’s been created, and the questionable research benefits from this line of work. The newspaper called the potential benefit from studying the newly made H5N1 variant “speculative” and questioned the level of security currently in place to safeguard the new virus.

But the Times’ concerns strikingly contrast with recent statements from officials at the National Institutes of Health, which co-sponsored this H5N1 research, as well as from officials at the World Health Organization.

On Dec. 30, an opinion piece in The Washington Post by Anthony Fauci, Gary Nabel, and Francis Collins of the NIH strongly defended the research and provided a simple, but unequivocal scientific rationale for it. “New data provide valuable insights that can inform influenza preparedness and help delineate the principles of virus transmission between species,” they wrote. “Identifying threatening viruses can also facilitate the early stages of manufacturing vaccines that protect against such a virus in advance of an outbreak…Decades of experience tells us that disseminating information gained through biomedical research to legitimate scientists and health officials provides a critical foundation for generating appropriate countermeasures and, ultimately, protecting the public health.” These NIH officials also defended the security in place, noting “the engineered viruses developed in the ferret experiments are maintained in high-security laboratories.”

The WHO issued its endorsement the same day, saying : “Studies conducted under appropriate conditions must continue to take place so that critical scientific knowledge needed to reduce the risks posed by the H5N1 virus continues to increase.” Although the WHO statement cautioned that the organization was “deeply concerned about potential negative consequences” of the research, it firmly stated that “research which can improve the understanding of these viruses and can reduce the public health risk is a scientific and public health imperative” that “must continue.”

The Times has been notable among U.S. papers in its thorough, thoughtful, and informative reporting covering several facets of the air-borne H5N1 story since it broke on Dec. 20. The big story initially centered on the suppression of details of how the ferret experiments were done, but since then the issue appropriately shifted to why the research was done and whether it had scientific merit. The Times greatly added to this discussion by publishing an interview with the head of the Rotterdam research team, and follow-up articles that examined the balance of potential benefits and risks from the work, as well as some of the underlying science behind avian flu transmission. Their interview with Dr. Fouchier, head of the Rotterdam group, included a memorable quote where he explained why he thought the research was so vital despite its danger: “In our opinion, nature is the biggest bioterrorist,” he said.

After producing such helpful and meaningful reporting over the past 2 weeks, it seems particularly curious that the Times’ editorial board looked at the totality of what’s been said on the subject and came down against the research, especially after it received renewed votes of confidence from several respected NIH leaders and from the WHO. It makes you wonder which infectious disease experts stand behind the Times’ position.

—Mitchel Zoler (on Twitter @mitchelzoler)

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Cancer Treatment: Problems Come With Success

Image courtesy of Wikimedia Commons user LadyofProcrastination

Thanks to earlier diagnosis and better treatments, we’ve started thinking of some cancers as chronic diseases — similar to asthma and diabetes. Cancer survivorship is definitely on the rise. The CDC recently reported that the number of cancer survivors in the United States rose from 3 million in 1971 and 9.8 million in 2001 to 11.5 million in 2007.

With a growing number of cancer survivors — who can live for years and  decades after diagnosis — there is a corresponding risk for pain medication addiction.  Gone are the days when oncologists can prescribe opioids like candy, according to a session at the annual meeting of the American Academy of Pain Medicine. Opioid misuse — and substance abuse in general — is a growing problem among cancer patients, according to experts at the session.

“We’re starting to see a lot more in the way of substance abuse of every stripe, in people – not necessarily who are developing substance abuse problems after they are exposed to opioids for their cancer pain – but actually the opposite. There are a lot of folks making it to tertiary cancer care centers with a history of addiction.”

Dr. Passik gave an example of a female patient, who lived with metastatic breast cancer for 11 years and who had a pre-existing polysubstance abuse problem as well. “What’s different about this case from before I had gray hair and before I spent 25 years working in psycho-oncology? When I first started in this field, this woman’s life expectancy would have been measured in months and now it’s measured in years to decades.”

Cancer patients need to be screened for abuse potential, said Steven Passik, Ph.D., a professor of psychiatry and anesthesiology at Vanderbilt University. Abuse risk management strategies are regularly used in non-cancer pain management, he said. It’s time for oncologists and other cancer specialists to start using the same strategies.

WHO Pain Ladder (courtesy of WHO)

Currently, in the WHO and NCCN guidelines, opioids are a mainstay for the treatment of cancer pain, said Dr. Dhanalakshmi Koyyalagunta, who is an associate professor of pain medicine at the MD Anderson Cancer Center in Houston. But “cancer is not a terminal disease any more … we have to change our paradigms as to how we approach these patients and how we treat them.” A good place to start is with a familiarity of the Clinical Guidelines for the Use of Chronic Opioid Therapy in Chronic Noncancer Pain.

It’s also important to identify and treat coexisting conditions that are frequently faced by cancer patients, said Diane Novy, Ph.D., who is a professor of pain management at MD Anderson. These include affective disorders, acute stress, problems related to cancer pain or treatment pain, family stress, and problems with work — and there are non-opioid treatment options for these issues.

Of course all this is not to say that opioids should never be used for pain management in cancer patients. Rather, clinicians need to screen for abuse risk factors before they prescribe these drugs and set up a monitoring system (random urine checks, pill counts, etc.).

Still — and not to belittle the suffering associated with substance abuse — having to change the way we look at cancer pain management to consider long-term treatment seems like a welcome challenge.

Kerri Wachter

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In the Developing World, Diseases Defy Definition

Before last week, I thought I knew the definition of “noncommunicable disease.” Then I attended “The Long Tail of Global Health Equity: Tackling the Endemic Non-Communicable Diseases of the Bottom Billion.”

 Held on the campus of Harvard Medical School in Boston March 2nd and 3rd, the 2-day conference was sponsored by Partners In Health, an international nonprofit organization that conducts research, does advocacy, and provides direct health care services for people living in poverty around the world. The “Bottom Billion” of the meeting’s title refers to the world’s poorest people living on less than $1 per day.

 In a 2008-2013 action plan, the World Health Organization refers to “the four noncommunicable diseases – cardiovascular diseases, diabetes, cancers and chronic respiratory diseases and the four shared risk factors – tobacco use, physical inactivity, unhealthy diets and the harmful use of alcohol.” Together, these conditions account for approximately 60% of all global deaths, of which 80% occur in low- and middle-income countries. 

A cancer patient in Rwanda receives chemotherapy as her husband and physician discuss her treatment / Photo courtesy of Partners In Health

But as I learned at the conference, among the Bottom Billion, rheumatic heart disease is often the result of an untreated streptococcal infection early in life, diabetes is frequently associated with malnutrition rather than over-nourishment, and cervical cancer due to human papillomavirus is far more common than in the developed world, where women routinely receive PAP screenings and a vaccine can now also prevent the infection.   

And most startling to me: Among the world’s poorest, smoking is not the most common cause of chronic obstructive pulmonary disease. Cooking with biomass fuels is.   

Individually, these and other so-called “endemic NCDs” including Burkitt’s lymphoma, sickle cell disease, and tropical diseases are far less common than those within the WHO’s “four-by-four” definition. But together, that “long tail” of chronic conditions contributes to a great deal of suffering. 

In May 2010, the United Nations announced that it would hold a high-level meeting on NCDs in 2011, now set for September 19-20. It will be only the 29th such meeting that the UN has ever held (formerly called “special sessions“), and just the second pertaining specifically to a health issue. The first one, the 2001 Summit on HIV/AIDS, is credited with focusing global attention and obtaining public and private funding for that cause. 

Speakers at the Partners In Health meeting stressed that the NCD movement should not be undertaken as an “us against them” competition with infectious disease for scarce resources. In a statement that will be presented to the heads of government at the UN summit, the group called instead for “strengthening and adjusting health systems to address the prevention, treatment, and care of NCDs, particularly at the primary health care level.”

—Miriam E. Tucker (@MiriamETucker on Twitter)

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A Pox on Both Your Houses: Should the United States Destroy Its Stockpile of Smallpox Virus?

 The situation: A potential standoff between Russia and the U.S., both of whom have stashed smallpox virus to develop emergency countermeasures in the event of biological warfare.

courtesy of flickr user hukuzatuna

In advance of the World Health Assembly this May, a commentary in a journal called Biosecurity and Bioterrorism (published online ahead of print on January 10, 2011) calls on the United States to get rid of most or all of its stock of smallpox virus.

The author, Jonathan B. Tucker, Ph.D., is a “professor of science and technology for peace and security” at Darmstadt University of Technology in Germany. That’s a title you don’t hear very often.

But Dr. Tucker writes that many public health experts and scientists, especially those in developing countries, would like to destroy any virus stashes, citing the overexaggerated risk of biological warfare and the existence of antiviral drugs that are in development but could be used in a public health emergency under an Emergency Use Authorization (EUA).

Failing an agreement between the U.S. and Russia to clean house and get rid of their smallpox viruses, Dr. Tucker offers some suggestions for compromise, including an agreement by the U.S. and Russia to share their smallpox research with World Health Organization (WHO) member countries and develop a stash of antiviral drugs to be controlled by the WHO for distribution to victims of a smallpox outbreak anywhere in the world. Both countries would then increase their contribution of smallpox vaccines to this WHO reserve.

What do you think? Should we keep some smallpox virus in reserve, or get rid of it?

–Heidi Splete (on twitter @hsplete)

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