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Biotech / Medical : Biotech Valuation
CRSP 54.84+0.2%3:59 PM EST

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To: Biomaven who started this subject12/14/2003 7:37:32 PM
From: Doc Bones  Read Replies (1) of 52153
 
The Big Bad Flu, or Just the Usual?

A couple of articles that emphasize that so far it is not known if this flu season will be unusually bad. It has hit early in the West and has received loads of publicity, but doesn't seem unexpectedly severe so far - the jury is still out. I would think that the fact that flu shots may be less effective this year may cause flu to be more widespread - all the more reason to rush out and inhale some fine MEDI FluMist. Oh yeah, disclosure, long MEDI, MEDI calls.

;-)

Doc


nytimes.com

December 14, 2003
NEWS ANALYSIS

By LAWRENCE K. ALTMAN

For all the public concern over the rapid spread of the new Fujian strain of influenza, health officials and doctors say there is still no way to know whether this year's flu season is particularly severe or just off to an early start. And for all the clamor for dwindling supplies of vaccine, no one knows how effective the current vaccine will be against the Fujian strain.

But the flu season has already thrown some realities about the public health system into sharp relief, these experts say. It suggests that the country needs to be far better prepared to deal with influenza — either the conventional strains that cause serious illness each year, or a horrendous strain like the one that caused the 1918-19 pandemic, which killed at least 30 million people worldwide.

Influenza is arguably the most unpredictable of viruses, and protecting the public against it is a tricky balancing act. It involves a number of factors: inadequate scientific knowledge of the virus; educated guesswork in choosing what strains of influenza to include in each year's vaccine; time-consuming, old-fashioned manufacturing techniques; and skills in communicating with a skeptical public.

Such protection also depends on a strong public health system. But years of underfinancing have weakened the system. And confidence in it was scarred by the flawed emergency swine flu immunization program in 1976, which was halted after a relatively few of the 45 million people who had been vaccinated became temporarily paralyzed from Guillain-Barré syndrome.

More recently, gaffes and miscommunication about events like the anthrax attacks of fall 2001 left Americans unsure what to think about public pronouncements, and insecure about the nation's capacity to deal with a severe epidemic of SARS or a new strain of influenza.

Communication has improved since then. Still, the government had little to say about influenza this fall, while the health and human services secretary, Tommy G. Thompson, and his top aides visited African countries torn by AIDS. Only after their return did news conferences about influenza resume.

Government health officials have repeatedly warned about the inevitability of another influenza pandemic. Yet the government has yet to approve final plans to counter such a disaster.

No one knows why influenza has hit the western United States in particular, or why it happened so early this season. No evidence exists to suggest that the Fujian strain is more virulent than other strains that have caused past epidemics or that this season's influenza is worse than those of the past. Although the Fujian strain also struck early in Europe, the World Health Organization said it was not aware of unusually severe influenza this season outside the United States.

Dr. Anthony S. Fauci, the director of the National Institute of Allergy and Infectious Diseases, put it bluntly: "No way will the Fujian strain cause a pandemic."

Dr. Julie L. Gerberding, director of the Centers for Disease Control and Prevention, says the vast majority of influenza cases are an annoyance, causing only a mild respiratory illness. But Dr. Gerberding also noted that influenza is lethal for 36,000 Americans on average each year.

The deaths are among the reasons health officials have been urging Americans to take influenza vaccine. An estimated 185 million Americans are eligible for it, but manufacturers produced enough vaccine for only 83 million Americans.

Each February and March, the World Health Organization and the United States government invite experts to meet independently to choose the three influenza strains they believe are most likely to cause outbreaks the following season.

The three strains are turned into the following season's vaccine, and W.H.O. provides the seed viruses free to all vaccine manufacturers.

The Fujian strain was detected too late to be included in this season's vaccine. Officials have said that the vaccine should still afford "some protection" against the Fujian strain but do not know how much.

Because the manufacture of influenza vaccine is entirely in the private sector in the United States, market forces determine the amount produced.

One reason for the gap between supply and demand this season is the perennial lack of response to pleas from health officials for most Americans to get flu shots. That consumer response forced manufacturers to discard 12 million of the 95 million doses produced last season at a loss of millions of dollars. So manufacturers produced 83 million doses for this season.

The time when the three strains are chosen is critical to vaccine production. One reason is that it takes tens of millions of chicken eggs to produce each season's vaccine, and they must be bought months in advance. Once production is complete, additional doses cannot be made without reducing the amount that could be produced for the next influenza season, Dr. Gerberding said.

Because the process is complex and even the best influenza vaccines are about 70 to 90 percent effective, a notch below the standard childhood immunizations, health officials have long urged researchers and industry to find new ways to produce influenza vaccine. Scientists have come up with promising new methods. But major problems, including those involving technology and intellectual property rights, are unresolved.

Dr. Barry R. Bloom, dean of the Harvard School of Public Health, said that because of industry's limited capacity to make vaccine, "we would be in terrible shape" if there was a pandemic of a virulent strain. "That is unlikely to change without government intervention," he said.

Soon after the swine flu episode in 1976, the government began drafting a plan for its response to a real pandemic. Then in 1993, it created a panel to come up with the plan. Many drafts have been prepared as the science has changed, but there is no final one, said Dr. Bruce G. Gellin, the director of the government's National Vaccine Program Office.

Critics say an official plan is needed. But even a draft, Dr. Gellin said, has been useful as a blueprint for preparing against a bioterrorism attack and in dealing with SARS.

"We need to diversify our manufacturing base and develop new techniques to improve our chances of success," Dr. Gellin said. "Ideally, that would produce a vaccine that would be given once and protect against all influenza viruses."

*****************

With Flu Season's Fear Factor, Vaccine Supply Just About Shot

latimes.com

News of outbreaks elsewhere worries patients and parents. O.C. clinics see an increase in sick people.

December 13, 2003
CALIFORNIA

By Lisa Richardson, Jeff Gottlieb and Jia-Rui Chong, Times Staff Writers

The outbreak is sweeping California, the contagion moving faster than the Santa Ana winds in a lonely canyon pass.

A flu epidemic? Not yet. Instead, health officials say, it is an epidemic of flu panic.

Frantic parents are filling pediatricians' offices in search of the now hard-to-find flu vaccine. The worried well are lining up — better late than never — for protection.

Driving their fear, largely, are reports of virulent outbreaks and deaths in other states. Not that people aren't catching the flu in California. The season appears to be peaking early in some places — especially Fresno and Sacramento counties.

The flu or its complications have been blamed for the deaths of an elderly San Luis Obispo resident and a 7-year-old Bakersfield boy, and possibly caused the deaths of a 5-year-old Arizona boy visiting Compton and a 13-year-old San Diego County girl.

But in some populous parts of this state, demand for the flu vaccine far outstrips the number of actual illnesses. Los Angeles County, for instance, is "pretty much par" for both the number of cases and their arrival, said Dr. David Dassey, deputy chief of the county's acute communicable disease unit.

"By and large this is the time when we begin to see an increase in complaints…. For us it's normal, and arriving on time."

That's not the case in Orange County, where doctors, emergency rooms and clinics have seen more people looking for flu vaccine in the last week and more patients with flu-like symptoms: high temperature, body aches and respiratory infections.

Charles Bonner, owner of Steven's Pharmacy in Costa Mesa, said that in three days last week, he went through 130 doses of vaccine, the amount he would normally use in an entire season. "I've never seen it like this," he said.

Two weeks ago he was wondering if he'd use all his vaccine. Then came the reports of deaths, followed by the huge surge of people who exhausted his supply. He's still getting 15 to 20 calls a day from people asking for vaccine.

Bonner said that many pediatricians who have run out of vaccine are prescribing antiviral drugs at the first signs of flu in their patients. He has been making a liquid compound of two of the drugs to make it easier for children to take them.

"I've never seen a demand for making oral antivirals for kids before," he said.

Last year, Dr. Joel Lewis, an allergist and immunologist in Costa Mesa, didn't use all of his flu vaccine. This year, he's run out. "I think there's hypersensitivity," he said. "I think parents are very nervous."

Officials with the Los Angeles County Department of Health Services say their phones are ringing constantly as desperate patients and parents search for doctors with a cache of the fast-dwindling vaccine. The manufacturers are running out.

Anyone in a high-risk category — children under age 5, senior citizens and people with chronic conditions such as asthma or diabetes — can still get vaccinated at Los Angeles County clinics, health officials say.

Others are left to seek the services of private doctors. Health officials advised against seeking vaccinations at emergency rooms.

With word of outbreaks in Colorado, Nevada and other states, everyone seems to want shots now, said Maria Iacobo, a Los Angeles County health department spokeswoman. Even while she is speaking, a worried mother calls, wondering where she can get her children vaccinated. Her own pediatrician, she tells Iacobo, has run out. Keep hunting, Iacobo tells her.

"If you went to the grocery store and you went to buy milk and they didn't have any milk, would you think there was no milk left in Los Angeles County? No, it's that that one store didn't have any milk and you'll have to work a little harder to find it," she said.

Iacobo and others said that while the flu vaccine is in short supply, a nasal inhalant called FluMist is readily available at pharmacies without a prescription. The mist, as protective as the vaccine, is appropriate for healthy patients ages 5 to 49.

Throughout the region, fear is pervasive. Last season, parents would wait a few days if their child had a cough or other symptoms before bringing him or her to the doctor, said Carol Schoger, manager of primary care at Children's Hospital of Orange County.

"Now you ask how long the child has been sick, and they [say], 'Since yesterday,' " Schoger said. "I think they're pretty scared by what's out there."

Gilbert Avila, 22, of Santa Ana said he waited an hour for a shot this week at the UC Irvine Family Health Center in Santa Ana, but the clinic ran out of vaccine before it was his turn. He went home.

"With all the sick kids waiting around, I got a little paranoid," he said.

Avila said he feels "a little ridiculous and dumb" that he didn't get the vaccination in October or November when it was easy to come by. "Then all the sudden there's this media coverage of all these people dying," Avila said, and he got scared.

Many health care providers say they are rationing their supplies. Some are fresh out.

Dr. Hsiao-Fen Chen in San Gabriel said she ran out of flu vaccine at the end of November, after dispensing 2,000 shots. People still call asking for the vaccine, she said, and she sees about 30 flu patients each day.

In Tarzana, Dr. Kenneth R. Keer also has run out of flu vaccine and has a waiting list of 50 to 60 families. "People are getting panicky," Keer said.

In an average year, 114,000 people nationwide are hospitalized with flu-related illnesses and 36,000 die.

Whether this year's flu season turns out to be worse than last year's remains to be seen, state officials say. What is clear is that this flu season began unusually early in some places.

If cases remain high through February, the nation could have record-breaking numbers of sick people.

"We won't know until it peaks and we see the figures on hospitalizations," said Dr. Howard Backer, acting chief of the California Department of Health Services.

Some parts of California have been hit harder than others.

"We've seen over 1,000 kids since Nov. 1," said Micheline Golden, a spokeswoman for Children's Hospital of the Central Valley in Fresno. "We have doctors who've been in our emergency room 25 years who say they've never seen this many kids."

For most people, catching the flu will not lead to dire consequences. It causes symptoms including nausea, headache, fever and congestion.

"You'll get sick and you'll be out for a week," said Iacobo of L.A. County.

While the season's most prevalent type of flu, influenza Type A, has historically been associated with more severe seasons and a higher number of hospitalizations and deaths, it is not inherently worse than other types, Dassey said.
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