WSJ - White House Gets Pressure on AIDS Plan

[Guest guest]

Wall Street Journal

White House Gets

Pressure on AIDS Plan

Activists, Drug Firms Duel Over Use of Funds

For Generic Combination Drugs in Africa

By SARAH LUECK

Staff Reporter of THE WALL STREET JOURNAL

March 25, 2004; Page A4

WASHINGTON -- Caught between its allies in the drug industry and its

promises to battle AIDS in Africa, the Bush administration is facing

mounting pressure to allow its multibillion-dollar AIDS fund to spend money

on generic combination drugs in Africa.

The generic drugs cost just a fourth as much as their name-brand

counterparts, a price that would make them available to many more of the 30

million Africans suffering from AIDS. They are being pushed hard by the

World Health Organization and various AIDS activist groups. But brand-named

pharmaceutical makers, already fighting a global flood of attempts to copy

their patented treatments, strongly oppose their use -- in part, they say,

for safety reasons.

The issue is likely to be hotly debated next week at a meeting in Botswana

on international standards for evaluating generic combination drugs, which

was called by the U.S. and involves regulatory and scientific experts from

numerous countries, U.S. agencies and WHO. It also is under discussion

among Bush administration officials, who pledged last year to spend $15

billion over five years on AIDS in Africa and say they must choose a course

by the fall at the latest, before a ramp-up in funding for AIDS programs.

That puts the issue at the doorstep of the presidential election.

BUSH ON GLOBAL AIDS

A brief look at President Bush's policy on combating AIDS overseas:

• Jan. 28, 2003: Bush announces a 5-year, $15 billion plan to fight AIDS in

Africa and the Caribbean, alludes to the use of cheaper generic drugs.

• Feb. 4: Bush requests $450 million for the first year of the initiative

in his FY 2004 budget.

• Oct. 23: Clinton Foundation HIV/AIDS Initiative secures deal with four

generic companies to cut the annual cost of triple-drug regimen to $139 per

person from $201.

• July 10: Bush tours Africa.

• Dec. 1: World Health Organization officially condones the use of generic

AIDS medicines from two Indian companies.

• Feb. 2, 2004: Bush pledges $2.8 billion for the effort in his FY 2005

budget.

• Feb. 23: U.S. begins issuing grants to fight AIDS abroad but doesn't say

whether money can be used to buy generic drugs to fight AIDS.

• March 29: U.S. participates in Botswana conference on generic drugs.

The big immediate question is whether treatment programs in Africa will be

able to use U.S. funds to buy the generic products used in the combination

treatment. They are made by two India-based companies -- Triomune, made by

Cipla Ltd., and Triviro, made by Ranbaxy Laboratories Ltd. The products

lack approval from the Food and Drug Administration, but they have won the

backing of WHO. The three patent holders on each drug in the WHO-listed

combination are GlaxoKline PLC, Bristol-Myers Squibb Co. and Germany's

Boeringer Ingelheim.

Drug-industry trade group PhRMA says it is leaving lobbying on the issue up

to individual member companies, but also is raising safety concerns. " You

can't just mix them together and put them on the market, " says PhRMA

spokesman Mark Grayson. " You have no idea how it's going to work in tandem.

You need to run at least a year's worth of clinical trials and testing. "

Those who favor using American money for the generics believe the U.S. has

been signaling its opposition to their use. These pro-generic activists are

stepping up their efforts, arguing that not only are the drugs less costly

but also simpler to use because they require patients to take fewer pills.

They have been joined by several legislators on Capitol Hill who have

turned up the pressure on the administration ahead of the meeting, with

letters urging acceptance of the generic combination drugs.

In a letter, Sen. Kennedy (D., Mass.) writes President Bush that he

is " concerned that your administration is developing a new process " to

review generics. " At worst, the new process will give the pharmaceutical

industry further opportunity to deny these urgently needed generic

medicines, " he writes. Rep. Sherrod Brown (D., Ohio) sent a similar letter

to the administration yesterday.

The controversy is unfolding at a time when the drug industry already is

trying to fend off election-year calls to legalize importation of cheaper

prescription medications from Canada and Europe, as well as ever-louder

complaints about the cost of drugs. Some in the industry worry that

overseas generic combinations will flood developed countries.

Mark Dybul, deputy chief medical officer in the office of U.S. Global AIDS

Coordinator Randall Tobias, says the U.S. is " agnostic " on the question of

whether to purchase the combination drugs, adding that he is confused by

the anger of some in the advocacy community. It already is a big shift, he

says, for the U.S. to consider how it might give approval to medications

that aren't approved by its own FDA.

" Our predilection is to use them if at all possible, " Dr. Dybul says. " The

activists should be jumping up and down and saying, 'Hallelujah, this is a

major movement in international health.' "

But the advocacy groups point out that President Bush's AIDS plan, released

last month, said procurement of drugs would have to comply with federal

intellectual-property protections. Moreover, they interpret recent

statements by Mr. Tobias -- a former chief executive of Eli Lilly & Co. --

as critical of generic drugs and WHO process for " prequalifying " them for

use in AIDS treatment. In testimony before a House subcommittee, Mr. Tobias

said, " The problem is there is no process, no principles, no standards in

place today, from a regulatory point of view, to make that assurance. "

While WHO isn't a regulatory body per se, it set up a process to review the

combination generics that included evaluations by regulatory experts from

Canada, Europe and Australia of the drugs' safety and quality, as well as

inspections of the facilities where the pills are made. Some WHO officials

were irritated that the U.S. wanted to revisit the issue, but say they are

keeping an open mind.

Dr. Dybul says U.S. officials aren't trying to subvert the WHO process, but

need more information about the drugs in question. " We're the ones buying

them; we need to see the data, " he says.

He adds that Mr. Tobias's comments during his congressional testimony

shouldn't be interpreted as negative. He says the U.S. suggestion to hold

the Botswana meeting was well received by an international community

clamoring for agreement on which drugs to use, and says he has seen no

interference or undue influence from the drug industry.

The advocacy groups say President Bush, in his January 2003 State of the

Union address announcing an unprecedented commitment to fighting AIDS

around the world, referred to the less-costly generic products. The cost of

antiretroviral drugs " has dropped from $12,000 a year to under $300 a year

-- which places a tremendous possibility within our grasp, " Mr. Bush said

in that speech. " Ladies and gentlemen, seldom has history offered a greater

opportunity to do so much for so many. "

Dr. Dybul agrees that Mr. Bush " had to have " meant the generic drugs. But

" that doesn't translate automatically to use, " he says. " You still have to

consider quality, safety and efficacy. "

Meanwhile, international health experts worry that if the U.S. decides not

to buy generic drugs, treatment could be a logistical nightmare.

Governments may have to decide whether to run separate programs with

generic and brand drugs and keep the U.S. funding stream separate.

Advocates for using the drugs say with a limited amount of money, every

dollar counts.

" If there were enough money for everyone, we would not care which drugs, "

says Mugyenyi, head of the Joint Clinical Research Center in Uganda,

which provides the generic combination drugs to AIDS patients. " We have a

moral imperative and an ethical dilemma -- how to choose among the patients

who should live and who should die. "

Write to Lueck at sarah.lueck@...

**URGENT**

Please visit www.doctorswithoutborders.org and sign MSF's petition calling

for the release of our colleague Arjan Erkel who was kidnapped more than a

year ago in Dagestan, a republic of the Russian Federation. Thank you.

***************

Kate

Program Associate, Campaign for Access to Essential Medicines

Doctors Without Borders/Medecins Sans Frontieres (MSF)

333 7th Ave, 2nd Floor *New York, NY *10001-5004*USA

Tel: +1-212-655-3773

Fax: +1-212-679-7016

E-mail: kate.evans@...

http://www.doctorswithoutborders.org

http://www.accessmed-msf.org