Health
Canada Under Massive Attack by Natural
Products Maker...
Opinion by Consumer Advocate
Tim Bolen
|
Reprinted from the
Lethbridge Herald... |
Saturday, 19
March 2011 02:01
Sherri Gallant - LETHBRIDGE HERALD
Truehope, the southern Alberta
supplement producer that developed a
natural treatment for mental
illness, is taking a Constitutional
argument against Health Canada to
the federal court of appeal Monday
in Calgary.
Anthony Stephan, co-founder of
Truehope Nutritional Support Ltd., a
Canadian not-for-profit mental
health support organization, said he
and his partner David Hardy are
returning to the Federal Courts on
behalf of all Canadians. At issue is
Health Canada's authority to remove
safe and effective natural health
products without evidence of harm or
risk to consumers - which the
government agency did with
Truehope's product Empowerplus in
2003.
At that time,
Truehope struck a deal with Health
Canada allowing continued access to
the supplement for at-risk patients,
but nonetheless, as a result of
Health Canada's actions, thousands
of Canadians were left in physical
distress leading to hospitalizations
and suicides.
Truehope was victorious in court the
following year when a judge
concluded that even as Health Canada
agents were denying access to the
formula, they were fully aware that
their actions would result in harm
or danger to those who depended on
the product for their health. The
men have decided that in spite of
legal bills now in the neighbourhood
of $750,000, they would mount a
Constitutional challenge to prevent
similar seizures involving other
products in the future. When they
were denied standing to file a
Constitutional appeal in February
2010, their lawyer Shawn Buckley
filed an appeal.
Added to their legal team this time
is Vancouver lawyer Jason Gratl,
known for assisting Robert Latimer
in obtaining release into parole,
and for succeeding in preventing
Shell Canada Energy from engaging in
coalbed methane extraction in the
Sacred Headwaters (Tahltan)
territory of northern British
Columbia.
"This will be an extremely
interesting case," said Stephan.
"Because if we're successful...
To read the entire
article, click
here...
|
Sunday,
March 20th, 2011
There is an important Court
proceeding coming up this Tuesday, March 22nd, 2011
in a Federal Appeals Court in Calgary, Canada.
Health Canada has already
circulated two Memorandums that indicate that it
knows they are going to lose this battle - and that
loss will radically change the way they have to
operate. I'll show you those memos, near the
bottom of this article.
There is no question that
Health Canada, the North-of-the-border equivalent of
the US FDA, is totally, and completely run by the
very drug companies it was designed to regulate.
Just the same, in fact, as the US FDA is.
Health Canada, like its US FDA
counterpart, has a well-lubricated revolving door of
drug company executives turned Health Canada
leaders, turned back to drug company executives.
Continuously.
So, it is no surprise that
Health Canada, itself, would take on the thought
processes, and the moral lack, of the drug companies
themselves.
There is no better example in
Canada of how the drug lord run Health Canada
operates than to point out how Health Canada attacks
competitors to drugs - espoused, for instance, in
the infamous raids, and seizures, involving
Truehope Nutritional Support ltd, of Alberta,
Canada, the manufacturer of
EmpowerPlus.
Truehope, as you may remember,
was, perhaps, the first natural products company to
thrash Health Canada in a courtroom for their
actions. More, they improved their corporate
bottom line during the process.
How'd that happen? I
wrote a whole article, with court filing details,
back on November 3rd, 2009. It was called "Truehope "Raids"
Health Canada..." The introduction paragraphs summarize the
situation:
"Tuesday,
November 3rd, 2009 -
Yesterday, a
Canadian company
Truehope, the makers of EMPowerplus, the first supplement product in North
America to be protected against attack by a government agency by the Court
System, started their second round of assault against Health Canada.
Let's wish
them well...
In their
first round they slapped Health Canada around a Canadian Courtroom, getting the
Court to Order Health Canada to leave them alone. The Court ruled, simply,
that EMPowerplus, a supplement product that reverses Bi-Polar issues, did not
require approval from Health Canada, and that it was "a necessity" to the
people that used it. Health Canada employees had stopped entry of the
product into Canada (it is manufactured in the US) causing several people to
die, and many others to suffer, without it. No Health Canada employees,
however, were ever criminally indicted for those deaths."
Yup - they are
attacking Health Canada one more time - and if they win this assault they will
have completely removed Health Canada's teeth, so to speak. Health Canada
might as well, after this, lock the doors and send the employees home.
Health Canada battled
desperately through the court system, and in middle
2010 the local Judge decided that, for various
reasons, Truehope did not have "Standing"
to sue Health Canada - and Dismissed the case.
On October 29th, 2010, however,
Truehope filed an Appeal, which you can read, in its
entirety, by clicking
here.
The Appeal will be heard, with
Oral Arguments limited to four hours each side, on
Tuesday, March 22nd, 2011, in the Federal Court of
Appeals, in Calgary.
In short, the Appeal, if
granted, would remove the drug lord's most effective
Canadian tactic - the use Health Canada as a tool to
remove an industry competitor's products from store
shelves on a whim. Health Canada would be
required to get Court permission, in the form of a
Warrant, to take any action - just like in any other
type of case. The Courts, of course, require
evidence of harm, etc..., a situation very
hard to find when discussing supplements.
In the
words of the Appeal:
But,
there are some important points to take hard look at
here...
In the
original case Truehope's basic Defense strategy
was simple. They were saying: (1)
This product is necessary to save, and preserve
lives and the mental health of thousands of
Canadians - "The Necessity Defense." And (2)
There is no possible way, or process, to get a
supplement product approved in Canada. We
tried everything. We were totally blocked at
every turn by Health Canada - "the Due Process
Defense."
Both of these Defenses were
successful. You can read the
original case decision here.
Step back, with me, and look at
this situation as a whole. For the first time,
and I mean as a solid legal precedent, something
called "The Necessity Defense," was SUCCESSFULLY
used in regards to a natural product in a legal
system based upon English Common Law - and that is
VERY important. The second Defense used in the
original case was "The Due Process Defense."
Both of these legal defenses have relevance to
what's going on with the USA FDA's attack on
supplements and devices that compete with drugs,
drugs, and more drugs.
English Common Law is the basis
for the legal systems in Britain, Canada, and the
US. So, cases decided in one of those
countries have merit in the others. In the US
we have virtually the same problem.
Here, we are going to take a
look at the importance of these two legal concepts
separately, and as a whole.
The
Necessity Defense...
Usually, West's Encyclopedia of
American Law says, that a "Necessity Defense" is
activated:
"Almost all
common-law and statutory definitions of the
necessity defense include the following elements:
(1) the defendant acted to avoid a significant risk
of harm; (2) no adequate lawful means could have
been used to escape the harm; and (3) the harm
avoided was greater than that caused by breaking the
law. Some jurisdictions require in addition that the
harm must have been
imminent and that the action taken must have
been reasonably expected to avoid the imminent
danger. All these elements mirror the principles
on which the defense of necessity was founded:
first, that the highest social value is not always
achieved by blind adherence to the law; second, that
it is unjust to punish those who technically violate
the letter of the law when they are acting to
promote or achieve a higher social value than would
be served by strict adherence to the law; and third,
that it is in society's best interest to promote the
greatest good and to encourage people to seek to
achieve the greatest good, even if doing so
necessitates a technical breach of the law."
Pay very close attention to the highlighted text
just above. There is a basis here, I
think, to challenge the way vitamins,
supplements, and devices that compete with drugs
are regulated into obscurity. Merchants,
product manufacturers, and developers are simply
NOT allowed to tell the truth about their
products, for, according to FDA dictum, "that
would make a claim," and such a claim would
require the over-a-billion-dollar process
reserved for drugs.
But, what if those US
rules were challenged on the simple basis that
those rules violate the founding legal
principles, as laid out below:
"first, that the highest social value is
not always achieved by blind adherence to the
law; second, that it is unjust to punish those
who technically violate the letter of the law
when they are acting to promote or achieve a
higher social value than would be served by
strict adherence to the law; and third, that it
is in society's best interest to promote the
greatest good and to encourage people to seek to
achieve the greatest good, even if doing so
necessitates a technical breach of the law."
Especially number three.
The
Due Process Defense...
Truehope, in their strategy,
pointed out, in depth, how far they went to get
their product approved for use by Health Canada, and
showed that no matter what they did, the answer was
always the same "shut down, or move to the US."
Then Health Canada would show up, once
again, with drawn guns.
The Judge, in the
original case decision, put it this way:
[51] The Defendants argued that getting a D.I.N.
(Drug Identification Number) was not an alternative.
The Defendants presented credible and reliable
evidence that it would have been impossible to
obtain a D.I.N. for a vitamin/mineral supplement
because the drug testing regime to which D.I.N.s
applied was not suited to the testing of a
vitamin/mineral supplement which was a health food
product. The Defendants presented expert evidence in
this regard through Mr. Dales, on the classification
of substances and on applications for approvals
under the Food and Drugs Act and Regulations. Also,
Mr. Stefan understood from his dealings with
representatives of Health Canada that the Defendants
would not be able to get a Notice of Compliance (a
pre-requisite to obtaining a D.I.N.) and that the
Defendants should not bother applying for a D.I.N.
In addition, Dr. Kaplan’s experiences in dealing
with Health Canada was that the Defendants would not
get a D.I.N.
[52] Another alternative was negotiations with
Health Canada. The Defendants made numerous efforts
to met with Health Canada to work out a resolution
to this developing problem. According to Mr. Stefan,
the Therapeutic Products Directorate of Health
Canada was not prepared to work towards a resolution
with the Defendants. The only alternative suggested
by representatives of Health Canada was to stop
selling the supplement or leave the country and take
the business to the United States. Despite numerous
and various attempts to negotiate a solution with
Health Canada, the Defendants were not successful in
negotiating a resolution such as a Ministerial
Exemption or an agreement with Health Canada.
However, when Mr. LaJeunesse of the Canada Mental
Health Association intervened with Health Canada on
behalf of specific individuals to continue to obtain
access to the supplement, his interventions were
successful in every case.
[53] Health Canada’s response to the public outcry
was to establish a 1-800 crisis line that received
over one thousand telephone calls. The callers were
advised to go to a psychiatrist. By this action,
Health Canada recognized that there could be serious
consequences and harm for individuals no longer able
to access the supplement or the Truehope program.
Because of the harm associated with conventional
psychiatric treatment with medications that had
negative side effects and the fact that participants
would refuse to undergo such treatments, the
Defendants did not consider referring the 3000
participants in the Truehope to psychiatrists to be
a reasonable legal alternative.
Health Canada knows it is
going to lose...
Click here to see the
Memorandums (1)
and (2)..
It will take a month or two for
the Appeals Court to issue its written decision.
Stay tuned.
Tim Bolen - Consumer
Advocate
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