Behind the Lines

Inamed Denied

The U.S. Food and Drug Administration (FDA) in January denied implant maker Inamed's application to market silicone gel-filled breast implants. Women's health advocates called the decision a victory for women and for science-based regulation.

"Women have been harmed by silicone-gel breast implants in the past. ... The FDA did its job, taking an important step to ensure that women will not be harmed by these devices in the future," says Cynthia Pearson, executive director of the National Women's Health Network.

The FDA removed silicone gel breast implants from the market in 1992 on the grounds that there was not enough information about the long-term safety of the devices. Women's health advocates argued that Inamed had failed to fill this information gap in its application for marketing approval. The data that did exist, they contended, raised major concerns about long-term safety and high complication rates, including ruptures and infections.

By a slim majority, an FDA advisory committee had recommended approving Inamed's device, but the FDA agreed with those who argued there was inadequate safety data to put the product on the market.

Multinational Monitor named Inamed one of the 10 worst corporations of 2003 for its effort to seek approval for silicone breast implants despite disturbing evidence of the product's dangers and many unanswered questions about its safety.

In denying Inamed marketing approval, the FDA issued new guidelines for what kinds of information it wants before it will approve silicone breast implants. The revised guidelines put more emphasis on long-term safety data.

"The FDA letter that we received provides directions for us to follow, and we intend to work cooperatively with the Agency to place the [application] in approvable form," says Nick Teti, Chairman, chief executive officer and president of Inamed.

BMS Stands Down

Bristol-Myers Squibb abandoned a long-running fight to defend its patent on an important AIDS drug in Thailand.

Thai AIDS activists had sued to challenge the validity of a patent on the formulation of didanosine (ddI), used as a component of the lifesaving drug cocktail for people with AIDS. Bristol-Myers Squibb had been granted a patent on making the drug into a pill.

The activists argued that Bristol-Myers process for formulating ddI powder into a pill did not meet the standards of "novelty" and "inventiveness" necessary for a patent to be granted.

After fighting the lawsuit for years, Bristol-Myers suddenly capitulated.

"We dedicate the patent to the people of Thailand," Dianne Jones of Bristol-Myers Squibb's regional office in Singapore, told reporters.

"This did not happen because the drug company wants to be kind to people living with HIV/Aids in Thailand" countered Nimit Tien-udom, director of Aids Access Foundation, in the Thai newspaper, the Nation. "It is the result of our fight to improve access to medicine."

The Thai Government Pharmaceutical Organization (GPO), a government-owned drug maker, has made ddI in powder form, which is not patent protected. In powder form, however, ddI has much more serious side effects than as a pill.

The GPO says it can make the drug as a pill for a fraction of the price charged by Bristol-Myers, more than $130 a month.

The Thai government in 1999 had considered issuing a compulsory license on ddI ó which would have authorized generic production of the drug ó but backed off in the face of U.S. pressure. Thai activists followed up by challenging the validity of the ddI patent.

The Shrinking U.S. Market

Developing countries betting their economic future on expanding their exports to the United States are making a huge mistake, according to "Fool's Gold," a report issued in January by the Washington, D.C.-based Center for Economic and Policy Research (CEPR).

Access to the U.S. market is typically the primary motivation for countries entering into trade agreements such as the Free Trade Area of the Americas (FTAA, now under negotiation) or the Central American Free Trade Agreement (CAFTA, expected soon to be presented to the U.S. Congress for approval) with the United States. In those agreements, developing countries typically make major concessions to the United States in areas such as intellectual property, investment and government procurement, agreeing to rules that will harm both local consumers and producers.

However, most developing countries will not be able to increase their exports to the United States in the foreseeable future, according to the CEPR report. The United States is now running an unsustainable trade and current account deficit, with the latter now at more than 5 percent of GDP. CEPR points to a consensus among economists that adjusting will cause the market for exports to the United States to shrink.

The CEPR report finds that under any plausible set of assumptions about the adjustment process, U.S. imports will actually decline. The estimated annual decline is between $90 billion and $375 billion.