A proposed Health Canada policy would make public currently confidential information about drugs’ safety and efficacy.
Health Canada plans to release reams of confidential documents that detail the clinical trials of prescription drugs and medical devices.
Much of this information, which the government relies on to assess the efficacy and safety of everything from popular heart pills to cancer medications, has never been seen by patients, the doctors who prescribe the treatments, independent researchers, or the trial participants who volunteered their bodies for science.
“People took on the risk of taking an experimental drug so we could all benefit,” said Matthew Herder, an expert in Canadian health policy and professor at Dalhousie University. This “could be the start of fundamental change in terms of the regulator making information that ought to have been public in the first place available for public consumption.”
Health Canada aims to make this information, submitted by companies looking to get their drugs and devices approved, “readily accessible to the Canadian public,” said a spokesperson for the regulator, which has been reviewing how it handles what it calls “confidential business information” since early 2016.
“Health Canada recognizes that opening up access to clinical data can have widespread benefits throughout the health-care system.”
The proposed policy still needs to go through consultations before it is made official through new regulations.
Researchers have long struggled to access these kinds of records from Canada’s historically secretive drug regulator.
Dr. Nav Persaud, of Toronto, has fought for several years to get clinical trial records from Health Canada about a popular morning sickness drug. He was initially given mostly censored documents, and the regulator told him much of the information was confidential and belonged to the drug maker.
Persaud finally got 9,000 pages of information about a clinical trial of the same morning sickness drug he had been researching, but only after he signed a confidentiality agreement with Health Canada.
Even though he has said his reanalysis of the trial raises questions about the drug’s efficacy and could change clinical practice, Persaud said the confidentiality agreement has made it difficult for him to get his research published and into the hands of doctors and patients. The maker of the drug, Diclectin, has said its product has been proven safe and effective.
Drug companies and doctors run clinical trials for new drugs and at any given time there are thousands across the country. Typically, an application is made to operate a trial for a new medication or a vaccine. Study subjects are selected and clinicians perform tests using the proposed drug, then study the results and record any side effects. If the trial is deemed successful, a drug company may make an application to Health Canada to get the drug approved for a certain treatment.
Experts have told the Star that the public should be made aware of all the results of the clinical tests, not just whether the drug has been approved. Each year Health Canada receives hundreds of new clinical trial applications for testing new drugs, or new uses of already approved drugs, on humans.
The trials allow Canadians to take part in research that could improve their health but can carry risks as there is often “limited information about the safety and efficacy of the drug being studied,” Health Canada says on its website.
Reports from these trials are written but not made public, and critics say transparency is needed so the drug’s efficacy and side effects are better understood.
Access to trial reports can lead researchers to re-analyze the data collected from patients and publishing new findings, which could change how doctors prescribe drugs to their patients.
Under its proposed new policy, Health Canada not only wants to make future clinical trial reports public, but also release reports of drugs that are already on the market, as well as trial reports submitted by companies whose drug approval applications were ultimately rejected, the regulator said.
It may take years for this proposed policy to come into force, Herder said.
In the meantime, medical researchers and doctors who want to know more about the medications must fill out an application form and sign a confidentiality agreement, as Persaud did, if they want the regulator to consider releasing the information to them.
Several researchers, including two in the U.S. who have recently tried to get information deemed confidential from Health Canada, say the devil will be in the details of any new policy and that for now questions remain unanswered:
How much will be censored from the publicly released reports?
Will the regulator be able to keep up if there are many requests for these reports?
Under the proposed policy, drug companies and medical device manufacturers would still be able to propose censoring certain “clinical information that may have ongoing commercial value,” a Health Canada spokesperson said.
The policy proposal also calls for proactively releasing clinical trial information from new drug approval submissions, while demand for old clinical trials would dictate how those confidential documents would be disclosed.
Persaud questions whether a new policy and regulations are even needed.
“Health Canada can and should release this information right now. No new regulations are required,” said Persaud, who also teaches at the University of Toronto and is a researcher at St. Michael’s Hospital.
“Today, Health Canada is in the habit of keeping this information secret when pharmaceutical companies ask them to. That is what has to change.”
Nevertheless, Persaud said he hopes the regulator adopts the policy as proposed and not a watered-down version, “so that everyone has access to important information about the effects of medications, so that patients can make informed decisions, and so that clinicians and researchers can carefully examine the evidence.”
Health Canada plans to release reams of confidential documents that detail the clinical trials of prescription drugs and medical devices.
Much of this information, which the government relies on to assess the efficacy and safety of everything from popular heart pills to cancer medications, has never been seen by patients, the doctors who prescribe the treatments, independent researchers, or the trial participants who volunteered their bodies for science.
“People took on the risk of taking an experimental drug so we could all benefit,” said Matthew Herder, an expert in Canadian health policy and professor at Dalhousie University. This “could be the start of fundamental change in terms of the regulator making information that ought to have been public in the first place available for public consumption.”
Health Canada aims to make this information, submitted by companies looking to get their drugs and devices approved, “readily accessible to the Canadian public,” said a spokesperson for the regulator, which has been reviewing how it handles what it calls “confidential business information” since early 2016.
“Health Canada recognizes that opening up access to clinical data can have widespread benefits throughout the health-care system.”
The proposed policy still needs to go through consultations before it is made official through new regulations.
Researchers have long struggled to access these kinds of records from Canada’s historically secretive drug regulator.
Dr. Nav Persaud, of Toronto, has fought for several years to get clinical trial records from Health Canada about a popular morning sickness drug. He was initially given mostly censored documents, and the regulator told him much of the information was confidential and belonged to the drug maker.
Persaud finally got 9,000 pages of information about a clinical trial of the same morning sickness drug he had been researching, but only after he signed a confidentiality agreement with Health Canada.
Even though he has said his reanalysis of the trial raises questions about the drug’s efficacy and could change clinical practice, Persaud said the confidentiality agreement has made it difficult for him to get his research published and into the hands of doctors and patients. The maker of the drug, Diclectin, has said its product has been proven safe and effective.
Drug companies and doctors run clinical trials for new drugs and at any given time there are thousands across the country. Typically, an application is made to operate a trial for a new medication or a vaccine. Study subjects are selected and clinicians perform tests using the proposed drug, then study the results and record any side effects. If the trial is deemed successful, a drug company may make an application to Health Canada to get the drug approved for a certain treatment.
Experts have told the Star that the public should be made aware of all the results of the clinical tests, not just whether the drug has been approved. Each year Health Canada receives hundreds of new clinical trial applications for testing new drugs, or new uses of already approved drugs, on humans.
The trials allow Canadians to take part in research that could improve their health but can carry risks as there is often “limited information about the safety and efficacy of the drug being studied,” Health Canada says on its website.
Reports from these trials are written but not made public, and critics say transparency is needed so the drug’s efficacy and side effects are better understood.
Access to trial reports can lead researchers to re-analyze the data collected from patients and publishing new findings, which could change how doctors prescribe drugs to their patients.
Under its proposed new policy, Health Canada not only wants to make future clinical trial reports public, but also release reports of drugs that are already on the market, as well as trial reports submitted by companies whose drug approval applications were ultimately rejected, the regulator said.
It may take years for this proposed policy to come into force, Herder said.
In the meantime, medical researchers and doctors who want to know more about the medications must fill out an application form and sign a confidentiality agreement, as Persaud did, if they want the regulator to consider releasing the information to them.
Several researchers, including two in the U.S. who have recently tried to get information deemed confidential from Health Canada, say the devil will be in the details of any new policy and that for now questions remain unanswered:
How much will be censored from the publicly released reports?
Will the regulator be able to keep up if there are many requests for these reports?
Under the proposed policy, drug companies and medical device manufacturers would still be able to propose censoring certain “clinical information that may have ongoing commercial value,” a Health Canada spokesperson said.
The policy proposal also calls for proactively releasing clinical trial information from new drug approval submissions, while demand for old clinical trials would dictate how those confidential documents would be disclosed.
Persaud questions whether a new policy and regulations are even needed.
“Health Canada can and should release this information right now. No new regulations are required,” said Persaud, who also teaches at the University of Toronto and is a researcher at St. Michael’s Hospital.
“Today, Health Canada is in the habit of keeping this information secret when pharmaceutical companies ask them to. That is what has to change.”
Nevertheless, Persaud said he hopes the regulator adopts the policy as proposed and not a watered-down version, “so that everyone has access to important information about the effects of medications, so that patients can make informed decisions, and so that clinicians and researchers can carefully examine the evidence.”
