Thalidomide Can Be Redeemed

If the name thalidomide scares people, it should. Unfortunately, people who ought to be scared the most - women of childbearing age - “have no clue” about the 12,000 severe birth defects blamed on thalidomide before it was banned worldwide in 1962.

The words quoted above are from Dr. Janet Woodcock, director of the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research. Her agency has been measuring public awareness of thalidomide as the FDA moves toward approval of the drug in the United States.

When that approval happens - and there are convincing reasons that it should - the FDA must impose stringent safeguards that include an assertive public education program.

Thalidomide was developed in the 1950s as a sedative that would be safer than barbiturates. It was sometimes used to treat morning sickness and in some parts of Europe, it could be obtained over the counter. Manufacturers called it safe for pregnant women, but it had been tested only on animals.

When U.S. manufacturer Richardson-Merrell applied to the FDA to distribute thalidomide here, FDA officials assigned the case to a newcomer in the agency, wanting to make her first case easy.

But Dr. Frances Oldham Kelsey’s skepticism was more than anyone bargained for. She questioned the level of testing. Then she stumbled upon medical literature citing possible connections between thalidomide and nerve damage.

While she was insisting on better information, Europeans’ alarming experience came into focus and thalidomide was spectacularly discredited.

Thanks to Kelsey more than to the FDA, thousands of unsuspecting American families avoided the heartache inflicted on Europe.

But the thalidomide incident demonstrated the role a responsible regulator could play. Congress strengthened the FDA. Policies were tightened. Today, we have an agency better prepared to evaluate research into thalidomide’s dangers as well as its many beneficial uses, such as alleviating an excruciatingly painful inflammation in leprosy patients - the purpose for which an advisory committee this month recommended FDA approval.

Thalidomide also combats extreme weight loss in AIDS patients more affordably than human growth hormone at $1,000 a week. It combats graft-vs.-host disease, a fatal side effect of bone marrow transplants. It may have applications with tuberculosis, certain causes of blindness, lupus, rheumatoid arthritis and various cancers.

Even those who agree that thalidomide should receive FDA approval expect it to cause some tragedies. At the same time, watchdogs such as the March of Dimes Birth Defects Foundation and the president of the Thalidomide Victims Association of Canada understand that millions of lives could be saved or improved if thalidomide were available.

Even if the FDA were to say no to thalidomide, which it’s not likely to do, many desperate patients would continue to obtain the drug illegally, often using the Internet. Bringing the drug into the legitimate market, with close monitoring, is a far more attractive approach.

Government has its excesses, but its regulatory structure often serves an invaluable purpose - such as balancing the risks and benefits of thalidomide.

, DataTimes The following fields overflowed: CREDIT = Doug Floyd/For the editorial board