Teratogenicity Testing

Ridings JE, James E. Ridings, Ridings, James E.

It is close to 60 years since thalidomide was created by the German company, Chemie-Grünenthal, and launched as "Contergan." This was soon to be followed in England by the launch of "Distaval." Of all the drugs developed in the intervening years, thalidomide has undoubtedly had the greatest influence on shaping the Pharmaceutical Industry as we know it today.Strong marketing pressure in an Industry hungry for new medicines brought an inadequately tested drug to the market, targeted outsourcing quickly expanded the client base and finally market forces prevented timely withdrawal, even when evidence was emerging of disastrous side-effects. The full story of thalidomide was told by the Sunday Times in "Suffer The Children" (Kingsley et al., Suffer the children: the story of thalidomide, the insight team of the Sunday times (UK), 1979).Many preventative measures have been taken in the intervening years in light of the lessons learned with thalidomide. However, many of the pressures that led to the thalidomide disaster exist today with record high management and shareholder pressures to achieve success, parallel worldwide marketing, increased numbers of targeted outsourcing by small companies forming alliances with "Big Pharma" and, according to some commentators, a breakdown in the system of checks and balances that have existed in the regulatory authorities in the intervening years.Using thalidomide as a point of reference, this chapter looks at drug development and testing, regulatory authorities and guidelines, outsourcing and in-licensing, pharmacovigilance, and factors that influence withdrawal of a drug from the market.