[Congressional Record Volume 150, Number 97 (Wednesday, July 14, 2004)]
[Senate]
[Pages S8110-S8113]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
THE GLOBAL FIGHT AGAINST AIDS
Mr. HARKIN. Mr. President, on July 11, the 15th Annual International
AIDS Conference began in Bangkok, Thailand. The theme of this year's
conference is ``Access for All,'' meaning access to lifesaving
medications. As
[[Page S8111]]
many of my colleagues know, the current AIDS pandemic threatens
approximately 38 million people worldwide. Last year, 5 million more
became infected. Sixty percent of all cases are in sub-Saharan Africa,
but the virus is spreading almost unchecked in Asia and Eastern Europe.
Twenty million people world-wide have died since the first case was
diagnosed in 1981.
Unfortunately, the theme of the Bangkok conference--``Access for
All''--is a hope and aspiration that bears little resemblance to the
harsh reality we confront today. In reality, most newly infected people
will not receive anti-retroviral drugs in time to do any good.
There are many barriers to progress: developing countries lack the
trained physicians, nurses, or support staff to properly distribute
anti-retroviral drugs and to monitor patients' progress. In addition,
contributions to the Global Fund to Fight AIDS are not sufficient. Some
countries are falling far short of what is needed.
And on July 1, the Wall Street Journal reported another big reason
why drug distribution has been difficult. Simply put, the United States
government will not purchase effective generic drugs; it insists on
brand-name pharmaceuticals. Let me give you an example of why this
matters.
On April 6, The Washington Post reported on pricing agreements
negotiated by the William Jefferson Clinton Foundation with
pharmaceutical companies that produce generic drugs. These agreements,
in cooperation with the Global Fund, the World Bank, and UNICEF, will
provide access to affordable AIDS drugs in 100 developing nations
around the world. As a result, as many as 3 million additional people
will be tested and treated for AIDS than before.
Under negotiated pricing agreements with five generic-drug
companies--four in India and one in South Africa--the Foundation will
reduce the cost of fixed-dose generic AIDS drugs by as much as half.
Fixed-dosage drugs combine several drugs in one pill. This makes the
treatments simpler to take. Research tells us that simplified treatment
programs have more successful outcomes. The cost to test and treat a
patient will drop from more than $500 per year down to $200 per year.
The drugs themselves will cost only $140 per person, per year.
These are significant savings. And the savings have positive results.
More people can be tested and treated than with existing programs. This
is progress. These negotiated agreements will save lives.
In his 2003 State of the Union Address, President Bush announced a
$15 billion plan to combat HIV/AIDS worldwide. Certainly, this was an
admirable initiative. Authorizing legislation passed overwhelmingly in
the House and Senate.
But, the administration has taken a different approach in
implementing this plan than the Clinton Foundation has with their
negotiated pricing agreements. I am concerned the $15 billion AIDS
policy the President is pursuing is not nearly as effective as these
negotiated agreements. Why? Because instead of negotiating for the most
effective drugs for the lowest cost, the administration purchases
brand-name pharmaceuticals from western countries at twice the cost.
For example, at a hospital in Zimbabwe, the Centers for Disease
Control will soon implement a program that calls for patients to take
six pills per day, from a variety of brand-name manufacturers, at a
cost of $562 per patient, per year. Yet at the very same hospital,
using the very same procedures, Doctors Without Borders purchases
fixed-dosage retroviral drugs --two pills per day--from an Indian
generic manufacturer. The treatment program costs $244 per patient per
year--$318 less than the price the CDC pays. The programs have the same
goals, at the same hospital, but the program sponsored by the U.S.
Government costs more than twice as much.
This is not the most effective use of taxpayer money. The
administration could use fixed-dosage, generic drugs, but won't.
Instead it chooses to purchase multiple brand-name drugs, and implement
a more complicated treatment regimen at more than twice the price. If
the goal is to treat the AIDS epidemic, then why are we spending twice-
as-much money on more complicated, less effective treatment? Where is
the outrage about waste, fraud, and abuse in the Federal Government--
not to mention plain old-fashioned stupidity?
Unfortunately, the answer is all too familiar. The administration has
chosen to side with the brand-name pharmaceutical industry-- despite
the cost, and despite the efficacy. We have seen this behavior before.
This brings us back to the Clinton Foundation's negotiated agreements
with generic firms. My colleagues will be interested to know the man in
charge of the Bush administration's AIDS initiative is Eli Lilly's
former Chief Executive Officer, Randall Tobias. Recently, Mr. Tobias
told Congress he had doubts about the quality of cheaper generic AIDS
drugs made in India--the same drugs which the Clinton Foundation
negotiated the pricing agreements. But, the World Health Organization
approved the drugs and has an approval process similar to our own Food
and Drug Administration. In fact, WHO's approval process was borrowed
from the FDA. In testimony before the Senate Foreign Relations
Committee on April 7, Dr. LuLu Oguda of Doctors Without Borders stated
that she was ``bewildered by the debate'' about the use of generic
fixed-dosage drugs to combat AIDS in Africa. She noted that the
generics used were not ``substandard'' as claimed by the Bush
Administration. Rather, they were made in some of the same facilities
as generic drugs sold every day in the United States. As a volunteer in
Malawi, a country where one fifth of the population lives with HIV, she
knows the value of these quality generics.
I am left to conclude that the Bush administration has made a
conscious choice. Cheaper, effective drugs are put aside in order to
purchase more complex treatments from domestic pharmaceutical
manufacturers. Fewer HIV/AIDS patients are treated, and more
inefficiently. This is no different than refusing to support
negotiation authority for Medicare beneficiaries. Fewer drugs can be
purchased because prices remain high.
Beyond the burden to taxpayers, these policies have grave human
consequences. People's lives are at stake. Prescription drugs are not
like other consumer products. They are not optional or discretionary.
For people with HIV/AIDS, lack of access to drugs can mean debilitating
illness and even death. It's not like buying a car--the customer can't
walk away from the deal with his or her health in tact. So the choices
that we make here in Washington, the choices that the pharmaceutical
industry makes, are fateful choices. And let's be clear, the pricing
practices favored by the administration and the pharmaceutical industry
will cost countless lives in Africa and here at home.
I fully appreciate the need to preserve the pharmaceutical industry's
ability to perform research and development. The Federal Government
already supports this through rich tax incentives. Likewise, I
certainly do not dispute the industry's right to make a profit. But we
are quickly coming to the point where the pursuit of reasonable profits
turns into flat out profiteering. Diseases are viewed as marketing
opportunities, not as scourges to be eliminated as rapidly and as cost-
effectively as possible.
There is no question in my mind that we need to reopen the issue of
how we negotiate drug prices in the program to combat HIV/AIDS
worldwide. If we take the Clinton Foundation's approach, we can reach
roughly twice as many patients. It is also time for us to reopen the
issue of negotiations with pharmaceutical companies in our own country.
It is time for our choices to put people ahead of profits.
I ask unanimous consent that an article from this morning's
Washington Post and a transcript of a recent radio program on the
International AIDS Conference in Bangkok be printed in the Record.
There being no objection, the material was ordered to be printed in
the Record, as follows:
[From the Washington Post, July 14, 2003]
U.S. Rule on AIDS Drugs Criticized
(By Ellen Nakashima and David Brown)
Bangkok, July 13.--The Bush administration's prohibition
against using money from its $15 billion global AIDS plan to
buy foreign-produced generic drugs is complicating
[[Page S8112]]
the delivery of medicine to some of the millions of poor
people who badly need it, according to AIDS experts at an
international conference here.
In an effort to sidestep the policy, some countries have
been using U.S. money to train AIDS clinicians and buy lab
equipment, while employing money from other sources to buy
the medicines.
U.S. officials at the conference said Tuesday that they
would go along with such an approach. They have also said a
fast-track plan announced in May would allow some of the
generics to receive rapid approval from the Food and Drug
Administration, which would make them eligible for U.S.
funding.
Specified in the giant President's Emergency Plan for AIDS
Relief, the restrictions against unapproved generics, which
for now include all foreign-made generics, have added to the
already long list of obstacles to bringing antiretroviral
(ARV) therapy to poor countries, experts attending the 15th
International AIDS Conference here say.
``It was very confusing. You're trying to figure out who
can buy what with what money,'' said Joia Mukherjee, medical
director for Partners in Health, a Boston-based organization
that has run an AIDS treatment program in Haiti for seven
years and is developing others in Latin America.
The policy ``slows the coordination'' between the Bush plan
and the people running treatment programs in the countries,
Mukherjee said in an interview at the conference.
The U.S. Government Accountability Office reached similar
conclusions in a report issued this week.
The GAO interviewed 28 U.S. government employees involved
in the plan in the 15 countries where it is starting to
operate. ``Twenty-one respondents indicated that they had not
received adequate guidance on the procurement of ARV drugs,
which makes it difficult for the U.S. missions'' to support
country programs.
The State Department, which runs the plan, has not
specified which activities the program ``can fund and support
in national treatment programs that use ARV drugs not
approved for purchase by the office,'' the authors wrote.
Partners in Health is expecting to receive at least $1
million in fiscal 2005 from the U.S. program. Mukherjee said
she first began about nine months ago to inquire about
whether it could be used to buy generic drugs. She--and
others--were told no several months ago. But last week,
she said, she was advised unofficially to use money from
another source to buy generics and use the U.S. money for
such things as salaries for health care workers, lab tests
and a van.
That was ``a compromise that wasn't acceptable before,''
said a person affiliated with one of the organizations that
received a large Bush administration AIDS grant last winter.
``We're still in the process of working out what drugs we
will buy . . . in the countries we're in,'' said the
official, who spoke on condition of anonymity.
Randall L. Tobias, the Bush administration's global AIDS
coordinator, officially ratified that view in a statement
Tuesday.
``We respect local governments' decisions as to how best to
manage their HIV/AIDS programs,'' he said. ``We will,
however, not use U.S. tax dollars to purchase medications
that have not passed the same consumer protection standards
as those we use for our own patients in the United States.
``In the event that a country elects to use non-U.S.
funding to purchase copy drugs that have not been approved
for quality and safety by the U.S., the president's emergency
plan will support non-pharmaceutical aspects of the country's
care, treatment and prevention programs, and will do whatever
is necessary to maintain integrated systems of care.''
AIDS treatment that uses generic pills containing three
antiretroviral drugs in one tablet--known as fixed-dose
combinations--can cost as little as $200 a year. That is less
than half the cut rates at which major pharmaceutical
companies are offering brand-name drugs in poor countries.
Most organizations that are providing money for AIDS drugs
in those countries--notably, the two-year old Global Fund to
Fight AIDS, Tuberculosis and Malaria--require that generics
they purchase go through a process called pre-qualification
that is run by the World Health Organization and is similar
to FDA approval.
The U.S. program does not recognize pre-qualification and
instead has specified that all drugs it pays for must be
approved by the FDA. In May, the agency established a fast-
track system by which it will rule on applications from
generics makers in two to six weeks.
Anthony S. Fauci, the physician and AIDS researcher who
heads the National Institute of Allergy and Infectious
Diseases, acknowledged the controversy over generics at a
news conference Tuesday.
``I know there's been criticism about that, but I think we
should give a chance to the FDA to prove if they're able to
do it or not,'' he said. ``The only way to do that . . . is
to submit the application for the approval process.''
Progress in the effort to put 3 million poor AIDS patients
on treatment by the end of next year has been a major topic
of discussion at the conference, whose theme is ``Access for
All.''
In Haiti, where 280,000 people are living with HIV, the
virus that causes AIDS, Partners in Health had about 50
patients on antiretroviral drugs in 2001. Today, largely with
Global Fund money, it is treating 1,500. The drugs are
administered free through a community health clinic.
Cissy Kityo of the Joint Clinical Research Center in Uganda
said that country's government cannot afford to pay for all
the drugs it is providing patients, even with a price of
about $300 per person per year for generics. Consequently,
about 90 percent of the 20,000 people on treatment are paying
for their drugs, she said.
Uganda's policy of making people pay for their drugs has
allowed it to spend funds instead to hire and train health
care workers, who are critical to prevention and treatment
efforts, Kityo said. ``We're just a small country trying to
do our best,'' she said.
Chief among nongovernmental organizations providing
antiretroviral drugs is Medecins Sans Frontieres, whose name
in English is Doctors Without Borders. Today it has 13,000
patients in 56 projects in 25 countries in Africa, Asia,
Eastern Europe and Latin America. About half are on fixed-
dose combinations, which spokeswoman Rachel Cohen termed a
``radically simplified'' treatment.
The organization is spending $200 per person per year. The
best available price worldwide for brand-name equivalents is
$562 per person per year. ``If you have the option of
spending $200 per person per year or $600 per person per
year, and you're electing to spend $600, that means you're
treating one person when you could be treating three,'' Cohen
said.
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[From NPR News Morning Edition, July 13, 2004]
Analysis: Small Indian Firm Cipla Manufactures Low-Cost Generic AIDS
Drugs, But Its Products Face Bans in Many Countries
Steve Inskeep (host). This is Morning Edition from NPR
News. I'm Steve Inskeep.
Renee Montagne (host). And I'm Renee Montagne.
At this year's International AIDS Conference in Bangkok,
most of the talk is about getting inexpensive, generic drugs
to tens of millions of people. Relatively small generic drug
manufacturers in four countries are at the center of the
debate. One of the more aggressive of these companies is the
Indian firm Cipla. In India, where five million people are
infected, Cipla had trouble persuading the previous
government to spend money on AIDS, even for generic drugs
that cost pennies a day. NPR's Brenda Wilson recently visited
Cipla.
Brenda Wilson (reporting). Once inside Cipla's corporate
headquarters in Mumbai, also known as Bombay, you're whisked
off to a large room. It is surrounded on three sides by a
glass wall of backlit shelves containing hundreds of samples
of the company's products. You're then shown a six-minute
promotional video that recounts Cipla's founding 70 years
ago.
Unidentified Woman No. 1. To heal and to hold, to wipe a
tear, bring back a smile, to give hope, to give life. That's
been Cipla's mission right from the time it started way back
in 1935.
Mr. Amar Lulla (managing co-director, Cipla). Welcome to
Cipla.
Wilson. Good meeting you, Mr. Lulla.
Mr. Lulla. Good to see you.
Wilson. That's Amar Lulla?
Mr. Lulla. That's me.
Wilson. OK, Amar.
Mr. Lulla. Yeah.
Wilson. So you are--what's your title exactly?
Mr. Lulla. I'm the joint managing director. I want you to
see the range of products that we do here. We have over 1,200
products, exporting to 150 countries. We first start here.
This is the range of our anti-infectives, antibacterials,
quinolones, microlites . . .
Wilson. Some of them, products that have been approved by
the U.S. Food and Drug Administration and are sold in the
U.S. Indian drugmakers, not just Cipla, have been something
of a thorn in the side of the big pharmaceutical companies,
who see generic versions of their brand-name products as
virtual rip-offs of intellectual property. They argue that
the companies that make generics have not put the billions of
dollars into research to develop drugs, just copied them.
They also say that the copies are not always safe and may not
have the same benefits.
Mr. Lulla. Here is the range of AIDS drugs. This is what
we're a little bit known for, if I may say so. And now we're
offering the triple-drug cocktail for less than 50 cents a
day now.
Wilson. And that's this drug right here.
Mr. Lulla. This drug.
Wilson. Triomune, yes.
Mr. Lulla. Triomune. That is a combination of lamivudine,
stavudine and nevirapine.
Wilson. All three in one pill, which means it's not only
cheaper but easier to take. It is this product more than any
other that holds up the hope of treating millions of people
in poor countries who have AIDS. The patents for the drugs
are held by three different manufacturers who, until
recently, could not agree to share and therefore combine the
compound in one pill.
Unidentified Woman No. 2. (Foreign language spoken.)
Wilson. The Y.R. Gaitonde Center, an AIDS clinic in the
southern city of Chennai, which treats more than 5,000 HIV
patients, is one of the few places where reduced-price drugs
are available in India. Oddly enough, Cipla sells most of its
AIDS drugs to other countries. Today patients have lined up
outside the pharmacy to purchase medications.
[[Page S8113]]
A pharmacist gives a gaunt young man his change and
explains just when and how to take the medicine. Patients pay
what they can. They're required to pay something. It's a way
of making sure that the patient wants to be part of the
program and will follow treatment regimens carefully. The YRG
Center gets a special discount, and Cipla assists in other
ways. Lulla says it's been trying for years to sell more
generic AIDS drugs in India, but the government has not until
recently agreed to Cipla's terms. But Amar Lulla insists that
the company's motive isn't money and it isn't publicity.
Mr. Lulla. If you've seen the face of disease and if you've
seen the face of death and if you've seen people dying
because they can't access medicines, and if you save one
life, it is worth it. To some of us, it's very important,
you know. And then I can see a lot of cynicism in the
media and in the way people do ask us, what is behind all
this, you know? What is the motive? What is the motive?
But sometimes doing this is an immense joy and serves the
need that we all have within us as human beings, you know,
to help someone. That's it. There's nothing more to it.
Wilson. Still, nowhere near the two million people in India
that it is estimated now need treatment get it. Vivek Divan
with the Lawyers Collective AIDS Unit says it's a profound
paradox.
Mr. Vivek Divan (Lawyers Collective AIDS Unit). A lot of
our clients are dying. They just continue to die. It's a
ridiculous situation. It's absurd because, you know, Cipla
and Ranbaxy make this medication in this country, and it
wasn't available and still isn't more or less available. When
you think about it, it is such an absurd situation, it's so
starkly absurd that it shocks you sometimes. It makes you
laugh also, unfortunately.
Wilson. Late last year the Indian government finally struck
a deal with Cipla, and in April, just before the national
elections, the government began distributing free
antiretrovirals for people with AIDS.
Ms. Meenakshi Datta Ghosh (Director, National AIDS Control
Organization). We have treated more than 800 people so far,
and we do want to very rapidly accelerate the treatment.
Wilson. Meenakshi Datta Ghosh is the director of the
government's National AIDS Control Organization.
Ms. Datta Ghosh. We have trained teams in 25 medical
hospitals, and that's where we are now moving to expand. And
so we do believe the numbers getting treated will rapidly
pick up.
Wilson. `Cause 800, you know, for a population this size,
seems incredibly small.
Ms. Datta Ghosh. That's very unfair. We've only been in the
treatment less than four months. Since May 2003 onwards, we
have concentrated on expanding and widening the availability
of services for people living with HIV and for the general
population. Political commitment for HIV and AIDS has grown
by leaps and bounds. All of this put together has enabled us
to commence treatment earlier than perhaps was originally
scheduled. And therefore, I do not--it's not entirely correct
to say the government has not done anything.
Wilson. By the end of this year, she says, the government
aims to provide treatment for 100,000 AIDS patients. India is
not alone in the caution with which it has taken on
treatment, using the generic AIDS drugs. Scientists and
health officials question Cipla's capacity to supply generic
drugs to the millions in developing countries who need them
and maintain that supply for the rest of their lives. There
are also concerns that generics may contribute to the
development of a more resistant AIDS virus. Again, Cipla's
Amar Lulla.
Mr. Lulla. This is such a beautiful argument, such a
beautiful one when you don't want the drugs to reach the
dying patients. The big pharmacy will say this argument is
never advanced. Why? The same drugs, the same side effects,
the same risk of developing resistance. Why is it not talked
about? Why is it talked about only when you want to make them
available to the patients, and you talk all this junk, I
mean, such rubbish, it's not even pardonable. So don't give
to anybody, right? If you can't give to 40 million, don't
give to one million. Don't make these drug available to
anybody. Let everybody die. What kind of argument is this?
And this is such a con, such a lie, it's a crime on humanity,
and everybody repeats it, you know. That's a pity.
Wilson. Some of the suspicions about generics and the
quality of Cipla's three-in-one pill Triomune were answered
by a recent study that was published in the British journal
Lancet. As doctors had already noted, Tromune was just as
effective at suppressing the AIDS virus as brand-name
medications. Brenda Wilson, NPR News.
Montagne. It's 11 minutes before the hour.
____________________