20090505-6

Flu risk: A doctor wearing full-body protective gear stands at a
hospital in Mexico City as patients, wearing face masks, stand in
line to be treated.  Credit: Reuters

Hunting for Clues in the Swine Flu Genetic Code

MIT Technology Review, May/April 2009, by Emily Singer  —  Within days of confirming fresh cases of the new swine flu in California and Texas last week, scientists at the Centers for Disease Control (CDC), in Atlanta, had sequenced the entire genome of the virus. By Monday, much of that genomic information was loaded into a publicly available database, allowing the world’s scientists to begin searching for clues to the origins of the mysterious virus and the severity of the threat it poses.

The World Health Organization (WHO) raised its alert to level 5 last Wednesday, signaling that a pandemic is imminent, and making the search for new information even more urgent. “The biggest question now is, how severe will the pandemic be?” said Margaret Chan, WHO director-general, at a press conference on Wednesday evening. Currently, symptoms appear to range from mild to lethal.

Researchers hope that the genome will shed light on the pathogen’s power, as well as on its origins. Clusters of cases around the world already suggest that it is highly transmissible between humans. But it’s not yet clear how deadly the virus is–namely, whether it’s significantly more lethal than the seasonal flu virus, which kills an average of 36,000 people in the United States each year.

It’s also unclear whether the high mortality rates of the swine flu observed to date in Mexico, as compared to in the United States, reflect differences in the virus itself, or are linked to environmental factors such as differences in treatment, or an underestimate of infection rates in Mexico. There have been about 160 suspected swine flu deaths among approximately 2,500 people treated with severe pneumonia in Mexico since the outbreak began (Mexico’s National Institute for Public Health reports 49 confirmed infections and seven deaths). As of Wednesday afternoon, the CDC reported 91 confirmed cases in the United States and one death.

“Right now, we don’t have any evidence of a difference in virulence, but that’s one possibility we’re looking at,” said Richard Besser, acting director of the CDC, at a press conference on Tuesday. As of Wednesday afternoon, sequence information from virus samples isolated from patients in Mexico was not available through the public database, but there was data from samples collected in California, Texas, New York, Kansas, Ohio, and Germany. Neither the WHO nor the CDC could explain why.

“Given that this is still a rapidly evolving story, we need to get a handle on the first gene sequences from California, and hopefully from Mexico and others, to see how this virus has evolved,” says Ram Sasisekharan, a professor of biological engineering at MIT. “Where does it really come from? And can we explain the observed differences in what has happened in Mexico, which seems much more severe than what has happened in the U.S.?”

Virus genomes constantly mutate and can easily swap genes with other viruses, sometimes endowing a pathogen with the power to infect different species or to trigger more serious disease in their hosts. The new swine flu virus appears to have done more swapping than usual, with genetic segments from four different sources: North American swine influenza viruses, North American avian influenza viruses, one gene segment from a human influenza virus, and two gene segments that are normally found in swine influenza viruses in Asia and in Europe.

“Parts of it are from the original 1918 virus, parts are similar to the current circulating H1N1 strain from seasonal flu,” says Sasisekharan. “We are still trying to understand what that means.” The 1918 Spanish flu triggered a pandemic that killed millions around the globe.

The new swine flu is of a subtype called H1N1, the class of influenza that is responsible for the majority of seasonal flu. (The 1918 virus was also an H1N1 strain.) But humans have no existing immunity to the novel swine flu virus. “We want to look and see how the [surface proteins] differ from current circulating H1N1 strains,” says Ian Wilson, a scientist at Scripps Research Institute, in La Jolla, CA.

One such protein, called hemagglutinin, sits on the outside of the influenza virus and determines which cells it can infiltrate. Preliminary analysis of the hemagglutinin gene for the new swine virus “has the telltale signatures for human receptor binding,” says Sasisekharan. “But until we make the protein and confirm whether it binds to receptors in human airways or deep lung,” we won’t know for sure. He adds that the gene for the hemagglutinin protein has close to 90 changes in the amino acids that make up the protein. “That’s significant from a vaccine-development point of view,” says Sasisekharan, since it suggests that existing seasonal flu vaccines will not be effective against it.

Report Suspected Fraudulent or Criminal Activity Associated with H1N1 Flu Virus (Swine Flu)

 

The U.S. Food and Drug Administration is alerting the public to be wary of Internet sites selling products that claim to prevent, treat or cure 2009 H1N1 flu virus, and is informing offending websites that they must take prompt action to correct and/or remove promotions of these fraudulent products or face immediate enforcement action.

If you wish to report suspected fraudulent/illegal activity relating to FDA regulated products associated with H1N1 Flu Virus (Swine Flu), please describe in detail the suspected fraudulent/illegal activity in the comment box below and click the submit button.

Notice: Your submission is voluntary and will be anonymous unless you choose to identify yourself. However, be advised that your decision to remain anonymous may limit or prevent our ability to conduct a follow-up investigation regarding your information. If you provide a contact e-mail address it may be used to initiate follow-up communications with you concerning your information and may be shared by OCI when appropriate with other law enforcement and judicial entities engaged in investigating or assessing the information. There is no penalty for failing to report a possible violation; however, if you knowingly report false information to FDA’s Office of Criminal Investigations, you may be subject to criminal or civil penalties.

20090505-5

Flu flow: HealthMap, created by Google and the CDC,
annotates a global map with news articles, official medical
alerts, and other data in real time. Credit: Google 

Tracking and communications could play a key role in combating a pandemic.

MIT Technology Review, May/April 2009, by Michael Day  —  The World Health Organization (WHO) admitted on Tuesday that it’s too late to contain swine flu, and experts say that it is now vital to track the spread of the virus in order to mitigate its effects. Vaccines and antivirals will be crucial to the effort, but tracking and communications technologies could also play a key role in monitoring the virus, distributing accurate health information, and quelling outbreaks.

Bloggers and social-networking sites were among the first to follow the outbreak’s rapid spread from its epicenter in Mexico–where swine flu has been linked to more than 150 deaths–to cities across the United States and on to Europe, Israel, and New Zealand.

The need for fast information has seen the Centers for Disease Control and Prevention (CDC) build up a large following on Twitter. Groups ranging from fellow federal institutions, such as the National Institute for Occupational Safety and Health, to local Red Cross divisions, as well as many regular Twitter users, are employing the service to receive updates. Some experts, however, warn that Twitter can just as easily spread misinformation and panic. According to data from the medical tracking site Nielson, conversations related to swine flu reached 2 percent of all messages on Twitter over the weekend. By contrast, Google’s Flu Trends, a site that aims to spot flu outbreaks by monitoring search queries related to flu symptoms and treatment, has shown little increase in activity in recent days.

Some Twitter users have also been criticized for spreading misinformation by, for example, warning friends and followers against eating pork, which is not related to the spread of swine flu. Evgeny Morozov, a fellow at the Open Society Institute, in New York, wrote in a blog post on Saturday, “Having millions of people wrap up all their fears into 140 characters and blurt them out in the public might have some dangerous consequences, networked panic being one of them.”

Meanwhile, other Internet tools are helping to track the spread of the virus geographically. HealthMap, which was created by researchers from Children’s Hospital Boston with support from Google, the CDC, the National Library of Medicine, and the Canadian Institute of Health Research, adds real-time news alerts, official medical information, and other data to a global tracking map.

Susan Perkins, a specialist in microbial evolution at the American Museum of Natural History, in New York, NY, who has previously applied geographical information systems to the study of how viruses evolve, hopes that Internet technology and “the new field of info-epidemiology” can make a difference in future epidemics, if not in the current swine-flu outbreak. “Sites like HealthMap or Google Earth are a good new way to visualize data,” she says. “These readily accessible platforms also let people in diverse fields–public health, evolutionary biology, et cetera–share the same information.”

Perkins believes that being able to process viral genomes more quickly could make a big difference: “In the future, I would hope that diseases will be able to be better tracked with software that can combine genomic information with real geographic information. That will give us the most power to solve–and then hopefully break–transmission patterns.”

Others say that tracking the spread of the virus could help reveal how deadly it is, how easily it spreads, whether drug resistance is emerging, and how to target precious public-health resources. Jeffrey Herrmann, an applied mathematician and software engineer at the University of Maryland, has developed software that can analyze the spread of a disease and pinpoint the best locations for treatment or mass vaccination. He says that this approach “could be used by local public-health departments to determine how many sites and how many staff they need to dispense antiviral medication or vaccinate people.”

The WHO’s Pandemic Influenza Task Force decided on Monday to raise the alert to level 4 on the pandemic scale. This means that confirmed human-to-human transmissions are now causing community-level outbreaks.

“We might expect up to 30 percent to 40 percent of the population to become ill in the next six months,” says Neil Ferguson, a member of the WHO task force and a professor of epidemiology at Imperial College London. He adds that the virus appears less lethal than H5N1 bird flu–but crucially, it’s more contagious. In the six years since its emergence in 1993, H5N1 has killed 257 people; swine flu has already killed 150 in a matter of weeks. The last pandemic, Hong Kong flu, killed about 700,000 (1 in 1,000 of its victims) in 1968.

So far, no deaths have been reported outside of Mexico, but the consensus among virologists is that it is too early to say whether suggestions that the death rate is higher in Mexico will be borne out. Some have suggested that better treatment in the United States has made infections there less dangerous. Or it could be that the much greater number of cases seen so far in Mexico–there are now more than 2,000 suspected–has made some deaths there more likely.

Pharmaceutical firms, meanwhile, have begun the race to produce a vaccine. Switzerland’s Novartis said on Tuesday that it had received the genetic code of the new virus strain, enabling it to begin work in earnest. The WHO estimates that an effective inoculation is still six months away, but this might be in time for a second wave of infection later in the year.

Peter Dunnill, a professor of biochemical engineering at University College London, warns that even if a vaccine is produced, not everyone will have access to it. “Based on calculations done in relation to H5N1, the global capacity for providing a vaccine at its most optimistic is less than 10 percent of the world’s people,” he says.

Antiviral drugs are likely to provide the first line of defense. In the United States, Homeland Security Secretary Janet Napolitano said recently that she will release a quarter of the 50 million courses of antiviral drugs in the national stockpile. She added that the Defense Department has another 7 million courses ready. But their effectiveness could be short lived–particularly if they are used now, and the virus resurfaces later in the year. Professor of immunology Peter Lachmann of the University of Cambridge says, “Tamiflu resistance is extraordinarily widespread and develops very quickly. We would be very lucky if this virus does not develop resistance.”

Hillary Rodham Clinton

Secretary of State

Washington, DC

 

Secretary Clinton delivered this statement at her testimony before the Senate Appropriations Committee

Before turning to the topic of today’s hearing, let me just give you a brief update on how the State Department is supporting the federal government’s response to the H1N1 flu virus.

We have established an influenza monitoring group within our Operations Center. We are tracking how other governments are responding to the threat and what assistance we might offer. We are constantly reviewing and refining our advice to Americans traveling or living abroad.

Our pandemic influenza unit, set up in the last years, is providing valuable expertise. Its director, Ambassador Robert Loftis, is keeping us apprised of their work and their interaction with health agencies and the World Health Organization.

Earlier this week, USAID announced it is giving $5 million to the World Health Organization and the Pan American Health Organization to help detect and contain the disease in Mexico.

We will continue to coordinate closely with the Departments of Health and Human Services, Homeland Security, the WHO, the CDC, and other agencies. And I’m very cognizant of the role that we all must play in attempting to stem and contain this influenza outbreak.

PRN: 2009/400

20090505-4

Statement of

Joshua M. Sharfstein, M.D.
Principal Deputy Commissioner and
Acting Commissioner
Food and Drug Administration
Department of Health and Human Services

before

Subcommittee On Health
Committee on Energy and Commerce
U.S. House of Representatives

May 2009

INTRODUCTION

Mr. Chairman and Members of the Committee, I am Dr. Joshua M. Sharfstein, Principal Deputy Commissioner and Acting Commissioner at the U.S. Food and Drug Administration (FDA or the Agency). Among its other responsibilities, FDA protects the public health by facilitating access to safe and effective human and animal drugs, human biological products, and devices. Recognizing the global nature of public health issues, we collaborate with foreign counterpart regulatory agencies and international organizations to carry out our mission. FDA plays a vital role in the Nation’s preparedness for, and response to, challenges such as the one presented today by the 2009-H1N1 Flu Virus.

FDA is part of a team led by the Department of Health and Human Services (HHS or the Department). Since the beginning of the 2009-H1N1 Flu Virus outbreak last Thursday, FDA has worked closely with the Department, our sister HHS agencies, other U.S. government agencies, the World Health Organization (WHO), and foreign governments.

I appreciate the opportunity to discuss the Agency’s response, including our approval of several emergency use authorizations earlier this week, and the efforts of several internal FDA teams.

Emergency Use Authorizations

Section 564 of the Federal Food, Drug, and Cosmetic Act, which was added by the Project BioShield Act of 2004 (Public Law 108-276), permits the FDA Commissioner to issue an Emergency Use Authorization following a determination and declaration of a public health emergency, provided certain statutory criteria are met. An Emergency Use Authorization allows the use of an unapproved product or an approved product for an unapproved use, in a declared emergency. To authorize the emergency use of a product, FDA must generally find that the agent (in this case, the 2009-H1N1 Flu Virus) can cause a serious or life-threatening disease or condition; that based on the totality of the scientific evidence available it is reasonable to believe that the product may be effective against the disease or condition; that the known and potential benefits of the product’s use outweigh the known and potential risks; and that there is no adequate, approved, and available alternative.

Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act provides that, before an Emergency Use Authorization may be issued, the Secretary of HHS must declare a public health emergency justifying the authorization based on one of three grounds, including “a determination by the Secretary of a public health emergency under section 319 of the Public Health Service Act that affects, or has a significant potential to affect, national security, and that involves a specified biological, chemical, radiological, or nuclear agent or agents, or a specified disease or condition that may be attributable to such agent or agents.”

This past Sunday, April 26, 2009, the Acting HHS Secretary issued a nationwide public health emergency declaration in response to recent human infections from a newly discovered influenza A virus, the 2009-H1N1 Flu Virus. On April 26 and April 27, the Acting Secretary issued declarations justifying emergency use of certain antivirals, in vitro diagnostics, and personal respiratory protection devices.

On April 27, 2009, FDA issued four Emergency Use Authorizations in response to requests from the Centers for Disease Control and Prevention (CDC). Three of these Emergency Use Authorizations make available to public health and medical personnel for emergency use two FDA-approved drugs, Relenza and Tamiflu, for the treatment and prevention of the 2009-H1N1 Flu Virus, and an rRT-PCR test for diagnosing infection with the virus. The fourth authorizes the emergency use of certain personal respiratory protection devices, specifically disposable respirators certified by CDC’s National Institute for Occupational Safety and Health, known as N95 respirators.

These authorizations expire by statute in one year unless previously revoked by the Agency, but they can be renewed if the conditions giving rise to the determination and declaration continue to exist.

Currently, Tamiflu is approved for the treatment of uncomplicated illness due to influenza and prevention of influenza in patients 1 year and older. Relenza is approved to treat acute uncomplicated illnesses due to influenza in adults and children 7 years and older who have been symptomatic for less than two days, and for the prevention of influenza in adults and children 5 years and older.

One of the emergency use authorizations allows for Tamiflu also to be used to treat and prevent influenza in children under one year. In addition, under the authorizations, both medications may be distributed with information pertaining to emergency use to large segments of the population without complying with the label requirements otherwise applicable to dispensed drugs. They may also be distributed by a broader range of health care workers, including some public health officials and volunteers, in accordance with applicable state and local laws or public health emergency responses.

The Emergency Use Authorization for the rRT-PCR 2009-H1N1 Flu Panel diagnostic test allows the CDC to distribute the 2009-H1N1 Flu Panel test to public health and other qualified laboratories that have the needed equipment and the personnel who are trained to perform and interpret the results.

The test amplifies the viral genetic material from a human sample. A positive result indicates that the patient is presumptively infected with the 2009-H1N1 Flu Virus, but it doesn’t identify the stage of infection. A negative result does not, by itself, exclude the possibility of 2009-H1N1 Flu Virus infection.

The Emergency Use Authorization for certain disposable respirators permits HHS to deploy these products from the Strategic National Stockpile for use to help reduce exposure to airborne germs. These products, when used properly and in accordance with information that is provided, may help reduce the chances of getting sick. They do not eliminate the risk of illness or death. They should always be used in conjunction with other infection control measures, such as frequent hand washing, and other measures recommended by CDC and state and local public health authorities.

The FDA’s Efforts on 2009-H1N1 Flu Virus

As soon as we became aware of the 2009-H1N1 Flu Virus outbreak, I asked Dr. Jesse Goodman, FDA’s Acting Chief Scientist and Deputy Commissioner for Scientific and Medical Programs, to coordinate and lead FDA’s efforts on the 2009-H1N1 Flu Virus. Dr. Goodman previously directed FDA’s Center for Biologics Evaluation and Research and is a world-recognized infectious disease expert with extensive experience in issues related to influenza vaccine development and evaluation.

Dr. Goodman leads an incident management approach that now includes seven substantive teams, which are cross-cutting and include staff from across the FDA as needed. All of FDA’s Centers are engaged in this important work.

These teams work with the Department, CDC, other agencies, national and international partners. The teams include: Vaccine Team, Antiviral Team, In Vitro Diagnostics Team, Personal Protection Team, Blood Team, Shortage Team, and the Consumer Protection Team.

The incident management structure also includes an operations section, a logistics section, and a communications section that coordinates external relations, including media, stakeholders, international, legislative, and Web site development. It includes FDA senior-level health, international, and legal advisers.

Below is a brief summary of the focus of each team. This management approach is flexible and likely to change over time.

Vaccine Team

Surveillance for novel strains of influenza is ongoing. If epidemiological data suggest the emergence of a novel human influenza virus, we have the infrastructure to begin work in the event that a vaccine needs to be manufactured for the novel strain. The Vaccine Team is working to facilitate the availability of a safe and effective vaccine to protect the public from the 2009-H1N1 Flu Virus as soon as possible.

Part of the team is growing and genetically engineering the 2009-H1N1 Flu Virus in the laboratory for possible use in a vaccine. FDA is also beginning to prepare reagents that will be needed to help manufacturers produce and test the vaccine. The Vaccine Team also is working with CDC and other WHO centers on laboratory studies that may help us understand how well the seasonal flu vaccine might protect against the 2009-H1N1 Flu Virus.

At the policy level, the vaccine team is also fully engaged in discussions with the Biomedical Advanced Research and Development Authority (BARDA), a component of the Office of the Assistant Secretary for Preparedness and Response (ASPR) in HHS, the National Institutes of Health (NIH), and manufacturers regarding the initiation of clinical trials to evaluate the immune response to vaccines derived from this 2009-H1N1 Flu Virus and in considering options for production. FDA is a WHO/Pan American Health Organization collaborating center and is already working closely with WHO on vaccine issues, including testing and development of seed strains in preparation for vaccine development. FDA is also fully engaged with sister regulatory agencies throughout the world.

Antiviral Team

The goal of the Antiviral Team is to identify and evaluate antiviral drugs that can be used to prevent and treat illness caused by the 2009-H1N1 Flu Virus and to facilitate access to these medications. This team led the Agency’s efforts to issue the April 27, 2009, Emergency Use Authorizations for Relenza and Tamiflu. In addition, the team is in communication with manufacturers to explore potential investigational options for treatment of the 2009-H1N1 Flu Virus. Like the Vaccine team, the Antiviral Team is working closely with sister regulatory agencies throughout the world.

In Vitro Diagnostics Team

The In Vitro Diagnostics Team’s goal is to identify and evaluate in vitro diagnostics that can help test for the 2009-H1N1 Flu Virus. This team led the Agency’s efforts to issue the April 27, 2009, Emergency Use Authorization for the rRT-PCR test developed by CDC. This team is in communication with the Biomedical Advanced Research and Development Authority at HHS and manufacturers regarding potential shortages with the FDA-approved rapid influenza A test.

Personal Protective Equipment Team

This team works to facilitate the availability of personal protective equipment that may help reduce the risks from exposure to the 2009-H1N1 Flu Virus. This team led the efforts to issue the April 27, 2009, Emergency Use Authorization for disposable N95 respirators. The team is in communication with manufacturers regarding current demand and ability to increase production to meet expected demand. The team is working with CDC on public communications about usage of various forms of respiratory protection.

Blood Team

The Blood Team is dedicated to the safety and availability of blood and blood products needed for transfusion by the American public during this influenza outbreak. Though we have no evidence to date that the 2009-H1N1 Flu Virus has affected our blood supply, we are monitoring the situation for developments, and working closely with HHS, our sister agencies, blood banks, and other experts.

Shortage Team

The Shortage Team works to facilitate the availability of antiviral drugs to the American public. The team participates in daily calls with HHS’ Biomedical Advanced Research and Development Authority and manufacturers to assess current needs and availability of these products. FDA will be referring private individuals, including health care providers, to their state and local health departments to obtain information about product availability in their locale.

Consumer Protection Team

This team has the goal of protecting consumers from fraudulent and potentially dangerous medical products. FDA is monitoring the internet for sites selling products that claim to prevent, treat, or cure the 2009-H1N1 Flu Virus, among other activities to protect consumers.

CONCLUSION

FDA is fully committed and engaged in protecting the public’s health during this difficult time. Among us are laboratory scientists, medical reviewers, epidemiologists, product experts and field inspectors. We will bring every skill and resource we have to this critical mission.

Thank you very much for the opportunity to testify today. I welcome your ideas and your questions.

 20090505-3

Adriana Zehbrauskas for The New York Times

At the General Hospital in Oaxaca, Mexico, a doctor examined a patient who complained of flulike symptoms

The New York Times, May/April 2009, OAXACA, Mexico – Adela María Gutiérrez fell ill in the beginning of April with what she thought was a bad cold. She tried aspirin and antibiotics, bed rest and moist towels, but nothing brought down her soaring fever, reduced her aches and pains, or boosted her energy level.  Also, she was a diabetic.

It would be more than a week before Mrs. Gutiérrez went to Oaxaca’s General Hospital, where she arrived listless and barely able to breathe, her extremities blue from a lack of oxygen.

That delay in getting expert help may explain why Mrs. Gutiérrez, 39, a mother of daughters ages 10, 17 and 20, became Mexico’s first death from a new, virulent strain of influenza A(H1N1). It may also suggest why this country’s death toll from the virus is higher than any other’s.

Epidemiologists are still puzzled by the virus, its origins and its modes of transmission. But they agree that prompt medical attention is crucial to treating it.

That has been where Mexico, which the Health Ministry said Thursday had 312 confirmed cases and 12 deaths, lags far behind.

“People wait too long to go to doctors,” said Dr. Marcelo Noguera, undersecretary of health for the state of Oaxaca.

“That’s a problem here in Mexico,” he continued. “If we can treat a disease like this early, we can stay ahead.”

There may well be other factors to explain why patients like Mrs. Gutiérrez, whose medical records show a desperate, belated scramble by doctors to keep her alive, are dying in Mexico at a higher rate than flu patients elsewhere. Mexicans may have been hit by a different, deadlier strain, or the flu may have infected more people who had other health problems, researchers speculate.

But one important factor may be the eclectic approach to health care in Mexico, where large numbers of people self-prescribe antibiotics, take only homeopathic medicine, or seek out mysterious vitamin injections. For many, only when all else fails do they go to a doctor, who may or may not be well prepared.

“I think it has to do with the culture, the idiosyncrasies of Mexicans,” said Dr. Nicolas Padilla, an epidemiologist at the University of Guanajuato. “The idea is that I don’t go to the doctor until I feel very bad.”

There also are logistical reasons that compel Mexicans to steer clear of hospitals. At overcrowded public facilities, they complain, they are often turned away, treated by indifferent doctors or made to wait endlessly.

Mrs. Gutiérrez’s husband, Luis, said Thursday in an interview in his home that when she arrived at the hospital, no bed was available, and no respirator. They give preference to people who are bleeding, who are near death, he said.

Making matters worse, because it was Holy Week, the hospital had lower staffing levels than normal, and she had to wait several hours before being seen.

The government is pushing to expand its public health network through a new insurance program that attempts to reach poorer people and those in remote areas.

But experts say the country has had a harder time improving quality.

Mexico’s public health budget is about 3 percent of gross domestic product – within the range of spending by other major Latin American economies, but well below the rate in developed countries, according to the World Bank; and Mexico has only about half as many hospital beds per capita than the United States.

To help Mexico meet the extra costs of the flu epidemic, the World Bank issued a loan of $205 million.

“The two key things that they need to work on now,” said Keith Hansen, a World Bank health official for Latin America and the Caribbean, “is surveillance, to pick up patterns of infection, and to make sure that everybody who needs care has access to it.”

In an acknowledgment that Mexicans frequently act as their own doctors, the government’s announcements, played repeatedly on the radio, advise people not to self-medicate and instead to seek out medical attention.

Mrs. Gutiérrez, in contrast, continued working as a field worker for the national tax agency after first showing symptoms. It took her three days to go to a doctor at a small clinic a few blocks from her home. She was told she had a throat infection and should take antibiotics. As her condition worsened, she sought other opinions but still avoided the hospital. On her third consultation, a doctor told her she had pneumonia and sent her to the hospital.

Once she was admitted, health officials appear to have acted relatively quickly. A laboratory test found an unusual virus. State and federal health authorities were notified. “She wasn’t responding,” said Dr. Yuri Roldán Aragón, one of her doctors. Her condition worsened by the day, and she died on the afternoon of April 13.

Her medical file, nearly an inch thick, sits on the desk of Dr. Jesús M. Salcedo, the hospital administrator, with the word “Defunción,” meaning she died, scrawled across the cover sheet in red marker. Her various diagnoses over the course of her treatment – pneumonia, coronavirus, SARS, among others – indicate the initial uncertainty about her condition.

Three days after she died, Mexican officials declared an epidemiological alert based on her case and others. That set in motion surveillance at 520 hospitals nationwide, and notification of an expanded flu season to the United States Centers for Disease Control in Atlanta.

The next chapter occurred on April 20, when the C.D.C. notified Mexican officials that two cases had been found in Southern California that showed components of human and swine flu, said Dr. Miguel Ángel Lezana, Mexico’s chief government epidemiologist.

On April 22, Mexican authorities sent samples, including ones from Mrs. Gutiérrez and a young boy in La Gloria, a small town in Veracruz, to the National Microbiology Laboratory in Winnipeg, Canada. The results came back the next day. Both Mrs. Gutiérrez and the boy, Édgar Hernandez, who survived, tested positive for the mysterious flu.

Epidemiologists in Oaxaca swung into action. They isolated Mrs. Gutiérrez’s family, disinfected her home and began more than 500 interviews with neighbors, co-workers and hospital workers.

Any who had flulike symptoms were tested, but none have been found to have the same virus that killed Mrs. Gutiérrez, said Dr. Rubén Coronado, a state epidemiologist.

Oaxaca, one of Mexico’s poorest states, has reported about 60 suspected cases. Mrs. Gutiérrez is the only confirmed death.

“We’re in a quandary,” Dr. Noguera said of how Mrs. Gutiérrez might have contracted the virus while others around her apparently did not. “I don’t have a theory. I just don’t know.”

Marc Lacey reported from Oaxaca, Mexico, and Elisabeth Malkin from Mexico City.

20090505-2

A boy wears a mask inside a bus in Bogota May 4, 2009.

 

New H1N1 Flu Could Mutate and Return in the Fall to Northern Hemisphere, More Virulent. WHO Must Remain Vigilant

 

GoogleNews.com, May 4, 2009- The World Health Organization is likely to raise its flu alert to the top of its six-point scale and declare a pandemic, its director-general indicated in an interview published on Monday.

In remarks setting the scene for another alert increase, but without saying when, WHO chief Margaret Chan warned against over-confidence following a stabilization in the number of new cases of the H1N1 strain that has proved deadly in Mexico.

“Level 6 does not mean, in any way, that we are facing the end of the world. It is important to make this clear because (otherwise) when we announce level 6 it will cause an unnecessary panic,” she told Spanish newspaper El Pais.

“Flu viruses are very unpredictable, very deceptive … We should not be over-confident. One must not give H1N1 the opportunity to mix with other viruses. That is why we are on alert.”

The WHO’s pandemic phases reflect views about how a virus is spreading, and not how severe its effects are.

Last week the United Nations agency raised the alert level twice, from 3 to the current 5, in response to the sustained transmission of H1N1 in Mexico and the United States.

Before issuing a level 6 alert, the WHO would need to see the virus spreading within communities in Europe or Asia.

A declaration of a full pandemic would send a signal to governments worldwide to institute their pandemic response plans, which may include measures affecting hospitals, schools or public events.

Phase 6 would also trigger increased support for developing countries which lack the drugs, diagnostic tests, and medical staff to respond appropriately to the flu that the WHO has said could be especially dangerous for people with HIV/AIDS.

While the top-level alert would not have an automatic effect on the world’s flu vaccine production, the WHO is expected to make an announcement alongside any such declaration to specify whether manufacturers should switch from making seasonal to pandemic flu vaccines.

In her remarks to El Pais, Chan said that weather patterns could play an important role in how the flu continues to spread. The southern hemisphere is about to enter winter, when seasonal flu cases normally spike, the infectious disease expert said.

“We have to be very careful. No one can predict what is going to happen when countries in the south have flu peaks and this new one arrives — which it is going to do, without a doubt,” she said.

On Sunday, a WHO spokesman said the relatively large number of infections in Spain of what has been commonly known as swine flu — at 40, according to the WHO’s count — seemed to be mainly “imported” cases involving people returning from Mexico, the epicenter of the disease outbreak.

Chan echoed this and said that so far, there were not many flu patients in Europe that have not been to Mexico or had direct contact with those who had.

“It is true that the number is small, but because of that I would say that we have not seen the full situation or the whole picture of what is happening. The situation is evolving and the virus is changing,” she said.

Chan, who fought SARS and bird flu in her previous job as Hong Kong’s health director, said it was too early to predict what proportion of the population would catch the new flu strain after the European Union predicted 40 percent of the population would become infected.

20090505-1

Reviewed by Louise Chang, MD

 

WebMD.com, May 4, 2009, by Daniel J. DeNoon  —  The new H1N1 swine flu is circulating in “virtually all the U.S.,” a CDC official said yesterday.

Anne Schuchat, MD, the CDC’s acting director for science and public health, noted that the count of states with confirmed flu jumped to 30 on Sunday — and said she expects that nearly all states soon will see cases.

“I believe that virtually all the U.S. has this virus circulating. It does not mean everyone is infected, but within communities, it has arrived,” Schuchat said at a news conference. 

In New York City, the new flu spread quickly through a high school, infecting one in three students.

“What we can learn from the New York City survey is this virus spread pretty easily in those high school students,” Schuchat said.

The H1N1 swine flu remains a relatively mild flu illness for most people who come down with it.

But to slow its spread and buy time for vaccine development, the CDC recommends that schools shut down for two weeks if a student comes down with a confirmed or even suspected case of the new flu.

This means parents should make plans for what they would do if their children’s schools were affected.

The sudden appearance of the new flu raises a number of questions. The one that worries Schuchat is whether the H1N1 swine flu can keep smoldering throughout the spring and summer months — and what will happen if it hits hard when flu season starts back up in the fall and winter.

“I am particularly concerned about what will happen in the fall,” Schuchat says.

Although most U.S. H1N1 flu cases have been mild, the CDC fully expects more hospitalizations and more deaths. 

It’s possible the new flu could mutate to become even milder. On the other hand, it’s also possible it could become much more severe. That is the specter that keeps public health workers awake at night — and working every weekend.

Keynote by Regenerative Medicine Expert Dr. Joseph P. Vacanti

CAMBRIDGE, MA — (Marketwire) — 05/04/09 — On May 14, the MIT Enterprise Forum of Cambridge will feature a panel discussion on the advancement and future of tissue engineering, also known as regenerative medicine. With recent advances in the fields of biochemistry, cell and molecular biology, and genetics, tissue engineering has progressed rapidly and has the potential to deliver dramatic improvements in medical care for hundreds of thousands of patients.

Dr. Joseph P. Vacanti, a John Homans professor of surgery at Harvard Medical School and chief of the Department of Pediatric Surgery at Massachusetts General Hospital (MGH), will give the keynote address. Following Vacanti’s presentation, a team of panelists will discuss the potential of tissue engineering, highlighting its unique challenges and successes and probing the issues behind translating the science successfully into business.

Keynote speaker:

Outside his work with the Harvard Medical School and the Department of Pediatric Surgery at MGH, Dr. Joseph P. Vacanti is also surgeon-in-chief at the MassGeneral Hospital for Children, co-director of the Center for Regenerative Medicine, director of the Laboratory for Tissue Engineering and Organ Fabrication, and chief of Pediatric Transplantation at MGH. Vacanti received a B.S. from Creighton University, an M.D. from the University of Nebraska’s College of Medicine and an M.S. from Harvard Medical School. He has been working in the field of tissue engineering since its beginnings in the early 1980s.

Panelists:

Damien Bates is chief medical officer at Organogenesis, Inc., a leading regenerative medicine company. Prior to joining Organogenesis, Bates served as global medical director for Baxter BioSurgery. He holds an M.D. from the University of Sydney and a Ph.D. in developmental biology from the University of Melbourne.

Sudha Kadiyala is the senior director for business development and strategic planning at Advanced Technologies and Regenerative Medicine LLC, a subsidiary of Johnson & Johnson. Kadiyala has served in multiple roles at other Johnson & Johnson subsidiaries, including director of cartilage and soft tissue technologies and director of bone and spinal biologics. Kadiyala has a Ph.D. in biomedical engineering from the Johns Hopkins University School of Medicine, a Master’s degree from the Thayer School of Engineering at Dartmouth College and a Bachelor’s degree from the Indian Institute of Technology.

Michael J. Lysaght is the director of the Center for Biological Engineering at Brown University. Before joining Brown in 1994, Lysaght held positions at Amicon Corp., the Max Planck Institute for Biophysics in Frankfurt, Germany, University Hospital of Munich, Baxter International and CytoTherapeutics. Lysaght received an A.B. from Georgetown University, a B.S. and M.S. in Chemical Engineering from MIT, and a Ph.D. in Biochemical Engineering from the University of New South Wales.

Gary Arlen Smith, Esquire, is vice president and general counsel at Tengion, a clinical-stage biotechnology company. Prior to joining Tengion, Smith served as VP and general counsel for Enzon Pharmaceuticals, and earlier was in private law practice, specializing in the life sciences industry. He is a member of the Health and Science Desk Advisory Committee of public broadcasting station WHYY. Smith earned a B.A. in chemistry from Franklin and Marshall College and a law degree from Temple University Beasley School of Law.

When: Thursday, May 14, 2009

      5:30pm: Networking

      6:15-8:00pm: Program

      8:00-9:00pm: Networking Reception

 

Where: Stata Center (Bldg. 32), Kirsch Auditorium, 32 Vassar St.,

Cambridge, MA

 

Program organizers: Richard Smith, Edwards Angell Palmer & Dodge LLP,

John L. Brooks III, Healthcare Capital Consulting, Pearl Freier,

Cambridge BioPartners, Adriana Jenkins, William Whelan, Mintz Levin

 

Registration and information: http://www.mitforumcambridge.org/may.html

 

Pricing: Forum members: $20, Non-members: $30, MIT Staff with ID: $20.

Students from all universities are free with college ID. Pre-registration

is encouraged.