While the drug shows promise in fighting some AIDS-related disorders, leprosy and other devastating diseases, the Food and Drug Administration already is taking steps to protect women who could bear children with no limbs or tiny flipper-like arms and legs after taking just one pill in early pregnancy.
"We never thought there would be another generation of thalidomiders," said Canadian Randy Warren, his voice choked with emotion, who was born with no hips and malformed legs.
Thalidomide, once sold in 48 countries as a sleeping pill and morning sickness cure, was banned worldwide in 1962 after some 12,000 babies were born with missing or malformed limbs, serious facial deformities and defective organs.
It was never sold in the United States, because FDA scientist Frances Kelsey uncovered signs of toxicity that its manufacturer had denied.
Last week, Kelsey, now in her 80s and still at the FDA, heard doctors explain thalidomide's unique ability to inhibit a substance that can spur immune-related diseases like lupus, leprosy and certain AIDS ailments.
Thalidomide also stops blood vessel growth-one reason for the birth defects-making it a possible future treatment for cancer and the incurable macular degeneration that blinds the elderly.
On Monday, Celgene Corp. of Warren, N.J., announced it will seek FDA approval by January to sell thalidomide to heal the most painful symptom, inflamed lesions, of the 200 people diagnosed with leprosy here each year.
Early next year, competitor Andrulis Inc. of Beltsville, Md., will seek approval for thalidomide to treat the excruciating mouth, throat and rectal ulcers that afflict AIDS patients. Then, Celgene also will seek permission to sell thalidomide to the 150,000 AIDS patients suffering from wasting, or severe weight loss.
The FDA is expected to decide those requests next year.
"Thalidomide has the capacity to cure, as well as to damage," said FDA Deputy Commissioner Mary Pendergast, who last week was told by the agency's scientific advisers to consider mandating two forms of contraception, among other measures, for women prescribed thalidomide.
That already is required in many of the dozens of thalidomide clinical trials now under way.
"If thalidomide is allowed on the market, there will be failures" in pregnancy prevention, birth defects expert J. David Erickson of the Centers for Disease Control and Prevention warned the FDA meeting. His dire prediction: Wide thalidomide use could expose as many as 500 pregnancies a year.
Already Brazil, where the drug is sold for leprosy with little oversight or education, has another thalidomide generation. Forty-six deformed babies have been identified, although experts say there may be hundreds more.
Birth defects aren't the only risk. Thalidomide also can severely damage patients' nerve cells, causing a painful, incurable condition called peripheral neuropathy.
AIDS patients are clamoring for thalidomide. Take the AIDS-related ulcers, so painful that some patients starve rather than swallow over the raw tissue. Studies indicate thalidomide healed the sores in just 10 days, said James Learned of the PWA Health Group in New York, which last year provided thalidomide underground until the FDA allowed more patients to use it in research programs.
Harnessing a thalidomide danger-inhibiting blood vessel formation- might even help treat brain tumors and macular degeneration that are fed by new blood vessels.
"We're putting this very bad side effect to a very good use," explained John Holaday of Entremed Inc., which is conducting Phase II trials.
"Sadly, we've resigned ourselves to the fact there probably is a use for this drug," said thalidomide victim Warren of Ontario, who heads North America's thalidomide survivors' association.
Warren was furious that the FDA didn't invite a single victim, including 14 who live here, to its public-protection meeting last week. Without the reality of victims before them, Warren argues, women today won't heed the danger.
The FDA's advisers want any patient getting thalidomide to sign a form with every prescription acknowledging the risks. One even suggested restricting thalidomide to sterilized women.
Thalidomide makers say don't underestimate the drug's notoriety: "The name is immediately a huge signal that says, 'Watch out,"' said Celgene Chairman John Jackson.
A day after the early morning blast rocked homes and businesses within several miles of the facility, officials with Texaco and the Los Angeles City Fire Department said they had not determined what caused one of four hydrotreating units at the refinery near Los Angeles harbor to explode, sending an ominous black cloud billowing thousands of feet into the sky.
"Right now, it is still under investigation (and) there's no way to tell how long that will take," Fire Department spokesperson Bob Collis said. "This is a complicated piece of machinery."
While fire investigators and Texaco's own experts descended upon the facility, company spokesperson Barbara Kornylo said no one was allowed until late yesterday to make a close inspection of the damaged hydrotreater.
The potent Washington lobby is trying to win a seat this week as an accredited advocacy group at the United Nations, where it will campaign against a possible U.N. push for tighter regulation of the firearms trade worldwide.
The U.S. gun owners' organization was alarmed when the General Assembly last December ordered a U.N. study to investigate ways "to prevent and reduce the excessive and destabilizing accumulation and transfer of small arms and light weapons."
The study group, the U.N. Panel of Governmental Experts on Small Arms, began its work in June.
"We had members concerned about what was going on at the United Nations," said the NRA's chief Washington lobbyist, Tanya Metaksa.