HIGHLIGHTED CBC QUOTES RE: ADVERSE DRUG REACTIONS

(1) "So if you take that kind of statistic, we have 450 deaths suspected in the database of Health Canada related to drugs and deaths, we can easily predict 4,500, and many people would say at least 10,000 deaths in Canada from drug reactions each year.”

(2) "You know, Health Canada has one-tenth the resources and staff as the Canadian Firearms Centre, which deals with guns that kill fewer people than drugs do in Canada.  It shows you, well it raises a question of where Canadian priorities are in terms of this very serious part of the health care system."

SOURCE: CBC-R

PROGRAM: THE CURRENT

DATE:  FEBRUARY 17, 2004

TIME:  08:40

LENGTH: 19 Minutes

ADVERSE DRUG REACTIONS

ANNA MARIA TREMONTI (Host): As you may have already head this morning on the news, beginning today CBC Radio and CBC Television are presenting a series called Faint Warning.  It’s about the system that is supposed to make sure that prescription drugs are safe to take after they are approved and put on the market.  Tragically that system has failed many Canadians.  Adverse drug reactions maimed or killed loved ones, leaving families wondering what happened to the governmental and professional guardians of a vital part of health care.

UNIDENTIFIED: She stood up, fell backwards on my study’s floor, dead.  No warning signs.  We were certainly not told that officially 80 people had died when she had been prescribed the drug.

UNIDENTIFIED: I don’t think it’s fair that I wasn’t told about the side effects.  It I went in and asked for cocaine, they wouldn’t have gave it to me.

UNIDENTIFIED: Where, where’s the teeth that Health Canada are supposed to have?  I mean, they just don’t seem to be there with it.

UNIDENTIFIED: I think we have a system that is working.  I don’t think we have a system that’s putting people at risk.  But I think we have a system that we can make better.

UNIDENTIFIED: If the doctors reported adverse reactions and if the people at Health Canada did what they’re supposed to do, we could save thousands of lives.

TREMONTI: Well those are some of the voices you will be hearing today and tomorrow in our special investigative report, Faint Warning.  The Current’s Bob Carty has been a member of this investigative team and he joins me now from Ottawa.  Good morning Bob.

BOB CARTY (The Current): Good morning Anna Maria.

TREMONTI: Before we start into your investigation, let’s step back a bit.  We’re talking here about problems after drugs are approved and are already on the market.  I thought they were safe by that time.

CARTY: I think most Canadians think that as well, that they are safe.  After all, they’ve been approved by our regulator, Health Canada.  They’ve gone through quite a rigorous process and a long process, almost a two-year process.  Often it can take, from beginning to end, many more years, six to eight years.  There’s animal trials, there’s human safety trials, there are clinical trials for efficacy.  But one of the problems with all of that, even after approval, is that by the time they’re on the market they’ve only been tested maybe in upwards of only about 3,000 people.

TREMONTI: But isn’t that enough?  Shouldn’t that be a good test run of a new drug?

CARTY: Well, it may in fact be quite safe for the 3,000 people who are tested.  But what if the drug hurts or kills, only one-in-three thousand say, or one-in-ten thousand or one-in-one hundred thousand?  Once we have millions of people taking a drug we can have unexpected reactions in the population as a whole and have a tremendous impact, a big health cost, a big death toll in fact.  Then there’s the problem with trials, Anna Maria, that most are done in fact with middle-aged men, middle-weight men.  Not enough are done with women, with the aged, with pregnant mothers, for example, or with children.  So we don’t know how drugs might react with them in the real world.  And that’s where drug marketing, post-marketing drug surveillance comes in.  In the real world about half of all drugs that end up on the market eventually cause some serious side effects.

TREMONTI: Half?

CARTY: Yeah.  And the Journal of the American Medical Association had a study out a few years ago suggesting that one-in-five drugs will have such serious effects it’ll either have to be withdrawn over its life or have a big black box warning put on it.   So those are some of the reasons why we need, actually, a good adverse drug reaction system to watch marketed drugs, to pull them when, when that’s required or to put warnings on them or just to inform patients and doctors when not to use them, how to use them most effectively.

TREMONTI: Well if you’ve looked at the database with Health Canada, what have you found?

CARTY: Well, I mean we found that there’s a lot of adverse drug reactions every year, perhaps 10,000.  Some would be very, very simple.  Some would be, you know, dizziness.  Some would be, you know,  acid indigestion from taking aspirin.  But we will find about 450 deaths last year in that database, which is really interesting because it actually confirms this cost factor I was just mentioning.  That, we know for example that fewer than ten per cent, maybe as low as one per cent, of actual adverse drug reactions are in fact reported to Health Canada.  So if you take that kind of statistic, we have 450 deaths suspected in the database of Health Canada related to drugs and deaths, we can easily predict 4,500, and many people would say at least 10,000 deaths in Canada from drug reactions each year.  In fact, many, many plane crashes.

TREMONTI: That’s staggering that the number is that high.

CARTY: This is really an unexplored and very, very central part of our public health system.

[SNIP]

CARTY: And Anna Maria, that was Dr. Sharma of Health Canada’s Marketed Health Products Division Branch.  And I think she makes some good points there, you know, about, you know, being able to judge risks and balances between different drugs.  It’s really important.  Some of these drugs are still important for people.  But at the end she talked about the resources at Health Canada.  You know, Health Canada has one-tenth the resources and staff as the Canadian Firearms Centre, which deals with guns that kill fewer people than drugs do in Canada.  It shows you, well it raises a question of where Canadian priorities are in terms of this very serious part of the health care system.

TREMONTI: Okay, Bob Carty, thank you.

CARTY: Thank you.

TREMONTI: Bob Carty will have more on this tomorrow on The Current.  He’s a documentary producer for The Current, based in Ottawa.

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