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CBC TV

SHOW: MARKET PLACE ( 8:00 PM ET )

Double click on the globe.

February 13, 2001, Tuesday

INSULIN

GUESTS: KATHY FERGUSON, mother of diabetic; COLLEEN FULLER, diabetic; DR.

LOREN GROSSMAN, Eli Lilly Canada Inc., ; MARTIN MacINALLY, Canadian

Diabetes Association; DR. ARTHUR TEUSCHER, endocrinologist and insulin

expert; DR. JOHN HUNT, endocrinologist; IAN MacKAY, Health Canada; DR.

CHRIS TURNER, Health Canada

ANCHORS: JACQUIE PERRIN, ERICA JOHNSON, DIANE BUCKNER

JACQUIE PERRIN (Marketplace): Hello, I'm Jacquie Perrin, and welcome to

Marketplace. Imagine you've become dependant on a drug, a drug that saves

your life. All of a sudden, you can't get it anymore, and you can't adjust

to the new, improved alternative. That's the case for thousands of

diabetics around the world who say genetically engineered insulin is

causing them serious health problems, even comas. Now a group of Canadian

diabetics is about to launch a class-action crusade for choice. Erica

Johnson investigates.

ERICA JOHNSON (Marketplace reporter): Insulin, discovered by Frederick

Banting and Charles Best at the University of Toronto eighty years ago,

one of Canada's proudest moments in research history. Now that drug,

animal-based insulin, is on the endangered species list. Today, just one

pharmaceutical company in Canada sells an animal-based insulin. It's

phased out its more popular animal insulins, and wants people to switch to

its newer, genetically engineered product. The company says it's a better

insulin that's safe for everyone. But some diabetics say they can't

tolerate it, and they want choice. Colleen Fuller has been a diabetic

since she was sixteen. She used animal insulin from the pancreas of a cow

for twenty-seven years, and managed her disease well. But six years ago,

her doctor suggested she try a newer synthetic insulin called Humulin.

COLLEEN FULLER (diabetic): The first night that he put me on Humulin, I

went into a coma. My husband, had to phone 911, and that happened about

four more times over the next month and a half. It was very awful.

JOHNSON: Humulin is a genetically engineered insulin, manufactured by Eli

Lilly and company. Thousands of people are switching to it because Lilly

has stopped making the two most popular animal insulins, the beef, and

beef-pork. They say it's a business decision: genetically engineered

insulin is popular and more closely resembles insulin made by the human

pancreas. Another company, Novo Nordisk, pulled all of its animal insulins

six years ago.

KATHY FERGUSON: (mother of diabetic): This is in Niagara Falls, we did the

Maid of the Mist.

JOHNSON: Kathy Ferguson wants animal insulins kept on the market too. Her

son, Chris, was on animal insulin as a child, but after he switched to

Humulin, he started having problems.

FERGUSON: I'd get him up to go to school, and he would start his breakfast

and insulin, and I start work at 8:30, so I'd leave. And I'd come home,

and he wouldn't know what had happened all day, so he wouldn't really even

know if he had gone to school that day or not.

JOHNSON: Besides memory loss, Chris began having seizures, black-outs. Ten

days after his seventeenth birthday, he died during the night.

FERGUSON: He was half way off the bed, from his waist down, at the

opposite end of the bed that he normally sleeps, so are you going to tell

me that he wasn't maybe awake and didn't know something was happening?

This is the autopsy report.

JOHNSON: The report says Chris died of natural causes: cardiac arrest, the

result of seizures caused by his diabetes. Ferguson wonders if her son's

insulin played a role.

FERGUSON: They say it's a natural death. Well, at seventeen, it's not a

natural death I don't think.

JOHNSON: Ferguson and Colleen Fuller aren't the only ones who say there

must be a choice of insulins available, that people's health depends on it.

Marketplace has obtained these adverse drug reaction reports from Health

Canada, reports made by doctors and patients across the country. Since

1998, 121 people on Humulin or its faster-acting version Humulog, have

experienced problems, comas, seizures, convulsions, hypoglycaemia--a

sudden drop in blood-sugar levels, the person is about to black-out. South

of the border, the U.S. Food and Drug Administration has been flooded with

similar reports. In the past few years, the agency has heard from

thousands of patients and doctors who believe Humulin and Humulog,

so-called human insulins, have caused disorientation, have sent people to

hospital, are even linked to dozens of deaths.

FULLER: I started to do my own research about the insulin, and what I

discovered is that there were thousands of people, not just a few, but

thousands of people, who are having problems with human insulin.

JOHNSON (on telephone): Does Health Canada have any concerns about the...?

...Health Canada wouldn't speak on camera about the adverse drug reaction

reports, but a spokesperson told us the reports are purely anecdotal, not

scientific, no cause for concern.

DR. CHRIS TURNER (Health Canada, on telephone): We don't want to discount,

in any way, the importance of someone having a coma, but those numbers, in

relation to the number of patients that get these products, is not

considered a signal or a trend.

JOHNSON: We asked Eli Lilly for an on-camera interview, but they refused,

wouldn't talk about any problems reported, and said all diabetics should

be able to use their man-made products.

DR. LOREN GROSSMAN (Eli Lilly Canada Inc.): When they switch from animal

to human insulin, with proper assistance, they can do so safely and

efficaciously.

JOHNSON: And, said Eli Lilly, even though they've stopped making the most

popular types of animal insulins, they're still producing an insulin made

from pork. But Marketplace surveyed thirty pharmacies in provinces across

the country, asked whether they carried the pork insulin. Only a few said

they had the product. Others told us:

UNIDENTIFIED: There are no more pork-based insulins, no.

UNIDENTIFIED: No, It's been discontinued.

UNIDENTIFIED: I haven't seen that in a while. I don't think you can still

get it.

UNIDENTIFIED: No, I'm afraid that's all gone.

JOHNSON: Colleen Fuller says, in desperation, she turned to the Canadian

Diabetes Association. Martin MacInally says his organization tried to

help, tried to get Eli Lilly and its competitor, Novo Nordisk, not to

discontinue their popular animal insulins.

MARTIN MacINALLY (Canadian Diabetes Association): We definitely asked them

to reconsider the decision, but the decision of the companies that

manufacture said this is final, this is what we're doing.

JOHNSON: But Fuller doesn't think the Canadian Diabetes Association has

done enough. She points to a survey published four years ago. The CDA

asked its members if they were having trouble switching from animal to

genetically engineered insulins. Forty-three percent of respondents said

they were.

FULLER: This would suggest that the CDA should follow up and find out

about what's going on with their members.

JOHNSON: The British Diabetes Association heard from its members when

synthetic insulins came on the market; it received three thousand letters.

Diabetics said they'd lose warning signs of dangerously low sugar levels;

some believed they would have died if they'd not been rescued as they lay

unconscious. The BDA never published a commissioned report, because it

considered it "too alarmist." ON it's packaging, Eli Lilly warns

that a few patients who switched to Humulin found their early warning

symptoms of hypoglycaemic reactions were less pronounced than they were

with animal-source insulin, but the company denies its synthetic insulins

are the cause of illness or death.

GROSSMAN: There is no evidence from the clinical studies that there is a

correlation or a cause and effect relationship between human insulin and

the symptoms that you're referring to.

FULLER: They're not listening. Hello? They're not listening. There are

thousands of people who are having these problems.

JOHNSON: Research published in prestigious medical journals like The

Lancet and British Medical Journal has documented

problems: people losing crucial warning symptoms of low blood sugar levels

when they switched to synthetic insulins. Dr. Arthur Teuscher is a Swiss

endocrinologist; he was one of the first physicians in the world to

prescribe the newer synthetic insulins. [to Dr. Teuscher] What happened to

one of your patients that made you change your mind about this human

insulin?

DR. ARTHUR TEUSCHER (Swiss endocrinologist): He had an abrupt, sudden

hypoglycaemia, he was rushed to the university department, and after three

days of re-animation, he was dead.

JOHNSON: Teuscher believes sudden deaths occur because some people on

synthetic insulins lose typical warning signs like sweating and trembling

as their blood sugars plunge.

TEUSCHER: We see all the time now patients who come to the office and say,

We don't feel hypoglycaemia symptoms anymore. Do something.

DR. JOHN HUNT (endocrinologist, speaking to patient): Now you're back on

the animal insulin, things are running smoothly again, and you're

reasonably stable again?

JOHNSON: Dr. John Hunt is an endocrinologist who's treated dozens of

patients struggling on Humulin. He doesn't understand how pharmaceutical

companies could deny that some people are having problems.

HUNT: To say somebody doesn't exist when they're having major problems,

and they recognize the problems, they know the solution, and the solution

is being removed from them, I think this is immoral.

JOHNSON: For the vast majority of diabetics, synthetic insulin works well,

but those who can't adjust aren't just frustrated, they're angry, and are

about to launch the first class-action suit of its kind in Canada.

UNIDENTIFIED: That's just outrageous.

JOHNSON: Colleen Fuller has teamed up with others who want insulin choice

on the market.

UNIDENTIFIED: I get so low that I'm not able to tell how low I am until I

can't help myself, and it wasn't always like that.

UNIDENTIFIED: Like, it's totally disruptive to someone's life to have

these ups and downs.

JOHNSON: They're working out complicated details, hoping others will join

their fight as they take on pharmaceutical giants Eli Lilly and Novo

Nordisk.

FULLER: I think that they need to take responsibility for their product

and the impact that it's had on people.

JOHNSON: The lawsuit will also target Health Canada.

FULLER: Eli Lilly is not the king of Canada, you know. We have a

government, and if the corporation won't provide animal insulin, then I

think that the government has to figure out a way to make sure that that

product is available.

JOHNSON: Ian MacKay is with Health Canada. He says when the drug companies

pulled their products, there was nothing the government could do.

IAN MacKAY (Health Canada): We simply just don't have the authority to

force a manufacturer to continue marketing something that they have chosen

to withdraw from the market for their own corporate reasons.

FULLER: I'm so sick of hearing that ? Oh, there's nothing we can do,

there's nothing we can do. There is something they can do: they can get

off the pot and make sure that this drug is available, so that we're not

subjected to these horrible experiences.

JOHNSON: Diabetics can get animal insulin through a special program run by

Health Canada, but there's a lot of paperwork, patients have to pay for

shipping and handling, and the insulins usually aren't covered by

provincial health care programs, so diabetics can pay several thousand

dollars a year for a drug that keeps them alive.

HUNT: If Health Canada were at all sensitive to their people, they would

say, If people really need it, let's make it easy for them, rather than

let's make it as difficult as we possibly can.

JOHNSON: Hunt has helped patients import animal insulins no longer on

pharmacy shelves in this country.

HUNT: Their problems disappear, they feel better, their control is easier,

they have less problems. They say, Thank goodness for that--now we can get

back to normal.

JOHNSON: Colleen Fuller knows her crusade will not be easy, a battle for

choice that started when she stopped struggling for Humulin and returned

to the animal alternatives.

FULLER: It was a decision which said to me, You are going to be using this

insulin, and you are going to be involved in the fight of your life. And

that's what's happened.

PERRIN: Prompted by our investigation into this story, Colleen Fuller's

MP, Libby Davies, brought the issue to the House of Commons today. She

demanded to know what Health Canada is doing to protect the health of

diabetics who say they need a choice of animal insulins. The deputy prime

minister, Herb Gray, said he'd look into it....

CBC TV

SHOW: THE NATIONAL ( 10:00 PM ET )

February 12, 2001, Monday

The concern over genetically engineered insulin

ANCHORS: PETER MANSBRIDGE

PETER MANSBRIDGE: Ever since it was discovered eighty years ago, insulin

has been a life saver for diabetics around the globe. But now there's a

controversy surrounding the critical drug. Its makers have changed the way

they manufacture it, and some diabetics say the newer formula is causing

them serious health problems. Erica Johnson of the CBC program Marketplace

has been investigating this story.

ERICA JOHNSON (Reporter): Colleen Fuller has been a diabetic since she was

sixteen. She used animal insulin made from cows and pigs, and managed her

disease well. But six years ago, her doctor urged her to try a newer,

genetically engineered, or synthetic insulin called Humulin.

UNIDENTIFIED WOMAN (1): Okay, Brook, let's go.

COLLEEN FULLER (Diabetic): The first night that he put me on Humulin, I

went into a coma. My husband had to phone 911. And that happened about

four more times over the next month and a half. It was very awful.

JOHNSON: Fuller isn't alone. Since 1998, Health Canada has heard from one

hundred and twenty-one patients and doctors who say synthetic insulins

have caused problems - comas, seizures, convulsions, hypoglycaemia, a

sudden drop in blood sugar levels that can cause a person to black out.

South of the border, the US Food and Drug Administration has received

thousands of similar reports. Some doctors and patients believe Humulin

has caused disorientation, sent people to hospital. It even leads to

death. No one from the drug company Eli Lilly would appear on camera, but

a spokesperson insisted everyone can handle the drug.

DR. LOREN GROSSMAN (Eli Lilly Canada): When they switch from animal to

human insulin, with proper assistance, they can do so safely and

efficaciously.

JOHNSON: For the vast majority of diabetics, synthetic insulin works well.

Thousands are switching to it because most of the animal insulins they

used to take have been phased out. The drug companies say, in the

long-term, synthetic insulin will be cheaper to make, and it's closer to

insulin actually produced by the human body, so that means just one animal

insulin remains available in Canada, and it's hard to find.

UNIDENTIFIED MAN (1): That's just outrageous.

JOHNSON: Fuller and other diabetics are angry their insulin choices are

disappearing. They claim their health is suffering.

UNIDENTIFIED MAN (1): I get so low, that I'm not able to tell how low I am

until I can't help myself.

JOHNSON: And, they say, Health Canada has a duty to keep animal insulins

on the market. But Health Canada says it doesn't have enough evidence to

be concerned, and it points out drug companies are entitled to stop making

a product.

IAN MacKAY (Health Canada): We simply just don't have the authority to

force the manufacturer to continue marketing something that they have

chosen to withdraw from the market for their own corporate reasons.

JOHNSON: Right now, diabetics who need their old animal insulins have to

import them from Britain, and most provinces won't pay for them. An

outrageous situation, according to Fuller, who's starting a campaign to

get the insulin she says she needs back on pharmacy shelves.

FULLER: I know it's going to be a long fight, and I'm ready.

JOHNSON: Erica Johnson, CBC News, Vancouver.

MANSBRIDGE: And you can watch Erica's full report tomorrow night on

Marketplace at eight o'clock, eight thirty in Newfoundland.

CBC TV

SHOW: MARKET PLACE ( 8:00 PM ET )

February 6, 2001, Tuesday

PREVIEW

ANCHORS: JACQUIE PERRIN, JIM NUNN, DIANE BUCKNER

JIM NUNN (Marketplace): Is there a problem with synthetic insulin?

UNIDENTIFIED: I know that if I had been sleeping alone, I would have died.

UNIDENTIFIED: The drug companies have been to be accountable for this.

NUNN: The potentially dangerous side effects of man-made insulin, next

They know.

week on Marketplace.

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