Healthy Skepticism Library item: 2648
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Publication type: news
Badsher K.
Pressure Rises on Producer of a Flu Drug
New York Times 2005 Oct 11
www.nytimes.com/2005/10/11/business/11drug.html
Notes:
Ralph Faggotter’s Comments:
Every year millions die from each of the following- TB, malaria, AIDS, malnutrition, cigarette smoking, motor vehicle accidents and handgun shootings.
But what are we afraid of?
None of the above.
We’re afraid of imaginary things.
We’re afraid of bogeymen, vampires, alien abduction and the ‘Bird Flu Pandemic’.
For a skeptical apprasial of the imaginary ‘Bird Flu Pandemic’see-
“ Don’t Worry, Be Healthy
Fear is more likely to get you than the avian flu.”
By Marc Siegel
Posted Tuesday, Sept. 13, 2005, at 9:39 AM PT on Slate at http://slate.msn.com/id/2126233/
Full text:
The New York Times
October 11, 2005
Pressure Rises on Producer of a Flu Drug
By KEITH BRADSHER
HONG KONG, Oct. 10 – Roche, the maker of the main drug that would be
used against a possible bird flu epidemic, is under growing pressure to
allow production of generic versions of the medicine.
But the company and some outside experts say production of the drug,
Tamiflu, is so complex and time-consuming that even generic makers could
not quickly expand global supplies.
Those putting pressure on Roche, a Swiss company, include the head of
the United Nations and health officials in some nations. They are asking
whether the health of hundreds of millions of people in a possible
pandemic should depend on the efficiency and productivity of a single
corporation.
Kofi Annan, the secretary general of the United Nations, raised the
issue last Thursday during a little-noticed visit to the Geneva
headquarters of the World Health Organization, a United Nations agency.
Mr. Annan stopped short of calling for compulsory licensing by Roche,
but spoke broadly about the need to make sure intellectual property did
not get in the way of ensuring the availability not only of Tamiflu but
also of vaccines at prices that poor people could afford.
During the weekend, in an interview, Dr. Kou Hsu-sung, the director
general of Taiwan’s Center for Disease Control, was even more critical,
saying that Taiwanese scientists knew how to make Tamiflu and were
trying to balance respect for Roche’s intellectual property with
Taiwan’s national security.
“We are disappointed that W.H.O. refused to press Roche to make it a
generic in a situation like this,” he said.
But the head of the W.H.O.‘s global influenza program, in a speech in
San Francisco on the same day that Mr. Annan was visiting the agency’s
headquarters, said that generic manufacture of Tamiflu could not happen
quickly because the production process was too complex.
“There will be no way in the next two years a company would be able to
produce generic Tamiflu,” said the W.H.O. official, Klaus Stöhr,
speaking at the annual meeting of the Infectious Diseases Society of
America.
But he also said that even if Roche produced Tamiflu at full capacity
for the next 10 years, and the drug was stockpiled, there would be
enough at the end of that period for only 20 percent of the world’s
population.
In a statement on Monday, Roche said that the production of Tamiflu was
a process involving 10 steps – one of them potentially explosive – and
requiring up to 12 months. “No one can do it faster,” the company said.
“Our assumption is that it would take a generic company about three
years to gear up,” the company said. “Therefore, it does not make sense
to out-license manufacturing.”
There is no proven preventive vaccine yet available in meaningful
quantities to work against the avian flu that is spreading widely among
birds in Asia and has begun showing up in some European flocks. So hopes
are riding on Tamiflu as a treatment once people become infected with
the disease.
Of the more than 100 people known to have been infected, about 60 have
died. But health officials fear a pandemic – a regional or even global
epidemic – if the disease mutates to allow human-to-human infection.
A single five-day treatment course of Tamiflu is priced at more than
$60. Analysts have estimated that Roche sells it to governments for less
than half that, but poor countries may not be able to afford even a
couple of dollars a dose for millions of people.
The pressures on Roche are similar to those exerted on manufacturers of
AIDS medicines in the 1990’s and on Bayer in 2001 to sell its Cipro
medicine at a discount after anthrax spores were mailed to Congress and
some journalists.
The pharmaceutical industry has consistently argued that if drug makers
are forced to sell drugs at a deep discount or are required to license
generic versions when they are most needed, then the industry will not
be able to afford research into the next generation of advanced drugs.
According to a W.H.O. transcript of Mr. Annan’s remarks last Thursday,
he said that the United Nations would be “encouraging pharmaceutical
companies and others to be helpful, making sure that we do not allow
intellectual property to get into the way of access of the poor to
medication, allowing for emergency production of vaccine in the
developing countries, and I wouldn’t want to hear the kind of debate we
got into when it came to the H.I.V.” drugs.
“So we should be clear that in this situation, we will take the measures
to make sure poor and rich have access to the medication and the vaccine
required,” Mr. Annan said. “And the decision should be taken ahead of
time so that we don’t have to quibble about it when the critical and the
crisis moment arrive.”
Roche currently makes Tamiflu at factories in several countries,
including the United States and Switzerland. A spokesman, Terence J.
Hurley, said that Roche would make enough Tamiflu this year to treat
tens of millions of people, but that the company could not immediately
supply the millions of doses being ordered by 40 countries for use in
case of a flu pandemic.
The company, which had Tamiflu sales of $450 million in the first half
of this year, has said it is in the process of an eightfold expansion of
its Tamiflu production capacity by the middle of 2006. Democrats in
Washington have been critical of the Bush administration for not having
placed large orders sooner to expand the American stockpile of Tamiflu.
But so far, the administration’s critics have not called for compulsory
licensing of the drug to other makers.
The drug industry’s main lobbying group in Washington, the
Pharmaceutical Research and Manufacturers of America – of which Roche is
a member – issued a statement Monday opposing such a move.
“Public health officials should not consider imposing compulsory
licenses on avian flu medicines, a step that would take away incentives
for other companies to undertake the difficult and costly work of
searching for new antivirals and vaccines for this possible health
crisis,” the group’s president, Billy Tauzin, said in the statement.
Roche’s enthusiasm now for expanding production is in contrast with its
position in the summer of 2004, when Tamiflu sales were a fraction of
the current level and the company had only one small factory in
Switzerland producing the drug.
At the time Roche rebuffed public pleas from prominent epidemiologists,
like Dr. Arnold Monto at the University of Michigan, to commit the money
for the immediate construction of additional factories.
But Dr. Monto said that it was not necessarily a good idea to allow
broader production of Tamiflu by more companies in more countries. If
Tamiflu becomes widely and inexpensively available to the general
public, especially in countries where medicines are distributed with
little regard for prescriptions, he warned, then Tamiflu might start
being used so heavily that the bird flu virus could develop resistance
to it, possibly even before the virus becomes an epidemic.
“Be careful of what you wish for,” he said.
Andrew Pollack contributed reporting from San Francisco for this
article, and Gardiner Harris from Washington.
