|
I harvested
this from my cyber reading today, thought it would be interesting from a
geopolitical as well as economic and property rights perspective. On another
interesting note, I read one comment that between the studies revealing that
toddlers ‘drive’ the garden-variety flu season, something every parent already
knew, but which might alter recommendations for vaccinations, the American
custom of handshaking may become less common, at least in flu season. Personally, besides the normal
precautions to avoid viruses in public such as frequent hand washing, I
recommend using only your own writing pen, wear gloves often (also protects
nails as well as skin) and avoid kissing babies other than your own – but not kissing
altogether. kwc Flu vaccine maker won't share patent: Roche rejects calls to allow production
of generic versions of Tamiflu Sabine Russell, San Francisco Chronicle Medical Writer,
October 13, 2005 Tamiflu, a pricey
antiviral pill invented in a Bay Area lab and made in part from a spice used in
Chinese cookery, has emerged as the world's first line of defense against bird
flu should the deadly strain begin its feared spread among human beings. As
nations begin to stockpile the drug in anticipation of a flu pandemic, calls
are mounting for countries to sidestep patents on the drug -- as Brazil first
did for AIDS medications -- and make their own generic versions. But Swiss
pharmaceuticals giant Roche, which acquired rights to the drug from Gilead
Sciences Inc. of Foster City in 1996, said Wednesday it had no intention of
letting others make it. "Roche ... fully intends to remain the sole
manufacturer of Tamiflu,'' said company spokesman Terry Hurley. The immediate problem is not the cost of
Tamiflu, which runs about $60 for a 10-pill course of treatment, but a
staggering gap between the sudden demand for it and the capacity of its sole
manufacturer to produce it. Although Roche has
increased production of Tamiflu eightfold in the past two years, it will take $16 billion and 10 years to
make enough of the drug for 20 percent of the world's population, said Klaus Stohr, director of the World
Health Organization's Global Influenza Program, in comments to reporters in San
Francisco last week.
"Something has to
be done,'' said Ira Longini, an Emory University professor whose computer model of a potential avian flu pandemic shows that an
outbreak could be snuffed out within
a month by rushing antiviral drugs to the place where it started. "When you think of the potential
damage a pandemic flu could do, and how little drug we have, the situation is
quite absurd. "It makes sense to do something along the lines of what was
done with AIDS drugs.'' James Love, director
of the Consumer Project
on Technology
in Washington, D.C., said that during the anthrax bioterrorism scare in 2001,
both the United States and Canada had threatened to bypass the patent of Bayer
Corp.'s antibiotic Cipro to assure a sufficient supply of the drug. The Tamiflu
problem is similar. "The WHO should buy stockpiles from generic suppliers,''
he said. "If patents are in the way, the WHO should ask the
manufacturing country to issue the appropriate compulsory licenses. The patent
owner will receive royalties, but we will have the stockpiles." U.N. Secretary-General
Kofi Annan has signaled a willingness to consider generic production of flu
drugs and vaccines. During remarks at the World Health Organization
headquarters in Geneva last week, he said drug companies should be
"helpful" by not letting their patent claims interfere with access to
medicines. "I wouldn't want to hear the kind of debate we got into when it
came to the HIV anti-retrovirals,'' he said. Roche will not release
its Tamiflu production figures, deeming it "commercially sensitive"
information, said Hurley, the company spokesman. However, he said the company
produced "many hundreds of millions" of the pills annually. In response to WHO concerns about bird
flu this summer, the company agreed to donate enough Tamiflu to treat 3 million
people. Although public awareness
of the pandemic threat posed by the bird flu has blossomed in recent weeks,
scientists have been warning since 1997 that the rogue influenza strain known
as H5N1 could be the one that triggers a pandemic rivaling the devastating
Spanish flu of 1918 -- which killed 50 million. Tests on laboratory
mice strongly suggest that Tamiflu -- and a lesser-known inhaled antiviral, Relenza -- are the only medications that can
treat infection with the H5N1 strain. Tamiflu has not been
effective in the treatment of the small number of people who've contracted the
H5N1 virus in Asia. Of 116 people infected since 2003, half have died. However,
most of those patients were admitted to hospitals days or weeks after they
became ill. Tamiflu
is thought to work best within 36 hours of symptoms. "Late treatment is clearly
ineffective,'' said Dr. Frederick Hayden, a University of Virginia expert on
flu drugs. As a treatment for
ordinary flu, Tamiflu has been effective, but in a Japanese study of children treated with the
drug, about 1 in 6 patients developed strains of flu resistant to the drug,
though the new flu strains were much weaker, causing less illness. At WHO's urging, 40 nations last year
began building stockpiles of Tamiflu. The United Kingdom, for example, has
ordered enough for 14.6 million people, a quarter of its population. The U.S.
stockpile goal for this year is 4.3 million 10-pill treatments, enough to cover
less than 2 percent of the population. Secretary of Health
and Human Services Michael Leavitt has said the U.S. government plans to buy 20 million
courses of Tamiflu, although no timeframe for the purchase has been revealed. To accommodate U.S. demand for the drug,
Roche is building Tamiflu production capacity in the United States, and
spokesman Hurley said the plant -- actually a series of facilities owned by the
company and subcontractors -- would be "up and running" by the end of
the year. The U.S. appetite for
Tamiflu, however, may quickly outstrip the capacity of any one company to make
it. A draft proposal by the National Vaccine Advisory Committee, charged with
developing a federal response plan to a pandemic, envisions distribution of
nearly 90 million courses of antiviral drugs. The pills
would be rationed according to need, with hospital patients and health care
workers who treat them at the top of the list. WHO flu chief Stohr is not optimistic that generic
producers would be able to make Tamiflu. He told reporters in San Francisco that the drug takes a
full year to make and involves a potentially explosive process that would drive
out all but the most sophisticated manufacturers. It would take a generic
supplier at least "two years" to put a plant into action. In addition, Stohr
said, the starter
ingredient for Tamiflu is a Chinese spice called star anise, whose seeds are
used in flavorings, medicines and cooking oils. Most of the world production of
star anise is located in four provinces of China, and the supply of it has been
back ordered, primarily for drug production. Meanwhile, the
shortage of Tamiflu has begun to trickle down to American hospitals, which
normally keep small quantities of the drug to treat garden variety influenza
each winter. Dr. Roger Baxter,
director of Kaiser Permanente's flu surveillance program in Northern California,
said the health care giant had stopped prescribing the drug to patients who
wanted it for their own personal stockpiles, or sought it for travel abroad. "Kaiser has a
very small supply,'' he said. "We don't have a stockpile that would cope
with a major outbreak.'' Only patients with so-called B-strains of
influenza
-- which like H5N1 do not respond to older line flu drugs -- and those who are hospitalized will be considered for Tamiflu, he said.
"We can't get a large amount of oseltamivir for stockpiling, even if we
wanted to,'' he said. http://www.sfgate.com/cgi-bin/article.cgi?file=/c/a/2005/10/13/MNG39F7MNG1.DTL |
_______________________________________________ Futurework mailing list [email protected] http://fes.uwaterloo.ca/mailman/listinfo/futurework
