The hero behind the thalidomide exposé

Dr. Frances Oldham Kelsey 1914 – 2015

by Roxanne Davies

When Dr. Frances Oldham Kelsey (photo, above) applied for post-doctoral work at the University of Chicago, the employer mistook her name for that of a man’s. Sharing with a professor she thought she might be accused of depriving a man of his capacity to support a wife and child, her professor replied, “Don’t be stupid, accept the job. Sign your name and put ‘Miss’ in brackets.”

Thankfully, Dr. Kelsey followed the advice and accepted the job. With an outstanding combination of character and career skills, she would eventually save countless pregnant women and their babies in the US from the thalidomide disaster. Tragically, Canada allowed the drug to be prescribed to Canadian women between 1960 and 1962.

In 1959, the American Food and Drug Agency (FDA) tasked Dr. Kelsey with reviewing thalidomide, a new drug synthesized in 1954 by the German drug manufacturer Chemie Grünenthal. Touted as a wonder drug in Europe to treat insomnia and alleviate morning sickness, which, in some severe cases can last for hours, thalidomide was available over-the-counter in at least 46 countries under many different brand names, from October 1, 1957 into the early 1960s.

Skeptical about the manufacturer’s clinical studies, Dr. Kelsey refused to authorize it for market in the US, noting the company’s arguments for safety were not convincing. Executives from the drug manufacturer wrote, phoned and showed up at her lab to try and persuade her to approve their application, but she would not budge. They called her an obstructionist nitpicker.

In early 1961, Dr. Kelsey spotted a letter in the British Medical Journal written by a Scottish physician who cited incidents of nerve damage among his patients taking thalidomide. Dr. Kelsey asked why the drug’s manufacturer had never mentioned the troubling side effect; she also began to press company officials about the effects of thalidomide on a fetus, for which the drug makers had not done any testing. By November 1961, she was vindicated when the full scope of the thalidomide tragedy began to unfold. News from Europe linked the drug to birth defects, including stunted or missing limbs, heart malformations, deafness and blindness.

Dr. Kelsey was instrumental in ensuring that thalidomide was never prescribed to any pregnant woman in the US. Although thalidomide was withdrawn from the West German and UK markets by December 2, 1961, it is shameful it remained legally available in some Canadian pharmacies until mid-May 1962.

It has been estimated that thalidomide maimed 20,000 babies and killed upwards of 80,000 worldwide. Many families with surviving children filed civil suits, but all the victims had to wait years without support because the criminal trial took precedence. When the criminal trial of employees of Chemie Grünenthal opened in the town of Alsdorf, in the district of Aachen, on May 27, 1968, it promised to be comparable in scale and emotional intensity to the post-war Nuremberg trials. Nearly 700 people crowded the biggest space in the region: a casino. Every day, the judges, lawyers, scientists, press and witnesses passed by three deformed children nursed by Red Cross sisters while their mothers waited inside hoping to learn the cause of their children’s affliction. The trial lasted two and a half years. The trial ended in April 1970 when proceedings were halted because it was deemed there was little public interest in securing a conviction.

More than half a century after the pill’s threat to an embryo was proven, the company that produced the first disaster continued to sell the drug in parts of Latin America, through prescription only, and babies continued to be born with malformations similar to the survivors from the 1960s. Initially Grünenthal had insisted that it was blameless, claiming the thousands of abnormal births were an act of God. The company now admits its role in the drug disaster and that the thalidomide tragedy will forever be part of their history. Grünenthal would eventually provide approximately 100 million marks as compensation for the victims.

Thalidomide is making a comeback as a strictly regulated drug prescribed by doctors to combat serious skin conditions such as leprosy and is being explored as an HIV/AIDS or cancer drug. Celgene Canada, based in Mississauga, Ontario, provides biotech therapies and has rebranded thalidomide as Nightmare Drug to Celgene Blockbuster.

In 2010, the British government officially apologized to people hurt by the drug, after earlier agreeing to pay £20m (US$31m) to thalidomide’s victims. In 2013, a class action suit by Australian and New Zealand victims of thalidomide against the drug’s British distributor Diageo Scotland Ltd. was settled for $89m.

It is unknown how many Canadian women and children were harmed by thalidomide, but in 1991 there were 109 Canadians who could prove they were thalidomide damaged. In May 2015, the Canadian Conservative federal government announced details of the compensation package for the 92 remaining Canadian survivors. They would receive annual pensions of up to $100,000 depending on the severity of their disability for the remainder of their lives. An additional $500,000 was placed in in a medical assistance fund to be accessed by individuals to help with mobility and adaptive tools as required. Prior to the government compensation package, the average thalidomide survivor “survived” on $14,000 a year.

I was humbled by the personal stories and photographs of our Canadian survivors who showed tremendous grit and grace in their daily struggles. It is a sad irony that Dr. Kelsey was not able to save her fellow Canadians, however, remaining survivors have graciously thanked her for her life’s work. Mercedes Benegbi, executive director of the Thalidomide Victims Association of Canada, said the tribute to Dr. Kelsey is deeply deserved: “To us, she was always our heroine even if what she did was in another country.” Dr. Kelsey was born in Shawnigan Lake on Vancouver Island and was a dual citizen for most of her professional life, visiting often, but returning to Canada in her late 90s.

Compassionate, courageous truth-tellers often are responding to a higher calling, a sense of duty and justice. Sadly, many of these men and women end up experiencing long-lasting problems. An Australian study looked at 35 men and women from various occupational backgrounds, who had uncovered harms to the public. “Although whistleblowing is important in protecting society,” the report reads, “the typical organizational response causes severe and long-lasting health, financial and personal problems for whistleblowers and their families.”

Dr. Kelsey showed strength and courage by refusing to bend to pressure from drug company officials and her actions saved countless American women and their babies. Hailed as a hero, she was the second woman only to be honoured by president John F. Kennedy for distinguished federal civilian service.

On her 101th birthday in 2015, Dr. Kelsey received the Order of Canada in a private ceremony in her daughter’s home in London, Ontario. She died less than 24 hours after receiving the award.

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