drug companies mess up

[nec209]

How can drug companies mess up in such modern times?

 

With such modern times how can this happan?

 

BERLIN, Sept 1 (Reuters) – Victims of thalidomide said on Saturday an apology from the German inventor of the drug that caused birth defects in thousands of babies around the world was too little too late.

 

Thalidomide, developed by the German firm Gruenenthal, was marketed internationally to pregnant women in the late 1950s and early 1960s as a treatment for morning sickness. About 10,000 babies were born around the world with defects caused by the drug, mostly malformed limbs or missing arms or legs.

 

 

 

http://o.canada.com/2012/09/01/bc-germany-thalidomide-update-1-tv/

[Phi for All]

This incident happened over 50 years ago. I don't consider it to have happened in "such modern times". Testing and standards were different back then.

[Cap'n Refsmmat]

It's worth noting that the FDA refused to approve thalidomide in the United States, saying that further research was needed. The process worked.

[CharonY]

Also, as an add-on note, this still could happen today (though hopefully at smaller scales), as obviously drugs can only be tested in a limited number of ways. Trials normally do not involve pregnant women, for instance (and for good reasons). And rats or other test animals do not necessarily have the same susceptibilities as humans. This is why nowadays most drugs have extra warnings in case of pregnancies.

 

There is no 100% certainty when it comes to tinkering with biology.

[Iota]

They didn't know at the time about the isometric form which is non super-imposable optical isomerism, nor did they know the danger involved with their possible effects.

Edited September 1, 2012 by Iota

[Joman122]

Also, as an add-on note, this still could happen today (though hopefully at smaller scales), as obviously drugs can only be tested in a limited number of ways. Trials normally do not involve pregnant women, for instance (and for good reasons). And rats or other test animals do not necessarily have the same susceptibilities as humans. This is why nowadays most drugs have extra warnings in case of pregnancies.

 

There is no 100% certainty when it comes to tinkering with biology.

 

well said ^

 

and tbh, pregnant women just should stick to natural substances instead of those crazy pharmaceutical compounds

[Ringer]

well said ^

 

and tbh, pregnant women just should stick to natural substances instead of those crazy pharmaceutical compounds

 

Yeah natural, like potassium cyanide.

[ewmon]

It's worth noting that the FDA refused to approve thalidomide in the United States, saying that further research was needed. The process worked.

Yet, the FDA had learned its lesson the hard way. Frances Kathleen Oldham Kelsey PhD MD of the FDA became suspicious of some results from the thalidomide drug trials due to her involvement 25 years earlier in the 1937 Elixir Sulfanilamide Incident in which 107 patients died (which had also resulted in the quickly enacted 1938 Federal Food, Drug, and Cosmetic Act). And even though the thalidomide disaster struck other countries and not the US, Congress enacted the Drug Amendments of 1962 as a result of it.

 

The S. E. Massengill Company had produced the Elixir Sulfanilamide. Authorities found that the company did not violate any laws — even though it's main component, diethylene glycol, was poisonous — except mislabeling it as an "elixir", which indicated that it contained alcohol (which it did not). The company's president, Samuel Evans Massengill expressed regret about the deaths but expressed no responsibility for them. However, Harold Watkins, the chemist at Massengill who developed the elixir, felt much differently and killed himself.

 

Interestingly, the Massengill Company now advertises its name “Massengill” as “the name you can trust.”

[John Cuthber]

well said ^

 

and tbh, pregnant women just should stick to natural substances instead of those crazy pharmaceutical compounds

 

Why?

Probably the most widespread teratogen is alcohol, and that's natural.

 

Incidentally, the prevailing "wisdom" at the time was that the placenta prevented harmful materials from reaching the foetus so testing in pregnant women was pointless.

I suspect that the FDA's decision to require more testing was a fluke. They were concerned about other forms of toxicity.

Edited September 2, 2012 by John Cuthber

[ewmon]

For me, one of the FDA's best improvements is its 20-year-old post-marketing surveillance (Phase IV drug trials), where the public reports directly to the FDA about adverse reactions to drugs.

 

Alcohol is the most common teratogen, and to describe the horrors of FASD (Fetal Alcohol Spectrum Disorder) in terms to which we can all relate, one well-known study slapped a $2 million price tag on every case of FASD, which includes medical care, special education, productivity losses, and residential care (including incarceration because FASD patients especially have difficulty telling right from wrong). A case involving one of my relatives easily topped $1 million, with about one-quarter due to lost wages, one-half due to "residential care" (ie, prosecution and long-term incarceration), and one-quarter due to medical care and other expenses. Society thinks it was just another crime, but it's my family's dirty little secret.