Evidence of meeting #16 for Health in the 39th Parliament, 2nd Session. (The original version is on Parliament’s site, as are the minutes.) The winning word was patients.
A recording is available from Parliament.
Liberal
The Vice-Chair Liberal Lui Temelkovski
Ladies and gentlemen, I call the meeting to order. We can take our seats and get started.
Today we have with us three groups of witnesses. From the Best Medicines Coalition we have Linda Wilhelm, vice-chair, and Gail Attara, member. We also have Terence Young from Drug Safety Canada and Michèle Brill-Edwards from the Canadian Health Coalition.
Could we start with Linda Wilhelm, please.
Linda Wilhelm Vice-Chair, Operations Committee, Best Medicines Coalition
I want to thank you for giving me the opportunity to come here today on this very important issue that's critical to patients living in this country.
The Best Medicines Coalition is a national alliance of organizations and individuals representing those living with or affected by chronic disease or illness. We have a core mandate of ensuring access to the best evidence-based medicines for Canadians.
BMC's patient representatives are actively involved in discussions about drug review reform, patient safety, and general health policy development. Improvement of post-market pharmaceutical surveillance in Canada is one of our key goals.
This coalition encourages implementation of a robust system of comprehensive reporting, monitoring, analyzing, disclosing, and communicating a prescription drug's adverse effects throughout its use over time. Even though drugs are studied extensively before being approved for sale in Canada, an adverse event might not emerge until it's been widely available in a real-world setting.
Identifying adverse events is critical, but we caution against knee-jerk responses that cut off medications from an entire population when only a particular subset are affected. We seek a national system whereby patients have full, timely access to medications and full disclosure of each medicine's known risks and benefits profile.
I am just going to speak to a few initiatives we've been involved with. One is the progressive licensing framework. We fully support the work of Health Canada's progressive licensing framework and the proposed life cycle concept. Ongoing work in modernizing the regulatory framework while working towards harmonizing Canada with international regulatory standards is imperative.
We recognize that the current outdated regulations are insufficient to address the current and future need for the complex and sophisticated treatment approaches needed by Canadian patients. We support the life cycle approach because we believe it will improve health outcomes while enhancing collective, ongoing knowledge of how each medication works, good and bad, in the real world.
We believe that adherence to the progressive licensing framework will enhance ongoing drug safety in Canada by better reflecting the safety, quality, and efficacy mandate of Health Canada. This approach will allow for a more comprehensive range of responses to drug safety issues, rather than necessitating a full retraction from the market, as prompted by current legislation.
Further, BMC applauds the Health Canada team, under the direction of David Lee of the therapeutic products directorate, for the inclusive, consultative, and, I would say, comprehensive approach to this policy development, and particularly for welcoming and inviting patient input throughout the whole process.
We also believe that you need multistakeholder involvement in any solutions moving forward. To move towards effective post-market surveillance, the system requires major advances and comprehensive adverse event reporting. The current statistics provided to the Expert Advisory Committee on Vigilance in Health Products at a recent meeting show that only 1% to 10% of current adverse events are reported.
It is incumbent on Health Canada to increase this reporting quickly and drastically. We recommended broadening the base of sources for adverse event reporting. All players in the health care system--patients, caregivers, professionals, institutions, industry, and government--have a role in ensuring comprehensive reporting of adverse events. Reforms must move forward that will balance responsibilities in the reporting of adverse events, which currently lie primarily within the pharmaceutical industry. Although controversial, we recommend exploring some measure of mandatory reporting.
Here are some suggestions for improving reporting within various sectors.
I'll begin with patients. Currently most patients are not aware that they can even report an adverse event directly. This warrants a major public education campaign. Through such a campaign, those taking medications and some over-the-counter products could learn to provide necessary feedback regarding their negative experiences. A newly developed, consumer-friendly form is in the final stages of development. Ideally, this could be handed out to patients when a prescription is filled.
In addition to being the conduit for information transfer to the patient, pharmacies could display reporting information notices and MedEffect banners to direct patients on how to report an adverse event.
Currently health professionals only report the most serious adverse events, and there is little evidence that reporting goes beyond this. Attitudes and practices regarding reporting must be addressed within the community, with a goal to increasing reporting rates. Medical education curricula, as well as those of all health professionals, should include a module on adverse reporting and the importance. Continuing education on this topic for practising professionals, as well as awareness campaigns aimed at these audiences, could be beneficial.
On hospitals, despite many obstacles and resourcing considerations, mandatory hospital reporting is integral to a comprehensive system.
I'll finish with resourcing and infrastructure. In any meaningful discussion about the future of post-market surveillance, resources must be addressed. This includes human and financial resources, in addition to infrastructure development. We encourage the Government of Canada to provide Health Canada with the authority and adequate funding for all components necessary to ensure a viable program. In addition, the Government of Canada must allocate resources so that other players in the system, including patients, professionals, and hospitals, can serve a meaningful role.
Post-market surveillance is uniquely complex and involves all stakeholders, and to date there have been some successful improvements in contributions to extending trying to improve the rates, and we hope these will continue.
Liberal
Terence Young Chair, Drug Safety Canada
Good morning.
My name is Terence Young. I'm the founding chair of Drug Safety Canada, a former Ontario MPP, and the author of the book, Death by Prescription, which will be published by Key Porter this coming September.
Drug Safety Canada promotes the safe use of prescription drugs. We accept no money from any corporations. As chair of Drug Safety Canada, I am party to the CanWest MediaWorks Inc. lawsuit in the Ontario Superior Court of Justice in support of Health Canada's continued ban on direct-to-consumer advertising of prescription drugs.
We focus on serious adverse drug reactions, those that are fatal, life threatening, disabling, incapacitating, or result in prolonged hospitalization, the ones that the pharmaceutical industry, which we call big pharma, want you to believe almost never happen. The term “big pharma” refers to the world's largest international drug companies as a group.
This morning I'll briefly summarize the results of six years of research begun after we lost our 15-year-old daughter Vanessa to the Johnson & Johnson prescription drug Prepulsid in March 2000.
We believe prescription drug safety will be enhanced with proposed mandatory adverse drug reaction reporting. A previous Minister of Health, Ujjal Dosanjh, went as far as announcing he would do it, and nothing followed.
About 1% of adverse drug reactions are currently reported, and yet the big pharma companies frequently publish the 1% on their drug labels as if that's all that occur. Big pharma tracks worldwide drug deaths centrally but generally does not report adverse drug deaths to Health Canada that occur in 192 other countries. They normally blame those deaths and serious reactions on overdose, contraindicated drugs, and conditions the patients might have, and change the fine print on the label that no one ever reads. They almost never admit their drug caused deaths, even after it has been pulled off the market, because the insurance they buy against drug crashes would therefore not pay.
First, we recommend that the new legislation empower and require Health Canada to demand all studies done on prescription drugs and all adverse drug reaction reports from the world market to be delivered immediately or within 48 hours, and not be held up, as they are now, from six months to a year.
We congratulate Minister Clement for introducing legislative change to implement this measure in hospitals, and we hope it will lead to a robust reporting system to which all health care professionals contribute. It will provide an early warning system for dangerous drugs and a living database from which to identify dangerous drugs and no doubt save lives.
Every decision to take a prescription drug should be based on an informed and objective appraisal of one thing: will the benefits outweigh the risk for this patient?
Here is the scope of our current problem. All drugs cause adverse reactions—not some, all—and many are deadly. The president and founder of Eli Lilly once said, “Any drug without toxic effects is not a drug at all.” “Rare” means between one out of one thousand and one out of ten thousand, so take no comfort with rare side effects. Three million Canadians are currently taking SSRI antidepressants, so between 300 and 3,000 will suffer any rare reaction.
To quote Dr. Andrew Weil, “The only difference between a drug and a poison is dosage.” So every drug has a potential to harm patients. For example, 16,000 to 17,000 people die every year in the U.S. alone from ordinary over-the-counter aspirin, ibuprofen, and naproxen.
Prescription drugs are the fourth leading cause of death in the U.S. and Canada, behind only cancer, heart disease, and strokes. Most of these deaths are covered up, which is why you will not find them recorded by StatsCanada. But three University of Toronto professors did a very comprehensive mega-study in 1998, in the United States, that showed 104,000 deaths in U.S. hospitals caused by prescription drugs administered as prescribed—not in error, but as prescribed. Many observers believe there could be as high as another 100,000 deaths caused by prescription drugs outside hospitals. That would be the equivalent of about 20,000 deaths a year in Canada.
One out of five new drugs in the U.S. is taken off the market for harming or killing patients or will have the highest level of warning placed on their label, and half of new drug withdrawals occur in the first two years.
One out of four adult hospital admissions to medical wards in Canadian hospitals is drug related, mostly adverse reactions, improper drug selection, or non-compliance.
So the human cost is staggering. What is the financial cost?
According to the Canadian Pharmacists Association, approximately $2 billion to $9 billion a year in Canada is wasted on inappropriately prescribed drugs. Inappropriate prescribed drugs injure hundreds of thousands of patients every year in Canada. Some estimates put the cost to our medical system at $10 billion a year.
Adverse drug reactions are really like an epidemic. How did it get to be that way? How high is our current standard for approving prescription drugs?
They have to be effective. What does that mean? Effective means slightly more effective than nothing. There is no regulatory requirement to show that any new drug is more effective than the current top-selling drug on the market for the same condition. All they have to do is prove that the drug works 1% better than nothing, which is a placebo. Even that is a major challenge for many of the drugs the big pharma companies have unloaded on trusting patients.
For example, in the U.S., it's shown that the drug Vytorin simply doesn't work. The drug companies that produce the two drugs that combine to make it covered that up for 18 months while they sold another $7 billion worth to unsuspecting American patients.
Dr. Allen Roses, the worldwide vice-president of GlaxoSmithKline, has said that the vast majority of drugs—more than 90%—only work in 30% or 50% of the people. He said that cancer drugs work 25% of the time, Alzheimer's drugs work 30% of the time, and many others only 50%. It's because of the powerful placebo effect that patients are often unable to determine when a drug is working. Millions of patients are put at risk of nasty or dangerous side-effects with no benefit, and billions are wasted.
Recommendation number two is, because governments are the largest customers for pharmaceuticals—about $8 billion a year—we believe new drugs should be tested for effectiveness against not just placebos but existing proven drugs. Governments should not pay for new drugs, which are always more expensive and offer new risks to patients, unless they are proven more effective for patients in the same condition.
Safe. What does safe mean? Safe does not mean safe as most patients think. Safe is relative to the drug and condition it is treating. Safe often means just less harmful than the current drug. If a new drug is approved, the one you are currently taking may no longer be safe.
Off-label prescribing. Three out of four doctors prescribe drugs off-label, a practice widely promoted by stealth in the industry. This means prescribing a drug for a condition for which it is has not ever been proven safe and effective. It is illegal for drug companies to promote it, but they do it in a myriad of ways anyway, using financial relationships and debts of gratitude to our doctors who do it for them.
A good example is Vioxx. It was originally approved around 2000 for arthritis and short-term pain. Merck promoted it off-label for many other kinds of pain and drove its use up to $2.4 billion before it was pulled off the market in 2004. Between 55,000 and 65,000 people died of heart attacks and strokes after taking Vioxx, about as many Americans as were killed in the Vietnam War.
Phase four of testing. We test drugs on the public without telling them. Phase four of testing is selling them on the open market. Any patient taking a new drug becomes a guinea pig in a giant drug trial. Doctors have no legal obligation to tell patients this, and most don't.
Our third recommendation is that doctors should be required to obtain truly informed consent for prescriptions and explain to patients that, by taking a new drug, they are in a trial, and that when they take a drug off-label the true risks are not known. This is currently done, by the way, for the acne drug Accutane.
Misleading communications. Patients are not informed of the risks they are taking. Big pharma risk communications are written by lawyers for lawyers in tiny print and cryptic euphemisms to encourage sales and confuse the reader. Drug labels, which patients never see and doctors rarely check, are up to 60 pages long, with safety information often on the last page, making sure few people ever read them.
Patient information leaflets handed out in drug stores are dangerous because they create a false sense of security, almost never mentioning serious adverse reactions. For example, the 29-page drug label for Viagra mentions side effects of vision loss, permanent damage to your penis, hearing loss, heart attack, stroke, and death on page 28. The truth is that hundreds of men have died within five hours after taking Viagra. Viagra, by the way, is also dangerous with grapefruit juice.
Recommendation number four is that patients should be getting independently written patient information leaflets—like the U.S. MedGuide—with each prescription that states up front, in plain language, all serious adverse reactions, all contraindications, the true safety record of the drug, and possible alternative therapies.
In 1997, Health Canada was directed to partner with big pharma, the pharmaceutical industry, but 41 drugs had been pulled off the market in Canada from 1963 to 2004 for safety reasons, often—like Prepulsid—for injuring and killing patients. In 1997 Health Canada's testing labs were closed in the budget to save $10 million. Let's look at what Health Canada has been doing since then. They did not even keep a list of drugs that had been withdrawn from the Canadian market or why. They did not routinely try to assign causality when evaluating adverse drug reaction reports; so they take the report and they don't try to find out what caused the patient's death. We could find only one occasion when Health Canada actually ordered a drug off the market, and that was Prepulsid, the drug that killed my daughter.
Post-market studies, which are promised in order to get drugs approved, are routinely left undone by big pharma. No one at Health Canada ever follows up.
Recommendation five is that new legislation should ensure that Health Canada officials collect important safety information and use it to order post-market studies and get dangerous drugs off the market. Health Canada will need the budget to hire and train more drug reviewers and safety officers to do that.
Big pharma view Health Canada as a client. By 2002, 82% of the therapeutic products directorate budget was being paid by international drug companies in exchange for faster drug approvals. This makes drug reviewers' jobs dependent on the industry.
No regulator should partner with those they police. The pharmaceutical companies are there to make money; Health Canada's mandate is to protect patients. We believe there should be no relation whatsoever between the jobs and investment in the pharmaceutical industry and what drugs we allow to be given to vulnerable patients. Health Canada should have no mandate to assist the pharmaceutical industry to make money, which is a clear conflict of interest for a regulator. Aircraft tire inspectors should not be worried about jobs at Michelin or Goodyear.
This ongoing problem could be resolved by establishing an arm's-length independent drug agency to handle all regulatory matters. This idea was germinated in 1964 by Justice Emmett Hall's Royal Commission on Health Services, expanded in 1992 in the Gagnon report, and recommended in 2002 by the Romanow commission.
Faster drug approvals can only be justified for 5% of new drugs.
Liberal
The Vice-Chair Liberal Lui Temelkovski
Mr. Young, could you please go through the recommendations, as opposed to the text as well, due to the time? Thank you.
Dr. Michèle Brill-Edwards Board Member, Canadian Health Coalition
Mr. Chair, I would be very pleased to give two minutes of my time to Mr. Young.
Chair, Drug Safety Canada
The big pharma companies call themselves “research based” and push to get their “cures” and “breakthrough” drugs on the market faster. Less than 5% of drugs introduced in Canada are considered to be breakthrough or substantial improvements over existing therapies. In 2006 only one drug out of the 89 approved would fit that category.
The truth is that Health Canada already prioritizes drugs identified as breakthroughs and assigns reviewers accordingly, having shortened the time for approvals by 2002 to 215 days. There is no justification for lowering the safety bar for the other 95% with conditional or fast-tracked approvals.
The recommendation proposed is that conditional drug approvals should never lead to faster approvals where benefits will not outweigh the risks by the evidence. Drug reviewers are like the air traffic controllers of drug safety. No one tells air traffic controllers to get those jets in faster.
Clinical drug trials are biased in many ways, the most common being burying those that show the drugs don't work. In January an entire class of drugs that three million Canadians take, SSRI antidepressants like Paxil and Effexor, was shown not to work for the vast majority of patients who take them. The drug companies had convinced our doctors that they do work for this large group by making sure that 88% of their clinical trials that showed the drugs didn't work were never published. Doctors believe that the drugs are 11% to 69% more effective than they are. Since 1988, SSRIs have caused thousands of excess Canadian suicides.
The recommendation is that we support the proposal for compulsory registration of every clinical trial at its start, and we add that it must include complete transparency. All data and results are to be published on the Internet, even if the trial is not completed. We recommend that the new legislation include an offence of “misleading the regulator”.
The precautionary principle. Risk management is the industry standard for conducting business responsibly. What it means in reality is that they're managing their risk of being sued successfully when their drugs harm patients. It is a practice that puts human lives on the same continuum as money, a key reason prescription drugs are the fourth leading cause of death. We are concerned that the paper's proposal for monitoring corporate risk management plans could be construed as Health Canada adopting corporate risk management.
The precautionary principle does not appear anywhere in Health Canada's documents. In its essence, the precautionary principle means better safe than sorry. It recognizes that in a complex system it's impossible to fully predict outcomes. It assumes that errors occur, and the higher the magnitude of the error, the greater the level of precaution required. It shifts the burden of proof to those who are favouring a risky course of action. With big pharma's dismal safety record, it is crucial to insist they provide evidence that their products are safe and effective before the products get into the bloodstreams and organs of our loved ones. The best way to do this is using the precautionary principle.
The Canadian Environmental Protection Act states that under the constitutional laws of Canada, the government must apply the precautionary principle where there are threats of serious or irreversible damage. Surely we must set the same high standard of managing risk to our loved ones as we do for waterways in our new legislation using the precautionary principle.
One final recommendation. “Cause and effect” is an extremely high standard. In fact, it's an inappropriate standard for regulating prescription drugs. Deadly adverse drug reactions are almost impossible to prove—for example, the hundreds of heart deaths after people took Viagra—because our regulators and courts often buy into the industry standard of proof, which is a higher standard than any court in the world. By cause and effect, cigarettes do not cause lung cancer.
We recommend that new legislation should authorize the whole range of regulatory activity to be triggered by the association of an adverse drug reaction with a drug based on worldwide epidemiological evidence. This will save hundreds and thousands of lives.
I have two additional recommendations, Chair, but I want to give the rest of the time to my colleague.
Liberal
The Vice-Chair Liberal Lui Temelkovski
We do have your recommendations, but only in English. We will have them translated and distributed to every member in the next few days.
Now we will hear from Michèle Brill-Edwards.
Board Member, Canadian Health Coalition
Thank you, Mr. Chair.
I am Dr. Michèle Brill-Edwards. Today I'm representing the Canadian Health Coalition. I'm a member of the board of the coalition. I'm replacing Mr. McBain, who could not attend today.
The Health Coalition has a mission to preserve and strengthen public medicare, and also to advocate for the protection of the health of Canadians. It is a not-for-profit, non-partisan organization dedicated to protecting and expanding Canada's public health system for the benefit of all Canadians. The CHC was founded in 1979 at the Canadian Labour Congress-sponsored SOS Medicare conference attended by Tommy Douglas, Justice Emmett Hall, and Monique Bégin, the leaders of public interest in health care in Canada.
I'll make some brief remarks.
Much of the view of the Canadian Health Coalition is already expressed in the presentation of Drug Safety Canada. I would like, however, to speak briefly to the scope of the problem, the nature of pharmacosurveillance in Canada currently and some of the problems, and then make a very few recommendations.
In essence, the scope of the problem is huge. As mentioned, the number of deaths due to the proper use of medications in Canada and the United States has been studied and is pegged at somewhere between the fourth and the sixth leading cause of death North America-wide. That tells us that we are not dealing with something rare and unusual. We're not dealing with a system that may help save the odd life here and there. We are dealing with a very major cause of mortality for Canadians.
The current system of pharmacosurveillance is in essence a passive system. In other words, input reports from health care professionals, doctors, pharmacists, nurses, and so on come into the system in a very haphazard manner, without any knowledge on the part of Health Canada as to the true number of serious adverse reactions that are really out there. The analysis that is then undertaken by Health Canada is problematic, partly because of the inherent difficulty of ascertaining a true signal of serious problem from the noise of adverse events that may or may not be related to the drug in question but may be related to the disease of the patient or other extraneous factors.
A second issue, however, is that the analysis within Health Canada of the reports received is, in essence, opaque. It is not transparent. So the messages go in, and there's no understanding on the part of physicians and pharmacists and people who need to know what analysis is done or how it's done or how valid it could be. The output of the system is often very belated and rather cryptic, and there are examples we could discuss regarding SSRIs, for example, and suicidality. SSRIs are antidepressants and have been now demonstrated, after many long years of tortured analysis, to be related to suicidality in both adults and children, but in children particularly. Recently we've learned that these drugs have no efficacy in the treatment of depression.
The belated and rather cryptic output doesn't tell doctors and other health care professionals how the drug safety analysis was really done and what supports the guidance. These outputs are largely ignored by the profession. So we have a real problem of trust in Canada with regard to the Health Canada drug safety system.
As a result of that lack of trust, there's very little reporting. Doctors and pharmacists feel there is no point in reporting to a system that doesn't give them back useful information. Another result is that heed is not taken of important messages that are put out by Health Canada, because of the perception that they are not well founded. The problem is compounded as we look to the future and ask how we could improve the system. The issue of trust comes up immediately.
It is very simple, in an academic way, to say that passive surveillance is not adequate. It certainly is not adequate. It is very easy to say we need active surveillance, better systems, targeted, focused adverse reaction reporting, and mandatory reporting, as Terence Young has discussed. It is very easy to say those things, but if we want those measures to work, we have to have trust on the part of health care workers that there's a thinking, concerned, committed Health Canada as the intermediary that acts in the public interest to reduce this burden of unnecessary deaths due to medicines.
I would like to add that in addition to active surveillance, meaning not only mandatory reporting but also focused studies that would ascertain epidemiologically the cause and effect likelihood, we also need a system for the investigation of what have been termed catastrophic drug safety failures. In lay terms, these are drug crashes, or drugs that arrive on the market and are on the market for many years, and unbeknownst to patients and their professional caregivers, there are very serious problems and many resulting deaths. Vioxx is probably the most famous example, with tens of thousands of deaths demonstrated through studies done by the FDA before the drug was removed.
My last recommendation is for an independent investigative drug safety board that is separate from the regulator and separate from the industry, and that can investigate problems arising after the industry and the regulator have made the decision to bring the drug to market. It is not acceptable for the industry and the regulator to investigate themselves behind closed doors when thousands of lives are at stake.
If the committee needs a model for such an independent board, it was proposed about a decade ago in The New England Journal of Medicine by two very prominent clinical pharmacologists with an interest in drug safety. The very handy analogy they used is that if the federal aviation authority sets the regulatory standards for flying, we automatically know we will need a separate air safety board to investigate plane crashes. That is just common sense; we don't want a conflict of interest there. Why do we not then have a similar situation where the FDA or the health products and food branch of Health Canada are the people who set the regulations, but then also have an independent, separate safety board that immediately investigates when a serious drug failure comes to light?
I would like to add on behalf of the coalition that many of the recommendations that have already been stated by Drug Safety Canada are recommendations we concur with.
Thank you.
Liberal
The Vice-Chair Liberal Lui Temelkovski
Thank you very much.
We will start questions now with Madam Kadis.
Liberal
Susan Kadis Liberal Thornhill, ON
Thank you, Mr. Chair, and welcome to all our witnesses today. I must say that you gave us information in great depth and answered many questions. I'm sure there are many more questions on this very important and vital area.
You referred to having an independent drug board, which seems to be something that is needed and was advocated for today, from what I'm hearing. We heard from Health Canada that adverse drug reactions are voluntarily reported, primarily by health professionals, but that patients can also report them directly through a toll-free phone line at several regional vigilance offices or via the MedEffect website.
So I want to ask you today, have you or your organizations or advocacy groups reported any adverse drug events, and to what degree, if that is so? Do these different reporting avenues provide sufficient access, in your opinion, to the Canadian public? I think you're saying that it's not necessarily so, but perhaps you could elaborate on this particular component, which I think is very important. Also, do you access any of the adverse reaction information available on Health Canada websites for information and/or analysis?
Vice-Chair, Operations Committee, Best Medicines Coalition
The question is directed at me, I guess.
I have. I do know of the MedEffect website. Unfortunately, I would say most Canadians do not know about it.
A couple of years ago the Canadian Arthritis Patient Alliance, an organization I am involved with, met with Health Canada and went over the consumer reporting. Our feedback to them was that the current form they were using was not consumer friendly. It was not written in language that patients could understand, and the whole process was very difficult for a patient to navigate.
The other issue was--and as a patient myself I've experienced it--when I experienced an adverse reaction. When I went to my specialist and mentioned that I was experiencing this reaction, he challenged me and said, “How do you know that's not just the progression of the disease?” So in effect, I was shut down. And it wasn't up to me to decide that. It was to be reported and then for all the patients to be able to report it, and for them to find out what the reaction was.
That's why we feel there needs to be far more education, and we're really happy to see Health Canada coming out with a consumer-friendly form, because we've spent two years trying to tell them it was needed. And now it's soon to be released and it is just being tested now.
And we need to be more aware. As for the pharmacists, there needs to be an education campaign about the fact that people can report, that they can self-report. Canadians don't know that. They rely on their doctors and pharmacists. Pharmacists do the majority of reporting, but it really isn't enough.
Gail Attara Member, Steering Committee, Best Medicines Coalition
I'd like to comment on that too.
I am the executive director of the Canadian Society of Intestinal Research as well as being a member of the Best Medicines Coalition.
In our organization a few years ago, when the MedEffect website was really launched, we put a big announcement in our newsletter and we let people know via our website with regard to that ability for people to report.
I think this is really an untapped area that can be used by Health Canada, by partnering with charities and saying.... The patient groups who are out there would be happy to get this information out too, and in our case, we're not asking you to give us money to do that. We're just saying this is awesome and we're really happy to see it. Let's partner with you. Give us the script that needs to be sent out to everyone and we'll be happy to put it through the vehicles of our newsletters and our websites.
Our website gets 500,000 hits a month, so certainly this is going to be a good way for people to communicate messages. So please don't underestimate the power of collaboration. And it doesn't necessarily mean it's going to cost money in this particular way.
Chair, Drug Safety Canada
Thank you.
The only death I ever reported was my own daughter's death, which was the day after she died, because I never felt anything useful was being done with the reports. We focused at the time on research.
We know the doctors don't generally report adverse drug reactions for a range of reasons. In fact, there's a form in the back of that big blue book that they all have in their office, the Compendium of Pharmaceuticals and Specialties. Most doctors have never used it or don't even know it's there.
One reason is that they're afraid of being sued. In fairness, sometimes it's difficult to identify adverse drug reactions, because they haven't been trained to do so. Sometimes they have 40 patients waiting in the waiting room and they don't want to take the time to fill out paperwork to the government, although with modern technology it's pretty easy to log on and fill out a form that says “suspected adverse reaction”.
So we support the initiative starting in the hospitals. We would also support patients reporting adverse drug reactions, if it's a robust system, because patients can provide more detailed information on what they experience. But there have to be people on the other end who are taking that information and doing something with it.
Another reason doctors don't report is that they haven't felt, for years, that anyone was doing anything with that information.
I looked up recently the most popular drug. The highest-selling drug in the world is a cholesterol-lowering drug--Lipitor. There are 2,000 adverse drug reaction reports on the Health Canada website. In our view that means there have been 200,000 adverse drug reactions that were so significant that the doctor, the health care professional, or the patients themselves had logged on and ordered....
By the way, the reporting of adverse drug reactions on the Health Canada website is the only significant change that we have seen in the eight years since Vanessa died. It's the only thing that has been carried out to improve the situation.
There was an inquest into Vanessa's death a year after she died. There were 59 recommendations made by the jury, and it's the only significant change we've seen.
So change is due. This is a great opportunity to make positive change.
Board Member, Canadian Health Coalition
As a practising physician, I have reported adverse drug reactions. It is equivalent to putting a note in a bottle and sending it into the ocean. There's no feedback at all.
The second thing is that in the time that I was a senior officer with Health Canada and involved in adverse reaction reporting evaluation and action, in a regulatory sense, I was aware that we in essence had no systems to carefully evaluate adverse drug reactions. A good example would be the case of Prepulsid. When the file was looked at--after I left government and through access to information--to see what had been done at Health Canada regarding reported deaths with Prepulsid, the drug that killed Vanessa Young, the earliest memos were one from the drug company's adverse reaction reporting officer saying, “I think I have five deaths”, and one from Health Canada saying, “I thought there were seven.” And neither of them had looked into any of the deaths.
This is a system where reporting is not the issue. People would report if there were something competent and timely in the way of useful information from Health Canada as a result.
Bloc
Christiane Gagnon Bloc Québec, QC
Thank you for joining us this morning. You have made a number of fairly specific recommendations.
I would like to talk about Gardasil. A number of people who took this drug in Europe and in the United States, but not here in Canada, later died. Here in Canada, a major campaign is underway to have young girls between the ages of 15 and 25 vaccinated. Of course, it is difficult to establish a link between the deaths and the use of this drug. I understand that a company is currently conducting an investigation in Germany and in Switzerland. For now, no one is able to establish a cause-effect relationship. Eight young girls have died in the United States.
I contacted officials at Health Canada because they are the ones who initially approve a drug for use and grant a patent. They told me that vaccinations were the responsibility of the Public Health Agency. It was the agency that had opted to go ahead with the vaccination program. In your opinion, is there not a breakdown of some sort in the chain between the moment a patent is issued and a drug is administered to patients? The chain is rather hard to follow.
Young girls continue to receive the vaccination despite the known risks involved. In light of the situation, I'm wondering if perhaps a moratorium could be imposed for a few months, depending on the type of investigation that we may wish to conduct. Were you aware that Gardisil could have serious side effects? How can patients be made aware of these possible side effects? Perhaps in the case of a young girl of 15, the parents should be notified as well. So then, I ask you, how could we be more vigilant under the circumstances? We feel completely powerless.