4. THE BENDECTIN COVER-UP

Richardson-Merrell Inc., the company that brought us Thalidomide, has now given us another drug charged with causing birth defects: Bendectin.

Bendectin is described as a "low-level" teratogen, suspected of causing heart disorders, limbs reduced in size or missing, cleft lips and palates, and a disease in which the brain is formed outside the head, in about one per cent of children whose mothers took the drug.

What is most alarming about this statistic is that Bendectin has been prescribed to about 30 million women since it was introduced in 1956. With an estimated 1.5 million women taking the drug in 31 countries around the world every year, if the incidence of deformity is as low as 2-5 in 1,000, as suggested by one study, Bendectin could still be creating between 3,000 and 7,500 deformed children every year.

Bendectin is prescribed only to women in the first trimester of Pregnancy, for treatment of nausea. It is the only drug on the market for this purpose. It is one of the more commonly used drugs during pregnancy: Richardson-Merrell estimates that 25 per cent of pregnant women in the United States take the drug.

Why is Bendectin still on the market? Despite the tragic Thalidomide experience, there appears to have been a cover-up. Evidence shows that Richardson-Merrell, and the Food and Drug Administration, each have on file numerous reports of birth defects suspected to be results of Bendectin -- but the reports have been largely ignored. There is also ample evidence that unfavorable reports of the drug's effects have been withheld en masse from the FDA by the drug company. At a 1980 FDA hearing on Bendectin, several studies were presented which denied that Bendectin causes defects; not mentioned was the fact that several of these studies were funded by the drug company, and at least one such study was found to have been falsified.

Although the FDA hearings resulted in a finding that the FDA has a "residual uncertainty" about the safety -- and the effectiveness -- of the drug, Bendectin continues to be marketed in huge quantities. In 1979, it produced an estimated profit of $15 million for Richardson-Merrell.

The failure of the media to fully inform the public of this grave and continuing hazard qualifies this story for nomination as one of the "best censored" stories of 1980.

SOURCES:

Mother Jones, November 1980, "The Bendectin Cover-Up" by Mark Dowie and Carolyn Marshall; Science, October 31, 1980, "Now Safe is Bendectin?" by Gina Bari Kolata.