“We have achieved progress in the fight against A/H1N1 influenza,” Chen said at a meeting in Beijing, at which health workers were rewarded for their research into A/H1N1 flu vaccine.

So far, about 800 deaths from A/H1N1 influenza had been reported in China, far below the death rate in the U.S. considering the large population of China, Chen said.

U.S. authorities have confirmed more than 10,000 deaths from the flu.

But Chen warned it was still too early to say the virus had passed as cases were reported occasionally in other countries and places.

“China has more than 20 million doses of A/H1N1 vaccines in store, and pharmaceutical manufacturers are always ready for production,” Chen said, adding that was enough to cope with any new epidemic situation.

The A/H1N1 virus was first identified in Mexico in April 2009. More than 211 countries and regions have reported laboratory confirmed cases of the flu, including more than 18,000 deaths.

“The indigenous vaccine should be out by the middle of May,” said Rao on the sidelines of the International Conference on Health Systems Strengthening, being held in Kelambakkam, Tamil Nadu.

The reason for this is that there may be new cases or incidence of H1N1 virus, Rao said.

“We’re expecting another one in September. We’re going to be prepared. We don’t want to be taken by surprise. We got away easy this time. It was a mild form of flu,” she said.

The indigenous vaccine has already been sent to health workers “to inoculate their own frontline workers.” The government is “advising” health care workers “to take the injection” for their own protection, she said adding that the government is monitoring the situation carefully.

As of March 28 this year, 1,443 people died in India because of swine flu, according to the Ministry of Health and Family Welfare.

Globally, swine flu has caused 18,001 deaths as of May 2 this year, according to the World Health Organisation.

-hindustantimes-

Scientists have asserted that H1N1 virus epidemic is not yet over and is probable to revisit in the winter, when flu is usually expected.

It has been found that in some regions of the nation, 85% have not yet got H1N1.

Scientists have said that usage of the vaccine has differed from around 10% to 30%, of those offered a lot of the most weak are not protected.

According to Prof Neil Ferguson, Director of the MRC Centre for Outbreak Analysis and Modelling, Dept of Infectious Disease Epidemiology, Imperial College London, there has been a renaissance of cases in the southern states of America.

It is said that H1N1 seems to be hitting people this time.

Prof Peter Openshaw, Director of the Centre for Respiratory Infection at the National Heart and Lung Institute, at Imperial College London, stated, “In London and the West Midlands up to 40 per cent of schoolchildren have had it but they are the exception. In most regions it was about 15 per cent so there are still a lot of people still to be infected”.

Prof Ferguson said that the number of people who died from swine flu was perhaps miscalculated in England because of the method the statistics was composed.

-Topnews.us-

Health Secretary Esperanza Cabral said the government is not letting its guard down against the flu virus even in the wake of delivery of 1.9 million doses of donated vaccines from the World Health Organization (WHO).

“It still remains a threat. We want to prevent an outbreak, particularly in high-risk population. It exists all the time,” she said, in an ambush interview, shortly after the awarding rites of the Presidential Award for Child Friendly Municipalities and Cities, led by President Arroyo at Malacañang’s Heroes Hall.

She said the Philippine government is expecting the remaining 90 percent of the 9 million doses of flu vaccines pledged by the WHO to arrive within the year. WHO Director-General Dr. Margaret Chan made the pledge in November 2009.

Nearly half a million heath workers are set to receive the vaccinations following the delivery of the 1.9 million doses of vaccines.

Health workers have been identified as among the most-at-risk population, along with pregnant women, people aged six months to 59 years old with chronic medical conditions, children five years old and below and adults 60 years old and above.

“I went to the health center at like two in the morning by myself, just walked there. It was terrible,” she said.

At Welty Health Center, like many Whitman students this year, Olson was diagnosed with influenza-like illness and sent home with a care packet of painkillers, masks and other supplies for caring with the flu; and they directed Olson to isolate herself in her dorm room. Because the health center did not screen Olson, or many others, for swine flu, it’s hard to be sure that what she and other students experienced was the H1N1 pandemic and not another type of illness, like the seasonal flu. However, Whitman, along with other colleges, did experience a outbreak of ILI, with many students falling ill, missing class and isolating themselves.

“It was the CDC and the American College Health Association’s suggestions that we don’t run a check on every single student who comes with these types of symptoms,” said Director of the Health Center Claudia Ness.

Checking for swine flu would have involved taking a swab and analyzing it, and doing it for every student who came in to the health center would have cost too much, and since the treatment for swine flu is the same as for other flues and flu-like diseases—treating the symptoms—tests would not have changed policy. The exceptions were students who had prior health concerns, like asthma, that made swine flu especially dangerous. These were also the students who the health center contacted to get the first chance at the early vaccines. However, of those tests that the health center ran, none came back positive for H1N1.

Olson, however, still believes that the disease she got was swine flu.

“I’ve had the regular flu before, and this is definitely different,” said Olson.

According to Ness, the outbreak this year last year was different from years before. The major outbreak at Whitman lasted from mid-October to early-December, petering out several weeks or so before winter break. In years past, the flu cases tended to be less concentrated, with fewer cases at one time but with a longer-lasting outbreak than this past year, where the outbreak was much more concentrated in time. The concentration of the flu cases likely increased the visibility of the recent flu epidemic compared to years past.

During the height of the outbreak, the flu was highlighted in the media every day; even The Pioneer declared its importance with headlines like “Flu hits Whitman campus hard, H1N1 vaccine near” and “Flu increases at Whiman, strain unknown.” While no stories directly raised fears of swine flu complications, most detailed the severe outbreak during the fall, where many students were sick and isolated.

In fact, the isolation policy promoted by the Health Center prompted senior Galen Bernard, former news editor, to write an editorial in November. Bernard argued that isolation was not necessary, hadn’t been used in previous years and lead to psychological consequences as a result of the lack of human contact.

After the visibility of the flu in the fall, the CDC predicted a possible outbreak of H1N1 in March and April, but according to Ness, the flu did not break out at Whitman or at other campuses. Another outbreak next year is possible, however, especially if the virus undergoes significant evolution between years.

American colleges are not the only ones worried about swine flu. According to Olivia Jones, a junior who studied abroad in Beijing, China, her university would check student’s temperature with “temperature guns” before letting students into the dorms. She experienced similar precautions at Chinese airports.

“It was mostly paranoia. One kid in the program did legitimately get swine flu. I definitely got the flu in the beginning, but I was afraid because this was right after the other kid got the swine flu and he went to the hospital and they put him in quarantine, and nobody had heard from him in a few days, so once I got the flu symptoms I didn’t tell anyone,” said Jones.

She theorized the heavy precautions in China about swine flu trace back to China’s experience with bird flu, a more dangerous type of influenza.

While swine flu can lead to dangerous complications, they are not that common. According to Ness, no Whitman students developed complications that necessitated hospitalization, and most recovered within a few days.

College living, however, does lead to increased illness, due to the close living conditions.

“Let’s face it, when you’re sharing bathrooms with other people, and you’re brushing your teeth, and turning the faucet on and off, there’s a lot of hand-nose-face contact—washing your face, putting your contacts in, all these sorts of things—that makes it very easy for these germs to thrive,” said Ness.

-whitmanpioneer-

For much of 2009, the swine flu was the biotech industry’s cash cow. The virus’s sudden contagion last spring spread rapidly and lucratively to the local life sciences community, where a handful of companies scrambled to assemble enough money and staffers to launch studies, conduct research and shape products to respond to the first documented flu pandemic in 40 years.

Their battle against the H1N1 virus generated millions of dollars in revenue and lifted some stock prices to new yearly highs, with some leaping as much as 700 percent over the course of last year.

But the pandemic’s relatively light impact — only 16,455 people died worldwide, compared with 1 million to 50 million deaths in past flu pandemics — and a shorter-than-expected flu season has brought some of those biotechs, not to mention their stock prices, back to earth. The companies are now evaluating their performance and lessons learned last year to push for improving flu vaccine technology in time for the next outbreak.

“The opportunity for a specific product for the swine flu has essentially passed,” said Frank Malinoski, a former MedImmune executive who spent most of last year consulting for the Centers for Disease Control and Prevention and small companies preparing for pandemic diseases. “The companies in the area now are either concentrating on how they can be part of the seasonal flu market or how they can prepare for the next pandemic.”

The swine flu frenzy touched several local biotechs in different ways.

One local behemoth, MedImmune, won a contract for up to $453 million to manufacture and deliver its FluMist vaccine to the federal government, boosting its parent company’s revenue and stock price. At least two other companies, Novavax Inc. and Cel-Sci Corp., sped up flu-related vaccine research. While they did not recognize any sales revenue from the pandemic, both companies watched their stock prices soar.

Though, MedImmune and its parent, London pharmaceutical giant AstraZeneca PLC, are now unlikely to see another federal dollar from contracts for their widely used FluMist vaccine tailored to guard against H1N1.

Last year, the government paid $389 million for FluMist, the first vaccine to reach the clinic shelves. The unanticipated income helped convert a potential 5 percent slide in AstraZeneca’s U.S. revenue into a 4 percent bump in the fourth quarter and turn what would have been a roughly 2 percent revenue increase into a 9 percent jump for of 2009.

But now the Department of Health and Human Services will likely leave $64 million of that original $453 million contract with MedImmune on the table. With 74 million unused H1N1 vaccine doses of its own, the department plans to redirect those toward the next seasonal flu vaccine, which will include the H1N1 strain. Overall, the feds spent $1.6 billion on flu vaccines last year.

Although MedImmune spokeswoman Karen Lancaster said the H1N1 revenue injection was always understood to be a “one-time event,” the loss of that money this year is already having an impact on the parent company. AstraZeneca said it expects a mid-single-digit decline in this year’s revenue compared with last year.

Cel-Sci, another company that positioned itself at the center of the swine flu stage last year, watched its stock price swell from an 18-cent low to a $2.10 high in seven months.

In that time, the company announced each step of a process that revived its longtime immune-system-modulating technology for a potential H1N1 treatment and tested it on blood samples of up to 40 total enrollees at the Johns Hopkins University School of Medicine. The company seized the opportunity to collect more than $20 million in a stock sale to put toward a cancer drug waiting in the wings for years to enter new trials.

But as the number of swine flu patients continues to wane, Cel-Sci’s stock is now trading around 70 cents, and a company official said a much-touted trial remains in a holding pattern with no more than a half-dozen blood samples at hand.

“The H1N1 this year has turned out to be a real enigma — it’s bamboozled everybody,” said Dan Zimmerman, Cel-Sci’s senior vice president of research for cellular immunology, who was rehired full-time last November to head these trials, which he said took “substantial” company financial and personnel resources. “We’re doing what we can, but we have not had the number of patients we really need to be able to evaluate this.”

Novavax perhaps shone most brightly in the swine flu spotlight last year. The Rockville company had been working for years on high-tech methods that would lead to faster production of vaccines, and it sped up those efforts last year amid the swine flu hysteria. For much of last year, it trumpeted two major endeavors: the largest clinical trial of its H1N1 vaccine candidate in Mexico and negotiations with Rovi Pharmaceuticals Laboratories of Madrid, Spain, to test and produce its seasonal and pandemic flu vaccine technology in Europe.

The biotech saw its shares swing from its yearly low of 52 cents to its yearly high of $7.79 in a five-month span last spring and summer, and national media from Bloomberg TV to Time magazine were quoting CEO Rahul Singhvi. By year’s end, the previously cash-hungry Novavax was $21 million richer from a major stock sale.

Now, however, the company’s shares are trading below $2.50, and talks with Rovi have ground to a halt.

Yet Novavax remains intent on convincing the U.S. government that its vaccine versions are faster, cheaper and still effective. The company recently announced that it finished enrollment of its pivotal H1N1 vaccine trials in Mexico, and it hopes the trials will help fine-tune a vaccine production method that uses only lab-created chunks of a virus rather than a full, live strain.

“There is a need for new technologies in spite of very valiant efforts of companies,” Singhvi said. “If the pandemic was any worse, then it could have been a very tragic situation.”

While Novavax concentrates on using virus-like particles, another small Rockville company, Bacilligen Inc., is working on assembling genetic sequences of the flu virus pieces responsible for immunity to draft a vaccine manufacturing manual of sorts.

Bacilligen CEO Steve Bende describes his company’s chosen method, funded by a National Institutes of Health grant, as even faster than that of purifying virus-like particles, aiming to take 70 days from strain discovery to patient injection.

National experts say that race to fashion newer, faster vaccines is the key to winning future pandemic battles, as the industry mulls options to replace its roughly 70-year-old vaccine production-process: growing each live virus strain in one or two chicken eggs that must also have matured within an all-too-specific time frame. It was that combination that helped lead to delayed deliveries and long patient waiting lines last year.

“It’s not so much about the strain as it is about the platform — how it’s made and what’s in it,” said Lisa Beth Ferstenberg, chief medical officer for Accelovance Inc., a Rockville contractor that conducts vaccine clinical trials for other drug developers. “Anything we can do to create an alternative to poultry eggs is helpful.”

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Registered nurse Susan Eager checks the breathing of diabetic Jane Awise last month in Thornton, Colo.

The studies are among the first large trials to test whether treatments recommended for diabetes patients also reduce the risk of heart attacks and strokes. Diabetics are between two and four times as likely to die of cardiovascular causes as nondiabetics. The lack of data on whether strategies to treat diabetes actually lower heart risk is of growing concern to physicians, researchers and regulators.

One new study, called Accord, found that treating blood pressure to lower levels than recommended in current practice doesn’t further reduce risk of death, heart attack and stroke among people with diabetes. The same study also found that the drug Tricor, marketed by Abbott Laboratories, failed to prevent such events even though it lowered levels of blood fats called triglycerides that are associated with high diabetes risk.

In the other report, dubbed Navigator, a diabetes drug called Starlix failed to prevent people at high risk of diabetes from progressing to the disease. The blood-pressure medicine Diovan did modestly reduce risk of developing diabetes in the same study, but neither drug significantly cut the risk of heart-related deaths, heart attacks and strokes. Both pills in this study are sold by Novartis SA of Switzerland.

The results from both studies were unveiled Sunday at the annual scientific meeting of the American College of Cardiology and published online in four different papers by the New England Journal of Medicine.

“Physicians and patients are looking pretty desperately to decrease the toll that comes with diabetes,” said David Nathan, director of the diabetes center at Massachusetts General Hospital, Boston, who wasn’t involved in the reports. “These studies don’t provide a new route or any new information about how to do that.”

More than 23 million Americans suffer from diabetes. The International Diabetes Federation, Brussels, puts the global total at 285 million, with projections that it will rise to 438 million within 20 years. The vast majority have Type 2 diabetes, an impaired ability to process dietary sugars that is typically associated with obesity and lack of exercise.

In the U.S., combined annual costs to treat the disease and for additional factors such as lost productivity amount to $174 billion, according to the American Heart Association. Heart experts worry that without better ways to prevent and treat diabetes, the disease threatens to reverse nearly a half-century of advances against cardiovascular disease, which remains the world’s leading killer.

Despite the disappointing findings, researchers said that overall, the data strengthen support for current treatment guidelines and that patients shouldn’t abandon proven medications and strategies that may be keeping them out of trouble.

“What we’re seeing is the effectiveness of our current therapies,” said Darren McGuire, a cardiologist and diabetes researcher at UT Southwestern Medical Center, Dallas. “It’s not that what we’re presently doing isn’t good; it’s just that more isn’t better.”

Researchers said the findings also underscore the value of physical exercise, healthy diets and weight loss. Even a loss of 5% of body weight, for instance, significantly lowers the risk of developing diabetes.

Among current guidelines for diabetes patients, one calls for treating systolic blood pressure–the higher number in a blood-pressure test–to below 130, though limited evidence exists for that recommendation. For patients with triglyceride levels above 200, advice is to try a so-called fenofibrate drug such as Tricor if a statin alone doesn’t help, especially if HDL, or good cholesterol, is low. Evidence for that strategy isn’t strong either.

In one part of the Accord trial involving 4,733 patients followed for 4.7 years, the group assigned to intensive treatment achieved systolic blood pressure averaging 119 (target: below 120), compared with 134 in the group getting standard care (target: below 140). Researchers said while the more intensive approach slightly lowered the likelihood of heart attack, stroke or death from cardiovascular causes, the difference wasn’t statistically meaningful. A second Accord paper found that adding Tricor to a generic statin successfully reduced triglyceride levels by about 25%, but that didn’t lead to fewer heart attacks, strokes and heart related deaths. Researchers said the results suggested women might do worse adding Tricor while men might do better.

In addition, the combination appeared to benefit a subgroup of patients with triglycerides above 204 and an HDL of 34 or lower, lending some support to current guidelines. But that finding didn’t quite achieve statistical significance and would need confirmation in new trial.

Abbott said it wasn’t surprised by the results because the average triglyceride level of patients when the study began was 162; it says most patients treated with its drug have levels over 200. Researchers said the study suggested adding Tricor to a statin might help some patients with high triglyceride levels. Tricor and a sister drug Triplipix together accounted for $1.3 billion in revenue for Abbott in 2009. The study was sponsored by the National Institutes of Health.

The Navigator study, sponsored by Novartis, examined whether Starlix or Diovan, when added to an exercise and diet program, would prevent diabetes and major cardiovascular events among high risk patients.

“For people who don’t have diabetes, neither drug will be recommended,” said Robert Califf, vice chancellor for clinical research, Duke University, Durham, N.C., and a leader of the trial, because neither achieved success against both diabetes and heart disease.

-WSJ-

The results are surprising and disappointing, heart and diabetes experts say. An estimated 21 million Americans have Type 2 diabetes, the kind once known as adult-onset, and they are at enormous risk for heart disease. The only measures proved to reduce their chances — avoiding cigarettes and taking medication to lower bad cholesterol and blood pressure — still leave diabetics with a heart attack risk equivalent to that of a nondiabetic who has already had a heart attack.

So doctors began trying other strategies they hoped would help: getting blood pressure to a normal range; raising levels of good cholesterol and lowering levels of dangerous triglycerides; or modulating sharp upswings in blood sugar after a meal.

It is not known how many doctors have been encouraging patients to take these measures, but medical specialists say it seemed reasonable and tempting to do so.

“Doctors always want to improve the lives of their patients, and that often leads to pressure to treat more and more,” said Dr. Henry N. Ginsberg, director of the Irving Institute for Clinical and Translational Research at Columbia University. The new studies, he says, could save a lot of people from taking drugs that will not help them.

The papers were presented at an American College of Cardiology meeting on Sunday and are being published online by The New England Journal of Medicine.

In Type 2 diabetes, the body is resistant to the hormone insulin, leading to abnormally high blood sugar levels that can cause eye, kidney and nerve disease. But heart disease is what kills most patients. A quarter to a third of heart attack patients have diabetes, even though diabetics constitute just 9 percent of the population. And 25 percent of heart attack patients are on the verge of diabetes, with abnormally high blood sugar levels.

High blood sugar levels themselves increase the risk of heart disease, but researchers found two years ago that rigorously controlling blood sugar did not prevent heart disease or deaths in people with Type 2 diabetes. Researchers said the failure was probably because most of those patients also had other problems that made their odds of heart disease soar, like high levels of LDL cholesterol, low levels of HDL cholesterol, high levels of triglycerides and high blood pressure. And most were older and overweight.

Type 2 diabetes “captures all these risk factors in one patient,” said Dr. David Nathan, director of the diabetes center at Massachusetts General Hospital.

It seemed logical to look at the other risk factors. One large federal study asked if getting high blood pressure down to a level considered normal, a systolic pressure of no more than 120, would help protect diabetics from heart disease and save lives.

This hypothesis was promising because studies that observed populations found that heart disease and stroke risk increase continuously as systolic blood pressure rises from 115 on up, said Dr. William C. Cushman, a study investigator and chief of the preventive medicine section at the Veterans Affairs Medical Center in Memphis.

To put the idea of a normal blood pressure to the test, half of the study’s 4,773 participants took drugs to get their systolic blood pressure to 120 or below. The rest had a blood pressure goal of less than 140.

But lower blood pressure did not prevent heart attacks or cardiovascular deaths, and those with lower blood pressure were more likely to suffer severe side effects from the drugs, like high potassium levels or dangerously low blood pressures. They also took an average of 3.4 drugs to lower blood pressure, compared with an average of 2 drugs for those with the higher pressure.

A second, less rigorous study, involving 6,400 patients with Type 2 diabetes and heart disease, asked whether getting systolic blood pressure lower than 130 was any better than getting it to 130 to 140. It found that patients actually were worse off: those with the lower blood pressure ended up with a 50 percent greater risk of strokes, heart attacks or deaths.

National blood pressure treatment guidelines call for a systolic pressure of 130 or lower. That was based on expert opinion and observational studies, Dr. Cushman said. Now, he said, it is likely to be reconsidered when the group that sets the guidelines prepares a report this year.

People with diabetes also tend to have low levels of HDL cholesterol and high levels of triglycerides, a combination known to increase the risk of heart disease. And in some studies, treating that combination with a type of drug called a fibrate reduced risk in diabetics and nondiabetics who were not taking statins. So it made sense to see if fibrates also helped Type 2 diabetics who were taking statins.

It did not, concluded another arm of the federal study involving 5,518 people with Type 2 diabetes.

“It’s a disappointment,” said Dr. Ginsberg, a lead study investigator. “But it’s very, very important,” because it says most people will not be helped by taking the additional drug.

It means, said Dr. Denise Simons-Morton of the National Heart, Lung and Blood Institute, the project officer for the federal study, that “doctors and patients now know that the inclination to do intensive treatment that people seemed to think would be better for cardiovascular risk reduction wasn’t better.”

A final studyinvestigated the popular hypothesis that rapid rises in blood glucose after a meal were dangerous and could lead to heart disease. Many doctors were giving drugs assuming the hypothesis was correct, Dr. Nathan said.

“Every meeting you go to, some academic is talking about how postprandial hyperglycemia is really bad and that you should aim specifically to get it lower,” Dr. Nathan said. The study, he said, “is a direct test of that.”

The study, which involved 9,300 patients at high risk for diabetes because their blood sugar was high, tested the drug nateglinide, which enhances insulin secretion. It also tested a blood pressure drug. Neither decreased heart disease risk.

“Neither drug should be used in people with impaired glucose tolerance but not diabetes in order to prevent cardiovascular events unless there is another indication, like significant hypertension,” said Dr. Robert M. Califf, vice chancellor for clinical research at Duke University School of Medicine and chairman of the study.

Dr. Nathan, who wrote an accompanying editorial in The New England Journal of Medicine, agreed. “It is a negative study,” he said.

Some, like Dr. Daniel Einhorn, president-elect of the American Association of Clinical Endocrinologists, say the results of that study and the others would not necessarily dissuade him from taking such intensive measures with individual patients.

“It’s hard to make a case for a public health recommendation,” Dr. Einhorn said. “But that doesn’t mean there isn’t a benefit in an individual case.”

But no benefit has been shown, Dr. Nathan noted. The lesson, he said, is that while making logical leaps to aggressively treat patients with Type 2 diabetes was “totally understandable,” it was also dangerous.

“Lower is not necessarily better,” Dr. Nathan said.

-NYTimes-