June 20, 2008

Whistleblower's letter on Bill C-51, health TYRANNY

Open Letter to Prime Minister Harper -- Re Bills C51&52, Helke Ferrie


KOS LOGO and address
June 15, 2008

793'rd
anniversary of the Magna Carta



The Right Honorable Stephen Harper
Office of the Prime Minister
80 Wellington Street
Ottawa, ON, K1A 0A2



Dear Mr. Prime Minister,

The Globe & Mail has on its masthead the following statement made by an 18'th century British political thinker known only by his nom de plume, Junius: "The subject who is truly loyal to the Chief Magistrate will neither advise nor submit to arbitrary measures." It is in this spirit that I am writing to you about the proposed bills C-51 and C-52. Nobody knows who Junius was; he might have been anybody, as indeed I am – just a Canadian who is exceedingly alarmed and cannot help but feel protective towards this great nation in the face of a public health emergency.

These two bills not only dramatically fail to address this crisis in public.

When a government falls into error, only the governed can correct that. It is my view, that in a parliamentary democracy it is the duty of the citizen is to pay careful attention to government and to offer correction to government policy when necessary – but to do so only if able to provide supporting evidence to show that government health, but actually threaten to increase this emergency to unmanageable levels, if passed. I am approaching your government in the spirit of Junius to advise against arbitrary measures and also to express clear resistance to such arbitrariness is in error. In a democracy we neither want government to shoot off their mouths, nor should we be allowed to do so either.

This book provides, I hope, that most significant supporting evidence for the contention that C-51 and C-52 are totally unacceptable, are impossible to amend, and must be withdrawn.

I should introduce myself first: For the past twelve years I have been researching medical politics and writing for various venues on a monthly basis. I also occasionally publish books written mostly by medical professionals who are especially concerned about environmental and nutritional medicine. This summer I am releasing Dr. Shiv Chopra's memoirs. Entitled Corrupt to the Core - Memoirs of a Health Canada Whistleblower . It is introduced by MP Paul Dewar (NDP), lawyer David Yazbeck, and three recipients of the Swedish Right Livelihood Award, namely public health scholar and oncologist Dr. Samuel S. Epstein, physicist Dr. Vandana Shiva, and Maude Barlow of the Council of Canadians. Dr. Chopra's book covers his four decades as a Health Canada regulator during which he determinedly fought to uphold the Food and Drugs Act and follow its Regulations, in order to protect the Canadian people from unsafe drugs.

As you will recall, he and his colleagues, Drs. Margaret Haydon and Gerard Lambert, managed to have that Act obeyed, against all political odds, so as to prevent bovine growth hormone (rBST – a carcinogen) from being passed in our food supply. For that service to the public, as you will also recall, they were fired in 2004 on grounds of insubordination by your predecessor, then Prime Minister Paul Martin.

At that time, given your campaign promises of transparency and accountability, many of us, myself included, had hoped and actually expected that you would take the necessary steps to reinstate these scientists and support them in their exercise of due diligence on behalf of public health. However, on May 20'th this year, the Canadian Association of Journalists listed you as the top nominee for this year's Code of Silence Award for "having muzzled cabinet ministers, civil servants, and particularly professional scientists." Then you closed the data base for freedom- of-information inquiries, a research tool meant to help Canadians keep their governments accountable and transparent.

Most governments, once elected in sufficient numbers to form a government, only partly fulfill their campaign promises. In general, the electorate is as forgiving of the human inconsistencies in our friends and loved ones as they are of broken government promises. However, when the inconsistencies become too overwhelming, the relationship breaks down, usually irreparably, and the injured party resorts instinctively to self-defense. We may have reached that point.

These glaring inconsistencies between promise and action in your administration make it hard to trust the stated intent of bills C-51 and C-52; they are not difficult to understand. If passed into law, they would pose a threat to public health, the rule of law, and the freedom of scientific research. Both bills, to my mind, display an equally unparalleled disregard for the spirit, and most probably also the letter, of Canada's Charter of Rights and Freedoms. The public has been repeatedly told that the government has only good intentions with regard to C-51 and C-52. Now, it seems to me that the contract between a people and its government cannot possibly ever be carried out on the basis of trust. Laws are guarantees.

Pronouncements of intent mean literally nothing.

The most recent attempt at calming down the tens of thousands of angry Canadians who have made themselves heard since April 8, has been a proposal to amend C-51; this was presented by the Honorable Tony Clement on June 9, 2008. Those amendments appear to be of dubious parliamentary legality, as pointed out by MPs Marlene Jennings in her e-mails, and as was stated in the House by MP Robert Thibault who suggested this was possibly Contempt of Parliament. MP Jennings wrote: "I've been an MP eleven years. It is the first time that I see such a thing! Normally, the government does not table amendments at committee stage, only after all the experts and witnesses have been heard."

Worst of all, Health Canada arranged for so-called "stakeholder" meetings across the country to reassure outraged citizens about C-51; this exercise bordered on the absurd: people were invited to meet with representatives from the largest drug companies, who were co-sponsoring most of these events, in order to discuss public concerns about a government bill which is supposed to regulate those very companies. Just how scary can it get?

We are in the midst of a public health crisis caused by food contaminated with health hazards such as pesticides, genetically engineered food plants that we now know promote systemic disease, and pharmaceutical drugs based on fraudulent science and therefore having become the leading cause of death. This assertion is supported by verifiable, non-industry funded science from around the world - I was as amazed and shocked to discover this as everybody else.

I myself used to wonder if the "natural health crowd" was just a bunch of treehuggers , but it turns out the are all mainstream scientists, some even Nobel laureates, and many are outraged refugee scientists from the genetic engineering industry itself. Much of the evidence is presented in this book.

With regard to pharmaceutical drugs being the leading cause of death, this has been made public by the premier medical institutions in the world and since 1998 has been the subject of many research projects published in the world's "big five" medical journals, including the Journal of the Canadian Medical Association. In fact, this line of inquiry was first started, with the cooperation of the United States FDA, by Professor Bruce Pomerance of the University of Toronto. Ten years ago, he concluded that properly prescribed and correctly taken pharmaceutical drugs might be the fourth leading cause of death in North America. More recently, Johns Hopkins Medical School refined this research, largely due to the increasing death statistics which became available in the intervening years, so that now it is the leading cause of death, outpacing cancer and AIDS.

As reported in the CMAJ, in Canada, at least 23,000 people die every year from pharmaceutical drug-related problems; these are only the reported deaths. Both the FDA and Canadian experts believe the rate is much higher. Due to this constantly rising death toll, the CMAJ observed on January 4 and March 15, 2005, that Health Canada is not adequately monitoring the safety of marketed drugs and has "demonstrated a structural inability to do ongoing safety monitoring of new drugs and devices."

Unfortunately, bill C-51 does nothing to improve this situation because it doesn't even define safety, while the Food and Drugs Act, which supposedly requires "modernization", has very clear concepts of safety in its regulations - the very ones that allowed Dr. Chopra and his colleagues to identify those dangerous drugs they persistently opposed. The same is true for C-52, and both bills share the fact that they import into the regulation of foods, drugs, and hazardous products the wholly inappropriate concept of risk management instead of risk assessment. The difference between these two concepts is that the first assumes there will be a body count and tolerates some exposure to hazardous substances; the decisions to be made under such management have to do with how many bodies and how much hazardous contamination the government can comfortably get away with. Risk assessment, on the other hand, determines the level at which people are harmed – and then such substances must be banned.

Defining safety in both bills would result in a huge number of drugs and hazardous substances having to have their original marketing approval re-examined for purposes of assessment and potential withdrawal – as the European Union is doing now. Many would have to be recalled because the original approvals were not based on the available science and often granted under political pressure. In medicine, we even know with which ones to start the clean- up. The CMAJ told us so in their June 2, 2008 issue: they include especially the antipsychotics that Truehope so successfully replaced with safe natural products that also are so truly effective.

These and many other potent pharmaceuticals also end up in the water and are ingested by people for whom they were not prescribed – something C-52 does not even address. About 14 million emergency room visits take place in Canada annually only due to adverse drug events.

Given there are only roughly 30 million Canadians, this number is staggering and suggests that hundreds of thousands of people have more than one such experience per year.

It is my understanding, that government is mandated to manage health care with integrity.

Therefore, I was astounded when I read in The National Post on May 6'th, 2008, that your former communications director, Geoff Norquay, was directly involved with the lobbying efforts of pharmaceutical companies to restrict the availability of the far cheaper (and far safer because of proven post-marketing experience) generic drugs. I also find it hard to swallow that within a month after one of your close colleagues, Ken Boessenkool, registered as a lobbyist for Merck Frosst, your 2007 budget had $ 300 million allocated for their genital wart vaccine (marketed for cervical cancer) that has the highest rate of deaths and complications reported for any vaccine, namely Gardasil. This is very disturbing optics.

Not a single death is known so far to have been caused by a natural health product. One of the overheads I frequently show at lectures is a chart provided by the World Health Organization showing that the most dangerous thing one can do in an industrialized country is to be admitted to hospital, while the chance of being harmed or killed by a natural health product is the same as being hit by a meteor. What complicates this drug crisis further is the fact that pharmaceutical drugs are the source of enormous wealth and that Canada is one of the governments that has supported the increase of wealth from that source, not the decrease of the damage these products are causing .

Your policies appear are falling into that principal error Junius advised against; these two bills provide the evidence. That error is arbitrariness. It is defined in the Oxford English Dictionary as: "Based solely on personal wishes, feelings, or perceptions rather than on objective facts, reasons, or principles."

Throughout C-51 and C-52, all sorts of enforcement provisions are relegated to Orders in Council – away from public scrutiny, unencumbered by messy parliamentary debate, and certainly free from probing questions from the press. Most surprising, and absolutely unacceptable, are those provisions that have to do with foreign governments and regulatory agencies – in which Canadians had no vote. I doubt this is legal. Unless Canadians read the Canada Gazette regularly, they would not even know that some deal has been struck with a foreign regulatory agency and that those foreign provisions have suddenly become law in Canada.

This is incomprehensible in view of your own publicly stated concern about Codex Alimentarius, for example, in 2003 when you were supporting MP James Lunney's bill C-420. Yet, as Prime Minister, I found on Health Canada's website that as of December 7 of last year, a "confidential" agreement already exists for such regulatory cross-Atlantic importation with the European Union and the European Medicine Agency. The only thing that seems to be still needed to make this all legal is the passage of C-51.

The Honorable Tony Clement's attempt at introducing some accountability into C-51 by changing "may" to "shall" in C-51's section 20.4, so now "the Minister shall establish, committees for seeking advice" on complex issues of science in medicine, insults every Canadians' intelligence . Unless those committees are independently picked, and unless such exercises are open to the public, and unless the results are debated in Parliament, this proposed amendment does not at all ensure that the same old cherry-picking of suitable "tobacco scientists" won't continue to happen: in the provisions in C-51 the industry is included among those the Minister may pick from for advisory committees. However, it is the industry that is to be regulated . In any case, who cares if "may" is now "shall", because none of the Order in Council provisions have been removed, as they should be, if any transparency and accountability is to be guaranteed to the public.

The assurance that the government wishes to introduce a separate definition for natural
health products, reported in the national press for the past few days, amounts to nothing at all in practice: natural health products are still part of the overall regulatory intent of bill C-51; the Natural Health Products Directorate of Health Canada did not incorporate the 53
Recommendations given by the Standing Committee on Health a decade ago, and C-51 is not correcting that blatant disregard of its own government advisers; all natural health products are still regulated as a "subcategory" of drugs and assessed within the drug model of approval, as the Minister himself has written in his many e-mails to Canadians; and Schedule A still stands prohibiting most diseases from being treated by natural health products (contrary to the mass of mainstream scientific evidence showing that they can); and the (sadly) most lucrative of all disease groups (depression, acute anxiety, including bi-polar disorder) was deliberately moved out of the category of diseases which may be treated with natural health products – even though none of them are Prozac-deficiencies and the Truehope clinical trials have proven that even the most severe mental health conditions are ultimately disorders of nutrient absorption and nutrient metabolization. Telling Canadians natural health products will be recognized as a special category of its own means nothing unless that category is on par with the pharmaceutical drug categories and entered into law as a choice patients can make – which is what about 70% of us want.

The entire damage-control exercise undertaken in the past couple of weeks leaves a very bad taste in the mouth and will inevitably cause the public anger to increase, once everybody has figured out that they have once again been had.

That brings me to the reasons provided both by the Honorable Tony Clement and the information found on Health Canada's website regarding the necessity for these bills. The examples given are of a batch of fluoridated toothpaste contaminated with some toxic chemical .

A simple, classic contamination event that was cleared up without difficulty under the existing law. Yet, the daily poisoning of people and the environment with fluoridation continues unchecked – despite the scientific evidence . There is nothing in C-52 that could even begin to deal with this problem, nor is fluoride listed among the substances to be banned – as it should, if science was heeded or, at the very least, the precautionary principle was applied.

Also mentioned were cases of alleged liver toxicity caused by a botanical remedy derived from black cohosh, and the contamination of some herbal product with the active ingredient in drugs that treat erectile dysfunction. Canadians are supposed to believe that this immense legislative exercise is justified and prompted by these tempests in a teapot. Given the ongoing disaster of hundreds of deaths per day from Health Canada-approved pharmaceutical drugs, and given the fact that almost every drug listed in the CPS has some level of liver toxicity associated with it, these examples are like having an emergency room full of people bleeding to death while the government attends to a nosebleed, as a doctor recently said at a rally in Toronto organized to protest C-51.

You may be interested to know that the information your Health Minister used to defend C-51 is problematic. He was apparently relying on reports now about 4 years old, still posted on Health Canada's website (the links provided for verification purposes are no longer accessible), and still not updated or substantiated. So, I went to the National Institutes of Health, whose entry on black cohosh was updated on January 16 of this year and therefore is somewhat definitive. It turns out, that the NIH is currently funding a double-blind placebo-controlled cross-over study on this botanical for treatment of menopausal symptoms. Furthermore, the American College of Obstetricians and Gynecologists recommends it as helpful and safe in their most recent consensus opinion, cited by the NIH. It is so safe, that it is considered a food and unregulated in the US. The alleged liver damage occurred in people who were on all sorts of drugs, including teenagers experimenting with hard drugs at the time of sustaining liver damage; five died in Canada and one in Canada, but the information on the circumstances can no longer be accessed.

In light of this information, it will be difficult to convince menopausal female Canadians, who are well aware of the risk of cancer and heart attack from standard hormone replacement therapy with synthetic drugs, that C-51 is needed to protect us from black cohosh.

As for yohimbine, it has indeed many properties in common with the active ingredient of Viagra (sildenafil), but the fact is that it was first nature that created aphrodisiacs, then drug companies made the synthetic analogs. Consequently, it is not surprising that the more likely story behind this otherwise unimportant contamination event is a potentially embarrassing federal case brought by Strauss Herbal Co. against Health Canada.

As for the references to toxic heavy metals, the current Food and Drugs Act is perfectly able to handle those types of emergencies and has done so in the past; heavy metals are known to be toxic since before even that act was written and have been one of the reasons public health legislation began in the 19'th century.

Finally, the explanation given that we must protect people against contaminated foreign foods, from China for example, is really a good case of the mote in Chinese eyes and the beam making vision impossible in Canadian eyes: if the government was truly guided by published science of verifiable integrity, it would be our food supply that should be cleaned up from pesticides, genetic and prion contamination and the like, so we could sell it to Europe, where they don't want our food products; they have even defied World Trade Organization court rulings, when ordered to import Canadian foods because they know much of our food products carry the risk of cancer, the potential of Mad Cow Disease, and may increase antibiotic resistance.

Thus, neither the Health Canada website, nor the communications that have so far come from the Honorable Tony Clement, have given Canadians any reasonable justification as to why we need our Food and Drugs Act urgently modernized. In contrast to the non-information coming from the Health Canada website and the Honorable Tony Clement's pronouncements, one of your own caucus' MPs, Dr. James Lunney, whom you strongly and publicly supported in 2003 when he brought forward bill C-420 – a bill which was informed by a radically different spirit and completely unlike C-51 – made some real sense when he spoke in the House on June 9.

He read into the record the statement made by the members of the 39'th International Congress on Nutritional Medicine which was then winding up in Vancouver. It was a resounding critique of the intent and purpose of C-51, all of which still applies after the attempts at damage control by the Ministry of Health. It would so much more reassuring if bill C-420 were brought back to life and you, too, would return to the principles that you stated in your letter of support at that time.
This now defunct bill was one of the main reasons Canadians gave you a hesitant chance at running this country. Much of what you said before you were elected had the full support of the public; most of what you have done since, has not. Bill C-51 also shows a remarkable disregard for the independence of scientific inquiry.

Even clinical trials would be subject to the Minister's arbitrary powers, both in agriculture and medicine. Possibly this is the most appalling part of both bills: the cavalier readiness to manage even science as if it was a commodity. This lack of respect for the necessary independence of science is coupled with an equally cavalier attitude to the courts, as best illustrated in the Truehope case.

In December 2007, almost two years after you took office, Health Canada proceeded to raise accusations against Truehope Nutritional Support Ltd as if no court order had been given by Justice G. M. Maegher of the Alberta Provincial Court. The order required Health Canada to back off totally and for Truehope to continue its clinical trials involving the treatment of extreme bi-polar disorder in some 3,000 patients, and this order was given under the Criminal Code of Canada; Health Canada failed to appeal it because there were no grounds for appeal.

What should have happened, following the July 28, 2006, judgment, is that Health Canada should have immediately cleared the requisite natural health products used in this trial, especially in view of the fact that the astonishingly successful results of this trial had already been, and are continuing to be, reported in the leading mainstream psychiatric journals.

Your government may go down in medical history as having stood in the way of one of the greatest medical discoveries – how to treat successfully one of the most expensive and difficult mental health condition that affects about 18 million North Americans and costs $ 4 billion in direct medical costs annually.

The sense I get is that there is a misunderstanding with regard to what – for the want of a better term – one calls "job description". A Prime Minister is not a CEO. Members of Parliament are not shareholders. Citizens and the scientific enterprise are not stake-holders.

Canada is not a terrain for prospectors seeking a fortune. Most importantly, whatever happens in our national home is established by the courts, not by a Cabinet that misunderstands itself as being a board of directors. If Canadians agreed with such changes to the very essence of government, changes to the Constitutions will have to be made first – by public consultation.

Canada is first and foremost the home of some 30 million people who do not wish to be used as means towards ends that their elected government decides upon and then merely announce these decisions as Orders in Council in the Canada Gazette. It is not the job of government to redefine citizens into customers for enterprises chosen by government.

Some 97% of us do not want to eat genetically engineered food. The Royal College stated in 2004 that on no issue in the history of public polling has there been such overwhelming consensus as on the public's rejection of genetically engineered foods. Therefore, why does your government not immediately proceed to pass bill C-510 and C-448?

More than 70% of us prefer medical therapies that have been developed by mainstream medicine from substances that cannot be patented and which do not carry the demonstrated risk of organ and systemic injury or death. So, why does the government not implement the 53 Recommendations of its own Standing Committee on Health?

Some 83% of us do not want to have our regulatory systems harmonized with those of the US and Mexico (or any other country or regulatory agency such as Codex) as proposed by the Security and Prosperity Partnership (SPP). By what legal right or mandate do you support the harmonization of health care and health regulation with other countries and large corporations?

Parliament makes laws, not corporations. We did not elect those corporations and we are not even partners in this Security and Prosperity Partnership; in fact, we are deliberately excluded.

Following the February 23, 2007, SPP meeting in Ottawa, one of its members, Ron Covais of Lockheed Martin (the world's largest weapons manufacturer whose products are hardly good for anybody's health) told a reporter: "The guidance from the [government's] ministers was: 'Tell us what we need to do and we will make it happen.'… [explaining that] rather than going through the legislative process in any country, the Security and Prosperity Partnership must be implemented in incremental changes by executive agencies, bureaucrats and regulators. 'We've decided not to recommend any things that require legislative changes, because we won't get anywhere.'"

I certainly hope they won't! Before corporations make our parliament buildings into a five-star hotel, the Charter will have to disappear, doctors have to be stopped from free and independent scientific inquiry, and some 30 million of us will have to become zombies through enforced intake of antidepressant drugs. I certainly don't think that will happen either.

Since bill C-51 does nothing for medicine and C-52 does nothing for the environment and neither protects us against known health hazards, it is difficult not to conclude that bills C-51 and C-52 are instruments for those "incremental changes" corporations want for their own purposes.

However, there is that major difficulty that stands in the way like a mountain: the Charter of Rights and Freedoms. It is the contract the people of Canada have with you. It spells out the terms of a civilized relationship.

Yours respectfully,

Helke Ferrie

KOS Publishing Inc.

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