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.
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.