Safe and effective has become a slogan to assuage fears, however, there is ample precedent that drugs once declared “safe and effective” by the regulating agencies can be anything but…safe and effective.

Only time reveals these kinds of horrors. It took many decades to reveal the unexpected consequences of antibiotic use and antibiotic resistant microbes, or the effects of X-ray radiation, or the dangers of arsenic and lead. DDT is another great example. Heck, even fluoride! And it’s still in our water, despite ample evidence that it’s harmful to our health.

We don’t have all the answers, and we shouldn’t just blindly trust someone or some agency who thinks they do have all the answers. Time reveals the answers. Sometimes it takes decades to reveal the true cost of something.

Thalidomide

Thalidomide was a sedative developed in 1953 used to treat morning sickness during pregnancy in the 1950s and the early 1960s. It was licensed in 46 countries, with sales nearly matching those of aspirin.

Ironically, it was not licensed in the United States. FDA inspector Frances Kelsey prevented the drug’s approval within the United States despite pressure from the pharmaceutical company and FDA supervisors. Kelsey felt the application for thalidomide contained incomplete and insufficient data on its safety and effectiveness. Among her concerns was the lack of data indicating whether the drug could cross the placenta, which provides nourishment to a developing fetus.

In 1961, two doctors saw an association between the use of thalidomide use in expecting mothers and congenital malformations. Once publicized, more than 10,000 children around the globe were thought to have been born with the malformation as a result of thalidomide use.

In addition to these abnormalities, thalidomide was associated with peripheral neuritis, and there was an increase in the number of miscarriages reported by women during the same period of time. It was withdrawn from use in 1961.

It is estimated that altogether, between 87,600 and 275,500 babies were affected by thalidomide.

Diethylstilbestrol (DES)

Diethylstilbestrol (DES) is a “synthetic estrogen.” During 1938-1971, U.S. physicians prescribed DES to pregnant women to prevent miscarriages and avoid other pregnancy problems. As a result, an estimated 5-10 million pregnant women and the children born of these pregnancies were exposed to DES. At the time, physicians thought DES was safe and would prevent miscarriages and pre-term (early) births.

In 1953, research showed that DES did not prevent miscarriages or premature births, but was continued to be prescribed until 1971, when the FDA added a warning based on a 1971 that identified DES as a cause of a rare vaginal cancer in girls and young women who had been exposed to DES before birth (in the womb).

DES daughters had about 40 times the risk of developing clear cell adenocarcinoma of the lower genital tract than unexposed women.

Primodos

Primodos was a hormone-based pregnancy test used from 1958 and 1978 that consisted of two pills that contained synthetic hormones. It would induce menstruation in women who were not pregnant, while absence of bleeding meant you were pregnant.

In the 1960s research showed a link between the use of the drug and severe birth defects, and then in the 1970s it was concluded the product should not be used by pregnant women. It was finally withdrawn from use in 1978.

However, the controversy surrounding Primodos continues. In 2017, a report of an expert working group of the UK Commission on Human Medicines published in November 2017 concluded there was no “causal association” between Primodos and severe disabilities in babies.

The expert group recommended that families who took a hormone pregnancy test and experienced “an adverse pregnancy outcome” should be offered genetic testing to establish whether there was a different underlying cause.