Thalidomide in Canada

Thalidomide

Thalidomide, an immunomodulatory drug, was developed in West Germany in the 1950s by pharmaceutical company Chemie Grünenthal. The drug was deemed safe for humans, because early testing on rodents proved it almost impossible to give a lethal dose. At the time, there were no requirements for teratogenic testing (a teratogenic substance is one that interferes with foetal development). In 1957, thalidomide was marketed in Germany as an anticonvulsant for epilepsy and as a sedative. It wasn’t long before pharmaceutical companies elsewhere began producing and marketing the drug under license.

By 1960, thalidomide was widely prescribed in Europe and across the world for a range of conditions, including anxiety and nausea. In Canada, the drug became available as a sample in late 1959, and as a prescription medication in April 1961 after it was approved for sale by the Department of Health and Welfare (now Health Canada).

The United States, however, didn’t approve thalidomide for marketing or distribution, although pharmaceutical companies gave samples to physicians under the guise of early-stage clinical trials. Frances Oldham Kelsey, a Canadian pharmacologist at the United States Food and Drug Administration, refused to approve the drug because the company couldn’t provide evidence that it was safe (Kelsey had read reports of nerve damage after long-term thalidomide use). Her concerns about safety were soon confirmed.

Thalidomide and Pregnancy

Thalidomide was originally prescribed as a sedative but was soon used to treat morning sickness (nausea) in pregnant women. At the time, scientists weren’t aware that drugs could cross the placental barrier and affect the foetus. It took several years before people realized that thalidomide caused serious impairments in babies when it was taken in early pregnancy. These impairments included phocomelia, a malformation of the limbs in which the hands or feet (or both) start from the main joint (that is, the shoulder or the hip). Babies were also born with abnormal or missing ears, cleft palate, kidney problems, heart problems, digestive system disorders, and defects of the spinal cord.

By November 1961, Australian obstetrician Dr. William McBride and German pediatrician Dr. Widukind Lenz suspected a link between thalidomide use in pregnancy and congenital malformations. Lenz warned pharmaceutical company Chemie Grünenthal of his suspicions, while McBride published a letter in the medical journal The Lancet. Their findings were soon confirmed by thousands of cases worldwide. By the end of December 1961, the drug had been withdrawn in both West Germany and the United Kingdom. Other countries soon followed their lead. Thalidomide continued to be sold on the Canadian market until March 1962, three months later. According to the Thalidomide Victims Association of Canada (TVAC), it was still available in some pharmacies until the middle of May 1962.

Regulatory Changes

The experience with thalidomide led many countries, including the US, UK and Canada, to improve pharmaceutical licensing policies. As physician and MP Stanley Haidasz remarked in the House of Commons on 7 December 1962, the thalidomide tragedy underlined the need for stricter legislation:

Mr. Speaker, in this period of rapidly advancing technological progress in the field of chemistry, the industrialized world is confronted with far reaching changes...responsible governments must update their legislation and regulations, thus discharging their responsibility for scientific progress as well as for public safety. ... It is unfortunate that the thalidomide tragedy, producing so many malformed infants and giving their parents untold grief, has forced this and other governments to pay more attention and to initiate a probe into the matter of drugs. I believe that public protection is the overriding motive in considering this probe and new legislation. 

Many countries developed stricter drug policies in the 1960s, with the US leading the way in October 1962 with the Kefauver-Harris Drug Amendments (see also Frances Oldham Kelsey). New legislation required pharmaceutical companies to prove that drugs were both effective and safe before going on the market. Supporting evidence had to be based on well-controlled clinical trials; drugs could no longer be approved for human use solely on the basis of animal testing. Moreover, no drug could be marketed to pregnant women unless it had been proved safe for use during pregnancy.

In Canada, changes included a December 1962 amendment to the Food and Drugs Act that allowed the distribution of drug samples only under “prescribed conditions” and prohibited the sale of several drugs, including thalidomide. Decades later, thalidomide was approved by Health Canada for the treatment of leprosy, multiple myeloma, and some autoimmune diseases; given its teratogenic effects, there are strict guidelines for its use.

Support for Canadian Thalidomide Survivors

In the late 1960s and early 1970s, many victims and their families around the world sued (or threatened to sue) the drug companies that had manufactured or distributed thalidomide. But the amount and terms of settlements varied. In 1987, the War Amps of Canada established a task force to lobby the government of Canada for support. In the 1990s, 109 Canadian thalidomide victims received lump-sum payments of between $52,000 and $82,000 from the federal government. However, these funds proved insufficient to cover the medical needs of survivors. Therefore, in 2014, the TVAC requested additional government compensation: a $250,000 lump-sum payment followed by annual payments of between $75,000 and $150,000. In March 2015, the federal government announced a $125,000 lump-sum settlement each for eligible thalidomide survivors under the Thalidomide Survivors Contribution Program (TSCP). Two months later, in May 2015, survivors learned that they would receive an annual pension from the government of up to $100,000 a year, depending on their disability. Eligible thalidomide survivors could also access an Extraordinary Medical Assistance Fund (EMAF), which would help pay for medical expenses not covered by provincial and territorial health plans, such as specialized surgery, or adjustments to homes and vehicles.

Thalidomide survivors argued, however, that this funding was inadequate. In December 2017, a new organization, the Thalidomide Survivors’ Task Group, demanded that the federal government double the compensation that it provided under the TSCP. In 2019, the government launched the Canadian Thalidomide Survivors Support Program (CTSSP), which replaced the TSCP and provided a tax-free lump-sum payment of $250,000, as well as ongoing tax-free payments, to eligible survivors. The government also recognized that some survivors may have been excluded due to the TSCP’s eligibility criteria and indicated that the CTSSP would “provide a fair and comprehensive approach to identifying thalidomide survivors that is based on international best practices.” More funds were also made available through the EMAF, which was increased from $500,000 to $1,000,000 per year.