[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.
                                  ____


             [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.

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       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.

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