KRIPPS HEALTHCARE Rx
Dr. Edward J. Thorpe, B.Sc. (Pharm), Ph.D.
5413 West Boulevard, Vancouver, B.C., Canada, V6M 3W5
Dear Kripps Customer, Constance Fogal,
We at the pharmacy email you for an unusual, urgent purpose. You may have
learned recently from the news media about the controversy over Bill C-51which
has just finished second Parliamentary reading in Ottawa. The Bill will go to
Committee for further study, and then proceed to the third and final reading.
We believe the Bill as currently worded is at best, ambiguous, inconsistent and
wrong-headed, and at worst is potentially dangerous to our consumer health-care
liberties. We believe it deserves citizens' examination (see item # 6 below)
and protest to our elected parliamentarians. We urge you to look into the
matter, and if you feel it justified, to voice your concern to a government
official.
Briefly, our specific concerns are as follows.
1] The prospective law can be used to remove your rightful access to vitamins,
herbs, spices, dietary supplements & medicinal food. Promoted as a means to
protect the safety of Canadians from untested natural health products, Bill C-
51 is a wide-reaching, little publicized and carefully crafted set of
amendments to the federal Food & Drug Act that threatens Canadians rights to
natural health products. Key changes include: replacing the word “drug”
with “therapeutic product” throughout the Act, giving the Canadian Government
broad-reaching powers to regulate the sale of all herbs, spices, vitamins, and
supplements.
C-51 would require all other therapeutic products to go through an even more
costly approval process than the current regulations require, which would be
financially impossible for many natural health product manufacturers to meet,
rendering the products unavailable to the public. Currently, 65% of the
applications to Health Canada are being rejected. In the future, as a possible
result of this legislation, only narrowly defined government approved natural
health products, possibly to be considered “prescription drugs”, would be
available to you - by prescription only!
2] C-51 will result in the outlawing of thousands of beneficial low risk
natural health products. It would grant alarming new “enforcement” powers to
federal inspectors to “protect” Canadians from “dangerous”
unapproved “therapeutic agents”. Without oversight or appeal, products as
benign as, for example, dandelion greens, blueberries, bottled water or vitamin
C could become illegal to possess or distribute. As written, Bill C-51 can
classify your food as a “therapeutic product”.
3] C-51 would also allow federal enforcement agents to raid your home or
business without a warrant, seize your bank accounts, and levy fines up to $5
million with jail terms up to 2 years for selling or drying herbs in your
kitchen, such activity now to be categorized as “controlled activity”. Bill C-
51 allows for the confiscation of your property, and then the charging of
storage fees on that property plus a charge for the government bureaucracy's
time! In effect, such legislation will destroy an industry that is the age-old
alternative to conventional allopathic medicine. Natural medicine works well,
is increasingly scientifically-based, and is traditionally and widely used in
North America, Europe, and Asia. Bill C-51 would criminalize the sale or even
the free distribution of “unapproved natural products”.
We appreciate your consideration of this matter. We believe this Bill should be
stopped in its entirety. Please see below for how you can act to make a
difference in the outcome of this legislation.
Sincerely,
Edward Thorpe
Tel: 604-687-2564 - Fax: 604-685-9721
Toll Free: 1-877-312-8822
www.krippspharmacy.com <http://www.krippspharmacy.com> - altermed@portal.ca
1) Contact your Member of Parliament ASAP.
Inform him/her that:
- you are opposed to Bill C-51;
- you want him/her to vote against Bill C-51;
- you want your access to natural health products protected.
To find out who your MP is, search by postal code at
http://www2.parl.gc.ca/Parlinf
2) Forward this e-mail to everybody you know and request that they do the same.
3) Phone your MP and the Prime Minister's Office to voice your concerns.
Dial toll-free 1-866-599-4999 and ask to be transferred to any MPs office. The
hours of this service are:
Monday - Thursday, 8:30 - 6:00 pm Eastern standard time
Friday only, 8:30 - 5:00 pm Eastern Standard time
Stephen Harper's phone numbers are (613) 992-4211 and (403) 253-7990.
Tony Clement's phone numbers are (613) 944-7740 and (705) 746-9053.
4) Introduce this issue to your local media.
5) Also write a handwritten letter to:
- your local MP;
- Prime Minister Stephen Harper;
- Tony Clement, Minister of Health.
You can send your letters without postage to:
(Name of person)
House of Commons
Ottawa, ON
K1A 0A6
6) Get more information
Read the transcript of April 30th's House of Commons debate on C-51 here (note
that the debate has not finished yet):
http://www2.parl.gc.ca/HousePu
Read a copy of Bill C-51:
<http://www2.parl.gc.ca/HousePu
Read a Draft Discussion Paper on Bill C-51 by Shawn Buckley, president of the
Natural Health Products Protection Association: http://www.nhppa.org/. See
also: www.stopbillc51.com
Thursday, May 1, 2008
Debate in the House of Commons on Food and Drugs Act
The House resumed from April 30 consideration of the motion that Bill C-51, An Act to amend the Food and Drugs Act and to make consequential amendments to other Acts, be read the second time and referred to a committee.
Mr. Speaker, I am pleased to speak this afternoon about Bill C-51. As always, the Liberal Party aims to improve the safety and health of Canadians. We support measures that strengthen the regulatory process so that Canadians can have access to the safest and best foods and therapeutic products. The drugs on the market are not a great risk for the health and safety of Canadians.
That being said, we see this bill and the other bill as a huge missed opportunity. As often happens with the government, it is what is not in the bill that is remarkable, including just taking out the whole section of the bill on the pride of Canadian health policy, which is the interdiction against directed consumer advertising.
We look again to a government that seems to be more interested in business than in patients. Although we believe there is a need for the minister to have the ability to take unsafe health and consumer products off the market if the companies are unwilling to do so, the powers given to the minister in this bill are unbelievably unreasonable. It is not putting in place the kind of scientific advice that would be very important in terms of a minister being able to administer the Food and Drugs Act based on evidence in science and not ideology, and the way the government's friends in business are behaving on just about everything else.
It is important that the Food and Drugs Act be updated. Up until now, as everyone knows, the product safety system has functioned purely on a voluntary basis. If a product is dangerous or poses a health risk, corporations can issue a recall.
This bill would grant the minister the power to enforce the recalls rather than depend on the voluntary system. Certainly, those of us in the health committee have heard this from many witnesses, including the department itself, that these are powers that the minister must have in the event of a recalcitrant company.
The bill would also grant the minister the power to seek an injunction, to enforce regulatory compliance through the Federal Court. This is a faster avenue for enforcement rather than the current system which fills up the courts by addressing each non-compliance matter at trial.
As well, the bill would improve the surveillance of therapeutic products both before and after they reach the market. This could have the effect of helping critical drugs, such as cancer therapies, get to the market quicker and yet remove them just as quickly if significant adverse reactions or incidents are reported. This has been very much the wish of a number of the groups, from cancer to HIV-AIDS, to both the providers as well as the patients.
As we have heard in committee many times, people are very concerned about hurrying and having less safeguards because we are now going to commit to doing a much better job post-market. We need to be very clear and it is the reason for the kind of scrutiny this bill would require, to make sure there is absolutely no less safe drugs coming on to the market because of this hurry up approach that is important in these very special drugs.
Because of the substantial regulatory powers the minister would have, it is obviously going to be important to study these powers to ensure transparency, effectiveness and accountability. We will see, in some aspects of this, that it seems a bit remarkable that the minister would be able to stop a clinical trial midway through without having information from the very people running the trial. There are things that just do not make a great deal of sense unless we in committee find out exactly how the government expects to carry this out.
The idea is that the Minister of Health can suspend a clinical trial authorization or the terms and conditions other than a prescribed term or condition or the suspension to prevent injury after giving the holder of the authorization an opportunity to make representation, and to suspend a clinical trial authorization if the minister is of the opinion that an immediate suspension is necessary.
My experience is that this only comes to the minister from the people supervising the trial, who are scientists. I hope we will hear in committee exactly how the minister is planning to carry this out.
It is interesting that time and time again these powers to the minister do not seem to have any provisions within the act to find out what science or which scientists the minister would be relying on in order to exercise these substantial new powers as given to him in the bill.
From licences to the discontinuing of clinical trials, to the disclosure of personal information to a person or government that carries out functions related to the protection or promotion of human health without the consent of the individual to whom the personal information relates, if the disclosure is necessary, is worrying. We will need to know from both privacy experts and from many other witnesses, particularly, I would hope, patient groups, what they think of that, as well as what they think about disclosing confidential business information to a government or to the following persons without the consent of persons to whose business or affairs the information relates without notifying that person. This is something the committee will have to look at very seriously.
Even in clause 24, it says that the minister can recall a therapeutic product or cosmetic. It also says that the minister may authorize a person to sell a therapeutic product or cosmetic even if the minister has directed a person to recall it. This will somehow need a great deal of explanation at the committee. I look forward to that.
We are prepared to allow the bill to go to the committee, but it is extraordinarily important, yet again, that the stakeholder reaction to the bill is very much around the elimination of the prohibition on direct to consumer advertising.
Barbara Mintzes, the health policy expert and professor at UBC Centre for Health Services and Policy Research, has stated clearly on the website, straight.com, that the amendment would introduce a loophole that could allow pharmaceutical companies to directly advertise drugs to consumers, a practice that is currently illegal in Canada. The proposed new wording of the bill tabled in Parliament on April 8 says: No person shall advertise a prescription therapeutic product to a person other than a practitioner unless they are authorized by the regulations to do so.
In the bill there is a general prohibition that covers direct to consumer advertising for drugs. That prohibition is now gone, which means the barrier of introduction of direct to consumer advertising through the regulations, because there is a sort of general prohibition in the bill, is gone, according to Barbara Mintzes.
Direct to consumer advertising and that prohibition has set Canada apart from our neighbours to the south in a very proud way. I am not sure why the minister is now trying to turn this around. Anyone who accidentally watches American television sees that barrage of advertising. It means people go to their doctors thinking that a certain drug will have a certain benefit, and we know that this increases the likelihood of harm as we learned the hard way with the Vioxx case.
Vioxx was brought on to the market for a very special group of patients, patients who had arthritis, but also had serious problems with their stomachs. The drug was to be just a boutique drug to deal with the patients with serious arthritis, but also for whom those drugs were too hard on their gastrointestinal tract. Instead, the drug was marketed widely to the whole population and people with arthritis thought they should be on that drug. That is when we found the drug had serious cardiac effects.
This would be a risk that one would take based on perhaps an equally serious gastrointestinal side effect for people whose ability to function would be improved by Vioxx. However, this was not the intent of the drug when it was put on the market in the first place. Now because of the serious increased risk of heart attack and stroke, it ended up causing much concern in terms of both life and disability.
It is so clear that the newer, better drug can have an effect on patients when there are cheaper, older drugs that are better, safer and have the same effect. From antibiotics to antidepressants to the kinds of drugs that are used around cholesterol, we want to ensure that physicians and patients have a real conversion about what really is the best and are not unduly influenced by television advertising. This is evidence based practice. Yet, again, we are finding the government preferring ideology and business over evidence. The evidence is that direct to consumer advertising is wrong and bad for patients. The bill would eliminate this serious prohibition on the evidence based policy and evidence based practice.
It is important therefore that we look to what other structures need to be placed around these undo powers to the minister. We need to look very seriously at the kind of advice the minister gets in order to do his best job. I have long been a believer in the fact that ministerial advisory committees need to give transparent advice to the minister. Whether it is the scientists that list endangered species, it is very important that politicians do the politics, scientists do the science and that the transmission of information from the scientists to the politician must be done in a transparent way such as the citizens of Canada can understand.
I believe people can understand why a minister might not list all 11 species on an endangered species list or species at risk list because of the politics, the economy and the reality in a certain community. However, politicians have to do their job and explain why they have made that decision when the scientists have said X and the politician or the minister has decided to do a version of X or even Y.
It is really important that we look to the models like NICE, the National Institute of Clinical Excellence in Britain, and the way in which it has involved citizens in the decisions. The bill very definitely needs resources to explain how the minister will do this.
As a family physician who did obstetrics, I quite often was at the hospital waiting for a baby to arrive during the national news. It would be quite clear that a drug would be recalled while I was not watching the news. The patients would arrive the next morning and tell me they were on whatever drug had just been recalled. I would have no information about it. A letter would arrive from Health Canada three days later telling me the drug had been recalled.
We have to get into the 21st century. If the minister is to have the powers to recall a drug or product, then the minister has to be able to communicate with the people who prescribe the drugs, not three days later after someone has lost his or her life because in that 72 hour window the doctor accidentally prescribed the recalled drug.
It will be extraordinarily important that the databases and the kind of two way communication between provinces and the federal government exist. Who actually is in charge of speaking to the doctors of the country about these products at risk? How do we get in touch with them? Until we have the resources for the infostructure, how will we get the minister and the ministry into this century to communicate with the people who count on him for timely advice on things as important as this?
It will be extremely important for the government to look at what the federal drug agency does in the United States and why that is a free-standing agency. The health protection of our country is half the people at Health Canada now. We have to decide whether we want to put a science based and a real structure in place for the drug evaluation post-market surveillance, working toward a common formulary.
Our national pharmaceutical strategy is in disarray. There are a few working groups, but there is really very little action toward the part of the 10 year commitment for health, which was in a national pharmaceutical strategy in the 2004 accord with the provinces.
The health minister has cancelled the next meeting of his counterparts supposedly for June. I do not know how we can do any of these things unless the provinces, territories and their health ministers feel they have a partner with the federal government. It will be extraordinarily important that we look at this, like we did in the very sensitive bill on reproductive technology, to ensure that any regulation must come back to the health committee so we understand the nuances and the decisions taken in the regulations, which can be so important to people's lives. It must come back the committee that has studied the bill and has now done this important study.
It is a bit rich, in the middle of a study on post-market surveillance, that the government has decided to table the bill without the information, without the recommendations of the very committee that has studied this. It was a bit shocking to hear that even the working group on the national pharmaceutical strategy, the working group on real world drug safety, was not even consulted in what should be in the bill. Yet again we have this top-down, ‘’father knows best, take it or leave it, trust us you will like it’’ approach from the government. It is extraordinary that when all of the witnesses came, when all the provinces and territories and working groups existed, that the government would not take counsel from these people who study this and who know it.
Also, almost every member of Parliament over these last weeks, since the bill was tabled, have been inundated by calls to their constituency offices on the natural health product risk. People using these products are worried again that their products are not understood because of the issue around health claims. We need to seriously look again at what the minister is considering in terms of natural health products and how we regulate these things. Some products have been used for thousands of years, but without a clinical trial. It is not evidence based, but Canadians have the right to be wrong on these things. They also have the right to be right in terms of the products that work for them. In studying the bill we want to ensure people have patient and client freedom.
These changes are just not good enough. Canada needs a national food policy. At the same time as we get this tinkering around the edges, we have from melamine in dog food, to re-labelled snap peas from China, to mushrooms from China called ‘’product of Canada’’ because they have been sliced here. We have orange juice called ‘’product of Canada’’ because Canadian water was added to it.
The government needs to sit down with all government departments that deal with food in this country, such as agriculture, fisheries, industry and international trade, and with the producers and the food security people.
We need a national food policy. We cannot even tinker with things in this bill unless we can actually have a commitment from the government to get on with it and protect the health and safety of all Canadians.
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