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To: Dan Spillane who wrote (2143)6/7/1999 9:47:00 PM
From: Anthony Wong  Read Replies (1) | Respond to of 2539
 
Ethics Debate Clouds New European GM Food Law

Updated 1:23 PM ET June 7, 1999

BRUSSELS (Reuters) - Sweden is calling for "ethical
considerations" to be taken into account in the approval of new
genetically modified organisms, complicating efforts to reach
agreement on a new approvals system, EU officials said
Monday.

EU diplomats met Monday to discuss the latest paper from the
bloc's German presidency, which Germany hopes will allow
ministers to agree later this month on plans to tighten rules on
releasing GMOs onto the market.

"Sweden -- supported by Denmark, Greece and Spain --
wants the ethical situation to be taken into account, and this is
making things a lot more complicated," one EU official told
Reuters.

Other EU governments argued that there is no place for ethical
questions in this piece of legislation, and the dispute seems
likely to make it even more difficult for ministers to find
consensus on the new law, the official said.

The EU is trying to amend legislation on approving new GMOs
amid growing public concern about the safety of foods derived
from crops altered by biotechnology.

At the same time, Europe is under increasing pressure from
trading partners such as the United States to open its market to
GM crops grown by American farmers and marketed by U.S.
life sciences companies.

European lawmakers face the tricky task of streamlining a
cumbersome process while reassuring a suspicious public.

Sweden suggested the new law should have as its objective "to
protect human health and the environment and to ensure that
ethical considerations are taken into account," according to a
draft obtained by Reuters.

The Swedish proposal reflects concern in some quarters that it
is not ethical to interfere with nature by changing the genetic
makeup of plants and animals.

A group of five countries led by Denmark also called for extra
safeguards to ensure that GMOs which could cause resistance
to antibiotics used in medicine could never be approved for
commercial use.

Most countries rejected a German proposal to create a
semi-independent, centralized agency for authorizing new
GMOs, saying the idea would detract from efforts to agree the
plans already on the table, officials said.

Almost all countries also rejected Germany's attempt to
reverse plans to give more power over GMO approvals to EU
governments, at the expense of the unelected European
Commission.

German Environment Minister Juergen Trittin is still pushing for
an initial agreement at a June 24/25 meeting of EU environment
ministers, officials said.

This would allow the European Parliament, which shares
decision-making powers on environmental issues, to give the
legislation a second reading in the autumn.

"They're making some sort of effort to get a compromise, but
the different countries remain a long way apart," one national
diplomat said.

news.excite.com



To: Dan Spillane who wrote (2143)6/7/1999 9:52:00 PM
From: Anthony Wong  Respond to of 2539
 
EU Vets In Emergency Meeting On Food Scare

Updated 11:49 AM ET June 7, 1999

By David Evans

BRUSSELS (Reuters) - European Union veterinary experts
held an emergency meeting Monday to assess measures taken
to combat Belgium's food safety debacle and may recommend
tougher curbs to contain the crisis, EU officials said.

More countries around the world closed their borders to
Belgian meat and dairy products after some, including the
United States, last week imposed temporary bans on all EU
countries after cancer-causing dioxin was found in animal feed.

In Washington, EU officials were working quickly to provide
the United States with information to help narrow the ban on
pork and poultry imports, an EU aide said.

The special meeting of the EU's Standing Veterinary
Committee -- made up of member states' chief veterinary
officers -- was convened to allow Belgium to explain national
sales curbs it has introduced and for the European Commission
to detail its tougher action plan unveiled Friday.

"It's a very important decision, we need to have all the facts on
the table to give confidence to consumers," Sweden's
veterinary officer Tor Bergman told Reuters Television News
before the meeting, which is expected to end around 1700
GMT.

"The vets will evaluate the situation and there could be further
measures. We just don't know," one EU official said.

The scare has spiralled into the EU's biggest food crisis since
mad cow disease. It has virtually paralyzed Belgium's meat
industry, rocked the government just days before an election
and led to around 1,000 chicken, pig and cattle farms being
sealed off and their products being banned throughout the EU.

The European Commission, outraged by Belgium's failure to
notify it of the poisoning quickly, Friday extended trade curbs
on Belgian chickens and eggs to pork, beef and dairy products
from farms believed to have bought contaminated feed.
Preliminary analysis suggested this represented about 10
percent of Belgian chicken production and two percent of the
country's pig meat output, EU officials said.

Monday Belgium banned butter sales because it is a high fat
food, making it particularly susceptible to retaining dioxin -- a
toxic chemical, which remains lodged in the body for years.

Belgium has also been asked to explain to the Commission
why there was a delay in passing on information -- it first
became aware of the dioxin contamination in late April. Legal
action has not been ruled out.

France and the Netherlands have also had to write to the
Commission, providing information on their national measures
taken and why, despite being informed of a potential problem
on May 3 and May 12 respectively, no public action was
taken.

The Commission says it was not informed until May 27.

Dutch Farm Minister Hayo Apotheker, who last week faced
opposition criticism over not acting quickly enough to respond
to the scare, resigned Monday but said his action followed a
failure to win support for his pig sector reforms.

Belgium's Dehaene said Saturday tests on pork had found no
poisoning so far and the impression abroad that the problem
affected the whole Belgian food industry was wrong.

EU officials in Russia said food aid deliveries, which included
beef and pork, were unaffected by the scare.

But meat sales in Belgium have plunged and Renman Group,
Belgium's largest butchers' chain, said its shops would stay shut
for three or four days this week.

However, sales of alternatives have soared.

"Rabbit and lamb sales have more than doubled -- and fish
sales have trebled," Jean-Pierre Roelands, commercial director
of supermarket chain Colruyt, told Reuters.

The dioxin is believed to have spread to animal feed from a
single haulage tank at a Belgian fats and oils processing
company. How the chemical got there remains unclear.

Belgian media estimate the crisis could cost some 30 billion
Belgian francs ($767 million).

($1-39.26 Belgian Francs)

news.excite.com



To: Dan Spillane who wrote (2143)6/7/1999 10:02:00 PM
From: Anthony Wong  Respond to of 2539
 
First GM farmer destroys his crops
This is London
June 7, 1999

by Geraint Smith

The farmer who agreed to having the country's first
large-scale trial of genetically modified crops on his land
has destroyed them with weedkiller.

Captain Fred Barker says the
trustees of his family farm at
Hannington in Wiltshire forced
him to end the trial because they
are opposed to the
Government-run experiment
and were unhappy that other
crops on the farm were to lose
their organic status because of
the trial.

Capt Barker sought advice from
the Environment Agency about
how to destroy the crops. On
Saturday, he applied the
weed-killer they had suggested. He regretted having to
abort the trial, and said he believed strongly in GM
technology.

The 26-acre crops of GM rapeseed were planted at
Easter. Farm trustees are there to safeguard the land and
its cultivation for future generations.

Capt Barker told Radio 4's Today programme that he was
"gobsmacked to be summoned to London" last Thursday
to be told that the trustees were insisting that he end the
trial. "They gave me a three to none majority that they did
not want it to continue," he said. "I had no choice. I
believe strongly in GM food, I think it is fascinating, and I
am convinced it is the future of agriculture. I think in 20
years we shall all be growing it.

"The trustees looked at the broader view of the land, the
children who live on the land and the neighbours than I did
as the farmer planting the crop. I am not saying they are
wrong. I am just sad that my beautiful trial, which was
looking so wonderful, is dead. I was very proud of it, in
fact."

The company which developed the GM crop seeds,
AgrEvo, said it was "deeply disappointed" that the trial
had been aborted. It said the trial was designed to answer
vital questions about the effect of GM crops on the
environment.

Friends of the Earth said the decision to terminate the trial
would be a bitter blow to the Government, which was
supporting it as one of six GM trials. Last month, a seed
company withdrew from all GM crop trials because of
attacks by environmental campaigners. CPB Twyford,
based in Cambridgeshire, said protesters had caused
thousands of pounds of damage to its crops.

Other farmers in Cambridgeshire have consistently refused
to get involved in the trials for fear of reprisals by
protesters.

"It's not just that they destroy the crop," said one. "It's
that, in order to get at the crop, they damage other crops,
fences, hedges - you name it."

The location of GM trials, including grid references, is
freely available as a public document, although the
accuracy of some of the references was called into
question recently when it was discovered that one of them
was somewhere in the North Sea.

Environmentalists want a four-year moratorium on the
licensing of GM crops - a demand the Government has
refused. It says deciding when licensing is safe is a matter
for the judgment of scientists not the expiry of an arbitrary
period of time.

thisislondon.co.uk:80/dynamic/news/story.html?in_review_id=145217&in_review_text_id=118194



To: Dan Spillane who wrote (2143)6/7/1999 10:05:00 PM
From: Anthony Wong  Respond to of 2539
 
GM crop trial destroyed
itn.co.uk:80/Britain/brit19990607/060704.htm



To: Dan Spillane who wrote (2143)6/7/1999 10:11:00 PM
From: Anthony Wong  Respond to of 2539
 
Who picks your drugs?

Sunday, June 6, 1999

By LINDY WASHBURN
Staff Writer

Margaret Falk's arthritis started a decade ago.
Her legs hurt so much, she sometimes has trouble
walking. Over the years, she has tried all sorts of
prescription drugs to fight the pain -- including
some that gave her an ulcer.

So she was surprised this spring to find that her
managed-care company wouldn't pay for
Celebrex, a new arthritis medicine her doctor had
prescribed -- one advertised as being easier on
the stomach.

These breakthroughs in prescription medicine
mean nothing to Falk and patients like her if they
can't get the drugs. And more and more patients
are finding that it's tougher to get such medicine,
even with insurance coverage.

"I got all the way to the drugstore, but no further,"
said the 49-year-old Northvale woman.

Controlling access to costly drugs is just one
tactic in increasingly aggressive campaigns by
most managed-care companies to contain the
runaway costs of prescription drugs, the
fastest-growing segment of health care
expenditures.

Having focused on hospital and physician costs,
private insurers are now zeroing in on prescription
benefits. Expenditures for drugs climbed a steep
22 percent in 1995, followed by 18 percent in
1996, and another 18 percent in 1997.

The result: More and more patients find the
medicine they receive is not what their doctor
initially prescribed.

Aetna U.S. Healthcare, the state's largest HMO
and the one that insures Falk, adopted a policy in
February that has made it harder to get new drugs
for arthritis and, coincidentally, ulcers -- two of
the top five ailments for which drugs are
prescribed. Before pharmacies can fill
prescriptions for new "second-line" drugs such as
Celebrex, which hit the shelves in January, the
patient must try at least two weeks on an older,
or "first line" -- and usually less expensive --
medicine. The policy is called "step therapy."

Aetna is not the only insurer to change the rules
on prescription drug benefits. In addition to
Aetna's step therapy, these measure are being
taken by many insurance companies to cut costs:

Three-tiered copayments. Horizon Blue Cross
and Blue Shield, Aetna U.S. Healthcare, United
Health Group, and Oxford Health Plans have
introduced policies that use three different
co-payments. The lowest is for generics; the
middle for brand-name drugs on the company's
preferred list, or formulary; and the highest for
drugs that are not on the company's formulary.
Typical copayments are $5, $10, and $25; or
$10, $15, and $30, with Oxford's top payment
going as high as $50. Experts believe most
prescription plans soon will have this structure.

Closed formularies. These plans, which are not
widely used in New Jersey, pay only for the drugs
on the company's preferred list; the patient pays
for non-formulary drugs.

Prior authorization. For very expensive medicines,
so-called "lifestyle drugs" such as Viagra, or those
that may cause serious problems when taken in
combination with other drugs, some plans require
the doctor to get approval before writing a
prescription. Plans sometimes limit the patient to a
30-day supply, with permission needed for a
refill.

Many insurers also require prior authorization
before paying for multiple sclerosis drugs, certain
types of insulin, and other specific drugs.

More headaches

for physicians

Doctors say this micromanagement, by dozens of
insurers with dozens of different lists of preferred
drugs, is a waste of time. They say it's impossible
to keep track of all the formularies, and they can't
afford to look up each prescription they write.
They resent the constant calls and letters from
pharmacists or benefit managers asking for
substitutions.

Dr. Howard Rothman, chief of cardiology at
Englewood Hospital and Medical Center, opened
16 letters in a single morning recently from one
pharmacy-benefit company recommending that he
change prescriptions for 16 different patients to
lower patients' copayments.

"I have to put the notice in each patient's chart,
and in their next visit or prescription renewal, I
now to have spend time to address this issue,"
Rothman said. "Why should I do that for a
formulary choice that's economically driven, not
clinically driven? If a medication is succeeding at
keeping a woman's high blood pressure under
control, why fool with it, just because she
changed insurance companies?"

Dr. Sam Snyder, the orthopedist who prescribed
Falk's Celebrex, says he had noted her inability to
tolerate other medication during 10 years as her
doctor. "What is most infuriating is I have to take
my staff and have them call the insurance
company, spend 20 or 30 minutes on the phone
to get permission," he said. "Nine times out of 10,
it's denied."

Aetna defends its policy, noting that Celebrex's
claims about causing fewer stomach problems are
not yet approved by the Food and Drug
Administration. Raphael Tancredi Jr., the
company's director of pharmacy for the
mid-Atlantic region, says cost should be a factor
in choosing among medications that are otherwise
similar.

Older drugs, he said, will usually cost both the
member and the company less. If those work,
that leads to significant long-term savings --
savings that go toward keeping health care
premiums under control, he said.

But patients are often confused: They think their
prescription-drug coverage means they will be
insured for whatever their doctor prescribes.

"I don't understand that restriction," Falk said.
"They flat-out refused to fill my Celebrex
prescription." She returned to her doctor to get a
prescription for Naprosyn, which she asked the
pharmacist to fill while she made do with
Celebrex samples from Snyder.

Pharmacists, of course, are caught in the middle.
"We bear the brunt of the anger," said Matthew
H. Kopacki, who owns the Rock Ridge
Pharmacy in Glen Rock. "I'm the one who gets to
say, 'I'm sorry, it's not covered. That will cost you
$87.' "

Managed-care companies say their careful
attention to prescription drugs has a flip side:
They're watching for underuse of drugs. If a
doctor is not prescribing proper medication for a
patient with hypertension or congestive heart
failure, these HMOs will point it out and urge the
doctor to change his habits.

Cost-cutting harms

patients, doctors say

Increased spending on prescription drugs is a
logical outgrowth of better health care, experts
say, as research advances and pressure increases
to reduce hospital stays and surgery. Spending on
inhaled steroids to control asthma saves money
on emergency room costs. Drugs that slow the
worsening of multiple sclerosis symptoms reduce
the number of hospitalizations for MS patients.
Control of cholesterol may slow the clogging of
arteries, postponing or eliminating the need for
costly and risky heart surgery.

One study, published in The Journal of Managed
Care in 1996, found that when more restrictions
were placed on prescription drugs, patients got
sicker, spent more time at the doctor's office or
hospital, and needed other drugs.

"From the patients' perspective, increased use of
health care services means greater inconvenience
and longer periods of illness and discomfort," said
the lead researcher, Shirley D. Horn of the
Institute for Clinical Outcomes Research of the
University of Utah School of Medicine. She is a
medical statistician who was on the faculty of
Johns Hopkins University in Baltimore for 24
years.

So a managed-care plan, then, must strike a
balance that makes effective drugs available while
containing health care costs, the experts say.

But doctors have doubts about cost-cutting for its
own sake and question whether the full medical
consequences of some decisions are being
considered. They are particularly concerned when
they are asked to switch to drugs that are
equivalent -- but not identical.

Some drugs, such as anti-seizure medications
used by epileptics, are absorbed into the body
differently, and the correct dosage of a substitute
must be recalibrated through trial and error.
Doctors wonder whether a seizure that occurs
while a patient works out the right dosage of the
new medication is an acceptable consequence of
saving the insurance company money.

Other drugs may be similar in terms of their
primary effect -- lowering cholesterol, for
example -- but different when it comes to
secondary effects, such as changing the way
blood clots. A careful doctor will want to
consider those secondary effects when choosing a
medication, Rothman says.

Some doctors don't trust studies that measure the
effects of a natural form of a drug when they will
prescribe its synthetic form. Or they find the data
"proving" equivalency to be weak. Financial
considerations -- rather than scientific rigor --
may have swayed the managed-care company,
they contend.

Even more important is that doctors build up
hands-on experience with certain drugs over time
and become familiar with their side effects and
efficacy, said Dr. David Swee, who teaches
family medicine at the University of Medicine and
Dentistry of New Jersey's Robert Wood Johnson
Medical School. If they constantly switch among
a dozen different medicines of the same type, they
won't have that opportunity.

But Paul R. Langevin Jr., president of the New
Jersey Association of Health Plans, dismisses that
argument. "A physician has to make a concerted
effort to go out and learn about other drugs," he
said.

The struggle to contain drug costs, Langevin said,
represents the larger dynamic of today's health
care system.

"We're trying to align incentives for members,
physicians, and health plans in the same
direction," he said "Everybody has got to work to
keep costs down." Physicians and patients must
understand the cost of their choices and decide
whether the benefit is worth spending more, he
said.

FDA collecting

reports of ill effects

As the switching of drugs to satisfy a
managed-care company has become more
common, the FDA has begun to monitor possible
adverse consequences. So far, says Laurie
Burke, branch chief for the division of drug
marketing, "The jury is still out."

The agency began soliciting reports from health
care providers about problems in March 1997,
and by the end of that year had collected 108
reports, she said. It is impossible, she added, to
estimate how widespread the practice is.

None of the problems reported to the FDA
resulted in death. Nearly half were in people over
age 65, and about 10 percent led to
hospitalization or other medical intervention. The
most common problems reported were for proton
pump inhibitors -- prescription antacids.

In some ways, New Jersey has been insulated
from the most restrictive drug-benefit policies
because drug manufacturers are among the largest
purchasers of health insurance in this state. To
them, free access to drugs is an article of faith.

The Aetna U.S. Healthcare prescription plan that
excludes coverage for certain drugs is least
popular among four choices available in New
Jersey, Tancredi said. The company insures 1.7
million New Jerseyans, 770,000 of them with
drug coverage.

"We actually don't like formularies," said David
Knowlton, president of the Health Care Payers
Coalition, which represents the purchasers of
insurance for 600,000 union members and other
workers. "No drug is identical. . . . When the
formulary is imposed based on cost
considerations, rather than clinical considerations,
we have a real problem."

Although some states have passed laws requiring
managed-care plans to disclose which drugs are
on their formulary and how exceptions can be
made, New Jersey has not done so.
Nevertheless, the New Jersey Association of
Health Plans this year published a guide for
physicians, comparing the formularies of nine
major managed-care plans.

Few complaints have reached the state
Department of Banking and Insurance about drug
coverage, and no company stands out as a target
of complaints, said spokesman Bill Heine.

The state Board of Pharmacy has not addressed
the issue of switching drugs, and simply requires
that pharmacists obtain the permission of the
prescribing doctor before substituting one drug
for another.

Copyright © 1999 Bergen Record Corp.

bergen.com:80/news/drugslw199906061.htm