Health Canada blocked quit-smoking aid after Pfizer complaint

smoking

Health Canada set out to drive a Canadian-made stop-smoking aid from the market after a complaint from Pfizer Canada Inc., a pharmaceutical company that makes competing products, a judge has found.

In its first few months on the market, a lozenge called Resolve, billed as a natural way to stop or reduce smoking, sold more than 250,000 cartons across Canada, according to its manufacturer, The Winning Combination Inc. (TWC) of Winnipeg. Then Pfizer wrote Health Canada a letter saying the product posed health risks. (That same year – 2007 – Pfizer sought and obtained Health Canada approval for a quit-smoking prescription medication, Champix.)

What followed, according to a scathing ruling from Federal Court Justice James Russell, was a process in which a lone bureaucrat, Robin Marles, set up roadblocks to Resolve while other Health Canada officials stood by or supported his efforts. At every stage, as the company tried to make its case for a licence to sell Resolve, Dr. Marles, the director of Health Canada’s clinical trials bureau, denied it any fairness, Justice Russell said. (Under Health Canada rules at the time, a company could sell a natural health product while its application for a licence was under consideration.)

Checks and balances “were abandoned and those with the authority and responsibility to make the decision simply followed Dr. Marles’ directions, whose directing mind appears to have lost all sense of objectivity and procedural fairness as he attempted to shore up his own misperceived conclusions,” Justice Russell wrote in his 68-page ruling this month.

The result: Resolve was wrongly banned from the market for eight years, he said. Rather than send the matter back to Health Canada to rethink whether Resolve meets its standards – the normal course for this situation, he said – he ordered Health Canada to approve a natural-health-product licence within 30 days.

“To simply return the matter for reconsideration to a system that has shown itself to be so dysfunctional might simply plunge TWC back into the quagmire and trigger more litigation,” he said. The judge did not criticize Pfizer.

Shazad Bukhari, chief executive officer of The Winning Combination, said the company did not receive fair treatment from Health Canada. “The sense of fair play you would expect and you hope the government would provide isn’t always the case,” he said in an interview.

Dr. Marles would not comment when reached by phone.

A spokeswoman for Health Canada said the department is appealing the court’s decision. “The department remains committed to a fair and impartial review of all health product licence applications,” she said.

Pfizer said it had been beyond reproach. “Pfizer Canada always conducts itself appropriately,” a spokesman said by e-mail after receiving a copy of the ruling from The Globe and Mail. “There is absolutely no conclusion or statement in the court decision to indicate otherwise.”

Justice Russell said that after Pfizer complained to Health Canada in mid-2007, the government claimed Resolve contained a substance drawn from passionflower, and would be harmful. The company showed independent lab tests confirming the product contained no passionflower, and Health Canada ultimately accepted that it was not harmful.

Next, the judge said, Health Canada said Resolve was not a natural health product, defined as one whose key ingredient occurs in nature, or is a synthetic version of a natural product. Instead, it said, Resolve was a drug, and would need a more thorough process to prove its effectiveness.

“Dr. Marles has conceded that he had no evidence that the active ingredient in Resolve was not a [natural health product]. All he had was his own opinion,” Justice Russsell wrote. “And yet Dr. Marles actively sought to have the Active Ingredient delisted … without giving any notice to TWC that classification was a problem.”

Then came a “reconsideration,” at the company’s request, in which Health Canada retained an expert – Dr. Marles’s former postdoctoral supervisor. The reconsideration came to the same conclusion – that the key ingredient was not natural. But the ruling said the expert had done a faulty search of a database, and missed convincing evidence that it was natural.

Finally, accepting that Resolve was a natural product and not a drug, Health Canada said it would need conclusive evidence it was effective – a standard that it had not applied to any other natural health products, or even to drugs, Justice Russell found.

Even in its handling of the court case, Health Canada allowed Dr. Marles to serve as its front man, the source of all evidence about how it handled Resolve.

“He is an advocate for himself. Health Canada remains firmly in the hands of Dr. Marles and is apparently unwilling to provide the court with reliable factual evidence from others in the system who were involved,” Justice Russell wrote in the ruling. Health Canada never should have fought to uphold Dr. Marles’s conduct in court, the judge said.

So reprehensible was the government’s conduct, he said, that Health Canada must pay The Winning Combination’s legal costs, which Mr. Bukhari estimates at $1-million. The company laid off 15 employees, at a time when it had just 35, and its suppliers laid off more, Mr. Bukhari said, adding that the company now has 100 employees, and plans to launch Resolve in Europe, Australia, South Africa and elsewhere.

Pfizer’s quit-smoking prescription medication, Champix, was described in a Canadian Medical Association Journal article in 2011 as being linked to an increased risk of cardiovascular problems. Health Canada has published warnings, but has allowed it to be sold.

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LSL -Welcomes Clancys Pub & Grill to our upcoming 2017 Calendar

Locals Supporting Locals is currently putting together our 2017 Calendar and we are putting together some quick shorts describing who they are what they do and how to find. Clancys Pub is located at 333 Martin street Penticton. Fb link – https://www.facebook.com/Clancys-Pub-…

If you wish to become a sponsor there is time our deadline is October 7,2016
Please contact us :Kevin Proteau -250-770-9789  or email us at kevinproteau.locals@gmail.com

Bayer has confirmed its $66-billion purchase of Monsanto

Please find below, today’s press release from CBAN.

Monsanto is already the largest seed company in the world, and dominates the sales of genetically engineered crops. The Bayer takeover of Monsanto is actually just one of three mega-mergers in seeds and pesticides that would result in just three companies controlling around 60% of the global seeds and pesticide markets. Six companies already control over half of the market. See the details below or at http://www.cban.ca/Resources/Topics/Corporate-Control

This merger is now subject to review by anti-competition regulators in countries around the world. Today, CBAN and the Quebec network Vigilance OGM submitted a request to Canada’s Competition Bureau, asking them to review this merger and investigate the potential for this merger to further increase the price of seed, decrease choice in the marketplace for Canadian farmers, and stifle research and development. You can read our submission here:http://www.cban.ca/Resources/Topics/Corporate-Control/Comments-submitted-to-the-Competition-Bureau
You can also send your own comment to the Competition Bureau here:http://www.competitionbureau.gc.ca/eic/site/cb-bc.nsf/frm-eng/GH%C3%89T-83KK9Y

For further discussion of the impacts of corporate control you can also read CBAN’s GMO Inquiry report “Are GM Crops Better for Farmers?”www.gmoinquiry.ca/farmers

Press release from the Canadian Biotechnology Action Network (CBAN)

Bayer’s Takeover of Monsanto Triggers Anti-Competition Fears
Groups in Canada request Competition Bureau review
http://www.cban.ca/content/view/full/2198

Thursday September 15, 2016. Ottawa. Reports that Bayer has confirmed its $66-billion takeover of Monsanto are triggering concerns over increased corporate control in the seeds and pesticides markets from groups monitoring the impacts of genetically engineered crops and foods.

Monsanto is already the world’s largest seed company and dominates the global market for genetically engineered crops. In 2013, Monsanto controlled 26% of the global commercial seed market, and Bayer controlled 3%. Monsanto controlled 8% of the agrochemical market, and Bayer controlled 18%. (1)

“This extreme level of corporate control in seeds and pesticides risks the future of food and farming in Canada, and around the world,” said Lucy Sharratt of the Canadian Biotechnology Action Network.

Bayer and Monsanto are two out of six seed and agrochemical companies that already control 63% of the global commercial seed market and 75% of the pesticides market. (2) In addition to this merger, Dow and Dupont agreed to merge in 2015 and earlier this year, Chinese company ChemChina bought Syngenta. If regulators allow these three mergers, the resulting three companies would control almost 61% of commercial seed sales and more than 65% of global pesticide sales. (3)

Over the past twenty years, seed prices have risen at a faster rate than most other farm inputs, and the price of genetically engineered (GE) seeds is higher than non-GE seeds. (4)

“We need to examine the impacts of these mega-mergers and increasing corporate consolidation in all aspects of our food system,” said Sharratt. “Farmers need access to a diversity of seeds, at fair prices.”

The Canadian Biotechnology Action Network and the Quebec network Vigilance OGM are asking Canada’s Competition Bureau to investigate the potential impacts of this merger on Canadian farmers and farm businesses.

Corporate consolidation in the seed market over the past twenty years has been driven, in part, by the interest in genetic engineering and the potential profits offered by gene patents in particular.

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For more information: Lucy Sharratt, Canadian Biotechnology Action Network,613 809 1103.

(1) 2013 data from ETC Group December 2015, Breaking Bad: Big Ag Mega-Mergers in Play http://www.etcgroup.org/sites/www.etcgroup.org/files/files/etc_breakbad_23dec15.pdfUnpublished data for 2014 is also available from ETC Group.
(2) Ibid.
(3) ETC Group. 2016. Merge-Santo: New Threat to Food Sovereignty. March 23http://www.etcgroup.org/content/merge-santo-new-threat-food-sovereignty
(4) Research discussed in “Are GM Crops Better for Farmers?” 2015 from the Canadian Biotechnology Action Network www.gmoinquiry.ca/farmers

The Canadian Biotechnology Action Network (CBAN) brings together 17 organizations to research, monitor and raise awareness about issues relating to genetic engineering in food and farming. CBAN members include farmer associations, environmental and social justice organizations, and regional coalitions of grassroots groups. CBAN is a project on Tides Canada’s shared platform. www.cban.ca

Lucy Sharratt, Coordinator
Canadian Biotechnology Action Network (CBAN)
Collaborative Campaigning for Food Sovereignty and Environmental Justice
Suite 206, 180 Metcalfe Street
Ottawa, Ontario, Canada, K2P 1P5

FL to spray for Zika with chemical that killed 3 million bees

Planes are actively spraying a powerful pesticide to combat the Zika virus near Miami Beach despite a week of protests. Similar deployments of the spray intended to fight Zika in South Carolina this month killed nearly 3 million bees. Jay Feldman, executive director of Beyond Pesticides, joins RT America’s Simone Del Rosario to discuss the risks to health.

FORTISBC INCREASING NATURAL GAS RATES

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FortisBC has received approval from the BC Utilities Commission to increase natural gas rates, starting October 1st 2016.“Natural gas prices have risen since spring 2016. The hotter-than-normal summer, for most of Canada and the US, has resulted in higher-than-expected continental demand for electricity, which is often generated by natural gas,” said Dennis Swanson, vice president of energy supply, FortisBC.“This, combined with a slowdown in natural gas production, has led to an increase in prices during the past few months.”

The majority of natural gas customers will see an increase to their cost of gas of $0.909 per gigajoule (GJ), meaning the cost of gas will change from $1.141/GJ to $2.050/GJ. That is an increase of just under 80%. However, commodity fees is just a part of a customers bill. The changes will result in a 12% bump on the average bill.

FortisBC says the change will cost the average BC customer an extra $82 a year, a number that will likely be significantly higher for northern climates. The increase will be reviewed in three months.

** a previous version of the story used a headline indicating natural gas rates are going up 80%. While the commodity price is, it’s just one part of what makes up an overall customer bill. Customers can expect a 12% increase at the end of the day.

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LSL- Interview with Ron Barillaro on Parking Meters in Penticton

This interview is an excerpt from the rally that took place on Sept 6,2016 from the group Penticton Citizens First. We talk with Ron in regards to paid parking meters potentially being erected on both of our lakes and the potential backlash that could bring on our tourism and locals. The City has NOT engaged the citizens of Penticton on this and many other issues. Hence the group Penticton Citizens First has been formed
You can find them on FB – https://www.facebook.com/groups/11495…

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