❇ Thalidomide incident and pharmaceutical industry

Introduction to Thalidomide

Thalidomide developed as an antidote to nerve gas poisoning. Marketed first in October 1957 to treat morning sickness and nausea in pregnancy.

At the beginning, It described to be very safe and wasn’t linked to any side effects.

Introduced by the German company (Chemie-Grünenthal) with the brand name “Contergan,” and launched in England as “Distaval.”

Effect of Thalidomide

Thalidomide withdrwan from the market between 1957 and 1961. Reported over 10,000 children were born with profound limb deformities.

Eventually, thalidomide use during early pregnancy was found to cause birth defects. A variety of abnormalities were reported, but the most common was phocomelia.

The most prevalent condition observed was phocomelia.

Phocomelia is a condition characterized by the absence or severe underdevelopment of limbs. It is rare condition with the type of congenital disorder.

Thalidomide & Pharmaceutical Industry

For over the years, thalidomide had the greatest influence in shaping the pharmaceutical industry as we are today.

With in 4 years of widespread and unrestricted prescribing to pregnant women. This event had a huge impact on global drug regulation and development practices.

The reassessment of clinical trials and pharmacovigilance activities had emerged as distinct discipline.

In a remarkable turn of events, thalidomide had changed the way from irrational use to immuno-modulator.

It prescribed today by demonstrating the cause of rational use of psychotropic drugs.

Preventive measures

Many preventative measures have taken in the intervening years in light of the lessons learned with thalidomide.

Yet, Many companies puts pressures to achieve success by hide the existing mistakes. Many small companies forming alliances with big pharma giants. According to some commentators, many breakdowns in regulatory authorities in system check.

Using thalidomide as a point of reference, and its consequent changes. Many companies changed the drug have become expensive.

It can now take more than 10 years and cost more than a billion dollars to bring a new drug to market.

This in turn means that only large companies with very deep pockets can now afford to take drugs all the way from discovery to the market.

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)
if you wish to read a full cover story, check out this links below: 
1. https://www.cambridge.org/core/journals/medicolegal-news/article/abs/suffer-the-children-the-story-of-thalidomide-by-the-insight-team-of-the-sunday-times-of-london-viking-press-new-york-1979-309-pp-1295/8850EBA7544DB02AFA1C688C2AB980FC
2. Story of Thalidomide
3. Tragic history of Thalidomide and phocomelia

Key Takeaways

1. The pharmacovigilance process just did not begin and end with the Thalidomide incident. It evolved into a comprehensive regulatory framework.
2. Thalidomide incident, while tragic, ultimately led to positive changes and advancements in societal safety practices.
3. Pharmacovigilance extends beyond mere prevention. It is an ongoing and evolving field with continual improvements and additions.
4. Thalidomide started evolution of Drug Regulation
5. The lessons learned from Thalidomide have led to more stringent drug development processes. I definitely takes over a decade and can cost more than a billion dollars to introduce.

Closing Thoughts

This straightforward blog gives you:

To clarify how and why Thalidomide has profoundly influenced the pharmaceutical industry. In particular with safety and the complexities involved.

Would like to explore specific aspects of pharmacovigilance or any suggestions?

Leave a comment below. Your input can help guide a deeper investigation into this critical area.

References:

1. Bibliography: Ridings, J.E., 2013. The thalidomide disaster, lessons from the past. Methods Mol Biol 947, 575–586. https://doi.org/10.1007/978-1-62703-131-8_36
2. Bibliography: Fadel, D.O., Serra, H.A., 2012. [Thalidomide and its legacy, the rational inside the irrational]. Vertex 23, 245–251.
3. Bibliography: Grover, J.K., Vats, V., Gopalakrishna, R., Ramam, M., 2000. Thalidomide: a re-look. Natl Med J India 13, 132–141.
4. Bibliography: Lachmann, P.J., 2012. The penumbra of thalidomide, the litigation culture and the licensing of pharmaceuticals. QJM 105, 1179–1189. https://doi.org/10.1093/qjmed/hcs148
5. Healthline