----- forwarded message ------
Date: Wed, 23 Oct 2002 14:28:38 -0400
From: "deborah barrie" <[EMAIL PROTECTED]>
Subject: Fwd: Transcript:Health Canada Regulation from BGH to Hormones and
Antibiotics
Subject: Transcript:Health Canada Regulation from BGH to Hormones and
Antibiotics
Date: Wed, 23 Oct 2002 14:14:57 -0400
Below is the transcript of a documentary titled 'WHAT'S IN THE BEEF?' a
special by "Country Canada" that ran on Sunday, October 20, at 12 PM on CBC
TV.
We need a re-run of this documentary at a time when the public will watch
it, i.e., in the evening during the week, for example, at about the same
time that 'The Nature of Things' is shown.
Please write to CBC and Country Canada at: [EMAIL PROTECTED];
[EMAIL PROTECTED] .
If there is enough demand from the public, it is possible that the show
will be aired again.
Also, please congratulate Country Canada for producing and CBC for airing
the show.
Thank you.
Rohini Peris
==========================================================
WHAT'S IN THE BEEF?
CBC News and Current Affairs
Sun 20 Oct 2002
Time: 12:00:00 ET
Network: CBC-TV
REG SHERREN: Hi. I'm Reg Sherren. Welcome to a brand new season of Country
Canada. We begin here in Ottawa where, among other things, it's the
government's responsibility to ensure the safety of the food you eat. Yet
some of the government's own scientists say that's not happening. They say
serious health concerns are being ignored or dismissed. You're about to meet
one of them.
UNIDENTIFIED: Ready, one, two, three!
UNIDENTIFIED: Let's go (inaudible)...
SHIV CHOPRA: Ah, don't go in the field.
SHERREN: Surrounded by his grandkids, this is when Dr. Shiv Chopra is
happiest. He can forget about the day-to-day demands of his job. He can stop
being a scientist and just play.
CHOPRA: Whoa! (Laughs)...
UNIDENTIFIED: (inaudible)...
SHERREN: But in those quiet times, his mind drifts. He remembers his work,
his public responsibility to keep the food we eat safe for his grandchildren
and for all of us, and he wonders why his job has become so difficult. They
call you a trouble maker.
CHOPRA: Well, they call me a trouble maker, but many other people in Canada
call me a hero.
SHERREN: What happened in this particular case?
CHOPRA: In this particular case, that drug should not have been approved.
SHERREN: There's been a big change in what we eat. Fifty years ago beef
cattle were not routinely injected with antibiotics or growth hormone.
(SOUND OF CATTLE)]
SHERREN: Now growth hormones implanted behind the ear can put an extra 40
kilograms on the average beef cow. That's roughly ten percent of its body
weight. Drugs can fatten the cow for slaughter in less time. That's good
business for the farmer. Today injections and implants are a regular part of
the business of raising food. Any drug that may end up in our food must be
safe... for the animal, and for us.
CHOPRA: Boneless is fine.
UNIDENTIFIED: How about drumsticks?
CHOPRA: Three should be fine.
UNIDENTIFIED: Three?
SHERREN: Dr. Shiv Chopra is one of the government scientists evaluating
those veterinary drugs. He's a microbiologist with nearly 40 years'
experience. His decisions are enormous. Public safety is on the line. So are
billions of dollars in revenue for drug companies.
CHOPRA: It's the job of scientists like me to assess and make a
recommendation whether the application complies with the law or not. It's
simple.
SHERREN: You are essentially supposed to be the front line, if you will.
CHOPRA: I am the front line and the bottom line and the only line.
SHERREN: And he's got a problem. This is an antibiotic called tylocin. Some
ranchers use it to help treat or prevent disease. Tylocin can also help
animals grow faster using less food. It's been available in Canada for a
number of years now. You don't even need a veterinary prescription to get
it. So it seemed like a routine approval when the drug's manufacturer asked
Health Canada to approve the use of tylocin in conjunction with growth
hormones already available on the market. It turns out that approval was
anything but routine.
CHOPRA: It came to my attention because of my particular expertise,
designated duty in antimicrobial resistance. And I said there's a problem
here. We need to look at it.
SHERREN: Since 1969 Chopra has been a government watch dog. And his
passionate work ethic has brought him notoriety, including a Governor
General's Award for a lifelong commitment to human rights. His passion has
also led to battles, both public and private, with his bosses. Chopra has
been reprimanded and suspended. He's been through court, testified at
government hearings, all, he says, to protect the public.
CHOPRA: My science has never been questioned by anyone in the department.
SHERREN: In 1999 Chopra has questions about the tylocin hormone application.
New research suggests tylocin may lead to bacteria resistance to human
antibiotics. This resistance could cause untreatable, potentially fatal
infections, especially in children. He wants more data from the drug makers,
human safety data.
CHOPRA: In this particular case there was no data. The company said approve
it, we've already had approval for some other uses and now we want to use
this drug in combination with hormones which are implanted in animals to
prevent abscesses.
SHERREN: Canada's food animal drug industry is approaching a half billion
dollars a year in sales. Big business with big investments. A drug company
will spend on average $250 million and 15 years getting a new animal drug
ready for the market. And there's no payback unless the government approves
that drug for use.
JEAN SCOTT NICKY: We want timely reviews, we want consistent reviews...
SHERREN: Jean Scott Nicky is a lobbyist for the animal drug companies, the
Executive Director of the Canadian Animal Health Institute. She says it
takes a long time to get a new drug approved in Canada, twice as long as the
United States or Britain. Delays mean lost revenue for the drug maker. Lost
revenue is bad for business.
NICKY: There are pressures on the system, yes. We're asking for a robust
review process, timely reviews process with current guidelines. So I think
if there's pressure that's the type of pressure you're seeing companies
put... in our institute... put on government regulators.
CHOPRA: The pressure is not put directly by the companies on me or my
colleagues. It comes indirectly by the pharmaceutical company lobbies on the
Prime Minister, the Ministers, the... the Privy Council and whatever.
SHERREN: And that trickles down to your supervisor?
CHOPRA: And then that comes down to my level.
DIANNE KIRKPATRICK: Hi. I'm Dianne Kirkpatrick.
SHERREN: Dianne Kirkpatrick is Chopra's boss, the Director General of the
Veterinary Drug Directorate. She says there's no pressure.
KIRKPATRICK: The only complaint that we receive from industry when making
submissions is could we do them a little quicker. But it's, you know, a
decision. Come up with a decision, do your reviews.
SHERREN: Is that not pressure?
KIRKPATRICK: No pressure it all. It's not...
SHERREN: So that doesn't trickle down in fact?
KIRKPATRICK: No. No, that certainly doesn't trickle down.
SHERREN: But Chopra tells a different story. In the late 1990s government
scientists assess a hormone designed to increase milk production. RBSC has
been used in the US for years, but Chopra doesn't believe sufficient safety
data has been provided for the Canadian review. He refuses to sign off, even
though years earlier the Chief of the Human Safety Division told the drug
maker human safety requirements had been met. In the end, approval is
stopped and Chopra exonerated, but it takes a Senate committee, a Labour
Board hearing and a federal court case.
CHOPRA: I felt very good because I felt vindicated in Canada. I felt greatly
honoured in Europe because, as a result of what happened in Canada, the
European Union banned it, even though their commission gave sanction to
approve it.
SHERREN: Two years later another drug in use in the US is under review here.
Batril is an antibiotic for chickens and cows. But Canadian scientists
believe batril may cause antibiotic resistant bacteria in food animals,
which could pass to humans. The resulting infection may not be treatable
because batril is much like a common human antibiotic. Chopra's assessments
keep batril out of Canada's food supply. But the drug maker writes to the
Health Minister and his Deputy Minister expressing 'extreme frustration with
your department's handling of our submission.' The government denies
pressure is put on its scientists, however Chopra's final report claims
several incidents of harassment, coercion and slander from within the
department against three specific drug evaluators connected to the batril
assessment.
CHOPRA: If I'm told approve this drug because it's already approved by the
US, I don't need to look at the data, that's where the buck stops, because
if I do that then I will be lying.
SHERREN: Following the RBSC scandal Chopra and 200 Health Canada scientists
write the Health Minister concerned about safety standards. After the batril
review Chopra and five other scientists write their professional association
regarding 'the many years of pressure and harassment that we have been
facing to pass various products.'
CHOPRA: I am a confirmed whistle blower. Whistle blower is like the referee,
simply saying, 'You're playing foul; don't. Stop.' Don't ask me to bend the
law. I cannot bend the law.
SHERREN: Chopra had kept two potentially dangerous drugs out of the Canadian
food supply. But he was about to battle his own bosses again, and lose. That
story when we come back.
REG SHERREN: Welcome back to Country Canada. Back in the spring of 2002,
scientists entrusted with keeping Canada's food supply safe are worried. An
animal drug banned in several countries because of human health concerns is
under new review here. The government places its most tenured evaluators on
the case, but their recommendations are dismissed by senior managers.
DIANNE KIRKPATRICK: I think we made a... I know we made a good, solid
decision.
SHIV CHOPRA: We don't know what... we don't know where to turn to now.
(SOUND OF CATTLE)
SHERREN: Drug maker Alanco wants government approval for a new cattle
medication, an injectible pellet mixing an antibiotic with growth hormones.
But government drug evaluator Dr. Shiv Chopra is worried about antimicrobial
resistance. He's not the only one concerned.
DR. GERARD LAMBERT: It was a controversy (inaudible)...
SHERREN: Dr. Gerard Lambert, another experienced government scientist, 30
years with Health Canada. Lambert has European data showing one of the
growth hormones to be mixed with tylocin may cause cancer and nourish
tumours. It's already banned in Europe. Lambert wants specific human safety
data from the drug maker, but his boss says not.
LAMBERT: We consider that there was no... it was not a finished
(inaudible)... there was no data to support that.
SHERREN: Kirkpatrick, the head of the entire department, hears the same
argument from Chopra: Don't approve without additional data. Essentially
your supervisor's telling you she has a scientific difference of opinion.
CHOPRA: It's not a scientific difference of opinion because there is no
data. If there were data and there's a scientific difference of opinion,
then of course we can sit and discuss. You cannot discuss on something
nothing. If there are no data, what can you discuss? That's precisely what
we... why we asked for a meeting.
SHERREN: Instead the file is assigned to a pair of relative newcomers in the
Health Department. On May 6th, 2002 they recommend to approve the implants
saying, 'One can assume tylocin should not cause an increase in
tylocin-resistant bacteria in the food animals.' The approval comes despite
their own comment, 'No in-animal residue data were submitted, and therefore
no definite conclusion could be made.'
CHOPRA: The law says data satisfactory to the Ministry shall be provided.
And my colleagues said there are no data. And if there are no data, nobody
can approve. Nobody should approve. And... and we... in fact we told the
department, the Director General, you... this is wrongdoing. You don't have
that authority.
KIRKPATRICK: I'm aware that there was a difference of opinion and...
SHERREN: So are they... are they wrong?
KIRKPATRICK: Well, in this case, what I would say is that their views were
taken into account and, notwithstanding their views, the overwhelming
evidence is that the product can be used safely if used in accordance with
the label directions.
SHERREN: The tylocin hormone implants become the latest in a number of
controversial animal drugs available in Canada. European inspectors came to
Canada in the fall of 2000 to evaluate the control of drug residues in food
animals. They found six growth hormones being used on livestock here which
were banned in Europe because of links to cancer, among them revelor-H,
approved by Health Canada in 1997, again against the advice of the
government's own scientists. The European inspectors also found what they
considered a lax government system of checking food animals for drug
residues. Some suggest Europe banned growth hormones to keep out North
American beef, but study after study suggests hormones pose a potential
health risk. And a growing body of evidence links bacterial resistance in
animals to resistance in humans. For that reason the World Health
Organization asked all countries to pan tylocin as a growth promoter.
LAMBERT: And now we come out with an antibiotic and hormones and we combine
it, and we don't (inaudible)... it's mind boggling. It's... I cannot... And
we are... it's... it's not acceptable.
SHERREN: Is there any guiding policy on the approval of drugs with
antimicrobial cross-resistance?
KIRKPATRICK: What we're doing is we've mounted a very substantive effort to
look at the whole issue of antimicrobial resistance, and for example...
SHERREN: But is there an existing policy?
KIRKPATRICK: ...we... No, we don't have a... we don't have a policy that I
can hand you and say here's the policy.
SHERREN: Why not?
KIRKPATRICK: We have guidelines. Because it's a very complex issue and
what...
SHERREN: It's been around for a while, though.
KIRKPATRICK: It has.
CHOPRA: They call it risk management. In other words, to make profit let us
take risk, and we will wait 20 or 30 years. If cancers occur, reproductive
disorders occur, if people... too many people die from antimicrobial
resistance, then we will think about it. Then we will manage it.
SHERREN: The tylocin implant approval produces a blizzard of memos and
e-mails through Chopra's department. Several scientists are dismayed by what
they see as a lack of evidence. Tensions increase when, the next day,
Lambert is demoted as Acting Manager and replaced by one of the scientists
who approved the implants.
LAMBERT: They... because I lack judgment.
SHERREN: (inaudible)...
LAMBERT: Yeah, that maybe I lack judgment for my career, but I don't lack
judgment for health, for science.
SHERREN: And Kirkpatrick defends her position to her own staff in this
confidential memo issued just days after the approval: 'This decision is
also consistent with conclusions reached in other countries, for example, by
the US Food and Drug Administration.' The manufacturer says tylocin hormone
implants are widely used in the United States with no controversy. This fall
Canadian cattle producers will also have the implants. They and the
consumers who will soon eat the meat are unaware of the months of scientific
hand-wringing that happened behind closed government doors.
CHOPRA: Either she's right or I'm right. And now the Minister or the Deputy
Minister has to make a choice.
SHERREN: When there is a difference of scientific opinion within your...
your department, who ultimately makes the decision?
KIRKPATRICK: Well, it depends. And it depends on...
SHERREN: In this case, who made the decision?
KIRKPATRICK: In the end, it was my decision as I have responsibility for
issuing what is tantamount to the approval for a use of a veterinary drug.
CHOPRA: She got herself appointed as Director General. She has a PhD in
physical chemistry. She's not a veterinarian, she's not a microbiologist,
she's not a biologist. All of those things.
SHERREN: What degrees does Ms. Kirkpatrick hold? We don't know. The Health
Department will not tell us. So you feel confident that you have the
competency level to make these sort of scientific determinations?
KIRKPATRICK: I certainly wouldn't claim to be able to make them on my own.
Again, that's why we have a very extensive breadth of competency...
SHERREN: Well, let me put it to you this way.
KIRKPATRICK: Let me answer.
SHERREN: You have two senior tenured scientists in your department that have
serious health concerns about approving tylocin. Why not err on the side of
caution?
KIRKPATRICK: If anything, as always, comes up that would bring new evidence
to that position, we would consider it and we would make decisions
accordingly thereafter.
(SOUND OF A HORN)
UNIDENTIFIED: Three cheers for West Carleton! Hip-hip...
CHILDREN: Hooray!
UNIDENTIFIED: Hip-hip...
CHILDREN: Hooray!
UNIDENTIFIED: Hip-hip...
CHILDREN: Hooray!
SHERREN: Chopra says there's now a growing list of drugs in Canada's food
system that make him uneasy.
CHOPRA: Nothing is going to happen to you tomorrow, or maybe even a year's
time. But over long term you may get cancer, there will be reproductive
disorders in... in your children and grandchildren.
SHERREN: When you look at your grandchildren, what do you think about what
you see going on?
CHOPRA: I feel even more helpless than ordinary Canadians do because I'm a
knowledgeable person. I know what's involved. I cannot even take care
effectively for the truth.
SHERREN: Health Minister Anne McLellan declined to be interviewed for this
story. Instead she deferred to her senior managers, saying they could
provide any of the information required on the running of her department.
Don't go away. We'll be right back.
