Wall Street Journal - June 5, 2003
Marilyn Chase, Staff Reporter of The Wall Street Journal

Eli Lilly announced Thursday that it is joining with the World Health Organization, the Centers for Disease Control and Prevention, and Harvard and Purdue universities in a four-year, $70 million technology transfer program to help companies in China, India, South Africa and possibly Russia make and sell their own supplies of two older Lilly antibiotics.

The drugs, capreomycin and cycloserine, have been supplanted by newer, less toxic drugs, and no longer have much of a market in the U.S. or Europe. But they are among the few treatments effective against tuberculosis that is resistant to standard TB drugs.

Lilly already had cut the prices of the two drugs by about 95%. Its new effort to transfer the rights to make them, in return for a pledge that the drugs will be sold cheaply, is also aimed at boosting the supply of the antibiotics. The plan was prompted by two globetrotting tuberculosis doctors.

"I'm not embarrassed to beg for our patients. ... I was a pest," says Harvard Medical School Professor Paul Farmer, whose group Partners in Health runs programs in Haiti, Peru and Russia. With colleague Jim Y. Kim, he lobbied for four years to secure Lilly's largesse.

At a time when high drug prices often curtail treatment in poor countries, Drs. Kim and Farmer say such cooperative ventures may provide the best route to affordable access to drugs. Last month, Swiss drug maker Roche Holding AG gave development rights to a new malaria drug to Indian generic firm Ranbaxy Laboratories Ltd.

Tuberculosis ranks second among the top epidemic killers, after AIDS. Each year, eight million people world-wide are diagnosed with the lung-eroding bacteria, and two million die of it. (In the U.S., TB sickens about 15,000 people a year, and kills 5%.)

Misuse of common TB drugs has fueled the rise of resistant TB strains now causing up to 4% of cases world-wide, or 320,000 people a year. These strains of TB, called multidrug-resistant, require 24 months of drug-combination treatment, with the two Lilly drugs being the most costly of the lot. Before Lilly's price cut, the treatment cost about $25,000.

Now it is about $2,000.

Under Lilly's tuberculosis partnership, announced with global and U.S. health officials in Geneva and Washington, the company will give away its manufacturing technology to several foreign companies in exchange for their pledge to charge reasonable prices.

Lilly also will sponsor programs at Harvard to teach health-care workers to better detect and treat multidrug-resistant TB, and at Purdue to train the overseas companies to make drugs under strict manufacturing practices required by the U.S. Food and Drug Administration. To track the spread of resistant bugs, Lilly will set up a surveillance outpost in Tomsk, Russia, where 40% of cases involve resistant bacteria. Lilly's collaborators also include the U.S. Department of Health and Human Services and the Bill and Melinda Gates Foundation.

"It's quite innovative," says Dr. Kim, who this month joined WHO as senior adviser to Director General-elect J.W. Lee. Dr. Farmer adds, "If [Lilly] can show other big pharma companies how to be better corporate citizens, then we'd have a better shot at taking on the plagues of the poor."

The partnership may help Lilly heal from recent public-relations bruises: controversy over the use of the preservative thimerosol in childhood vaccines, recent manufacturing problems and concerns about diabetes among users of its antipsychotic drug Zyprexa.

Lilly expects no profit from the partnership. "There is absolutely no money to be made on this," says Chairman and Chief Executive Officer Sidney Taurel. A Lilly spokesman says the company will be able to claim a small tax benefit from the drug-rights transfer.

One beneficiary of Lilly's decision to cut the price of its drugs is Natacha Jean, a teenage Haitian orphan who dreamed of being a pop star like her idol, Jennifer Lopez. But after contracting tuberculosis in 2000, she could barely breathe, much less sing. "I had no hope, and thought I would die," says Ms. Jean, who coughed incessantly, suffered nightly fevers and lost 30 pounds. Her case resisted most standard treatments.

But at Dr. Farmer's clinic in Cange, Haiti, Ms. Jean got a five-drug regimen that began to clear the infection after a month, and healed her lungs in a year. She's 18 now, and back in high school with a new goal: becoming a nurse.

Although multidrug-resistant TB is largely a problem of the developing world, it has reached the U.S. In the 1980s and early 1990s, New York City suffered a wave of tuberculosis, infecting 20,000. At the epidemic's height, one fifth of the cases were multidrug-resistant. The outbreak cost some $1 billion to quell.

Drs. Kim and Farmer began jawboning Lilly executives four years ago. "We made the case [to CEO Taurel] that this could be Lilly's ivermectin," Dr. Kim says, alluding to Merck & Co.'s famous drug giveaway for Africans with river blindness. Mr. Taurel says, "They impressed me with how urgent, acute and growing the problem of multidrug-resistant TB was."

Drs. Farmer and Kim brought together Lilly with physicians from TB-stricken countries and the group Doctors Without Borders. Lilly responded by boosting supplies and slashing prices. Doctors at Harvard, WHO and CDC formed a committee to ensure the TB drugs were properly administered. But supplies still fell short of WHO's projected needs.

Michael Spink, a Lilly manufacturing expert, scoured the world for production partners. He chose three: Shasun Chemicals & Drugs Ltd. of Chennai, India; Zhejiang Hisun Pharmaceutical Co. Ltd. of Taizhou, China; and New Heights, a new black-owned firm in Douglasdale, South Africa. He is still searching for a Russian partner. In exchange for drug know-how, the companies are expected to agree to limit prices to 20% over cost.

"Instead of giving people a fish," Lilly's Mr. Taurel says, "we are teaching people to fish."

Write to Marilyn Chase at Marilyn.Chase@wsj.com

030605
WJ030603

Copyright © 2003 - The Wall Street Journal. Reproduction of this article (other than one copy for personal reference) must be cleared through the WSJ Permissions Desk.

Always watch for outdated information. This article first appeared in 2003. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2003. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .