Washington Editor

WASHINGTON - Scientists developing drugs for rare diseases will have a greater opportunity to win federal grants since President Bush signed legislation doubling funding for orphan product research.

Bush in November signed the Rare Diseases Orphan Product Development Act of 2002 (HR4014) and the Rare Diseases Act of 2002 (HR4013), which increase federal funding for orphan drug research from $12 million per year to $25 million per year through 2006.

Rep. Mark Foley (R-Fla.), the author of HR4014, released a prepared statement saying, "Too often, people with rare diseases are ignored because they're in the medical minority. No matter what financial or ethnic background, or whether somebody suffers from a well-known disease or a rare disease, they suffer equally. We can't afford to keep paying 50 cents on the dollar when they're feeling 100 percent of the pain."

The Foley legislation and the Rare Diseases Act, authored by Rep. John Shimkus (R-Ill.), are similar to the Rare Diseases Act of 2001 (S.1379) sponsored by Sens. Edward Kennedy (D-Mass.) and Orrin Hatch (R-Utah).

Lincoln Tsang, an attorney with Arnold & Porter in London, told BioWorld Today that the Foley-Shimkus legislation encourages partnerships between government and industry, adding that rare diseases are defined in the legislation as diseases that affect fewer than 200,000 people in the U.S. Comparatively, in the European Union, rare or orphan diseases are defined as affecting fewer than five people in 10,000.

"I think the legislation is ahead of Europe because our procedure is much younger compared with the American situation," Tsang said. "What this says to the industry is that the government is aware that there are a lot of companies out there developing products for orphan [indications]."

According the Washington-based National Organization of Rare Disorders, 25 million Americans suffer from at least one of the known 6,000 rare disorders, including sickle-cell anemia, Lou Gehrig's disease and Tourette syndrome.

The FDA's orphan drug research program is responsible for helping to create 23 new drugs and four medical devices for rare disorders, Foley's office said.

Researchers Not Convinced Company Cloned Baby

The view of mainstream science appears to be skepticism regarding reports that a 31-year-old American woman gave birth to her female clone with the help of Clonaid, a company founded by the religious leader Rael, who believes that life on earth was created scientifically in laboratories by extraterrestrials.

Clonaid has not released the location of the child, who was said to have been born Thursday at 11:55 a.m. and is called Eve, according to reports.

Sen. Bill Frist (R-Tenn.), the incoming Senate majority leader, released a prepared statement saying, "Today's announcement is disturbing. While its validity is unclear, it should serve as a chilling reminder that individuals are still trying to clone human beings. These actions offend our human sensibilities and the decency of human life. Today's announcement reinforces the need for Congress to continue its efforts to enact a ban on human cloning."

David Stevens, executive director of the Christian Medical Association, of Bristol, Tenn., released a prepared statement saying, "Whether or not this claim is true remains to be proven, but it certainly highlights our need to pass a ban on human cloning before a true tragedy happens."

Meanwhile, Carl Feldbaum, president of the Washington-based Biotechnology Industry Organization, released a prepared statement saying, "BIO reiterates its strong opposition to human cloning on both safety and ethical grounds. If this announcement is proven true, we hope the child enjoys a full, healthy life and has a loving family."

Congress is expected to take up the issues of therapeutic and human cloning sometime next year. While the House and Senate are divided on whether therapeutic - or research - cloning should be legal, no one has claimed to support human cloning.

President Bush supports a ban on all cloning.