The trend, which is slowly gaining momentum, is being driven by several factors, including the emergence of “personalized’’ medicines based on an individual’s genetic makeup, and the success of companies such as Genzyme Corp. that already specialize in making drugs to treat rare diseases.

Swiss pharmaceutical company Novartis AG is developing drugs for as many as 40 rare diseases from tuberous sclerosis to spinal muscular atrophy as well as medicines for diseases seen in the developing world, such as liver cancer and infectious illnesses.

Now it’s seeking to open a conversation — especially with academic researchers and smaller biotechs with whom it can collaborate — on how to broaden the drug discovery approach, through a two-day “health equity symposium’’ that concludes today.

The event is being held at the company’s global research and development headquarters in Cambridge and features keynote speaker Dr. Julio Frenk, dean of the Harvard School of Public Health and the former minister of health in Mexico.

“It’s a very important and neglected area, this discrepancy in health,’’ said Dr. Mark C. Fishman, president of the company’s research operation, called the Novartis Institute for BioMedical Research. “Drug companies historically focused on certain populations in certain countries and not on others.’’

As the field of personalized medicine evolves and individual genomes can be sequenced for close to $1,000, “we will have more information about your genetic profile,’’ Fishman said. “We will know what rare variance of genes you possess that will determine what diseases you have and what treatments are available.’’

Novartis isn’t the only company working to expand its disease targets as it becomes more financially attractive to target smaller patient populations.

French drug maker Sanofi Aventis AG, which has research and cancer operations in Cambridge and last month bought Genzyme, plans to use the newly acquired biotechnology company as a global platform for expanding its own research into rare diseases. Genzyme is known for its expensive drugs to treat enzyme deficiencies such as Gaucher and Fabry diseases.

“There are some learnings that we gain out of that business,’’ Sanofi chief executive Christopher A. Viehbacher told European investors in February, suggesting Genzyme’s expertise in producing treatments for rare genetic disorders could hasten Sanofi’s push into personalized medicine. “People might say if you follow personalized medicine to an extreme, every disease is a rare disease.’’

Even companies that concentrate on more common diseases are coming under pressure to test their drugs on different segments of the population.

At a public hearing of a Food and Drug Administration antiviral drugs advisory committee in Silver Spring, Md., last week, some committee members faulted Vertex Pharmaceuticals Inc. for not recruiting more African-American patients into clinical trials for telaprevir, the Cambridge company’s experimental drug to treat hepatitis C. The FDA is expected to decide later this month whether to approve the drug.

“I was disappointed your recruitment of blacks was so low given the significant portion of the disease in that population,’’ said Dr. Elizabeth Connick, a member of the advisory panel who is an associate professor of medicine at the University of Colorado Denver.

Vertex has said it plans to launch a post-approval trial on the effects of telaprevir — which it will market under the name Incivek — on black patients.

“One of our priorities following approval will be to conduct an additional study of Incivek in African-Americans,’’ said Vertex spokesman Zachry A. Barber.

Minority populations may be more susceptible to certain diseases, such as diabetes and hypertension, and may respond differently to medications, said Kenneth Getz, founder and chairman of the Center for Information and Study on Clinical Research Participation in Boston. As a result, the FDA has guidelines, but not requirements, that minorities be represented in clinical trials — though they often continue to be underrepresented.

“The onus is on the companies to be more inclusive,’’ Getz said. “When we think of the growth of the minority populations in our nation, this points to the need for us to be smarter and more targeted in the way we design our studies and the way we test in patient populations.’’

Getz cautioned that researchers don’t fully understand the biological basis for diseases that disproportionately affect certain populations, and diet and culture are factors that also come into play.

The court ruled 6 to 2 that going before a special tribunal set up by Congress is the only way parents can be compensated for the negative side effects that in rare instances accompany vaccinations.  The majority said that Congress found such a system necessary to ensure that vaccines remain readily available, and that federal regulators are in the best position to decide whether vaccines are safe and properly designed.

The National Childhood Vaccine Injury Act of 1986 “reflects a sensible choice to leave complex epidemiological judgments about vaccine design to the FDA and the National Vaccine Program rather than juries,” Justice Antonin Scalia wrote, referring to the Food and Drug Administration. Justices Sonia Sotomayor and Ruth Bader Ginsburg dissented, saying the threat of lawsuits provides an incentive for vaccine manufacturers to constantly monitor and improve their products.

The decision “leaves a regulatory vacuum in which no one – neither the FDA nor any other federal agency, nor state and federal juries – ensures that vaccine manufacturers adequately take account of scientific and technological advancements,” Sotomayor wrote.

The decision is a victory for vaccine makers such as Wyeth and GlaxoSmithKline. Kathleen Sullivan, who represented Wyeth in the case before the court, told justices that ruling against the company could lead to thousands of lawsuits in which parents claim, for instance, that the mumps, measles and rubella vaccine played a role in their children’s autism.

It also marks another chapter in the court’s evolving jurisprudence on “preemption,” the question of when federal laws and regulations displace state actions or lawsuits. Those questions often divide the court on ideological grounds, but in this case, liberal Justice Stephen G. Breyer joined the court’s consistent conservatives.

The Obama administration also backed the vaccine makers, and Justice Elena Kagan was recused because of her work on the case as President Obama’s solicitor general.

The case was brought by Russell and Robalee Bruesewitz on behalf of their daughter Hannah, 18. Hannah began to have seizures as an infant after receiving the third of five scheduled doses of Wyeth’s Tri-Immunol diphtheria-pertussis-tetanus vaccine. The company, now owned by Pfizer, has taken the drug off the market.

The 1986 federal law said that all such claims must first go to a special tribunal commonly called the “Vaccine Court.” The program has awarded nearly $2 billion for vaccine-injury claims in nearly 2,500 cases since 1989. It is funded by a tax on immunizations.

But the tribunal ruled against the Bruesewitzes, saying they had not proved that the vaccine harmed Hannah, who will need lifelong care.

The couple then sued under Pennsylvania tort law. The company had the case moved to federal court, and judges have consistently ruled that the suit cannot proceed, because federal law prohibits claims against “design defects” in vaccines.

The justices at oral argument debated ambiguous wording in the federal law. It says that no vaccine maker can be held liable for death or injuries arising from “side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.”

Scalia said the word “unavoidable” would be meaningless “if a manufacturer could be held liable for failure to use a different design.”

Sotomayor read the language to mean the opposite, and said “text, structure and legislative history compel the conclusion that Congress intended to leave the courthouse doors open for children who have suffered severe injuries from defectively designed vaccines.”

Consumer groups and others had supported the Bruesewitzes, but the American Academy of Pediatrics applauded the decision.

“Today’s Supreme Court decision protects children by strengthening our national immunization system and ensuring that vaccines will continue to prevent the spread of infectious diseases in this country,” AAP President O. Marion Burton said in a statement.

The case is Bruesewitz v. Wyeth.

In other action, the court decided not to revisit its 2005 ruling that struck the display of the Ten Commandments in two Kentucky courthouses.

Lower courts had continued to bar McCreary and Pulaski counties from posting the commandments even though each changed the display to include other religious and historic documents. The court did not comment on why it was not taking the case.

By Robert Barnes, Washington Post Staff Writer, Tuesday, February 22, 2011; 10:46 PM

[NYTimes] On Monday, in a Manhattan town house that once belonged to polio’s most famous victim, Franklin D. Roosevelt, Bill Gates made an appeal for one more big push to wipe out world polio.

Although that battle began in 1985 and Mr. Gates started making regular donations to it only in 2005, he has emerged in the last two years both as one of the biggest donors — he has now given $1.3 billion, more than the amount raised over 25 years by Rotary International — and as the loudest voice for eradication.

As new outbreaks create new setbacks each year, he has given ever more money, not only for research but for the grinding work on the ground: paying millions of vaccinators $2 or $3 stipends to get pink polio drops into the mouths of children in villages, slums, markets and train stations.

He also journeys to remote Indian and Nigerian villages to be photographed giving the drops himself. Though he lacks Angelina Jolie’s pneumatic allure, his lingering “world’s richest man” cologne is just as aphrodisiacal to TV cameras.

He also uses that celebrity to press political leaders. Rich Gulf nations have been criticized for giving little for a disease that now chiefly affects Muslim children; last week in Abu Dhabi, United Arab Emirates, Mr. Gates and Crown Prince Sheik Mohammed bin Zayed al-Nahyan jointly donated $50 million each to vaccinate children in Pakistan and Afghanistan. In Davos, Switzerland, Mr. Gates and the British prime minister, David Cameron, announced that Britain would double its $30 million donation. Last month, when the Pakistani president, Asif Ali Zardari, went to Washington for the diplomat Richard C. Holbrooke’s funeral, Mr. Gates offered him $65 million to initiate a new polio drive. Twelve days later, publicly thanking him, Mr. Zardari did so.

However, even as he presses forward, Mr. Gates faces a hard question from some eradication experts and bioethicists: Is it right to keep trying?

Although caseloads are down more than 99 percent since the campaign began in 1985, getting rid of the last 1 percent has been like trying to squeeze Jell-O to death. As the vaccination fist closes in one country, the virus bursts out in another.

In 1985, Rotary raised $120 million to do the job as its year 2000 “gift to the world.”

The effort has now cost $9 billion, and each year consumes another $1 billion.

By contrast, the 14-year drive to wipe out smallpox, according to Dr. Donald A. Henderson, the former World Health Organization officer who began it, cost only $500 million in today’s dollars.

Dr. Henderson has argued so outspokenly that polio cannot be eradicated that he said in an interview last week: “I’m one of certain people that the W.H.O. doesn’t invite to its experts’ meetings anymore.”

Recently, Richard Horton, editor of The Lancet, the influential British medical journal, said via Twitter that “Bill Gates’s obsession with polio is distorting priorities in other critical BMGF areas. Global health does not depend on polio eradication.” (The initials are for the Bill & Melinda Gates Foundation.)

And Arthur L. Caplan, director of the University of Pennsylvania’s bioethics center, who himself spent nine months in a hospital with polio as a child, said in an interview, “We ought to admit that the best we can achieve is control.”

Those arguments infuriate Mr. Gates. “These cynics should do a real paper that says how many kids they’re really talking about,” he said in an interview. “If you don’t keep up the pressure on polio, you’re accepting 100,000 to 200,000 crippled or dead children a year.”

Right now, there are fewer than 2,000. The skeptics acknowledge that they are arguing for accepting more paralysis and death as the price of shifting that $1 billion to vaccines and other measures that prevent millions of deaths from pneumonia, diarrhea, measles, meningitis and malaria.

“And think of all the money that would be saved,” Mr. Gates went on, turning sarcastic. “It’d be like 5 percent of the dog food market in the United States.”

(Americans spend about $18 billion a year on pet food, according to the American Pet Products Association.)

Both he and the skeptics agree that polio is far harder to beat than smallpox was.

One injection stops smallpox, but in countries with open sewers, children need polio drops up to 10 times.

Only one victim in every 200 shows symptoms, so when there are 500 paralysis cases, as in the recent Congo Republic outbreak, there are 100,000 more silent carriers.

Other causes of paralysis, from food poisoning to Epstein-Barr virus, complicate surveillance.

Also, in roughly one of every two million vaccinations, the live vaccine strain can mutate and paralyze the child getting it. And many poor families whose children are dying of other diseases are fed up with polio drives.

“Fighting polio has always had an emotional factor — the children in braces, the March of Dimes posters,” Dr. Henderson said. “But it doesn’t kill as many as measles. It’s not in the top 20.”

Also, the effort is hurt by persistent rumors that it is a Western plot to sterilize Muslim girls. The Afghan Taliban, under orders from their chief, Mullah Muhammad Omar, tolerate vaccination teams, but the Pakistani Taliban have killed some vaccinators.

Victory may have been closest in 2006, when only four countries that had never beaten polio were left: Nigeria, India, Pakistan and Afghanistan.

Those four have still not conquered it, although India and Nigeria are doing much better. Now four more — Angola, Chad, the Democratic Republic of Congo and Sudan — have had yearlong outbreaks, and another 13 have had recent ones: eight in Africa, along with Nepal, Kazakhstan, Tajikistan, Turkmenistan and Russia.

And polio migrates. In 2005, it briefly hit both an Amish community in Minnesota and Indonesia, the world’s fourth most populous country. Both outbreaks were stopped by vaccination.

Proponents of eradication argue that it would be terrible to waste the $9 billion already spent, and a new analysis concluded that eradication, if successful, would save up to $50 billion by 2035.

The United States is still committed.

“If we fail, we’ll be consigned to continuing expensive control measures for the indefinite future,” said Dr. Thomas R. Frieden, director of the Centers for Disease Control and Prevention, which leads the country’s effort.

Dr. Ezekiel J. Emanuel, chief bioethicist for the National Institutes of Health, who is seen as a powerful influence within the Obama administration, said he had “not seen enough data to have a definitive opinion.”

“But my intuition is that eradication is probably worth it,” he added. “As with smallpox, the last mile is tough, but we’ve gotten huge benefits from it. But without the data, I defer to people who’ve really studied the issue, like Bill Gates.”

The W.H.O. recently created a panel of nine scientists meant to be independent of all sides in the debate to monitor progress through 2012 and make recommendations.

Dr. David L. Heymann, a former W.H.O. chief of polio eradication, said he was still “very optimistic” that eradication could be achieved.

But if there is another big setback, he said — if, for example, cases surge again in India’s hot season — he might favor moving back the eradication goal again to spend more on fixing health systems until vaccination of infants for all diseases is better.

“When routine coverage is good, it’s no problem to get rid of polio,” he said.

Asked about that, Mr. Gates said, “We’re already doing that.”

The background to this important judgement is in Switzerland. A 57-year-old Swiss national, Ernst G. Haas, felt that he could no longer live a dignified life after battling a serious bipolar affective disorder for 20 years. He twice attempted suicide, but then hit upon the idea of using sodium pentobarbital, a prescription-only drug. But no psychiatrist would prescribe it for him. He then asked the Swiss government for permission to obtain sodium pentobarbital without a prescription. He argued that Article 8 imposed on the State a “positive obligation” to create the conditions for suicide to be committed without the risk of failure and without pain.

Various Swiss courts refused. Mr Haas then asked 170 different psychiatrists whether they could examine him with a view to getting his hands on some sodium pentobarbital. They all refused.

As a result, Mr Haas invoked Article 8 of the European Convention on Human Rights, which guarantees a right to privacy, and sued the Swiss government in the European Court of Human Rights.

On January 20, the Court handed down its decision. It acknowledged that there does appear to be a right to suicide implied in Article 8. This has been strengthened by the 2002 Pretty case, in which the Court approved the right of a British woman to kill herself if she found life undignified and distressing.

However, Article 2 of the Convention also guarantees the right to life. Most member states give the right to life more weight than the right to suicide.

The Court pointed out that a prescription system is supposed to protect vulnerable people from making hasty decisions and to prevent abuse. That was all the more true in a country such as Switzerland, where assisted suicide is legal. It also declared that the risk of abuse inherent in a system which facilitated assisted suicide can not be underestimated. That is why a prescription from a doctor and a psychiatric examination to ensure free will are proper safeguards.

For the original Human Rights Europe article visit:
http://www.humanrightseurope.org/2011/01/court-judgement-on-swiss-assisted-suicide-row/

Since the Health Ministry announced the World Health Organization-backed measles vaccination plan last week, authorities have been flooded with queries and Internet bulletin boards have been plastered with worried messages. Conspiracy theories saying the vaccines are dangerous have spread by cell phone text messages.

The public skepticism has even been covered by state-run media, which noted the lack of trust was about more than vaccines.

“Behind the public’s panic over the rumors is an expression of the citizens’ demands for security and a crisis in confidence,” a columnist wrote in the Chongqing Daily newspaper.

“The lack of trust toward our food and health products was not formed in one day,” said the Global Times newspaper. “Repairing the damage and building credibility will take a very long time. The public health departments need to take immediate action on all fronts.”

In recent years, government agencies have dragged their feet or withheld information about the spread of SARS, bird flu and, last month, an outbreak of cholera. China’s slow response to SARS, or severe acute respiratory syndrome, was widely blamed for causing the outbreak that swept the globe in 2003, and led to deep mistrust both internally and internationally.

Milk products contaminated with industrial chemicals are still found despite mass recalls and several criminal convictions, including executions, after tainted infant formula sickened 300,000 babies and killed at least six two years ago.

Feeding into worries about the measles vaccine were media reports in March that vaccines for encephalitis, hepatitis B and other diseases possibly killed four children and seriously sickened dozens in one province. The health ministry said an investigation showed those vaccines were improperly stored but subsequent illnesses were unrelated. Many remain unconvinced.

Meanwhile, two Chinese vaccine makers recently said they shut operations after rabies vaccines they produced were found to be substandard.

The ministry has tried to calm the public’s anxieties about the 10-day measles immunization drive, which started Saturday. It has busily issued statements, refuted rumors and held briefings to emphasize the need for the vaccine as well as its safety.

The campaign, likely the world’s largest, targets all children ages 8 months to 4 or 14 years, depending on locality, and is intended to include remote areas, migrant communities and other places where previous vaccination coverage has been spotty.

Yet the publicity is not likely to easily reassure a public increasingly skeptical of reassurances from a government often seen as opaque and unaccountable, especially where public health is involved.

“This time how could the public have no doubts? They are asking: ‘Is there an outbreak of the disease? Are previous vaccinations not working? Are the people in the government trying to make money from this?’” newspaper commentator Wei Yingjie said in an interview.

The public push-back marks a turnaround from the mass campaigns in the communist heyday under Mao Zedong and shows how prosperity and greater access to information are creating a more assertive populace.

“This campaign would have been no problem in the Mao era, but today we know with globalization, the Internet, the information explosion, this increasingly assertive civil society, they want to participate in the public policy process,” said Yanzhong Huang, senior fellow for global health at the Council on Foreign Relations in New York.

Measles is a highly contagious viral disease that can develop into blindness, pneumonia and encephalitis and lead to death, and health experts say China needs an effective vaccination program.

Despite previous vaccination drives, China recorded 52,000 measles cases last year, including 39 deaths. The infection rates mean China is far from meeting its national pledge from 2005 to eradicate measles by 2012.

Mass drives in other parts of the world have either virtually eliminated measles or significantly reduced the number of infections. The disease has been nearly nonexistent in the Americas since 2002 and cases in seven countries in southern Africa fell from 60,000 in 1996 to 117 by 2000, according to the WHO.

Dr. Lisa Cairns, head of immunization at WHO China, said many of those infected with measles in China are young children who were likely never vaccinated.

“Because the disease is not as common as it used to be, it is easy to forget how serious it is,” she noted.

China’s Health Ministry has repeatedly said that the measles vaccine is safe, with random samples tested from stores around the country, and has tried to assure the public that medical personnel are prepared for emergencies, including any adverse reactions.

On Friday, a senior ministry official promised that no one would be forced to take the vaccination.

“Vaccination will only proceed after parents sign an agreement,” the ministry’s deputy director for disease control Hao Yang said. “We heard that some places were linking vaccination with admission to kindergartens and schools. So yesterday we issued a notice that admission to school should never be used to force children to vaccination.”

Health care professionals, however, have questioned the immunization drive’s broad scope, given that many children have previously been inoculated and thus would be vaccinated again.

A blog posting by a prominent immunization expert, Wang Yuedan of Peking University, urged the government to focus on formerly underserved groups like the children of rural migrants now living in urban areas, instead of vaccinating some children again. By Friday, Wang withdrew his reservations and backed the campaign, saying he was convinced by the Health Ministry’s explanations.

Still, Wang said in an interview that he winced at the thought of his 4-year-old daughter suffering a possible fever from the vaccine.

“I’m a man and a father first, who has emotions and who can’t watch his child suffer pain blindly,” he said.

Associated Press researcher Xi Yue contributed to this report.  Copyright © 2010 The Associated Press. All rights reserved.

[NYTimes] Pfizer and GlaxoSmithKline will supply hundreds of millions of doses of their pneumonia vaccines to the world’s poorest countries at heavily discounted prices under a novel agreement announced Tuesday.

But at least one expert maintains that the prices are still too high.

The deal was announced by the GAVI Alliance, a nonprofit organization, which estimated the program could save a total of 900,000 lives by 2015.

The vaccines — Pfizer’s Prevnar 13 and GlaxoSmithKline’s Synflorix — prevent pneumococcal disease, which includes pneumonia and meningitis. Pneumococcal disease kills 1.6 million people a year worldwide, including 800,000 children before their fifth birthday, according to GAVI.

Under the agreement, Pfizer and GlaxoSmithKline will provide up to 300 million doses each of their vaccines over a 10-year period. The price for the first 20 percent of the supply will be $7 a dose. Then the price will drop to $3.50 a dose for the remainder. The vaccines would be paid for by donations raised by GAVI and by the governments of the countries that ordered the vaccines.

In Western markets, the pneumococcal vaccines sell for $54 to $108 a dose.

“For the price of a Starbucks latte, developing countries are going to be able to buy a dose of a life-saving vaccine,” said Orin Levine, director of the international vaccine access center at the Johns Hopkins Bloomberg School of Public Health, who has worked with GAVI.

But Tido von Schoen-Angerer, who directs the essential medicines program at the international group Doctors Without Borders, said that even with the discounts, “it’s still quite an expensive vaccine in a developing country context.” With at least three doses required, the price would initially be $21 per patient.

The agreement is the first example of GAVI’s program called advance market commitments, in which donor money is used to essentially guarantee a market for vaccine companies if they undertake development of vaccines for poor countries, or if the companies agree to build extra capacity to supply those markets with an existing vaccine.

Such a strategy, if it works, might be particularly useful in spurring companies to develop vaccines for diseases like malaria, for which virtually the entire market would be in developing countries.

GAVI has already received pledges that total $1.5 billion for the pneumococcal disease campaign from the governments of Italy, Britain, Canada, Russia and Norway and the Bill and Melinda Gates Foundation.

But GAVI, which is also known as the Global Alliance for Vaccines and Immunization, still needs to raise another $1.5 billion by 2015 to pay for the procurement and distribution of the vaccines over the 10-year life of the program.

Dr. von Schoen-Angerer said that the multibillion-dollar cost of the project was straining GAVI’s finances and that the success of the pneumococcal program should be evaluated before the advance market commitment strategy was tried for another vaccine.

He said that experts he consulted estimated the cost of making each dose at $1.50 to $2.50, so Pfizer and Glaxo were still making a little profit.

The two companies would not disclose their costs but did not deny they would make money. “Certainly the whole notion was to create a sustainable model,” said Gwen Fisher, a spokeswoman for Pfizer. “It wasn’t to make it into a money-losing proposition.”

Costs could come down if vaccine makers from developing countries take part in the program. Two vaccine makers in India — Panacea Biotec and Serum Institute of India — are already moving toward supplying pneumococcal vaccines.

Officials involved in the deal say that it formerly took many years for a vaccine developed in the West to trickle down to developing countries. But the new program would make the first vaccines available to Africa this year.

“American kids and African kids will get this new vaccine in the same year,” Dr. Levine of Johns Hopkins said. “That’s just never happened before.”

Pharmaceutical companies already sell many of their drugs and vaccines at lower prices in poorer countries. Still, the agreement for the pneumococcal vaccines took four years to negotiate, in part because of all the parties involved. The World Bank, the World Health Organization and Unicef will all play a role in the program.

[BBC] The 64-year-old man was a neighbor of the first two people to die from the plague in Ziketan in Qinghai Province.

Police have set up checkpoints around Ziketan, as medics are disinfecting the area and killing rats and insects.

Pneumonic plague, which attacks the lungs, can spread from person to person or from animals to people.

A spokeswoman for the World Health Organization, Vivian Tan, earlier said an outbreak such as this was always a concern, but praised the Chinese for reacting quickly and for getting the situation under control.

A BBC correspondent in Beijing, Michael Bristow, says that unlike in the past the authorities are being very open about this outbreak.

Local officials in north-western China have told the BBC that the situation is under control, and that schools and offices are open as usual.

But to prevent the plague spreading, the authorities have sealed off Ziketan.

About 10 other people inside the town have so far contracted the disease, according to state media.

No-one is being allowed leave the area, and the authorities are trying to track down people who had contact with the men who died.

Initial symptoms of pneumonic plague include fever, headache and shortness of breath.

The local health bureau has warned anyone with a cough or fever who has visited the town since mid-July to seek medical treatment.

According to the WHO, pneumonic plague is the most virulent and least common form of plague.

It is caused by the same bacteria that occur in bubonic plague – the Black Death that killed an estimated 25 million people in Europe during the Middle Ages.

But while bubonic plague is usually transmitted by flea bites and can be treated with antibiotics, pneumonic plague is easier to contract and if untreated, has a very high case-fatality ratio.

The move will trigger heightened health measures in the WHO’s 193 member states as authorities brace for the worldwide spread of the virus that has so far caused mainly mild illness.

WHO Director-General Dr Margaret Chan was to hold a news conference on the outbreak at 1600 GMT. Flu experts advising Chan, who met earlier on Thursday, were expected to recommend moving to the top phase 6 on the WHO’s six-point scale, the sources said. 

That would reflect the fact that the disease, widely known as swine flu, was spreading geographically, but not necessarily indicate how virulent it is.

“Phase 6, if we call a phase 6, doesn’t mean anything concerning severity, it is concerning geographic spread … Pandemic means global, but it doesn’t have any connotation of severity or mildness,” WHO spokesman Gregory Hartl said.

“In fact, what we are seeing with this virus so far is overwhelmingly to date mild disease. So we would think that this event is really a moderate event for the time being, because the numbers are high but the disease is overwhelmingly mild,” he told Reuters Television before the talks.
David Heymann, a former top WHO official now chairing Britain’s Health Protection Agency, said that countries had tried to contain the virus through measures including school closures during the current phase 5. This has extended the precious time needed to prepare for a full-blown pandemic.

“During phase 5, the government and people in the U.K. have had the time to prepare for a pandemic — this has hopefully decreased any surprise and concern that might be associated with a WHO announcement of phase 6, if one is made,” he told Reuters.

As it spreads in humans, science cannot predict what course the virus will take, the disease it causes and the age groups infected, Heymann said. “The severity of that disease, the effectiveness of antiviral drugs and the stability of the virus must all be watched closely,” he added.

A pandemic could cause enormous disruption to business as workers stay home because they are sick or to look after family members and authorities restrict gatherings of large numbers of people or movement of people or goods.

World markets shrugged off the possibility of a pandemic, as investors focused on possible global economic recovery.

AUSTRALIA LIKELY TRIGGER

Widespread transmission of the virus in Victoria, Australia, signalling that it is entrenched in another region besides North America, is likely to be the trigger for moving to phase 6.

Five people have been admitted to intensive care in Australia and more than 1,000 cases confirmed following widespread testing in the state. [ID:nSYD482995]

“We have tested 5,500 people in the last two weeks, that is more people than we test in our whole influenza season,” said Victorian state premier John Brumby.

One health source, who declined to be named, said the experts were also expected to recommend finishing production currently under way of seasonal flu vaccine for the northern hemisphere next winter.

“They might say finish seasonal vaccine and say begin pandemic vaccine as soon as it is feasible,” he said.

Drugmakers have obtained the new influenza A (H1N1) seed virus in the past two weeks, enabling them to begin the production process by growing the virus in eggs. [ID:nLA644931]

Company officials said on Wednesday that they were on track to have a vaccine against the new strain ready for the northern hemisphere autumn.

Seasonal flu each year kills up to half a million people, mainly elderly, and causes severe illness in millions, so a premature switch in vaccine production to cope with the new strain could put many people at risk.

The new strain can be treated by antiviral drugs oseltamivir, the generic name of Roche Holding’s Tamiflu tablets, and Relenza, a spray made by GlaxoSmithKline.

The strain, which emerged in April in Mexico and the United States, has spread widely in nations including Australia, Britain, Chile and Japan.

Authorities in Germany have confirmed 27 cases of H1N1 at a school in the industrial Rhineland city of Duesseldorf, the most concentrated outbreak of the virus so far in Europe’s biggest economy. [ID:nLB407116]

There have been 27,737 infections reported in 74 countries to date, including 141 deaths, according to the WHO’s latest tally of laboratory confirmed cases, but the real number of people with the disease is likely to run into at least hundreds of thousands, as mild cases may not have been detected. (For more Reuters swine flu coverage, please go to: here ) (For WHO information on swine flu, go to: here ) (Additional reporting by Anne Richardson and Vincent Fribault in Geneva, Dave Graham in Berlin and Michael Perry in Sydney) (Editing by Jonathan Lynn and Richard Balmforth)

-Stephanie Nebehay

I began to caution “Miguel” about unprotected sex, but he insisted that he didn’t have, or plan to have, a lover. As his T-cell counts dropped and his viral counts rose, I referred him to an infectious disease expert who began treatment with anti-retroviral drugs. After several months of this treatment, the counts stabilized, and he remained relatively healthy, though he was frequently depressed.

Four years later, he sent “a close friend” to see me. The friend, also a Dominican, had been brought into the country three years before by Miguel, who had then helped him establish citizenship. Now the friend was returning the favor by marrying Miguel’s sister so she could become a U.S. citizen. The friend, “Carlos,” and the sister had come to see me at the same time. In my visit with her, she immediately revealed that the marriage was in name only and that her husband was gay. I saw Carlos next, and he openly acknowledged being gay and asked me to test him for HIV as part of his routine blood work.

The test came back positive, and I called him back to my office to discuss the results. During that visit, Carlos readily admitted that Miguel was his lover — and feared that he had unintentionally put Miguel at risk. At that point, I realized Miguel had never told his lover that he had the virus.

The truth slowly dawned on Carlos as well. Although initially afraid that Miguel would be angry, he then recalled that he had tested negative for HIV just nine months before. “Did Miguel give me this?” he asked. “Does he have it?” “You have to ask him,” I replied. “I can’t say.”

Although Carlos may have thought I was communicating the necessary truth by not denying it, I not only owed my patients confidentiality, I was bound by law from revealing one patient’s information to another.

Carlos was surprisingly calm, saying he still loved Miguel despite having been seduced into becoming his condom-less lover years before.

My office nurse, who had spoken with Carlos and knew the circumstances, described Miguel’s apparent silence on his HIV status as attempted murder. That comment caused me to examine the laws regarding HIV disclosure more closely — and my own actions.

My hospital’s legal counsel informed me that I wasn’t under any legal obligation to inform someone at risk, though I was required to report HIV patients and known partners to the health department. On the other hand, according to the American Medical Assn.’s code of ethics, “If a physician knows that a seropositive individual is endangering a third party, the physician should, within the constraints of the law (1) attempt to persuade the infected patient to cease endangering the third party; (2) if persuasion fails, notify authorities; and (3) if the authorities take no action, notify the endangered third party.”

Ultimately, in Carlos’ case, the point was moot — it was too late to warn him. He already had acquired the virus.

The state law of New York, where I was practicing, allowed for prosecution of people who were deliberately spreading HIV, but for a physician to suspend his code of confidentiality and turn a patient in would seem to require certain knowledge that such an act was about to take place.

If I believed that Miguel intended to do this again with someone else, then I would have considered whether I had an obligation under the law to report it. But I didn’t know. I still don’t.

I felt horrible for the man manipulated into posing as a husband for his lover’s sister while receiving HIV for his troubles.

I also felt uneasy in my role as messenger.

Meanwhile, I still had to be careful about what I said about Miguel’s HIV, while he himself was forgiven and even loved. His sister, who remained my patient, luckily had been a wife in name only, so she was spared.

But I wondered — and still do: What would I have done if I had surmised this situation before the virus had been transmitted?

I’d had many patients with HIV over the years, and had warned these patients on several occasions about the risk of transmission, but this was the first time I suspected one had refused all responsibility for his partner’s safety.

If I had known in advance, would I have found the legal and ethical basis to warn Carlos? Or would I have had to let it happen?

Further, going forward, how can I find an effective way to warn potential victims if I don’t always know who they are? Sometimes medicine is too complicated to be practiced fairly — or with any moral gratification.

Dr. Marc Siegel is an internist and an associate professor of medicine at New York University’s School of Medicine. He is also the author of “False Alarm: The Truth About the Epidemic of Fear.” He can be reached at marc@doctorsiegel.com  http://www.latimes.com/features/health/la-he-inpractice12-2008may12,0,4300247.story