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On April 1, 1961, the Government of Canada authorized the marketing of the drug Kevadon on the Canadian market.
It was also known as thalidomide.
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.
{snip}
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.
{snip}