Swine Flu website last updated Monday, April 27, 2009

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Human cases of swine influenza A (H1N1) virus infection have been identified in the United States. Human cases of swine influenza A (H1N1) virus infection also have been identified internationally. The current U.S. case count is provided below.

Investigations are ongoing to determine the source of the infection and whether additional people have been infected with swine influenza viruses.

CDC is working very closely with officials in states where human cases of swine influenza A (H1N1) have been identified, as well as with health officials in Mexico, Canada and the World Health Organization. This includes deploying staff domestically and internationally to provide guidance and technical support. CDC has activated its Emergency Operations Center to coordinate this investigation.

Laboratory testing has found the swine influenza A (H1N1) virus susceptible to the prescription antiviral drugs oseltamivir and zanamivir and has issued interim guidance for the use of these drugs to treat and prevent infection with swine influenza viruses.

CDC also has prepared interim guidance on how to care for people who are sick and interim guidance on the use of face masks in a community setting where spread of this swine flu virus has been detected. This is a rapidly evolving situation and CDC will provide new information as it becomes available.

http://www.cdc.gov/swineflu/index.htm

April 27, 2009

NYTimes update

Dr. Richard Besser, acting director of the Centers for Disease Control and Prevention in Atlanta, Ga., called the European Union’s advisory against traveling to the United States unwarranted, saying that only 20 cases had been diagnosed here, just one of which required hospitalization.

By DONALD G. McNEIL and ANAHAD O’CONNOR

The New York Times, April 27, 2009 — Hoping to head off a global pandemic of swine flu that has surfaced in North America, the European Union’s health commissioner on Monday urged Europeans to avoid traveling to the United States or Mexico if doing so was not essential.

The warning came as health officials in Spain confirmed early Monday that a man hospitalized in eastern Spain had tested positive for swine flu, becoming what appeared to be Europe’s first case of the disease. Health authorities were also testing 17 other suspected cases across Spain, a major hub for travel between Mexico and Europe.

Britain and other European Union nations had already issued travel advisories for those traveling to Mexico, but the European Union’s health commissioner went a step further on Monday in urging Europeans to avoid nonessential trips. Europeans, she told reporters in Luxembourg, “should avoid traveling to Mexico or the United States of America unless it is very urgent for them.”

The fear that outbreaks of the flu might severely curtail travel was enough to unnerve markets in Europe and Asia, sending stocks tumbling, particularly shares of airlines and other companies in the travel industry.

But Dr. Richard Besser, acting director of the Centers for Disease Control and Prevention in Atlanta, Ga., called the European Union’s advisory against traveling to the United States unwarranted, saying that only 20 cases had been diagnosed here, just one of which required hospitalization.

“We are looking very hard for cases of swine flu,” he told CNN early Monday. “I expect we’re going to find some, and we’ll find some of increasing severity and more of the mild cases. At this point I would not put a travel restriction or recommendation against coming to the United States.”

The European Union’s travel advisory followed an advisory by Hong Kong on Sunday that called for residents of that territory to avoid all travel to Mexico and to try to avoid travel to cities with confirmed cases in the United States.

Other nations also imposed travel bans or made plans to quarantine air travelers over the weekend as additional confirmed cases appeared in Mexico and Canada, and at least 10 suspected cases appeared in New Zealand. Eight of the 20 confirmed cases in the United States were diagnosed in New York City, where Mayor Michael R. Bloomberg was expected to hold a news conference early Monday afternoon.

Top global flu experts struggled to predict how dangerous the new A (H1N1) swine flu strain would be as it became clear that they had too little information about Mexico’s outbreak — in particular how many cases had occurred in what is thought to be a month before the outbreak was detected, and whether the virus was mutating to be more lethal, or less.

“We’re in a period in which the picture is evolving,” said Dr. Keiji Fukuda, deputy director general of the World Health Organization. “We need to know the extent to which it causes mild and serious infections.”

Without that knowledge — which is unlikely to emerge soon because only two laboratories, in Atlanta and Winnipeg, Canada, can confirm a case — his agency’s panel of experts was unwilling to raise the global pandemic alert level, even though it officially saw the outbreak as a public health emergency and opened its emergency response center.

President Obama, said on Monday that the outbreak was “a cause for concern” but not alarm. Speaking at the National Academy of Sciences in Washington, he promised that “Department of Health and Human Services as well as the Centers for Disease Control will be offering regular updates to the American people so that they know what steps are being taken and what steps they may need to take.”

Concerns about the potential economic impact of the outbreak sent stocks tumbling across the globe, hitting travel-related companies particularly hard. Most Asian and European markets were down by the end of trading Monday, with tourism and airline industry stocks leading the decline. Shares of United Airlines, Delta Airlines, and other major carriers plunged as well.

In Spain, the Ibex 35, a benchmark stock index, was off 2.5 percent. A health official there said that the man who tested positive had been hospitalized in Almansa, in eastern Spain, but was not seriously ill. The other suspected cases were scattered around the country, with 10 in the northeastern region of Catalonia and cases in Madrid, Valencia and the Basque regions.

Normally, there are about two dozen flights between Spain and Mexico each day.

Other governments tried to contain the infection amid reports of potential new cases, including in New Zealand. Health officials there said that nine students and their teacher had tested positive for influenza A after returning to Auckland from a trip to Mexico. The W.H.O. was conducting tests to determine if the virus was in fact swine flu. In the meantime, airport workers in Auckland were stepping up their screening of people traveling from North America.

On Sunday, at a news conference in Washington, Homeland Security Secretary Janet Napolitano called the United States’ emergency declaration “standard operating procedure,” and said she would rather call it a “declaration of emergency preparedness.”

“It’s like declaring one for a hurricane,” she said. “It means we can release funds and take other measures. The hurricane may not actually hit.”

American investigators said they expected more cases here, but noted that virtually all so far had been mild and urged Americans not to panic.

The speed and the scope of the world’s response showed the value of preparations made because of the avian flu and SARS scares, public health experts said.

The emergency declaration in the United States lets the government free more money for antiviral drugs and give some previously unapproved tests and drugs to children. One-quarter of the national stockpile of 50 million courses of antiflu drugs will be released.

Border patrols and airport security officers are to begin asking travelers if they have had the flu or a fever; those who appear ill will be stopped, taken aside and given masks while they arrange for medical care.

“This is moving fast and we expect to see more cases,” Dr. Besser said at the news conference with Ms. Napolitano on Sunday. “But we view this as a marathon.”

He advised Americans to wash their hands frequently, to cover coughs and sneezes and to stay home if they felt ill; but he stopped short of advice now given in Mexico to wear masks and not kiss or touch anyone. He praised decisions to close individual schools in New York and Texas but did not call for more widespread closings.

Besides the eight New York cases, officials said they had confirmed seven in California, two in Kansas, two in Texas and one in Ohio. The virus looked identical to the one in Mexico believed to have killed 103 people — including 22 people whose deaths were confirmed to be from swine flu — and sickened about 1,600. As of Sunday night, there were no swine flu deaths in the United States, and one hospitalization.

Dr. Fukuda of the W.H.O. said his agency would decide Tuesday whether to raise the pandemic alert level to 4. Such a move would prompt more travel bans, and the agency has been reluctant historically to take actions that hurt member nations.

Canada confirmed six cases, at opposite ends of the country: four in Nova Scotia and two in British Columbia. Canadian health officials said the victims had only mild symptoms and had either recently traveled to Mexico or been in contact with someone who had.

Other governments issued advisories urging citizens not to visit Mexico. China, Japan, Hong Kong and others set up quarantines for anyone possibly infected. Russia and other countries banned pork imports from Mexico, though people cannot get the flu from eating pork.

In the United States, the C.D.C. confirmed that eight students at St. Francis Preparatory School in Fresh Meadows, Queens, had been infected with the new swine flu. At a news conference on Sunday, Mayor Michael R. Bloomberg said that all those cases had been mild and that city hospitals had not seen a surge in severe lung infections.

On the streets of New York, people seemed relatively unconcerned, in sharp contrast to Mexico City, where soldiers handed out masks.

Hong Kong, shaped by lasting scars as an epicenter of the SARS outbreak, announced very tough measures. Officials there urged travelers to avoid Mexico and ordered the immediate detention of anyone arriving with a fever higher than 100.4 degrees Fahrenheit after traveling through any city with a confirmed case, which would include New York.

Everyone stopped will be sent to a hospital for a flu test and held until it is negative. Since Hong Kong has Asia’s busiest airport hub, the policy could severely disrupt international travel.

The central question is how many mild cases Mexico has had, Dr. Martin S. Cetron, director of global migration and quarantine for the Centers for Disease Control, said in an interview.

“We may just be looking at the tip of the iceberg, which would give you a skewed initial estimate of the case fatality rate,” he said, meaning that there might have been tens of thousands of mild infections around the 1,300 cases of serious disease and 80 or more deaths. If that is true, as the flu spreads, it would not be surprising if most cases were mild.

Even in 1918, according to the C.D.C., the virus infected at least 500 million of the world’s 1.5 billion people to kill 50 million. Many would have been saved if antiflu drugs, antibiotics and mechanical ventilators had existed.

Another hypothesis, Dr. Cetron said, is that some other factor in Mexico increased lethality, like co-infection with another microbe or an unwittingly dangerous treatment.

Flu experts would also like to know whether current flu shots give any protection because it will be months before a new vaccine can be made.

There is an H1N1 human strain in this year’s shot, and all H1N1 flus are descendants of the 1918 pandemic strain. But flus pick up many mutations, and there will be no proof of protection until the C.D.C. can test stored blood serum containing flu shot antibodies against the new virus. Those tests are under way, said an expert who sent the C.D.C. his blood samples.

 

David G. Fairchild, MD, MPH, Editor-in-Chief
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U.S. Declares Public Health Emergency as Swine Flu Continues to Spread
Federal officials declared a public health emergency on Sunday as more human cases of swine influenza A (H1N1) were confirmed in the U.S., bringing the current total to 20, they said. The virus spreads via person-to-person contact.

The CDC has confirmed cases in California, Kansas, New York, Ohio, and Texas. The 20 patients have recovered (only one required hospitalization).

The outbreak is more severe in Mexico, where the illness likely first emerged: Some 1600 suspected cases have been reported there, with about 100 deaths, according to the New York Times. (CDC testing has confirmed swine flu in several Mexican specimens.) Some of the U.S. cases have occurred among travelers to Mexico.

The Times also reports that there are six confirmed cases in Canada, and suspected cases in Spain and New Zealand.
When swine flu is suspected, the CDC says, clinicians should obtain a respiratory specimen, store it in a refrigerator, and contact their local health department to arrange transport to a state lab for testing. In addition, empirical treatment should begin as soon as possible — either with zanamivir (Relenza) alone, or with a combination of oseltamivir (Tamiflu) plus either amantadine (Symmetrel) or rimantadine (Flumadine).

(The CDC’s website provides links to guidance on diagnosis, treatment, and infection control, among other topics. See below.)

fear1

Fears of Swine Flu Pandemic Increase

The World Health Organization has declared the swine flu outbreak, first detected in Mexico and the United States, a “public health emergency of international concern.”

The Washington Post, April 27, 2009 — After flu infections, people can develop an additional bacterial “superinfection” that could be lethal, said Brian Currie, an infectious-diseases doctor and director of clinical research at Montefiore Medical Center in New York City. Currie said it remained a mystery why people in Mexico were dying while the cases reported in the United States have been relatively benign.

“You’ve got to remember, this is a strain of flu nobody has seen before,” Currie said.

Even though there is no known vaccine for humans for this strain of swine flu — which combines genetic material from more common types of pig, bird and human flus — Mexican officials have stressed that it is curable. President Felipe Calderón said Sunday that of the 1,324 patients with flulike symptoms as of Saturday, 929 have been treated and released from the hospital.

Mexican officials said there is no shortage of antiviral medication. The difference between who lives and dies seems largely linked to how quickly patients receive treatment, officials said.

“With a sickness like this, if you don’t take it seriously, if you don’t go to the doctor right away, it can have very grave consequences,” Calderón said in a televised address Sunday.

Calderón gave a national lesson on public health, instructing people to wash their hands regularly, wear surgical masks, cover their mouths when they cough and avoid sharing food. Officials in Mexico City have handed out 6 million masks.

“Everyone, absolutely every Mexican, needs to make a special effort to avoid contacting other people who could potentially be infected with the virus,” the president said.

Jorge Francisco Guzmán Suárez, a 24-year-old who died Saturday at the National Institute for Respiratory Illnesses, was initially treated by a private doctor for a stomachache, rather than the flu, his aunt, Herminia Guzmán, told the Reforma newspaper.
“We are devastated,” the aunt told the paper. “The miracle did not arrive.”

An outdoor market in the colonial neighborhood of Coyoacan on Sunday was a shadow of its usual self. Candelaria Villanueva, 72, a vendor of jewelry and blouses, said sales have plummeted. She was worried, she said, because her 20-year-old granddaughter recently got sick and was told by a doctor that it was “just the flu.”

“I think you have to have faith in God,” she said.

A double-decker tour bus was nearly empty. Bus worker Karla Yañez said people are scared to ride.

“Everybody’s inside, places are closed, the parks are closed, people don’t go out,” she said. “Mexico is a social place — people like to go out and be together. The sickness has taken that away.”

Staff writer David Brown in Washington and special correspondent Jonathan Roeder in Mexico City contributed to this report.

Target Health would like to congratulate our friend and colleague, Dr. Andrew Mulberg, Senior Director of Clinical Research & Development, at Johnson and Johnson, for writing the first comprehensive textbook devoted to an understanding of the issues surrounding pediatric drug development of pharmaceutical-based therapies. The textbook, entitled, Pediatric Drug Development: Concepts and Applications, published by Wiley Blackwell, was created in collaboration with John van den Anker, Professor of Pediatric Clinical Pharmacology, Children”s National Medical Center, Washington, DC and many of his J&JPRD/academic/government colleagues. The book explores the scientific differences between the pediatric and the adult subject in the development of medicines, while taking into account the ethics and medical needs of pediatric patients. In addition, the book examines the overarching business case for the proper development of drugs for children, as well as the technical feasibility studies and processes that are necessary for a successful program. The book aims to provide the information necessary to ensure better and safer drugs for pediatric patients.

For more information about Target Health and any of our software tools for paperless clinical trials, please contact Dr. Jules T. Mitchel (212-681-2100 ext 0) or Ms. Joyce Hays. Target Health’s software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website, and if you like the weekly newsletter, ON TARGET, you’ll love the Blog.

By examining the patterns in which light bounces off cell surfaces, researchers may be able to assess chemotherapy’s success in inducing cancer cell 1) ___, according to a study led by investigators in the Duke Comprehensive Cancer Center and Duke’s Pratt School of Engineering. The technique might be used as a tool for measuring patients’ response to 2) ___ more quickly and non-invasively. The goal of this study was to assess if light-scattering techniques could identify nuclear and cellular structure 3) ___ following treatment of breast cancer cells with chemotherapeutic agents. One goal was to see changes due to the cell death process induced by chemotherapy, called apoptosis. The researchers presented their findings at the 100th annual American Association of Cancer Research meeting on Tuesday, April 21, 2009, in Denver. The researchers treated breast cancer cells, in a dish, with one of two standard chemotherapeutic agents, paclitaxel and doxorubicin. They then applied light to the cells at various time intervals and observed the way the light deviated, depending on the size and shape of the 4) ___ through which it passed. The technique is called angle-resolved low coherence interferometry, and it was developed in the lab of Adam Wax in the biomedical engineering department at Duke’s Pratt School. The scientists observed that in cells experiencing apoptosis, there were marked changes – both early in the process and then up to a day later – in 5) ___ structure that could be captured by light-scattering. In contrast, in cells treated with a dose of drug that does not induce 6) ___, some early changes, were seen, but no later changes. If successful in laboratory studies, this technique could be applied as a non-invasive way to quickly determine whether chemotherapy is working or not. Typically, patients undergo chemotherapy and then return several weeks later for a scan to measure changes in their 7) ___ size. Down the road, there is hope that there may be faster ways to tell if a patient is being successfully treated, or if he or she might benefit from an adjustment to their therapy strategy.

ANSWERS

1) death; 2) chemotherapy; 3) changes; 4) cells; 5) cellular; 6) apoptosis; 7) tumor

Amber

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Amber pendants date back to the Stone Age. Ancient Greeks and Romans believed that amber’s electrostatic energy had the power to draw out pain and misfortune. Tiny pieces of amber have been discovered inserted beneath the skin covering the hands of Egyptian mummies. The earliest accounts of amber’s medicinal properties found in the works of Hippocrates (460 – 377 BCE), the father of medicine and Pliny the Elder. Callistratus states that a short string of amber beads worn around the neck brought relief to the wearer in some cases of severe head, neck and throat complaints. Wearing amber bracelets was thought to be beneficial to sufferers of rheumatism and arthritis and reduced fatigue and feelings of general weariness. A similar effect was said to be achieved by rubbing the body with a fairly large piece of amber. Various other creams, balms and infusions of amber steeped in alcohol were also recommended for external use. Many concoctions using amber as the main ingredient, were widely used to remedy respiratory complaints, asthma, bronchitis, bowel and bladder disorders, heart problems and ailments of the circulatory system. Pliny the Elder in his Historia Naturalis (Book XXXVII) from the 1st century CE. writes, “amber is good for affections of the tonsillary glands and fauces, it is good for any age, as a preventive of delirium and as a cure for strangury, either taken in drink or attached as an amulet to the body. Worn upon the neck it is a cure for fevers and other diseases, and, triturated with honey and oil of roses, it is good for maladies of the ears. Beaten up with Attic honey, it is good for dimness of sight. The powder of it, either taken by itself or with gum mastich in water, is remedial for diseases of the stomach. It is beneficial for infants also, attached to the body in the form of an amulet.“ In Medieval medicine Saint Hildegard of Bingen (1098-1178), the prioress of the local Benedictine convent, recommended taking amber as a beer, wine or water tincture for stomach ache, and as a milk tincture for bladder conditions. Powdered amber mixed with wine was also supposed to protect from the Black Death. Albert the Great, a 13th -century Dominican theologian and philosopher, listed amber among six medications of the utmost effectiveness. Arabian Medieval physicians, recommended amber for many diseases, including diarrhea and hemorrhage (Avicenna, al-Razi), while Arabian scholar al-Biruni emphasized the magical and protective power of amber by saying that “it repels the injury inflicted by the evil eye.“ Teutonic Knights valued white amber, to which exceptional medicinal properties were attributed. With his wishes “for this good stone to cast out the evil ones,“ Prussian prince Albrecht Hohenzollern Prince of Prussia sent a white amber nugget to Martin Luther for his gall stones. In his scientific treatise on amber (Succini historia, 1551), Andreas Aurifaber’s court physician included 46 prescriptions on how to use amber for the following ailments: toothache, stomach ache, rheumatism, heart arrhythmia. Also, Nicolaus Copernicus would prescribe amber powder for heart ailments. Sixteenth century medical treatises attributed special properties to amber one of them reads: “if you put amber on the breast of your wife, while asleep, it will cause all her evil deeds to be revealed“ (physician to Caesar Borgia Camillus Leonardus, Speculum Lapidum , 1502). Georgius Agricola, a renowned German humanist and physician (1494-1555), described in his treatise herbal concoctions containing white amber, while Polish doctor and botanist Stefan Falimirz in his herbal O ziolach i mocy ich /On Herbs and their Powers/ praises amber for being able to “gladden the hearts, avert melancholy and raise the spirits.“ Medical guidebooks recommended that amber best “be worn in a ring upon the little finger of the left hand; for, in stones, there is great efficacie, and vertue“ (J. Harrington, School of Salerne, 1624), and also that places afflicted by the plague be incensed with amber smoke. Sources from the end of the 17th century recorded a significant fact that no amber craftsman who worked in the cities of the Baltic died during the plague. Smoke from burnt amber, as well as powdered amber taken internally as tincture, were supposed to help in treating inflammations of the respiratory tract, watering eyes, headaches, sleep disorders and convulsions, menstrual ailments, hemorrhage and help in childbirth. In China, Baltic amber was mixed with opium and used as an effective sedative, painkiller and antispasmodic. In Polish and Eastern European folk medicine, amber was popular in many medicaments and used to remove objects from eyes, given to children to ease teething pain; it was used to treat rheumatism, eye and throat illnesses, or even infertility. In 19th century pharmacies, amber was advertised as an effective remedy against negative effects of tobacco smoking; this resulted in the mass production of pipes and cigarette-holders with amber mouthpieces.

The FDA has approved Simponi (golimumab), a monthly treatment for adults with moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis. All three conditions are chronic disorders in which the immune system attacks multiple joints, causing stiffness, pain, and restricted motion. Simponi is injected under the skin and is intended for use in combination with the immunosuppressant drug methotrexate in patients with rheumatoid arthritis. It also may be used with or without methotrexate for psoriatic arthritis and alone in patients with ankylosing spondylitis, a chronic inflammatory arthritis of the spine. In clinical trials, patients who received Simponi for one of the three conditions showed improvements in the signs and symptoms common to their form of arthritis. Simponi is in a class of drugs that target and neutralize tumor necrosis factor-alpha (TNF-a), a protein that, when overproduced in the body due to chronic inflammatory diseases, can cause inflammation and damage to bones, cartilage and tissue. Like other TNF- a blockers, Simponi labeling includes a boxed warning alerting patients and health care professionals to the risk of tuberculosis and invasive fungal infections with use of the drug. The FDA also required a risk evaluation mitigation strategy (REMS) for Simponi, as it required for other TNF-a blockers. The REMS for Simponi includes a Medication Guide for patients and a communication plan to help prescriber’s understand the drug’s risks. The most common adverse reactions to Simponi include upper respiratory tract infection, sore throat and nasal congestion. Simponi is marketed by Centocor Ortho Biotech Inc., Malvern, Pa

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