The CEO of a B.C. biotechnology company says the treatment his firm has developed for COVID-19 is sitting on shelves while people continue to die, despite it being approved for use by Health Canada in the fall.
"Canada was quick to authorize it. The federal government moved quickly to procure it. So we signed a procurement agreement and bought doses back in November," Dr. Carl Hansen, co-founder and CEO of Vancouver-based AbCellera, told CBC News Network's Power & Politics.
"But because of some decisions that happened at the provincial and territorial level, through committees that are making decisions on recommendations of use, thus far this treatment has been used in almost no one in Canada."
Bamlanivimab is an antibody therapy that Hansen says acts as a synthetic immunity. He said it can be given to patients in the early stages of COVID-19 to reduce the possibility of developing severe illness and death by up to 80 per cent.
"I stand behind the fact that we have therapies here that could help people, the fact that they have not been delivered to patients and that we have not taken a single step to make that happen is unforgivable and very difficult to understand," Hansen told host Vassy Kapelos.
Bamlanivimab was approved for interim use in Canada and for emergency use in the United States in November. Both authorizations came with a series of conditions.
Health Canada's authorization requires AbCellera to provide reports of serious adverse drug reactions, further data on the drug's effectiveness, data from ongoing clinical trials and information confirming manufacturing quality, among other requirements.
The U.S. FDA approved it for use in patients 12 years of age and older who have tested positive for COVID-19 and who display mild to moderate symptoms but are at risk of progressing to a more serious form of the illness.
Provinces seeking more trial data
In the U.S. the treatment is not authorized for patients sick enough to be hospitalized or who require an increase in baseline oxygen flow to be treated for COVID-19. The U.S. authorization also comes with a long list of conditions.
According to the Ontario government two expert panels — the Canadian Agency for Drugs and Technologies in Health and the Institut national d'excellence en santé et en services sociaux — did not have as favourable an opinion of the treatment as Hansen.
"Neither recommend the routine use of bamlanivimab in outpatients with mild-to-moderate disease as a result of uncertainty in clinical benefit, as well as other concerns, and both encourage participation in clinical trials to generate more evidence," the provincial government said in a statement.
Both the Alberta and British Columbia governments are conducting further trials of the treatment and say they will put off any decisions on further use until they have more evidence of its effectiveness.
"We welcome more evidence to improve care for people and look forward to more data on Bamlanivimab, and other therapies, to combat COVID-19 in B.C.," said a government statement.
Alberta which is also awaiting results of the trial it is running said that current data is "unable to identify a specific patient population or setting where the benefits exceed the risk of administering bamlanivimab."
A statement from Alberta Health Services (AHS) also said that the proposed use of the treatment would require support from front-line medical staff in an outpatient setting.
"Decisions around its use need to weigh any potential for benefit and feasibility of use, and careful consideration would need to be taken to ensure AHS would be able to maintain adequate staffing allocation to support the needs of COVID-19 patients admitted to hospitals," the statement said.
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