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WHO to ignore powerful producers of substandard medicine

4/8/2015

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Posted by Roger Bate

The World Health Organization just posted its new report on inferior medicines (http://apps.who.int/gb/ebwha/pdf_files/WHA68/A68_33-en.pdf). It is called the member state mechanism (MSM) report on Substandard/spurious/falsely-labelled/falsified/counterfeit medical products - SSFFC for short. This report is the culmination of multiple meetings of health bureaucrats to finalize how to combat inferior medicines. Or rather that is what one hoped for when the SSFFC process began a few years ago. But the reality is that this interim report does not advance the effort far and instead of reporting to, and demanding action at, the World Health Assembly this coming May, it has postponed doing so until 2017.

Perhaps worst still one can see the hands of the usual suspects in this interim report – notably India. It should be remembered that India was the reason that the anti-counterfeit IMPACT initiative of WHO was scuppered a few years ago. It’s not that the Indian government wants the world flooded with inferior medicines, but it doesn’t want anything that will undermine the rapid growth of its generic drug industry, some of whom play fast and loose with the rules on drug manufacturing.

On page 5 of the report the MSM says it will undertake “a study to increase understanding and knowledge on the links between accessibility and affordability and their impact on the emergence of SSFFC medical products and to recommend strategies to minimize their impact”.  A balanced study on this topic of pricing and access to medicines as they relate to drug quality, would be useful, whereby one would examine how driving prices too low can lead to cutthroat competition and lower quality, as well as how high pricing can encourage counterfeiters to enter markets. However, one can tell from the MSM text that only the latter type of concern will actually be investigated.

More worrying still is Annex 2, which covers items not to be covered by MSM on SSFFC. Page 16 items 2 and 3 of this Annex covers “authorized” products and “minor” infractions of reporting requirements.  Excluding such products may seem reasonable but many of the problems we encounter with substandard medicine are made by authorized firms, with minor deviations in products and reporting. After all a product with the right ingredients produced in a compliant plant by a legal firm, but that doesn’t work, is just as bad as a total fake

Take Femulan (mycophenolic acid), until recently made by Landsteiner, a Mexican manufacturer. Femulan is a generic immunosuppressant used post-transplant in patients to limit organ rejection. As such it is extremely important that it work properly, in order to ensure that the risk, suffering and expense of a transplant does not go to waste. Femulan was authorized by the Mexican government, and also several other Latin American nations. When tested it conformed to the content requirement for the medicine. It was used widely, but unfortunately it didn’t work properly.

To work it required that the tablet did not dissolve and release the active ingredient when in the acidic stomach (or it would have not functioned properly), but that it did dissolve afterwards in the more alkaline small intestine. The innovator product had an enteric coating that ensured that this occurred. Femulan’s coating did not release the product in the stomach as per the innovator, but it also did not release in the small intestine so that patients were barely receiving any active ingredient.

It wasn’t until a study was undertaken and published in 2010 in Transplantation Proceedings, that Femulan was exposed as a non-equivalent copy of the innovator, which ultimately led to its withdrawal. Although it was still available in several Latin American countries until very recently, according to Jose Santiago, a physician based in Bogota, Colombia.  The minor infractions of this product meant it probably would not be combatted under WHO SSFFC, but the product was completely useless to patients.

It is ironic that the reason that WHO IMPACT was undermined was because health activists, claimed that it was more important to combat substandard medicine than counterfeit medicine, and IMPACT was too focused on intellectual property violations and counterfeiting. The direction the WHO MSM is taking means it is unlikely to combat any of the most widespread problems with substandard medicine. 
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The Hill today highlights the recent recommendation by Europe's chief drug regulator to suspend 700 generic drugs

3/15/2015

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Posted by Roger Bate

My op-ed with Dinesh Thakur in The Hill today highlights the recent recommendation by Europe's chief drug regulator to suspend 700 generic drugs whose approvals were based on flawed – or forged – clinical studies conducted by GVK Bio, an Indian contract research organization.

We urge U.S. Federal regulators to follow Europe’s lead and move to rescind market approval for these drugs while conducting their own investigation.

You can read the op-ed here:
http://thehill.com/blogs/congress-blog/healthcare/235439-fda-should-follow-europes-lead-on-indian-drug-suspensions


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Compulsory licenses, prices and drug quality

3/10/2015

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Posted by Roger Bate

A new research paper in Health Affairs suggests that the use of compulsory licenses may not lead to cost savings, when compared with voluntary negotiations.

Compulsory licensing (CL) allows low-income countries to break innovator patents and accelerate cheap alternatives, either produced locally or imported. In some cases the price cuts of CL can be substantial, notably in Thailand, where key medicines dropped to about 10% of the original price.

But researchers (including Amir Attaran a contributor to this site) at Universities of Ottawa and Denver demonstrate that negotiations of companies with foreign governments and multilateral and bilateral donors was more efficient at lowering prices.

The paper does not analyze the quality of the drugs actually procured, but it is instructive that in only 2 of 13 cases where CL was used for local production was the price cheaper than would have been delivered by negotiation. And some of the companies, notably in Indonesia and Equador that produced as a result of CL have dubious quality records, according to local experts I spoke with.

Of course, CL remains a legitimate tactic for emerging nations when companies remain intransigent in tiering their prices for lower incomes, but it should always be a last result. The price of drugs will probably be worse, and the quality less likely to be good either.


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Ebola is not the only health concern for Africans or Americans: how Egypt aims to improve its drug quality oversight

10/30/2014

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Posted by Roger Bate

Cairo, Egypt – While its economy is still suffering from weak tourism, its new government is trying to do its best to bolster its modest regulatory structures to oversee medicines. With a population of approaching 90 million, Africa’s third most populous nation, is an important final destination for medicines, and a key transit point too. But it’s not just good medicines that Egypt needs to assess and ensure are procured, it has to prevent the bad – counterfeits made by criminals and substandard products made by legal firms.

The fake of the cancer drug Avastin that hit America in 2012 probably transited Cairo, and trade in fakes of all sorts of medicines is an ever present threat to health. Only Jordan and Israel in the region do a better job of overseeing the medicines on the market. Lebanon’s authorities try too but are often overwhelmed by the skilled and ever present Lebanese traders who trade in medicines of all varieties.

Our limited data show that Cairo’s drug quality is far better than Sub-Saharan Africa and on a par with that of India. Only a few samples of one type of antibiotic failed quality assessments (overall roughly 6% fail and roughly half of those are fakes). But the worrying thing for the Egyptian Drug Authority is that as a transit point it has a lot of unregistered drugs entering the market. Unregistered drugs may work fine, but our evidence shows they not as well made and are 5 times more likely to be substandard as registered products.

And here the drug regulator cannot do it alone. As the EDA Vice Minister, Dr Tarek Salman, is well aware the Ministry of Health needs the assistance of other agencies, such as customs, police and health authorities, in order to intercept such potentially dangerous products. A Task Force to achieve this end is being planned.

Working out the details will probably take time, but at least Egypt has identified a problem and is going to try to resolve it, which puts it far ahead of most nations, including many developing ones.

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Is India right on its processes but wrong on its drug quality?

10/13/2014

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Posted by Roger Bate

India’s government is contemplating suing my coauthors and I for defamation for some research we published last month. In our National Bureau of Economic Research working paper on the quality of Indian medicines exported to Africa we concluded that poorer quality products were intentionally being sent to Africa because of the continents generally weak oversight of drug quality. Litigation is rarely an effective method of finding the truth, more often a process to limit investigations and hide the truth, especially when those threatening have problems with jurisdiction, standing and no case at all. But the obvious indignation of many well-educated Indians made me think that there could well be folks within the Indian government and even Indian industry that have absolutely no idea of the problems its Industry has.

Assuming the data we presented in our NBER paper are accurate, is there a possible explanation for the bold-faced denial of leading Indian commentators? One possibility is that Indian companies actually do largely follow good practices, but still make some even many bad products.

Suppose a company follows decent pharmaceutical practices in formulating medicines, one could still make an inferior medicine if the ingredients were incorrect in some way. If you’re using a regular supplier, one you’ve used for years, you might have initially tested what they sent, but after a while decided to limit or cut testing in order to save costs. In such a way inferior, incorrect or generally sub-par ingredients could be used in otherwise correct formulations.

In fact your regular supplier may not have changed its practices either, but the practices of another intermediary they buy from may have changed. The world of pharmaceutical chemical supply is convoluted and largely ignored by drug regulators. Customs agents pay attention to what is transported but only to the extent that paperwork demanded is complied with – in many places the paperwork doesn’t have to be accurate. Even when it is exposed as incorrect many customs agents have neither the incentive nor the ability to follow up. If a criminal act has been exposed, or trade in a dangerous (immediately toxic or explosive) product, has been exposed then customs agents in most parts of the world will act. But many ingredients for drugs are inert and never immediately dangerous, and paperwork irregularities for such products are a low priority for customs agents.    

My research in Asia and the Middle East over the past decade culminated in several papers and books documenting some of the flaws in the intermediary stage (
see most recently this article with links). Ignoring flagrant criminal action such as cargo theft, most problems for drug quality come from inaccurate paperwork, sometimes flagrant fraud. For example I saw a bill of lading indicating that chemicals had originated in Italy, when they had been processed somewhere in China. Presumably one of the reasons for passing off Chinese chemicals as Italian, is because of the latter’s better reputation for quality. Italy remains one of the largest producers of active pharmaceutical ingredients in the world. If Chinese production is of Italian quality then there will be no problem, but if the ingredients were inferior in some way, and an Indian firm is buying what appears to be good value Italian chemicals that are no such thing, then correct production could take place in India, but an inferior medicine being produced. At that stage, assuming testing is undertaken the problem may be unearthed, but it may not. Perhaps the product is entirely fine in good storage conditions but is unstable at higher temperatures or humidity – conditions that may exist in Africa. In such a way inferior products may end up being consumed in Africa with few errors from the Indian producer, and certainly no intent to export inferior products.

Investigating deeper into the middle of drug supply chains is not straightforward, but it may be vital if we are to root out substandard medicines. Companies have to secure up those parts of the chain that others cannot follow easily. If they don’t they will continue to hear bad news about their products, and potentially damaging economic consequences to them and devastating consequences to patients.


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Indian industry doth protest too much

9/29/2014

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Posted by Roger Bate (on behalf of the authors of the paper)

India’s pharmaceutical industry wants its government to sue us because of our “smear campaign” against it (Click here) and if today’s media in India are correct, India’s government is considering it (Click here).

This so-called campaign is actually an academic study which identifies uncomfortable data that some Indian companies, or their distributors, seem to be sending inferior medicines to Africa (see below for a point by point response to their unfair allegations). The reaction by Indian industry is disgust, dismay and anger, and absolutely no self-reflection.

Every time an independent entity, be it a think tank, academic institution, physician or US FDA, finds fault in either a product or process of India’s pharma industry, the reaction is the same, deny that there are any problems. 

As Indian Prime Minister Narendra Modi meets with US political leaders he will not want to contemplate the problems of one of his leading export industries, but if he doesn’t improve oversight, India’s drug industry reputation will continue to decline, and eventually their exports will follow suit.

N.B.

1.      The vast majority of data in our paper (roughly 85%-90%) are a meta-analysis of previously peer reviewed studies in the scientific/medical literature as well as the socio-economic literature (see the peer review section in media tab of this web site for these papers). This is why some of the data may appear old. It was only when enough data had been collected did the authors of this paper start to notice the problem with Indian exports to Africa – no original study targeted Indian medicines.

2.       We did not name the companies due to concerns about litigation, which have proven correct given the alarming response from India’s industry (see point 3.).

3.       When samples were originally collected and tested, numerous attempts were made to contact Indian companies to ask about problems with quality, yet only one company,  VS International, responding to a request to confirm fakes of its ciprofloxacin on sale in Nigeria, provided any useful information. Most never bothered to reply, and those that did refused to provide any information since we were not regulators or trading partners. This means it is impossible to be 100% certain of a product’s provenance and hence another reason not to name the companies, since albeit unlikely, it is possible they are not responsible for failing products.

4.       NBER is one of the most respected research associations in the world. To be able to post a working paper requires one to be a member. Indian companies may be unaware that it is typical within the economic literature for working papers to be posted and then for peer review to take place. This is a process the same authors have followed before. All previous working papers have resulted in peer review publications and while the contents change in subtle ways due to review, the conclusions have remained consistent.  Scientific/medical publications tend to have faster peer review and hence fewer working papers promoted as widely.



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Indian manufacturers still deny drug quality problems and use same old rebuttals

9/16/2014

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Posted by Roger Bate

The Economic Times of India covered our new paper today (see here). The paper published by the National bureau of Economic Research and not AEI as claimed by the Economic Times (see here), shows that Indian firms send their worst quality medicines to Africa.

It is a shame that Indian Industry hack DG Shah continues to trot out the same arguments attacking us rather than addressing the paper’s findings. For example, he asks why did it take so long to publish a study with data going back to 2009? Many of the data were collected and published in previous papers on drug quality (see the papers on this site), what this new paper does is pull together all the data on drugs made by Indian firms over the past five years. The results are interesting yet if DG Shah’s opinions are repeated across India’s industry, then no new studies or data will do anything to cause inward investigations.

It is still too soon to see whether the new Modi Government addresses quality concerns, but assuming it also does not, then the result will be more problems with Indian products and ultimately more patient suffering.


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Canadians kept in the dark over substandard medicines

9/11/2014

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Posted by Roger Bate

A Star Newspaper investigation of drug quality in Canada (see here) demonstrates the risks patients in rich nations like Canada run from receiving poor quality medicines, especially imported from India. What is most worrying is the lack of transparency at some western health agencies. What the investigation shows is that Health Canada has hidden information about problems with medications. While it is true that educated people occasionally make bad medicine choices (think of celebrity boycotts of vital vaccinations), on the whole educated people deserve to be informed about the risks they face. They will make decisions accordingly. Health Canada, and all other health agencies, should treat us as grown-ups and give us ALL the facts.    

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Health Canada: We do not enforce the law when Canadians poison Americans

9/10/2014

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Posted by Reed Beall and Amir Attaran (respectively Phd Candidate and Professor, University of Ottawa)

On September 8, we posted a blogspot about our recent article published in Health Law in Canada, in which we write that Canada is providing haven for internet pharmacies located on Canadian soil that advertise and sell unapproved medicines illegally.  We called this a transnational transnational organized crime, which Canadian officials are knowingly facilitating.  We offered examples of our government (both of us live in Canada) of turning a blind eye, even in a case where a Manitoba-based pharmacy and its affiliated companies trafficked fake, indeed poisonous, cancer medicines to Americans.  We outlined over a year’s worth of our complaints to the Canadian government at the highest levels—including the Prime Minister, Stephen Harper—which have resulted in no law enforcement response. 

More to the point, we promised readers that we would offer updates on the complaint letter that we sent to Health Canada and other regulators on July 3, 2014, in which we alleged three bricks-and-mortar, licensed pharmacies in British Columbia and Manitoba are involved in illegally advertising and selling unapproved medicines over the internet.  As of our last blogspot on September 8, Health Canada had not even acknowledged our complaint.

What a difference a day (and a pointedly-worded blog) makes!  Lo and behold, the next morning at 7:12 AM, Health Canada wrote us the acknowledgement we were waiting for.  Here is their response—and it contains a shocking admission. 

Simply put, Health Canada admits that it does not intend to enforce the law on Canadian internet pharmacies that sell to foreigners.  We suspected this was the excuse, but now it’s official. As Health Canada’s response says:

Health Canada prioritizes its work according to the risk to health that the incident may pose to Canadians. Incidents that present a potentially higher risk to health will be actioned first. Incidents of low or nominal risk will be assessed and entered into our tracking system for possible future compliance action as deemed appropriate.

Note the underlined words: it is only when there is a health risk “to Canadians” that Health Canada prioritizes any action at all.  But if the health risk is to Americans, Europeans or anyone else, Health Canada does not even bother to assess and track those cases, much less act on them.

The dangers of Health Canada’s mentality are obvious.  It creates safe havens in which organized criminals, who may or may not be licensed pharmacists, are left unfettered to advertise and sell medicines illegally. Money is made, and while it generates externalities felt abroad, it’s without domestic ramifications.

We understand that regulatory bodies must make difficult choices when it comes to prioritizing their efforts, but we believe Health Canada’s choice to tolerate organized crime is lawless and unethical.  Canada’s courts have ruled that internet pharmacies on Canadian soil are not exempt from this country’s enforcement jurisdiction, even if they sell medicines only to foreigners. 

In behaving otherwise, Health Canada is not only putting foreigners’ lives in danger, but is thumbing its nose at the rule of law.

Craven choices like this invite retaliation, even in other sectors.  Therefore, if regulators in the United States chose to enact trade sanctions to get back at Canada’s Conservative government, that is understandable (an extreme example could be blocking new oil pipelines that Canada is counting on for billions of dollars in revenues).  After all, when Canada chooses to tolerate organized criminal groups that traffic unapproved or counterfeit medicines into the mouths of American citizens—medicines that can kill—even stern trade sanctions seem proportionate.  

Now that Health Canada has put its cards on the table, we urge the United States to aim for a very serious response that the Canadian government cannot ignore.  At very least, the United States should make enforcement action a precondition for the planned regulatory tie-up between Health Canada and the Food and Drug Administration (the Joint Forward Plan) that Canada is counting on to boost trade.

We will update this blog with future developments, as they occur.


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Canada: A Haven for Internet Pharmacies and Organized Crime

9/8/2014

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Posted by Reed Beall and Amir Attaran (respectively Phd Candidate and Professor, University of Ottawa)

In 2005, the FDA launched an investigation into pharmaceuticals bought from “Canadian” internet pharmacies online and shipped to US consumers. Of 1700 packages these pharmacies supplied, fully 85 percent of those actually came from somewhere else, but 15 percent really came from Canada.  Worse, 32 of the drugs were found to be counterfeit.  All of these pacakges were entering the US illegally, so it is interesting to ask, why is there a Canadian theme—both authentic and copied by others—to the internet pharmacy business?

We recently published an article with some answers to this question – read it (here) . Canada gained a reputation for internet pharmacy when it became big business around the turn of the century (yielding about $400 million annually by 2003) when Andrew Strempler, Kris Thorkelson, and others from the province of Manitoba discovered the wealth to be made from selling prescription drugs to Americans who could capitalize on favorable exchange rates and price controls north of the border.

At first the products that these Canadian internet pharmacies sold were legitimately sourced in Canada and approved by Health Canada, but later, the internet pharmacies began sourcing medicines from farther afield, such as India or Turkey—places where medicines entirely bypass Health Canada and its safety regulations.  Doing so is unequivocally illegal in Canadian law.

Yet despite the law being broken on a daily basis, Canada has taken suspiciously little action to enforce the law.  Canadian officials have never brought a prosecution—not even one—against Canadians who trade medicines online illegally.  Canada has even refused to prosecute those Canadians who have been found guilty of crimes in the US, such as Mr. Strempler or Nathan Jacobson, another Manitoban who conspired to launder money for an Israeli internet pharmacy. 

Canada’s inaction is not mere oversight, but a deliberate policy choice to make this country a haven for organized crime.  As long ago as 2005, the Conservative Party of Canada passed a motion in Parliament declaring that the Health Minister should not take any action against even illegal internet pharmacies.  But refusing to enforce the law does make the actions of the internet pharmacies legal, and Health Canada’s own legal opinion makes that abundantly clear:

It is a violation of the [federal] Food and Drugs Act and Food and Drug Regulations to advertise or sell, at retail or via the Internet, drugs that are not approved for sale in Canada. This applies to all Canadian pharmacies selling over the Internet, even in cases where the unapproved drugs do not enter Canada but are dispensed by foreign pharmacies and delivered to patients outside of Canada. Pharmacies licensed in Canada that engage in such activity are considered to be advertising and selling unapproved drugs in Canada.

In the wake of last year’s Avastin scare, which involved a fake cancer medicine trafficked by companies affiliated with Winnipeg-based CanadaDrugs.com, we wrote to Canada’s Prime Minister, Stephen Harper, in March 2013 complaining that the federal government never enforces the laws against illegal internet pharmacies.  We got back a polite, but empty response from the Prime Minister’s office, who forwarded our letter to the Health Minister. After more than half a year, her staff answered stating that Health Canada is “aware of the health and safety risks”, and admitted that while “some of Health Canada's authorities are quite clear,” it prefers instead to focus attention “where authorities are unclear.”

We question why a regulatory authority would refrain from enforcing laws that it says are clear, so as to focus its attention on laws that are unclear.  But avoidance seems to be Canada’s preferred approach, and in none of the responses from the Prime Minister or Health Canada was it promised that the authorities will investigate, much less prosecute, the CanadaDrugs.com family of companies for the appalling act of furnishing patients fake cancer medicine. 

But that is not all.  When two months ago we provided the authorities with fresh evidence of what appear to be rampant criminal violations nobody seems to be investigating.

On 3 July 2014 we sent a written complaint to Health Canada, the Royal Canadian Mounted Police, the Pharmacists’ Colleges in Manitoba and British Columbia, —and even the personal Blackberries of the Minister of Health and Minister of Public Safety—alleging the illegal selling and advertising of unapproved drugs by specific internet pharmacies in British Columbia and Manitoba.  You can read our (complaint here)  with all the supporting evidence. 

Basically, we alleged that 17 internet pharmacies on Canadian soil are breaking the law, by advertising medicines sourced from foreign countries or medicines that do not even exist in Canada in any form.  All these Canadian internet pharmacies have an appearance of legitimacy: they either hold accreditations from PharmacyChecker.com or the Canadian International Pharmacy Association, or have licenses for online sales from the College of Pharmacists of Manitoba, or are affiliated with brick-and-mortar pharmacies in British Columbia.  

Over a month after filing this complaint, we have had a cursory acknowledgement from the College of Pharmacists of British Columbia, but nothing from Manitoba, the RCMP, Health Canada, or the two Ministers.  Nobody has told us that criminal investigations are underway.

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The refusal to investigage clear breaches of law leads to an incontrovertible conclusion: Canada’s highest officials—including the Health Minister, Public Safety Minister and even the Prime Minister—are aware that Canada is a haven for organized medicine crime, but cannot bother to act, even on matters as serious as the fake cancer medicines allegedly trafficked by CanadaDrugs.com.  There are even close relationships between some of the criminals and people holding high office.  Prime Minister Stephen Harper even posed for a photo with Mr. Jacobson, the convicted money launderer, right under the noses of his RCMP security detail, despite the fact that Jacobson had jumped bail and was an internationally-wanted fugitive according to Interpol. 

What might it say about the Prime Minister that his heavily-armed police security detail did not apprehend Jacobson right then and there—or any time since?

Whenever politicians have close relationships with criminals, who somehow avoid arrest, it is a sure sign that the rule of law is in severe danger.  We will be reporting back on this blog if there are any developments with our complaint to Health Canada, the Royal Canadian Mounted Police, the Pharmacists’ Colleges in Manitoba and British Columbia and the Ministers of Health and Public Safety.  We will be posting their replies, or denouncing their failure to reply.  Stay tuned.


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