Ottawa seizing Mexican Thalidomide
First the medical isotope fiasco, now this!?
Canadian patients 'starting to die,' drug firm says
Cancer patients desperate enough to order cheaper, unlicensed versions of the drug thalidomide from Mexico now face another challenge to getting treatment: Federal authorities have reportedly begun seizing supplies of the life-extending medicine at the border.
"Health Canada is stopping every single box of thalidomide," said an official with a Mexican company that makes the pills, who asked not to be named. "Patients are starting to die because of this."
Patient advocates said they had also heard reports that Health Canada and the Canada Border Services Agency have instituted a crackdown on shipments of thalidomide from Mexico and other developing countries.
Health Canada officials would not comment directly on whether they had stepped up seizures, but said their policy has always been to bar unsanctioned imports of such drugs into the country.
The development has nevertheless heightened calls on provincial governments to reimburse the steep costs of the one permitted brand of thalidomide and a similar, newer drug, both of which can add years to the lives of people with multiple myeloma, a rare blood cancer.
Some Ontario patients are even thinking of moving to British Columbia, the one province that covers the newer medicine, said Lori Borsos, a myeloma sufferer in Hamilton.
"If you need this drug to stay alive and you can't afford it, what's your choice?: move to B. C. or move six feet under," she said.
"We all live in Canada and some of us have better health care than others. It's not right."
Thalidomide -- infamous as a morning-sickness remedy that caused widespread birth defects in the 1950s and 1960s -- has proven to be one of the most effective myeloma treatments, but its cost is not officially picked up by any province.
Revlimid, a new drug that acts in a similar way and can cost $100,000 a year, is covered only in British Columbia. Velcade, the other medication widely used by myeloma patients, is financed to at least some extent by most provinces, but is not suitable for all patients.
Private insurance and manufacturers provide some funding, too.
The "core" issue is that provincial governments should pay for all three drugs, said John Lemieux, president of the Myeloma Canada support group. "The patients ... are the sole victims" of the current patchwork of funding policies, he said.
The North American-patented version of thalidomide, made by Celgene Corp. of New Jersey, can cost $40,000 a year, though the firm says it provides it free to about 60% of patients prescribed the medicine. Myeloma Canada says it has been unable to confirm that figure.
Regardless, the rest must either pay out of their own pockets, go without and face shortened lifespans or order versions made in Mexico, Brazil or elsewhere in the developing world.
The cost of one Mexican brand is about one-twentieth of Celgene's. The firm says approximately 100 Canadians have bought thalidomide from it, while other patients have sought supplies from as far afield as India.
Days after a National Post article revealed patients were importing the medicine from overseas, however, Canadian authorities began seizing Mexican shipments of the drug, the pharmaceutical company official said.
Mr. Lemieux said in an e-mailed response that his group has heard reports of as many as 20 patients having their shipments seized, but could not confirm them.
"If they don't have this drug, they will die," said the Mexican company official of her customers.
Some doctors have warned that patients risk consuming substandard product if they order thalidomide from such manufacturers, whichcurrently face no scrutiny from regulators here. Others physicians, though, say the Mexican drug seems to be just as effective and safe as the Celgene product, called Thalomid.
Thalomid is not licensed in Canada, but can be legally ordered by doctors under Health Canada's special-access program, designed to make treatments not yet approved here available on an emergency basis.
It was allowed under the program partly because Celgene, the manufacturer, has an extensive program for dealing with the drug's infamous side effects, Health Canada said in an e-mailed statement. Celgene only provides a month's supply at a time, and requires doctors to submit negative pregnancy tests for female patients of child-bearing age before dispensing more pills, the regulator said.
"Health Canada believes that this care and caution is both necessary and appropriate and is commensurate with the risks associated with the drug," the statement said.
A request for the Mexican thalidomide was made under the special-access program a few years ago, but its maker had no such program in place, the department said.
Source: http://www.nationalpost.com/news/story.html?id=1696051
Canadian patients 'starting to die,' drug firm says
Cancer patients desperate enough to order cheaper, unlicensed versions of the drug thalidomide from Mexico now face another challenge to getting treatment: Federal authorities have reportedly begun seizing supplies of the life-extending medicine at the border.
"Health Canada is stopping every single box of thalidomide," said an official with a Mexican company that makes the pills, who asked not to be named. "Patients are starting to die because of this."
Patient advocates said they had also heard reports that Health Canada and the Canada Border Services Agency have instituted a crackdown on shipments of thalidomide from Mexico and other developing countries.
Health Canada officials would not comment directly on whether they had stepped up seizures, but said their policy has always been to bar unsanctioned imports of such drugs into the country.
The development has nevertheless heightened calls on provincial governments to reimburse the steep costs of the one permitted brand of thalidomide and a similar, newer drug, both of which can add years to the lives of people with multiple myeloma, a rare blood cancer.
Some Ontario patients are even thinking of moving to British Columbia, the one province that covers the newer medicine, said Lori Borsos, a myeloma sufferer in Hamilton.
"If you need this drug to stay alive and you can't afford it, what's your choice?: move to B. C. or move six feet under," she said.
"We all live in Canada and some of us have better health care than others. It's not right."
Thalidomide -- infamous as a morning-sickness remedy that caused widespread birth defects in the 1950s and 1960s -- has proven to be one of the most effective myeloma treatments, but its cost is not officially picked up by any province.
Revlimid, a new drug that acts in a similar way and can cost $100,000 a year, is covered only in British Columbia. Velcade, the other medication widely used by myeloma patients, is financed to at least some extent by most provinces, but is not suitable for all patients.
Private insurance and manufacturers provide some funding, too.
The "core" issue is that provincial governments should pay for all three drugs, said John Lemieux, president of the Myeloma Canada support group. "The patients ... are the sole victims" of the current patchwork of funding policies, he said.
The North American-patented version of thalidomide, made by Celgene Corp. of New Jersey, can cost $40,000 a year, though the firm says it provides it free to about 60% of patients prescribed the medicine. Myeloma Canada says it has been unable to confirm that figure.
Regardless, the rest must either pay out of their own pockets, go without and face shortened lifespans or order versions made in Mexico, Brazil or elsewhere in the developing world.
The cost of one Mexican brand is about one-twentieth of Celgene's. The firm says approximately 100 Canadians have bought thalidomide from it, while other patients have sought supplies from as far afield as India.
Days after a National Post article revealed patients were importing the medicine from overseas, however, Canadian authorities began seizing Mexican shipments of the drug, the pharmaceutical company official said.
Mr. Lemieux said in an e-mailed response that his group has heard reports of as many as 20 patients having their shipments seized, but could not confirm them.
"If they don't have this drug, they will die," said the Mexican company official of her customers.
Some doctors have warned that patients risk consuming substandard product if they order thalidomide from such manufacturers, whichcurrently face no scrutiny from regulators here. Others physicians, though, say the Mexican drug seems to be just as effective and safe as the Celgene product, called Thalomid.
Thalomid is not licensed in Canada, but can be legally ordered by doctors under Health Canada's special-access program, designed to make treatments not yet approved here available on an emergency basis.
It was allowed under the program partly because Celgene, the manufacturer, has an extensive program for dealing with the drug's infamous side effects, Health Canada said in an e-mailed statement. Celgene only provides a month's supply at a time, and requires doctors to submit negative pregnancy tests for female patients of child-bearing age before dispensing more pills, the regulator said.
"Health Canada believes that this care and caution is both necessary and appropriate and is commensurate with the risks associated with the drug," the statement said.
A request for the Mexican thalidomide was made under the special-access program a few years ago, but its maker had no such program in place, the department said.
Source: http://www.nationalpost.com/news/story.html?id=1696051
posted by gwg at 11:18 AM
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