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The Green Guide

Thousands of Diabetics Report Adverse Effects from GE Insulin

Remember how safe and well tested GE products are? Well try these:

1.Real Video: Watch Fox TV investigation into claimed deaths from GE
'Humalin' at:
http://members.tripod.com/diabetics_world/movies/fox13-2-12a.ram

2. More material at:
http://members.tripod.com/diabetics_world/fox131.htm

Why should we believe anyone from the genetic engineering industry? It's no
different to the tobacco industry.

This is to say nothing of the regulatory authorities who are implicated in
this: see Canadian Class Action below.

'It was a decision which said to me, 'You are going to be using this
insulin - you are going to be involved in the fight of your life.' And
that's what's happened'. Colleen Fuller, Candian GE insulin litigant (see
reports below)

NATURAL LAW PARTY WESSEX
nlpwessex@bigfoot.com
www.btinternet.com/~nlpwessex
============================================================================
======
http://www.webtribe.net/d/diabetic/market.htm

Marketplace CBC Television
13 February 2001
Health problems linked to synthetic insulin

>From Marketplace.

A British Columbia woman is set to launch a lawsuit against the makers of a
genetically engineered insulin, saying the drug put her in a coma. Colleen
Fuller says she will also name Health Canada in the suit, claiming the
department has a duty to provide alternative treatments.

The genetically engineered or synthetic insulin is called Humalin. It is
gradually replacing animal insulin, which is being phased out. Health Canada
confirms that since 1998, it has received 121 reports of problems related to
synthetic insulin use including:
* Comas
* Seizures
* Convulsions
* Hypoglycaemia or low blood sugar

In the United States, the FDA says it has received thousands of similar
reports.

One of the makers points out that the vast majority of diabetics have no
problem with the drug. Dr Loren Grossman of Eli Lilly says 'Clinical studies
have shown that when people switch from animal to human insulin, with proper
medical assistance, they can make the switch safely'.

Only one animal insulin is available in Canada, and its hard to find. Fuller
says that's outrageous, and the government has an obligation to provide
animal insulin. But Ian MacKay of Health Canada says companies can't be
forced to keep making a product. 'We simply 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'. he says.

The manufacturers say Humulin is cheaper to make in the long run, and is
closer to the insulin actually produced by the human body.
----------------------------------------------------------------------------
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http://cbc.ca/consumers/market/files/health/insulin/
Marketplace CBC Canada. 13 February 2001

Imagine you've become dependent on a drug that saves your life. All of a
sudden, you can't get it anymore. Your body won't adjust to the new,
'improved' alternative. That's the case for thousands of diabetics around
the world who say a genetically-engineered insulin is causing them serious
health problems. A group of Canadian diabetics is about to launch a
class-action crusade for choice.

Insulin was discovered by Frederick Banting and Charles Best at the
University of Toronto 80 years ago. It was one of Canada's proudest moments
in research history. Now, animal based insulin is on the endangered list.

Only one pharmaceutical company in Canada sells an animal-based insulin. It
has phased out its most popular animal insulins and it wants people to
switch to its newer, genetically engineered product. The company says the
newer insulin is better and it's safe for everyone. But some diabetics say
they can't tolerate it and they want the right to choose.

Adverse reactions

Among those diabetics demanding the right to choose is Colleen Fuller of
Vancouver. She's been a diabetic since she was sixteen years old. She used
animal insulin, made from the pancreas of cows, for 27 years. Fuller says
the insulin worked well. Six years ago, Fuller's doctor suggested she try
the newer, synthetic insulin, called humulin.

'The first night that he put me on humulin, I went into a coma', Fuller
recalls. 'That happened about four more times over the next month and a
half. It was very...awful'.

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 animals insulins - one made from cow pancreas
and the other made from cow and pig pancreases.

Lilly says it was a business decision. The company asserts that 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.

In Vancouver, Kathy Ferguson is also demanding that animal insulins remain
on the market. Her son, Chris, was on animal insulin as a child. After he
switched to humulin, he started having problems.

'I'd get him up to go to school and he would start his breakfast and
insulin'. Ferguson told Marketplace. 'I start work at 8:30, so I'd leave,
and I'd come home and he wouldn't know what happened all day. So he
wouldn't really know if he'd gone to school that day or not'.

Besides memory loss, Chris began having seizures and blackouts. Ten days
after his seventeenth birthday, he died during the night. 'He was halfway
off the bed, from his waist down', Ferguson remembers. 'He was 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?'. The
autopsy report says Chris died of natural causes. The official cause of
death was cardiac arrest, the result of seizures caused by his diabetes.
Ferguson wonders if her son's insulin played a role. 'They say it's a
natural death. Well, at 17, it's not a natural death, I don't think'.

Incidents not isolated

Ferguson and Colleen Fuller are not the only ones who say there must be a
choice of insulins available. Marketplace has obtained several adverse drug
reaction reports from Health Canada. The reports were filed by doctors and
patients across the country.

Since 1998, 121 people on humulin, or its faster-acting version humulog,
have experienced problems including comas, seizures, convulsions and
hypoglycaemia (a sudden drop in blood sugar levels).

South of the border, the U.S. Food and Drug Administration has been flooded
with similar reports. Between September 1999 and September 2000, the agency
received more than 700 reports from patients and doctors who believe that
humulin and humulog have caused disorientation, sent people to hospital, and
have been linked to dozens of deaths.

'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 were having problems with human insulin'. Fuller told
Marketplace. Health Canada would not speak on camera with Marketplace
about the adverse drug reaction reports. But a spokesperson said the reports
are purely anecdotal and not scientific. They are no cause for concern.

Looking for help

In desperation, Colleen Fuller turned to the Canadian Diabetes Assocation.
The CDA's Martin MacInally says his organization tried to get Eli Lilly and
its competitor, Novo Nordisk not to discontinue their popular animal
insulins. 'We definitely asked them to reconsider their decision', MacInally
told Marketplace, 'but the companies...said 'This is final. This is what
we're doing'.

But Fuller is not convinced the CDA has done enough. She points to a survey
published four years ago. The Association asked its members if they were
having trouble switching from animal to genetically engineered insulins.
Forty-three per cent of respondents said they were. 'This would suggest the
CDA should follow up and find out what's going on with their members'.
Fuller says.

The British Diabetes Association heard from its members, too. It received
3,000 letters from diabetics who said they would lose warning signs of
dangerously low sugar levels. Some believed they would have died had they
not been rescued as they lay unconscious. The BDA never published a
commissioned report because it considered it 'too alarmist'.

On its packaging, Eli Lilly warns that 'a few patients' who switched to
humulin found their 'early warning symptoms' of hypoglycemic 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. 'There is
no evidence from the clinical studies that there is a correlation, or a
cause and effect relationship between human insulin and these symptoms that
you're referring to', Eli Lilly's Dr. Grossman told Marketplace.

Problems documented

Research published in prestigious medical journals like The Lancet and the
British Medical Journal has cited problems like people losing crucial
warning symptoms when they switch to synthetic insulins.

Dr. Arthur Teuscher is a Swiss endocrinologist and one of the first
physicians in the world to prescribe the newer, synthetic insulins. But he
changed his mind after seeing how one of his patients reacted. 'He had an
abrupt, sudden, hypoglycaemia', Teuscher said. 'He was rushed to the
university department and after three days...he was dead'.

Teuscher believes sudden deaths occur because some people on synthetic
insulins lose typical warning signs like sweating and trembling as their
blood sugars plunge. Dr. John Hunt is an endocrinologist who has treated
dozens of patients struggling on humulin. He does not understand how
pharmaceutical companies could deny that some people are having problems.
'To say somebody doesn't exist, when they're having major problems...they
know the solution, and the solution is being removed from them. I think this
is immoral'.

Synthetic insulin works well for the vast majority of diabetics. But those
who can not adjust aren't just frustrated that no one appears to be
listening. They are angry.

Lawsuit in the works

Colleen Fuller has organized a group of people who are about to launch the
first class action lawsuit of its kind in Canada. They're working out the
complicated details of the lawsuit and are hoping others will join their
fight as they take on pharmaceutical giants Eli Lilly and Novo Nordisk.

'I think that they need to take responsibility for their product and the
impact that it's had on people'. Fuller said. The lawsuit will also target
Health Canada. Fuller says if the drug companies won't provide choice in
insulin, the government has to figure out a way to make it possible.

Health Canada's Ian MacKay says when the drug companies pulled their
products, there was nothing Ottawa could do. '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',
MacKay told Marketplace. Fuller dismisses comments like that. '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 this
drug is available to people so that we're not subjected to these horrible
experiences'.

Diabetics can get animal insulins from other countries through a special
access program run by Health Canada. But there is a lot of paperwork and
patients have to pay for shipping and handling. On top of that, the insulins
usually are not covered by provincial health plans. That can leave diabetics
responsible for insulin bills of several thousands of dollars a year for a
drug that keeps them alive.

'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 making it as
difficult as we possibly can', according to Dr. John Hunt. Hunt has helped
patients import insulins no longer on pharmacy shelves in this country. He
says people who are able to get the animal-based insulins report fewer
problems and can get back to normal.

Colleen Fuller knows her crusade will not be easy. Her battle for choice
started when she stopped stuggling with humulin and returned to the animal
alternative. 'It was a decision which said to me, 'You are going to be using
this insulin - you are going to be involved in the fight of your life.' And
that's what's happened'.