The Canadian Tragedy

The Tragedy of Thalidomide in Canada

Except otherwise indicated, the information on this page is mostly taken from the Report of the Thalidomide Task Force of the War Amputations of Canada, published on February 14 1989. If you wish to read the synopsis of this report, click here. TVAC thanks them for this important work of research.

Everything began with the first time thalidomide was put on the market, in 1956 in Western Germany by the pharmaceutical Chëmie Grünenthal. It was then marketed in several other countries, including the United Kingdom (1958), Japan (1958) and Norway (1959). The drug would have entered the Canadian market in late 1959, first as samples before being officially authorized in 1961. The American pharmaceutical Richardson-Merrell was the first to distribute thalidomide within Canada, under the name Kevadon.

The laxity of Canadian laws at the time first allowed Richardson-Merrell, without any authorization or verification from the Canadian authorities, to distribute thalidomide samples to physicians known as ‘clinical investigators’.

It is important to note that at the time, the US Food and Drug Administration (FDA) refused to approve thalidomide because of the lack of sufficient research. Ironically, it is a Canadian doctor working as a pharmacist for the FDA, Dr. Frances Kelsey, who, thanks to her rigor and integrity, has prevented the drug from being marketed in the US. Having been made aware of the risks of peripheral neuropathy associated with thalidomide, Dr. Kelsey had even specifically requested that Richardson-Merrell demonstrate to the FDA that the drug was safe for pregnant women, evidence that the company never provided. Only samples were distributed by Richardson-Merrell in the United States, limiting the ravages of thalidomide in that country to 17 recognized victims.

In spite of its obligation to ensure public safety when authorizing new drugs, the Government of Canada at that time authorized the marketing of thalidomide in our country based on the same informations that the American authorities did not find sufficient. The information provided by Richardson-Merrell was from Grünenthal, the German firm who invented thalidomide. Apparently, no study had been done by independent researchers. It appears that the competent Canadian authorities did not question the objectivity and credibility of the information presented by Richardson-Merrell.

On April 1st 1961, the Government of Canada authorized the marketing of the drug Kevadon on the Canadian market, upon prescription. In the fall of 1961, Frank W. Horner, a company from Montreal, Quebec, commercialized its own version of thalidomide, under the name Talimol, also available upon prescription.

Frances Kelsey was awarded the President's Award for Distinguished Federal Civilian Service by President John F. Kennedy for her refusal, as an FDA reviewer, to authorize thalidomide on the US market.
Frances Kelsey was awarded the President's Award for Distinguished Federal Civilian Service by President John F. Kennedy for her refusal, as an FDA reviewer, to authorize thalidomide on the US market.

“The physicians who prescribed thalidomide, the pharmacists who dispensed it and the patients who ingested it were entitled to the assumption that reasonable precautions had been taken by the appropriate federal government officials to ensure that the drug would not harm an unborn child.”

Report of the Thalidomide Task Force of the War Amputations of Canada, p.2.

On December 2 1961, the drug was taken of the German and British markets, after several doctors brought up concerns as it appeared more and more plausible that thalidomide, when taken by pregnant women, was responsible for severe birth defects. Thought the Government of Canada was informed of these suspicions about the possible teratogenic effects of thalidomide, we had to wait until March 2 1962 for the Canadian authorities to react and, in their turn, withdraw thalidomide from the market. As unbelievable as it can appear, thalidomide was legally available in Canada for three full months after being withdrawn from its origin country.

To this day, in Canada, there are more than a hundred persons living with malformations that are attributable to thalidomide. Who knows how many victims could have been spared if Health Canada had not wait three months after the withdrawal of the drug in Germany before taking it off the market as well? This is beside the fact that the Canadian thalidomide tragedy altogether could have been avoided, had our authorities been as vigilant as the United States’.

Soon after the tragedy, on December 4, 1962, the Canadian legislation regarding new drugs control was reinforced (Bill C-3, An Act to amend the Food and Drugs Act). During the bill’s second reading, the Honourable J.W. Montheith, Minister of Health and Welfare, did refer directly to the thalidomide tragedy:

The Honourable J. W. Monteith, Canadian Minister of Health and Welfare, from August 22, 1957 to April 21, 1963.
The Honourable J. W. Monteith, Canadian Minister of Health and Welfare, from August 22, 1957 to April 21, 1963.

“Mister Speaker, I should like to make a somewhat extended statement in moving the second reading of Bill C-3, an act to amend the Food and Drug Act. I feel justified in doing so because of the circumstances which have led the government to put forward our experience with the drug thalidomide, an experience which hon. members will appreciate has been shared in greater or lesser degree by countries throughout the western world.”

The Honourable J.W. Montheith, Minister of Health and Welfare, October 26, 1962

In the wake of the tragedy, the federal government also created two committees: the  Special Committee to study Existing Legislation on Investigational Drugs and the Expert Committee on Rehabilitation of Congenital Malformations Associated with Thalidomide.

Around the world, in the late 1960’s and into the early 1970’s, the victims of the drug thalidomide and their families entered into class action legal suits, or threatened actions, against the various drug companies who manufactured and/or distributed the drug, and they were eventually awarded settlements. In most countries, these settlements included monthly or annual payments based on the level of disability of the individual.

In Canada, the story was quite different.  On January 29, 1963, the Minister of Health and Welfare acknowledged the duty of the Government of Canada to grant thalidomide victims all the necessary support:

“ It is our job to ensure that these [thalidomide] victims are cared for in the best possible manner, that their needs are met to the fullest extent we can devise and to ensure, as much as possible, that a similar tragedy will never occur again”

The Honourable J.W. Monteith, Minister of Health and Welfare, January 29, 1963

Despite this declaration, Canadian victims of the drug were forced to cope alone, family by family. No case ever reached a trial verdict. Rather, families were forced to settle out-of-court with gag orders imposed on them not to discuss the amounts of their settlements. This resulted in wide disparity in the compensation amounts, with settlements for individuals with the same levels of disability varying by hundreds of thousands of dollars.

In 1987, the War Amputations of Canada established The Thalidomide Task Force to seek compensation for Canadian-born thalidomide victims from the government of Canada. As Canada had allowed the drug onto the Canadian market when many warnings were already available about side effects associated with thalidomide, and as Canada left the drug on the market a full three months after the majority of the world had withdrawn the drug, it was felt and argued that the government of Canada had a moral responsibility to ensure that thalidomide victims were properly compensated.

In 1991, the Ministry of National Health and Welfare (now Health Canada), through an “Extraordinary Assistance Plan” awarded small compassionate lump-sum financial assistance grants to Canadian-born thalidomiders. These payments were quickly used by individuals to cover some of the extraordinary costs of their disabilities, and for most victims, these monies are long gone.

Considering this situation unacceptable, and confronted to serious problems of physical degeneration and impoverishment among thalidomide survivors, TVAC set up a task force in 2013. The latter consisted of lawyers, lobbyists, journalists, and survivors of thalidomide. In 2014, the task force conducted an intensive campaign to obtain adequate compensation for Canadian victims of the thalidomide tragedy, called Right the Wrong. Thanks to the hard work of the task force, the campaign garnered the support of the public and the government. On December 1, 2014, the House of Commons unanimously adopted a motion presented by the New Democratic Party recognizing the urgent needs of thalidomide victims and the Government of Canada’s duty to support them. The Thalidomide Survivors Contribution Program was launched in 2015 after consultation with TVAC and other experts on the matter.

Although it has shown its concern for the victims of thalidomide, amended the legislation for the control of new drugs, and provided financial assistance to the thalidomide survivors, to this day, the Government of Canada has never formally acknowledged  its share of responsibility for this tragedy.