Canadian Victims of Thalidomide Concerned About Its Return

A variant of thalidomide could be returning to the market as a treatment for multiple myeloma, but the thalidomide victims of are concerned.

Thalidomide Victims Association of Canada has regretted that the drug appears to be becoming a drug of first choice again instead of the drug of last resort it should be.

Back in 2004 at an international conference of the drug victims, it had been noted, “The Governments of those countries that have users of thalidomide must learn the lesson from the world-wide thalidomide tragedy of the fifties and sixties. Governments should make every effort to prevent the occurrence of a new disaster by implementing a comprehensive system of vigilance and an education programme about the associated risks of using thalidomide. This should be done even if licensing for the production of thalidomide has not been granted.”

The drug once seemed to help people sleep and took care of symptoms of morning sickness for pregnant women, before its devastating effects came to be known.

It was developed by the German pharmaceutical company Grunenthal and hit the market in October 1957.

There were initial reports of peripheral neuropathy, or damage to the nervous system that serves limbs and organs. This can lead to pain, numbness and gait imbalance.

There were also more disturbing side effects reported. Women were giving birth to babies with severe defects like abnormally short limbs, flipper-like arms and toes growing out of the hips.

It's estimated that as many as 12,000 babies were born with deformities linked to thalidomide.

There were numerous lawsuits and settlements worldwide in the years after thalidomide was pulled. In 1970, a case was settled in Germany with Grunenthal for $31 million US plus an estimated $13.5 million to $27 million US from the German government.

In Canada, U.S.-based Richardson-Merrell Inc. distributed the drug, and each family reached undisclosed individual settlements. In 1990, the federal government extended assistance of $7.5 million to the Canadian-born "thalidomiders."

While the drug was officially off the market, it was never totally gone. In 1964, an Israeli doctor found that thalidomide helped ease erythema nodosum leprosum (ENL), a very painful complication of leprosy. Thalidomide is effective at relieving the pain of ENL because it limits the immune system's response to leprosy bacilli in the body.

The body responds by trying to attack the bacilli, which causes burning red nodules to break out on the skin. Thalidomide acts as a powerful anti-inflammatory, reducing the body's production of a protein that stimulates inflammation within the body.

In 1998, the FDA approved an application by the maker of thalidomide — Celgene Corporation — to market the drug under the name of thalomid for the treatment of ENL.

The drug was also found to be effective at treating cachexia — severe weight loss experienced by people dealing with diseases such as AIDS, TB and leprosy. The weight loss is believed to be triggered by tumour necrosis factor, the same protein that stimulates inflammation within the body.

Thalidomide was also found to be helpful for AIDS patients suffering from painful lesions in the mouth and throat, which affects their ability to eat. In 1994, the FDA formed a Thalidomide Working Group to monitor use of the drug. The agency also imposed severe restrictions on the distribution of thalomid — the current name the drug goes by — through the System for Thalidomide Education and Prescribing Safety (STEPS) program.

In May 2006, the FDA approved thalidomide in combination with dexamethasone for the treatment of patients with multiple myeloma, a type of bone marrow cancer. Patients with the disease don't generally live long after diagnosis.

But studies have suggested that while taking thalidomide in combination with dexamethasone won't cure multiple myeloma, patients could live longer than those being treated with other drug combinations.

The latest findings, published in the Nov. 22, 2007, edition of the New England Journal of Medicine, stated that a thalidomide derivative, lenalidomide , when taken with the steroid dexamethasone slowed progress of multiple myeloma, an incurable bone marrow cancer, and prolonged the lives of patients who had relapsed from previous treatment.

The website of the drug-makers, the Celgene, admits to a long list of thalidomide's side effects, including:

Severe, life-threatening human birth defects

Deep-vein thrombosis

Drowsiness, dizziness, and seizures

Constipation

Nearly a decade ago, the Canadian victims had wondered, “We, the Thalidomide Victims Association of Canada, ask the question, why have researchers never studied the long-term effects of Thalidomide on those who took the drug 37 years ago, before applying for license, or renewed research into the benefits of Thalidomide? As there exists such a population, we find it irresponsible that such research has never been undertaken.”

Vowing to never accept a world with Thalidomide in it, they had stated then, “We demand that resources and energies aggressively be applied to the development of analogues to replace Thalidomide -- analogues with the benefits but without the horrific side effects!”

The message is still relevant, it is argued.

Source-Medindia
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