| WASHINGTON
- October 18 - The following is a letter
from Ralph Nader and James Love to Secretary Thompson regarding
ciprofloxacin:
October 18, 2001
Tommy G. Thompson
Secretary of Health and Human Services
The U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201
Dear Secretary Thompson:
We were shocked by your comments in the October 17, 2001
Washington Post, indicating that you do not have the legal
authority to authorize generic production of ciprofloxacin, a drug
used to treat victims of an anthrax attack. This, of course, is
not true. As your own staff is well aware, you may use 28 USC 1498
to issue compulsory licenses for patents, and you could immediately
authorize the five companies who have already satisfied U.S. FDA
requirements for the quality of their products to speed the
manufacturer of ciprofloxacin, and indeed this could and should be
done for any other medicine needed to confront the current crisis.
By failing to act, you are putting Americans at risk. By acting
to authorize generic competitors to manufacture ciprofloxacin, you
would reduce public anxiety over the supply of the drug, and take
steps to introduce competition which would ensure redundant
capacity and a more favorable procurement environment.
It is our understanding that public health authorities are
seeking a stockpile of 1.2 billion pills in order to ensure that
there are treatments for 10 million Americans. It is obvious that
the fastest and most efficient way to accomplish this is to
authorize every qualified pharmaceutical company who can supply the
drug to do so. Anything short of this is cutting corners. Why put
the lives of millions of Americans at risk?
Americans are facing a public health crisis that demands
leadership and action. It is unacceptable, in the face of a
biological assault against U.S. citizens, to fail to secure
adequate supplies of medicines in the event that anthrax exposure
spreads. Moreover, you may soon find we confront a different
access problem for another medicine, in the face of a different
biological or chemical threat. You need to ensure that there are
systems in place to protect the public health, and you must use
every necessary mechanism to ensure an adequate, affordable supply
of medicines.
Under 28 USC 1498 it is clear. You can authorize immediately
the production of needed medicines. As you and your staff know,
the U.S. government has used 28 USC 1498 in many cases for less
serious matters, to authorize contractors to use patents held by
others in order to provide goods and services for the government.
This includes cases involving pharmaceutical products, in far less
difficult circumstances.
Bayer, the giant German pharmaceutical firm, currently markets
ciprofloxacin on an exclusive basis in the United States. Drug
stores are charging in some cases more than $700 for a two month's
supply of medicine that can be obtained for as little as $20 in
some foreign county generic markets, and now it seeks to be the
exclusive company that can supply 1.2 billion pills to the federal
government. Bayer stands to make hundreds of millions if not
billions of dollars in the wake of the September 11 terrorist
attack on Americans.
In the absence of adequate government stockpiles, families who
cannot afford the hundreds of dollars per month per family member
for ciprofloxacin risk not having access to this product, should
the need arise. This is an unethical and unnecessary form of
rationing. Some government officials and those who can afford
the high prices have secure supplies of ciprofloxacin. It is your
duty to see that all taxpayers and especially those who are less
affluent are protected, and are protected as soon as is possible,
not as soon as it is possible for one firm, Bayer, to supply the
market. And it would make sense to have redundant sources of
supply, for all of the obvious reasons.
More generally, you need to be forward looking, should other
cases arise with similar constraints on the access to medicines,
and you need to find ways to obtain whatever medicines may be
needed. You need to provide a framework for acquisition of needed
medicines, including the steps that will be taken to address issues
of pricing and affordability.
In this review, you should examine U.S. government obligations
for compensation under 28 USC 1498, to see if there is a need for
statutory changes that would ensure that firms cannot exploit the
current situation, or engage in bio-terrorism profiteering. In
that respect, you are urged to look at models such as those in HR
1708 which would give the U.S. government the same tools that most
European countries have to protect consumers from abusive prices,
refusals to license technologies, unreasonable restrictions on the
use medical research tools, and other areas of public interest.
Your official responsibility is to protect the public's health,
and not to defend large profiteering pharmaceutical companies,
which are already making a fortune because of our country's current
problems. How do you define the patriotic choice here?
Sincerely,
Ralph Nader
James Love
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