- Recall destroys local business
- By: John Towns(Story originally published in the Selkirk Journal February 2010, Winner of a 2011 Manitoba Community Newspaper Award for Best Feature or Column on a Business Topic)When the owners of NorthRegentRx decided to get into the nutraceutical health supply business in 2004, they had no idea that six years later they would be engaged in a deadlock with Health Canada that would cost them most of their business, their professional reputation, and even their life savings.
“They’ve forced us virtually right out of business,”explained Cheryl Swarath, one of the business partners who owns NorthRegentRx, along with her husband Jerome and friends Jody Baxmeyer and Carol Shelton. The company is based in the small hamlet of Gonor, Manitoba, just south of Lockport.
“We’ve used up virtually every cent of our savings, and we’ve gotten ourselves even deeper in debt than when we started this business,” said a frustrated Swarath. “We’re on the verge of losing it all.”
NorthRegentRx’s trouble stems from a little beige capsule called Libidus – a circulation improvement pill that’s billed as a “natural sexual performance enhancer,” which Health Canada claims is tainted with a form of the drug Vardenafil, an ingredient in the prescription drugs like Levitra or Viagra.
The problem, Swarath says, is that Libidus doesn’t contain any undeclared Vardenafil or any of its variants – and she says she’s got not only the testing to prove it, but also has a signed affidavit from a former Health Canada drug inspector that calls into question the results from Health Canada’s own testing of the product.
NorthRegentRx’s involvement with the product began in 2005, when the company inked a deal that gave it the exclusive rights to distribute Libidus in Canada. The product had, according to Swarath and her partners, been selling all over the world under the same name with no ill-effects reported, however a little over a year after NorthRegentRx signed off on their distribution deal, the US Food and Drug Administration issued a statement claiming that Libidus was tainted with Acetildenafil, an analogue of Vardenafil. Health Canada picked up on the warning and began running their own tests on Libidus, and in September 2006 – before final test results on Libidus had come back– issued a “Class I Recall” of the product, a procedure that is usually done when Health Canada suspects a “reasonable probability that the use of, or exposure to, (the product) will cause serious adverse health consequences or death.”
All samples of Libidus were removed from stores and held for destruction. Swarath says that NorthRegentRx readily complied with Health Canada, handing over all their samples, which had previously been tested as clean of any contamination by multinational chemical lab ALS Technichem, which has some of the largest testing facilities in theworld.
Swarath believes that the FDA inspectors who ran initial tests on the product were duped by a knockoff brand being sold under the name of Libidus by an online retailer. Jody Baxmeyer, another of NorthRegentRx’s owners had called the FDA office who ran the initial tests shortly after the FDA warning was issued, and discovered that the agents who purchased what they believed was Libidus had purchased a blue box of loose white pills – a very different product from authentic Libidus’ beige capsules, packaged in blister packs in a white box. After Health Canada ordered the recall of Libidus, NorthRegentRx willingly supplied them with the ALS Technichem test results in an attempt to show Health Canada that an error had been made, and that authentic Libidus contained no variants of Vardenafil.
“We just thought it’s a mistake. They’ve made a mistake,” recalled Swarath.“But, unfortunately nobody was willing to take a look at this so-called ‘mistake,’ and finally after months and months of letter writing and phone-calling, we received (Health Canada’s case file for the tests that had been run on Libidus).”
Almost two years after the initial recall, NorthRegentRx finally got their hands on the results of the Health Canada tests that had been run on Libidus through an Access to Information request. What Swarath and her partners found, she says, was that the tests themselves were flawed – not only did they not find any traces of Acetildenafil in Libidus, but the tests also failed to prove conclusively that any kind of contamination existed at all.
While the Health Canada report stated that there were indeed no traces of Vardenafil or Accetidenafil found in Libidus, it did state that Libidus contained Piperidenafil, a different variant of Vardenafil, and was therefore dangerous, according to the health agency. After looking at the test results, Swarath and the rest of her partners enlisted the help of a former Health Canada drug chemist who is now employed at a Winnipeg post-secondary institution to analyze the Health Canada results.
Though Swarath wants to avoid having his name published in case NorthRegentRx decides to take Health Canada to court, in a copy of a signed affidavit presented to the Journal, the chemist wrote that he “believes testing failed to prove the presence of Piperidenafil and the determination of the amount of Piperidenafil is flawed.”
The affidavit goes on to state that the testing done by Health Canada was not done to scientific standards, and that the determination of any contamination “cannot be concluded for legal purposes.”
Swarath says that when her scientist looked at the Health Canada test results, he was shocked to find that the testing done on Libidus varied widely, and that it seemed like samples of the product were tested very differently.
“I’m told unequivocally that there is no margin, and no gray area. Retention times on samples and standards must match exactly, end of story,” said Swarath. “It doesn’t matter if something in the tests matches if the tests are run differently.
“(In Health Canada’s tests there are) retention times that are way off, spikes that have been conveniently integrated to match. It’s what every scientist I’ve spoken to has been calling ‘bad science.’”
In documents presented to the Journal that come directly from NorthRegentRx’s copy of the Health Canada access to information file, clear discrepancies can be seen in the test reports. The two samples of Libidus tested have two very different “retention times,” meaning that the testing on the samples was run differently, but graphs of the results somehow show the same spikes that point to the product containing Piperidenafil.
In an email pertaining to the test results, one Health Canada official states that the Libidus samples were tested against caffeine, not Piperidenafil, and that the “appropriate peaks” of the test results were “integrated” by lab technicians. Testing against caffeine in place of the element a lab is actually looking for was a practice used almost 30 years ago, according to Swarath’s chemist, but it is not done any more as it is notoriously unreliable for false positives.
According to Swarath, Health Canada was actually unable to source any Piperidenafil (an apparently notoriously expensive and difficult drug to find samples of) for its testing, and approached NorthRegentRx for a sample.
“How we, a small rural company, were supposed to have had the resources to find that I don’t know,” Swarath snorted.
Now, Swarath says, thanks to a recall that was based on those flawed test results, she and her business partners are on the verge of having to shut down.
“As a result of this recall, they have destroyed our company. There’s no nice way of putting it. They have destroyed everything that my husband and I and our partners have worked for,” she said.
Swarath has spent the better part of the last two years writing letters and making phone calls to government, including to Selkirk-Interlake MP James Bezan, who has written to Minister of Health Leona Aglukkaq on behalf of NorthRegentRx.
“I am convinced that (NorthRegentRx) officials have done everything they can to satisfy the regulations and rules set in place by (Health Canada) in order for them to continue to market their marquis product, Libidus, but seem to be unreasonably thwarted at every turn by your Department,” he wrote in a letter in January of last year. “I look forward to your immediate attention to this urgent matter.”
Unfortunately for NorthRegentRx, “immediate attention” has not been forthcoming from Health Canada, who, Swarath believes, was hoping that NorthRegentRx would simply fade away and stop being a problem.
“I do believe that they’ve done everything they can in the last three and a half years to sweep this under the rug,” she said. “We’re at the point where we don’t believe that Health Canada is going to stand up and do the right thing.”
Swarath says that NorthRegentRx is still hoping Health Canada will come forward with a settlement to cover the costs of their prolonged battle, so that the four partners can move on to do something else with their lives.
“We were well on the way to crossing the $2 million mark in sales. They’ve taken away our livelihood; we’ve wound up having to take a second mortgage just to stay afloat,” she said. “They’ve damaged us, they’ve hurt us, and our reputation as a company is shot.
“Once Health Canada accuses you of selling a tainted product, most stores won’t touch you with a ten foot pole,” Swarath continued. “We were in over 700 stores and doctor’s clinics across the country. And if we’ve got 50 stores left that buy our other products, then we’re doing well.”
Calls to Health Canada officials were referred to the public relations department, who called back only to inquire about the product and NorthRegentRx, but not to offer any clarification on where Health Canada stood on the matter.
Also, calls directly to Diana Dowthwaite, Director General for the Health Products and Food Branch Inspectorate of Health Canada, who had spoken to Swarath several times about NorthRegentRx’s case, went unreturned by press time.
- Put Woody out to pasture
- By John Towns(Editorial originally published in the Selkirk Journal, September 2010)While I may have missed it when it was first released, I had the distinct pleasure (?) of viewing Selkirk-Interlake MP James Bezan's latest You Tube video slamming the long gun registry earlier this week when one of my friends emailed it to me.
Bezan has been a vocal opponent of the registry, actively toeing his government's line that the 10-year-old law requiring that Canadians register their shotguns and rifles be scrapped.
With a vote to do so set for later this month, and support for Candice Hoeppner's Private Members Bill to pull the pin on the registry fairly evenly divided in the House of Commons, Bezan took to his faithful steed Woody to try and shame Liberal and particularly NDP MPs to vote with the Tories and get rid of the registry once and for all.
What ensued was…odd, to say the least.
Bezan, atop Woody (who you might remember as Bezan's equine co-star from his introductory You Tube video) made some very serious statements about why the long gun registry should be scrapped, intercut with bizarre asides in which Bezan mugs to the camera with a series of horse-related puns.
Featured in the video were such gems as "(Liberal leader Michael Ignatieff) is whippin' his caucus? I wouldn't even whip my horse, Woody." and "Iggy needs to be reined in!" as Bezan leaned forward to pick up Woody's reins.
I'll admit, I was chuckling, but probably not for the reasons Bezan intended.
The video has since vanished from Bezan's You Tube account, but is still available online – because, as any number of internet celebrities can tell you, nothing ever disappears from the web completely.
And that's unfortunate for both Bezan and the message he was trying to get across.
The gun registry has proven itself a highly contentious issue in recent months, and one that probably shouldn't be taken lightly. On the one hand, you have the Grits and police chiefs across Canada insisting that the registry is a lifesaving policing tool. On the other, you have the Tories saying that the registry unfairly persecutes law-abiding gun owners – after all, they say, most gun crime probably isn't committed by someone using their own registered firearm.
And, frankly, nowhere in that debate is there room for jokes that wouldn't be out of place on an episode of Hee Haw.
Thankfully, Bezan realized that – unfortunately for him, he realized it too late. He and Woody's latest appearance has effectively stampeded (hey, you're right James, this is kind of fun!) over any credibility Bezan's arguments may have had. It's mildly distressing to see such a lapse in judgment from Bezan – a perfectly competent and hard working MP – or his staff, and it's a lapse that assuredly hasn't gone unnoticed by other MPs.
"It hurt his message, how on earth is anyone supposed to take his thoughts on a this issue seriously when he's making bad horse puns?" e-mailed a friend of mine who has worked extensively with both the federal and provincial Liberal parties. "I'm sure all his Tory caucus mates who are doing some tough behind the scenes lobbying to win over 3-4 rural NDP MPs are thrilled with this.
"It was a bad idea and I would never recommend that any politician I worked for ever do this," he wrote.
A bad idea is right. Bezan will now have to do some serious work to rehabilitate his image, which in just over three-and-a-half minutes slipped from "competent and hard working MP" to "awkward man making awkward jokes on a horse that looks like it would rather be anywhere but making this video."
My advice? Bezan needs to get off of Woody (who is unfortunately becoming something like the equine equivalent to Stockwell Day's infamous wetsuit) and get back to the drawing board if he still wants to do videos after this awful production.
- Nicol tapped for water taskforce
- By John Towns(Story originally Published in the Selkirk Journal, September 2011)
After raising concerns over the summer about where the Selkirk was going to be looking to renew its water supply, Deputy Mayor Duane Nicol has been named head of a Water Use Taskforce for the city.
During debate over a motion brought forward in August to authorize the drilling of new test wells for the city, Nicol said that according to figures brought forward earlier in the year, water consumption for the city is falling, and Selkirk should be looking at how to maximize its current wells while at the same time establishing a reserve fund to fund new infrastructure when it's absolutely necessary.
The drawing capacity of the city's wells is lowering as the infrastructure ages, but Nicol said that if water use was going down, the city should maximize the use of the infrastructure already in the ground before simply drilling for new wells at a huge cost to taxpayers.
Nicol was appointed to head the new Water Use Taskforce, which will also include Couns. Darlene Swiderski and Ken Beerman.
"Basically we're going to create a vision for water use in Selkirk and outline a plan to ensure that residents have access to safe and clean drinking water now and into the future," explained Nicol of the taskforce's mandate, adding that with proper planning and some water conservation practices, the city would be able to implement a new solution easily and cost-effectively.
According to Nicol, the first step for the taskforce is to determine exactly how much water the city is going to need in the coming years, based on water use rates and population projections.
"One of the first things we're going to do is try to develop a model and try and project in the future what we're going to need," he said. "Then, really, we have to look at how to meet that need."
Nicol said that the next step is to look at what kind of water drawing infrastructure the city currently has and what it will need in the future.
"We'll need to strike the right balance between water use and water conservation. We'll look at our current water infrastructure, what we need to do to make it more efficient and effective, take a look at comprehensive water conservation programs, similar to what's been done in other municipalities, and then what, in terms of new infrastructure, we'll need, and when we'll need it," he said. Once the taskforce can determine what new wells or other infrastructure will be needed and when, it can start to plan for how to fund it.
"We can start planning for that and earmarking money to put (new infrastructure) in the ground in the future, rather than hit our utility users with a massive increase at some point when we suddenly need new wells and pipes," he said.
- Oak Hammock going to the birds
- By John Towns(Story originally Published in the Selkirk Record, March 2012The Oak Hammock Marsh Interpretive Centre is about to become home to a lot of birds – but of two very different types.
The first is, of course, the massive number of migratory birds that will be returning to Manitoba now that spring is upon us once again, while the second type is...well, a little more stationary.
The OHMIC is currently busy setting up a new display of meticulously hand-crafted carvings of Neotropical Migratory Birds that the centre plans to unveil on March 25.
According to centre Events, Promotion and Marketing Coordinator Jacques Bourgeois, the exhibit came about after a trip that some OHMIC staffers made down south to do workshops about the importance of tropical mangroves to migratory birds.
“It was kind of strange coincidence – every year someone from Oak Hammock goes down to either the Caribbean or South America to do workshops with teachers about the importance of conserving wetlands and tropical bird habitats,” Bourgeois explained. “We just happened to have someone in Barbados for a short while, and they went to a nature conservatory and saw all these beautiful carvings. It turned out that the conservatory had to get rid of their carvings, so they asked if we were interested in having them – and we obviously said yes, because they're just gorgeous.”
After finding a family in British Columbia that was willing to sponsor the carvings' trip up to Manitoba, the centre has been working to make sure they now have afitting home at Oak Hammock.
“We've had an artist painting all around behind the area where we're going to have the birds – Mandy Van Leeuwen, she does a lot of big murals in Winnipeg and stuff like that,” Bourgeois noted. “It's basically set up to look and feel like you're walking into an observation area in the Caribbean. We've done a huge mural that's in the scene of a mangrove, and you're walking on this beautiful wooden boardwalk, and there's little trap doors that you can open to take a look at the carvings and stuff.”
Bourgeois explains that anyone who comes to the exhibit can expect to see a lot of familiar avian faces – even though they might not expect to.
“We often assume that there's our birds and then tropical birds, but a lot of the species actually travel back and forth and a lot of species that are found there in the winter are here in the summertime,” he said. “They're called Neotropical – for example, the Yellow Warbler is found here throughout the summer, but spends all winter in the Caribbean.”
In addition to the Yellow Warbler, there are species of herons and egrets (like the Great Egret, immortalized here in one of the centre's carvings) that spend time in the tropics once the winter freeze sets in here in Manitoba, Bourgeois explained. In addition to teaching people about the nature of these migratory birds, the display will also have a bit of an environmental component to it as well, he added.
“We want to talk about how those tropical habitats are very important for the birds to winter in, and their degradation can impact how many birds we even see up here,” he noted.
The official opening of the exhibit on March 25 will coincide with the OHMIC's “Snowbird Beach Day,” which will see the centre celebrating Caribbean culture.
“We'll have something like 50 live parrots in the building, some steel drum bands – it's a tropical themed event,” explained Bourgeois.