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This month in 2010: How one woman helped prevent a health crisis in the US

The FDA's Frances Oldham Kelsey honoured for her work to prevent the use of thalidomide
Thalidomide medal

For all the good the pharma industry has achieved – from letting people with type 1 diabetes live a long life with insulin to the numerous treatment advances in HIV and AIDs – its reputation in some quarters is still in question.

It's a mindset that hasn't been helped by recent scandals, such as GlaxoSmithKline's (GSK) bribery accusations in China and recent big payouts from GSK, Johnson & Johnson (J&J) and others over allegations of illegal and fraudulent marketing.

However, some scandals go beyond marketing malpractice and take deep root in the public mind, especially when the consequences are evident on a person's body long after the event.

This is the case with thalidomide – a drug given to pregnant women in the late 1950s and early 1960s that led to a spate of children born with birth defects, such as missing or deformed limbs and even death.

These devastating effects are apparent on adults in their 50s today, and have certainly contributed to the mistrust and concern felt by some critics of the pharma industry.

The story of thalidomide began with very different intentions, however, when in 1954 German pharma company Grünenthal obtained a patent for a drug it thought had potential as a sedative, tranquiliser and to alleviate nausea in pregnant women.

This was a simpler time for the industry, with no regulations in Germany governing the development, production or sale of medicines.

As such, Grünenthal was able to develop the drug at a pace without full safety studies monitored by an official body, and just three years later on 1 October 1957, Thalidomide was launched on to the market in West Germany as an over-the-counter (OTC) product under the brand name Contergan.

This was followed by launches in other regions until a total of 46 countries had access to the drug for use in insomnia, coughs, colds and headache, and, of course, morning sickness.

Grünenthal's joy was short-lived, however, and medical concerns about the drug were first raised in October 1959 when the company received reports suggesting thalidomide might cause polyneuropathy - nerve damage in the hands and feet.

With this information, Grünenthal updated the drug's package leaflet with these side effects and made it prescription only, but the worst news was still to come.

Led by the likes of German paediatrician Dr Widukind Lenz and Australian gynaecologist Dr William McBride, healthcare professionals were beginning to voice their concerns about the drug's effect on unborn children, and Grünenthal withdrew the drug from sales in November 1961.

For many, this withdrawal came too late, however, and it is thought that more than 10,000 children in 46 countries were born with deformities as a consequence of thalidomide use.

One country where the consequences were far less profound was the US, where only 17 children were thought to be born with thalidomide-associated deformities.

It's a remarkable figure amid a sea of poor regulation and one that can be attributed to one woman working for the Food and Drug Administration (FDA) – Dr Frances Oldham Kelsey.

Back in 1960, Dr Kelsey was a new recruit at the FDA, joining as a medical officer to evaluate new treatments. And the very first one to land on her desk was an application from Richardson-Merrell Company of Cincinnati to sell a sedative named Kevadon, or thalidomide to give its generic name.

Dr Kelsey had gained experience in the effects of medicines on foetuses through her work trying to find a new malaria treatment to replace quinine, and she was aware drugs could pass through the placental barrier between mother and unborn child.

This was something her colleagues in other parts of the world lacked, and it was knowledge that meant Dr Kelsey wasn't going to let thalidomide pass through the FDA's regulation process that easily.

According to an article in the FDA's Consumer magazine from 2001, Dr Kelsey had many concerns about the drug's chronic toxicity.

“We were concerned about the non-absorption,” she said. “That you could give enormous amounts, both to animals and humans, without toxicity. We felt that there might be conditions, illnesses, or other drugs that might change the absorption, and toxic effects might appear.”

She requested more data, pushing the 60-day FDA review period to another 60 days and so on, despite the frustrations of Dr Joseph Murray, Richardson-Merrell's representative, who complained to Dr Kelsey's superiors about her unnecessary delays.

“I think I always accepted the fact that one was going to get bullied and pressured by industry,” said Kelsey. “It was understandable that the companies were very anxious to get their drugs approved.”

The constant delays meant the full horror of thalidomide's effect on unborn children was known before the FDA could approve the drug, and Richardson-Merrell withdrew its FDA application in 1962.

Dr Kelsey's actions didn't just mean an unsafe drug wasn't released on to the market – they also meant that potentially thousands of children were saved from being born with birth defects.

As a result of her crusading actions, she received the medal for Distinguished Federal Civilian Service from President John F Kennedy in 1962 before being inducted into the National Women's Hall of Fame in 2000.

Perhaps her most significant and lasting honour came in September 2010, however, when she was recognised by her regulatory peers with the FDA's very first Kelsey award – an honour named after Dr Kelsey to celebrate the pioneering work of an FDA staff member. A fitting tribute, and one that demonstrates the good in the industry.

Article by
Thomas Meek

PMGroup editor

18th September 2013

From: Regulatory, Healthcare



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