^(ndy) (ATTN: Editorial page editors)<

^Lessons to Be Learned From Development of New AIDS Treatment Drug<

^Arno, a health economist at Montefiore Medical Center, and Feiden, a<

^specialist in public health issues, are authors of ``Against<

^the Odds: The Story of AIDS Drug Development, Politics and Profits.''<

^By Peter S. Arno and Karyn L. Feiden<

^Special to Newsday=

Ten years after the AIDS epidemic struck with brutal force, the Food and

Drug Administration has approved a second drug to treat the virus that causes

the disease. The development, distribution and approval of ddI (dideoxyinosine)

is good news, not only for people suffering from AIDS but for all health care

consumers. The story highlights the lessons learned during the f!Ast stormy

decade of the epidemic _ and shows what remains to be done.

AZT, approved for use in AIDS patients in March, 1987, and ddI were

developed primarily by researchers at the National Cancer Institute. Burroughs

Wellcome was granted the right to market AZT, and the company promptly slapped

on a $10,000 annual price tag, making it one of the most costly prescription

drugs in history. Public outrage, Congressional pressure and several highly

publicized stunts by AIDS activists forced the company to reduce its price by

40 percent. And now Burroughs Wellcome stands accused of having obtained its

lucrative AZT patent illegally, mostly by negating the contributions of

government scientists. A protracted court battle lies ahead.

Despite predictions to the contrary, a cascade of new drugs did not follow

AZT, which typically loses its effectiveness within two years. As a result,

tens of thousands of people with AIDS clamored for ddI when the drug's promise

was disclosed.

At first, many researchers claimed that giving out ddI during the early

stages of testing was medically risky, would curtail enrollment in controlled

clinical trials and would destroy scientists' ability to study the drug. People

with AIDS responded that they had no time to wait for full research results.

Bristol-Myers Squibb, manufacturers of ddI, weighed the cost of giving away

ddI and the potential liability against the public relations and marketing

benefits it could realize as a drug development pioneer _ and decided to take a

chance. Eventually, nearly 23,000 patients received the drug free, outside

official trials, and 6,000 more were enrolled in formal studies in the United

States and abroad. Bristol regularly sought advice from both AIDS activists and

scientists as the experiment progressed. The FDA was another key player.

Defying their historical rigidity, regulators bent the rules to get the drug

approved. In a highly unusual move, the FDA did its own legwork to confirm

ddI's safety and effectiveness. And, for the first time ever, the FDA accepted

``surrogate markers'' to help determine ddI's effectiveness. Traditionally, the

FDA has measured a drug's value against life-threatening illnesses by how long

it allows a patient to survive. With ddI, evidence of reduced HIV activity and

a bolstered immune system was used instead, significantly shortening the review

process.

The FDA now intends to go a step further by formalizing an accelerated

approval system for many drugs targeted at life-threatening diseases.

The ddI experience is welcome evidence of a new flexibility in the drug

development process. Now the challenge is to make drugs affordable.

There are some encouraging signs that government has learned a lesson from

the AZT scandal. Before granting marketing rights to Bristol-Myers, National

Cancer Institute scientists patented ddI under their own names, underscoring

the government's role in the drug's development. A clause was inserted into

Bristol's license, making it revocable if ddI becomes unfairly priced.

Bristol-Myers has priced ddI at $1,745 per year _ less than one-fifth the

original price of AZT _ and has pledged to provide it free to those who can't

afford it.

Still, unfair pricing practices remain business as usual in the

pharmaceutical industry, which saw prescription drug prices jump more than 150

percent during the 1980s _ almost three times the general inflation rate. This

in an industry that has, by any measure, more than double the profit margins of

the average Fortune 500 company, and this year will spend $10 billion to market

its wares, $1 billion more than it has committed to research.

There are ways to control drug costs and remedy lingering inequities, but

they require a national commitment to accessible health care that is still

lacking in the United States. Although the federal government subsidized the

cost of AZT for patients who could not afford it, that approach allows the drug

industry to continue its usurious practices unhampered. Imposing a windfall

profits tax or price controls, tying the cost of drugs to the consumer price

index, reforming the Orphan Drug Act, or negotiating bulk discounts are better

avenues for Congress to pursue. If drug development _ not only for AIDS but for

all diseases _ is truly to become collaborative rather than confrontational, it

must not leave the neediest behind.

^Distributed by the Los Angeles Times-Washington Post News Service=