Sunday, January 15, 2006

CDC: Two influenza drugs don't work - Jan 14, 2006

CDC: Two influenza drugs don't work
Doctors asked to stop prescribing amantadine and rimantadine

CDC Director Julie Gerberding said the flu virus's resistance wasn't expected to be "quite as dramatic."
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How did the strain become resistant? (2:44)
SPECIAL REPORT

• Season tempered by bird flu fears
• The animal connection
• Interactive: Flu 101
• Interactive: Superflu creation
• Gallery: The cold facts
• Special ReportATLANTA, Georgia (CNN) -- With flu season reaching its peak, two drugs typically prescribed to fight the virus will be ineffective this season and should not be prescribed, the Centers for Disease Control and Prevention announced Saturday.

The CDC found in tests that the antiviral drugs amantadine and rimantadine were ineffective 91 percent of the time against H3N2 influenza, the dominant strain this season.

However, two other antiviral drugs, Tamiflu and Relenza are still effective, said CDC Director Dr. Julie Gerberding. Amantadine and rimantadine are older, less-expensive and less commonly prescribed drugs.

There has been a global trend toward drug resistance, but Gerberding said health officials didn't expect the resistance "to be quite as dramatic so soon." (Watch Dr. Marc Siegel explain how the strain became resistant to some drugs -- 2:44)

"We don't know exactly why resistance has risen to these drugs," Gerberding said, adding that the flu virus may have mutated, but there is no evidence to support that. "Flu constantly evolves, and we are always one mutation away from drug resistance."

There is no "magic bullet" to prevent drugs from becoming ineffective against certain flu strains, she said.

There is plenty of Tamiflu and Relenza for this flu season because the CDC stockpiled the drugs in case of an influenza pandemic, Gerberding said.

The flu is widespread in Arizona, Texas, New Mexico, Nevada, California, Oregon and Colorado.

The season, which can begin as early as October and stretch into May, typically is most widespread in December, January and February.

Sunday, January 08, 2006

News: U.S. Tamiflu shipments increase - myDNA

Roche Pharmaceuticals, maker of the influenza drug Tamiflu, has stepped up shipments to U.S. cities with high incidences of the flu.

States that have been particularly hard hit this season include California, Arizona, New Mexico, Utah, Texas, Oregon, Nevada and Kansas.

Tamiflu targets the most common influenza strains, types A and B. Roche temporarily halted some Tamiflu shipments to the United States during the fall, when consumers fearful of a bird flu pandemic hoarded the drug. Tamiflu has shown some promise for treating people infected with the H5N1 bird flu strain, but it has not been approved for that use.

"When demand for Tamiflu rose last year, Roche took appropriate precautions to ensure adequate supplies would be available for the treatment and prevention of seasonal influenza," said George Abercrombie, president and CEO of Hoffmann-La Roche Inc. in a company statement.

"Because of those precautionary measures, Tamiflu is readily and widely available to patients who need it for flu treatment and prevention, while we continue to work with governments to supply stockpiles for pandemic preparedness."

Friday, December 23, 2005

Beware when buying Tamiflu online: Health Canada

Consumers should be cautious about buying the prescription drug Tamiflu over the internet and avoid products claiming to be a generic version, Health Canada warned Friday.

Tamiflu, also known as oseltamivir, is considered the best early defence against a pandemic that could be triggered if H5N1 avian flu mutates into a form that spreads easily between people. The drug is also prescribed during the regular flu season.


Real versions of Tamiflu have a drug identification number on the box.
Regulators in Canada, the United States and Britain are concerned fears of a pandemic and shortages of the drug for the public could be fuelling internet sales of fake Tamiflu.

There are no authorized generic versions of the antiviral on the market, Health Canada said. It's made by the Swiss drug manufacturer Hoffman-La Roche.

The advisory comes as British regulators investigate internet sales of products purporting to be flu-fighting drug.

Reports from the U.K. suggest several internet sites, including two Canadian ones, have been selling illegal Tamiflu to British customers, Health Canada said.

U.S. border patrol agents have also stopped more than 50 shipments of bogus Tamiflu.

"As with any medication purchased online, consumers should only buy Tamiflu with a prescription from a doctor they know, using a pharmacy where they have an established relationship," Health Canada advises.

Consumers should look for the drug information number, or DIN, on the product, and buy from internet pharmacies that provide a street address and telephone number in case there is a problem.

British regulators are testing to determine if drugs purchased online are really Tamiflu.

Consumers who suspect they have received counterfeit drugs should check with Hoffman-La Roche, which may advise them to call the RCMP. The company can confirm if it manufacturered the product.

Monday, December 12, 2005

Roche Selects Potential Tamiflu Partners

BASEL, Switzerland — Swiss drugmaker Roche Holding AG said Monday it has chosen 12 potential partners for the production of Tamiflu and granted one sublicense for the antiviral drug to Shanghai Pharmaceutical.

Roche said it compiled the shortlist of potential partners, which it did not identify, after evaluating around 200 applicants interested in helping with certain steps in the manufacture of Tamiflu. It didn't say how many it would finally choose.

Roche said it would mainly use the partners, which include major pharmaceutical makers, large generic manufacturers and specialty chemical producers, as backups, to meet specific regional needs and to prepare for any large additional government orders in the future.

"We are now also in the position to have a backup supply in case of an emergency," said David Reddy, who heads Roche's influenza pandemic task force.

Roche has come under international pressure to ease its monopoly grip on the manufacture of Tamiflu, which is considered the most efficient treatment in case of an outbreak of human influenza caused by a mutation of the bird flu virus.

The company has been pressed to step up production, cut prices and allow other companies to make copies of the drug.

Roche said it will now evaluate the potential partners' specific skills, the quality of their production and their delivery speed before making the final choice. "We will then choose among the companies to help us with certain steps in the production process such as fermentation or alcoholic granulation," said Roche spokesman Daniel Piller.

Roche has pledged to increase the production of Tamiflu by nearly six-fold by planning to make 300 million treatments annually by 2007 in order to meet government orders amid fears of a flu pandemic.

Separately, Roche said it will grant Shanghai Pharmaceutical rights for the overall production of Tamiflu, also known as oseltamivir, for use in China.

"They are allowed to and they will produce the drug from the beginning to the end," said Piller.

Roche said it could already produce the 300 million annual treatments with its existing partners such as Mylan Laboratories Inc. of Pittsburgh or Israeli drugmaker Teva Pharmaceutical Industries. The making of Tamiflu is considered very complicated.

Although some 50 companies around the world have bought or ordered supplies of Tamiflu for pandemic stockpiles, so far Roche has no firm orders for 2007. That leaves the company with a large degree of uncertainty over possible future needs.

For example, Roche has not yet received any large orders from the United States _ although President Bush has proposed stockpiling anti-flu drugs Tamiflu and GlaxoSmithKline PLC's Relenza for 81 million people. and U.S. Department of Health and Human Services Secretary Michael Leavitt has called for a Tamiflu stockpile to treat 20 million Americans. So far, the United States has only enough anti-flu drug doses in stock to treat 4.3 million people.

Roche said it has already brought forward delivery schedules for countries that have had large bird-flu outbreaks, or are near countries that have. Roche has also allowed Vietnamese companies to encapsulate Tamiflu locally.

Tamiflu is not patent-protected in Thailand, the Philippines and Indonesia. As a result, local governments can purchase and manufacture oseltamimivir at their discretion.

Tuesday, December 06, 2005

Bird Flu Threat Prompts Stockpiling of Roche's Tamiflu Pills

Dec. 5 (Bloomberg) -- Susan Wolfson says her teenage daughter became frightened in September by a TV news program highlighting the threat that avian flu will mutate into a pandemic capable of killing millions of humans.

Wolfson responded by getting a doctor's prescription for Tamiflu, the antiviral drug that has shown some benefit against the flu in lab tests. She then hid 30 capsules behind other items in a medicine chest to reduce chances that anybody visiting her home might swipe them.

``I know it sounds really crazy, but this drug seemed more precious than other things that I own,'' says Wolfson, 52, the president of Sensei, a New York public relations firm. ``It's the best available defense that I know of to protect my kid and myself.''

Now Wolfson -- and thousands of other Americans who have stocked up on the drug -- must face the reality that guarding against the looming threat of a flu pandemic with Roche Holding AG's Tamiflu may not be as surefire or simple as many consumers think, according to infectious-disease specialists.

``It's a difficult drug to use properly,'' says John Treanor, a 51-year-old professor of medicine at University of Rochester in Rochester, New York. ``People who hoard the drug might use it improperly or store it improperly, so it won't work. Hoarding is a panic thing.''

Misuse would waste drugs -- needed if a pandemic does occur -- and squander the money spent on Tamiflu, Treanor says. Ten capsules, or enough drugs to treat one person for five days at Roche's recommended dose, cost $78.99 on Drugstore.com, an Internet seller.

Hoarding

``There's no reason to hoard Tamiflu,'' Treanor says. ``The likelihood of a pandemic is extremely small.''

Tamiflu sales are jumping nonetheless. U.S. drug stores filled almost 422,000 prescriptions for Tamiflu during the 14 weeks ended Nov. 18, more than four times the total in the year- earlier period, according to Verispan LLC, a research company in Yardley, Pennsylvania.

The sales increase might have been ever larger had not Roche, based in Basel, Switzerland, temporarily suspended Tamiflu sales in late October to ensure that supplies would be available later.

Some doctors are refusing to comply with requests for the drug.

``We're trying to explain to parents that avian flu is really not a concern at this point for their children,'' said Kathryn Mandal, a 31-year-old pediatrician in Waldorf, Maryland. She said has declined to write Tamiflu orders for about 10 parents who requested Tamiflu during the past two months.

Upset Parents

``Most of them have gotten upset,'' Mandal says. ``Some parents told us they'd go to other sources.''

There have been 133 confirmed cases of the H5N1 avian influenza in humans -- resulting in 68 deaths in five Asian countries -- since late December 2003, according to the World Health Organization. Health authorities believe the victims came into direct contact with the feces or blood of infected poultry.

Experts at WHO, an arm of the United Nations, say the world appears closer to a flu pandemic than at any other time since 1968, as the H5N1 avian flu virus might mutate into a form readily transmissible between humans.

The extent to which Tamiflu would help fight a pandemic flu won't be known until such a virus emerges. The drug, available since 1999, can help someone with seasonal flu by blocking the virus from spreading once it is inside the body and has infected some respiratory cells.

Studies have shown that Tamiflu can cut as much as day off the period that the symptoms persist, its use by an infected person can reduce the virus's ability to spread to others, and taking the drug can lower one's risk of getting the flu.

Mouse Studies

Research this year found that mice infected with bird flu that were given large doses of Tamiflu were more likely to survive than those who received a regimen more like what is now prescribed to patients. No studies have been done in people infected with the bird virus.

Even if people correctly diagnose the flu, their timing must be precise to benefit from Tamiflu, Treanor said. Treatment must be initiated within the first 48 hours of symptoms such as fever, sore throat or muscle aches, according to Roche. The need for proper timing -- and the requirement that patients get the drug prescribed by doctors -- is one reason that the antiviral and a similar one from GlaxoSmithKline Plc. called Relenza have not proved popular in the past, according to infectious disease specialists.

While Tamiflu could be taken to protect against a flu, the price would add up. A flu season can extend several weeks or months. People who now have saved 10, 20 or 30 pills may have difficulty getting many more, given shortages of the drug as a result of Roche's production limits.

Zero Refills

Drugstore.com, citing shortages, says on its Web site that it currently will dispense no more than 10 capsules per person, ``with zero refills.'' Larger quantities may be dispensed in regions with flu outbreaks, the site said.

``The drug is effectively only while you are taking it,'' Treanor says. ``You need to administer it during the entire period'' -- that is, from beginning to end of the flu threat.

If a pandemic flu does hit, and just one member in a family falls ill, there is a question of whether giving Tamiflu to the sick person would increase danger to the others -- by making the virus resistant to Tamiflu.

``The chance of getting resistance in that person is very high, and then we lose the protective effect in the other family members,'' Stephen Wolinsky, a professor of medicine at Northwestern University in Evanston, Illinois, said at a conference on avian flu held on Nov. 16 in New York.

The unanswered questions haven't stopped people from squirreling away Tamiflu.

``It's human nature,'' says Stephen S. Morse, a 52-year-old associate professor of epidemiology at Columbia University in New York. ``There's almost a talismanic quality to it,'' Morse says. ``It's like having an amulet to ward off evil: It can give a false sense of security.''

Saturday, December 03, 2005

State sets Tamiflu restrictions

Officials want full supply available in case of emergency
By Annette Wells, Staff Writer



Thinking about stuffing your medicine cabinet this holiday season with Tamiflu?
If you don't have it, chances are, you won't get it in California unless you're elderly or chronically ill.

The state's Department of Health Services has issued guidelines for physicians who have pesky patients wanting to stockpile it in case of a bird flu pandemic.

Tamiflu, already in limited supply across the world, is used to treat flu symptoms. It can't stop you from getting the flu.

Under the state's new guidelines, the drug is priority for the elderly and those who are at high risk of complications from seasonal flu such as very young children and people with chronic health conditions.

The guidelines note that inappropriate use of Tamiflu may promote the development and spread of influenza viruses and resistance to them.

"The intent of the guidelines is to help support physicians whose patients might be asking for a prescription for their own stockpiling purposes," said Leah Brooks, a spokeswoman for the department.

"We have anecdotally information that this has been happening."

The guidelines also encourage health-care providers to educate their patients about how to stay healthy during the current flu season.

This includes urging patients to get the flu vaccine, wash their hands and stay home from work or school if sick.

Some health officials have already seen an increase in Tamiflu prescriptions from last year. They too have put a stop to it.

"We did see a slight increase in prescriptions but that was 35 to 45 days ago," said Jennifer Resche-Silvestri, a spokeswoman for Kaiser Permanente Medical Center in Fontana.

"We've since held it back, not writing as many. We're trying to keep it in stock."

About a week ago, Riverside County's Department of Public Health sent out its own notice to the public about inappropriate stockpiling of Tamiflu, said Barbara Cole, director of disease control.

Cole praised the state for reinforcing Tamiflu restrictions.

San Bernardino County's Public Health Officer Eric Frykman also endorses the state's efforts.

"We're not against prescribing Tamiflu, we just don't want it going to people who do not have illness or aren't susceptible to illness," he said.

Last week, Frykman gave a brief presentation to the county's Board of Supervisors about bird flu and the possibility of an outbreak here.

During the meeting, he said we were overdue for a flu pandemic.

Whether or not it will be Avian flu or when that pandemic might occur is unknown.

In an effort to keep school-aged children from getting the seasonal flu and spreading it, public health will be vaccinating students with FluMist, a nasal spray.

Shipments of the nasal spray are expected to arrive sometime this week, Frykman said. They have been donated by manufacturer MedImmune Vaccines, Inc.

Several school districts have shown interest in participating.

Arrowhead Regional Medical Center in Colton is piloting a similar program within the Colton Unified School District.

Approximately 1,000 of the FluMist vaccines have been administered, said Gerald Greene, chairman of the Department of Pediatrics at Arrowhead Regional. Greene estimates that one-third of the 25,000 students in the district and students will get the vaccine must have parental consent.

"There are some statistical models and research suggesting that if we could protect children, it would reduce the spread of influenza throughout the community," said Greene, an unpaid adviser for MedImmune.

"This is the first time there has been an organized approach like this in junior high and high schools. We hope once the flu season is over to go ahead and query families, both those who got the vaccine and those who didn't and maybe get some results."

While the state does have some Tamiflu in stock, Brooks said it's not enough. She said it is actively pursuing more of the drug from the federal government, though its stock is nearly dry as well.

In preparation for a potential bird flu pandemic, President George W. Bush has announced a $7.1 billion plan that calls for spending $1 billion to stockpile antiviral drugs such as Tamiflu.

No sustained or ongoing transmission of bird flu among humans has occurred and there is no evidence of bird flu in humans or birds in the United States.

On Wednesday, several Japanese quail were discovered suffering from a low pathogenic strain of the bird flu at a Sun Valley quail farm in Los Angeles County.

The state Department of Food and Agriculture confirmed three cases of bird flu were found at the L.A. Quail Farm, but said the low pathogenic strains are not uncommon.

Brooks said the state Department of Health Services is aware of the Sun Valley quail situation and is monitoring it.


The Associated Press contributed to this report.

Tuesday, November 29, 2005

Philippines and Thailand free to make Tamiflu

ZURICH: Thailand and the Philippines are free to begin making their own versions of the anti-viral drug Tamiflu in preparation for a bird flu pandemic, the medicine’s maker Roche Holding said on Monday.

The pill, which governments are stockpiling as a precaution against a virulent outbreak of flu, does not have patent protection in either country, meaning that the Thai and Philippine governments are free to make their own versions. The move follows a similar decision by Indonesia last week and could create a source of cheap Tamiflu for other developing countries who are unable to afford the Roche-branded drug.

“Tamiflu is not patent protected in these countries and so there is no question about granting a licence or sub-licence (for production),” a Roche spokesman said.

There will be no financial consequences if the two South-East Asian countries begin their own production of the drug, he said.

Taiwan, where the drug has a patent, has said it will produce Tamiflu under compulsory licence if its stocks run dry, surprising the Swiss firm which says it can meet demand. The drug is protected in China and has a patent pending in India. Roche maintains that Tamiflu is hard to produce, taking around a year since it requires a chain of different processes, some of which are dangerous.

The spokesman declined to comment on how close any of the three governments are to being able to produce Tamiflu domestically. “It is not up to us to speculate about that. As a responsible company we remain willing to discuss with them whether we can contribute,” the spokesman said. Indonesia, which has confirmed 12 cases of human infection with the H5N1 avian flu virus, said on Saturday it will begin making the anti-viral drug in three to five months.