Tuesday, December 17, 2013

Diane-35: Family whose daughter died after taking drug sues Shoppers Drug Mart The family of a teen who died suddenly after taking a controversial acne drug is suing Shoppers Drug Mart for failing to warn their daughter about the medication’s most dangerous side effects.


Diane-35: Family whose daughter died after taking drug sues Shoppers Drug Mart
The family of a teen who died suddenly after taking a controversial acne drug is suing Shoppers Drug Mart for failing to warn their daughter about the medication’s most dangerous side effects.



The family of eighteen-year-old Marit McKenzie, who died of a massive bilateral pulmonary embolism, is suing Shoppers Drug Mart for failing to warn of dangerous side effects of the drug Diane-35. McKenzie had been taking the drug for a mild acne condition for 11 months when she died.
By: Diana Zlomislic News reporter,


The family of a teen who died suddenly after taking a controversial acne drug is suing Shoppers Drug Mart for failing to warn their daughter about the medication’s most dangerous side effects.


While other major pharmacies highlight the “very serious” and “sometimes fatal” risk of blood clotting connected with Diane-35 on the drug information sheets they supply to patients, Shoppers does not. A senior pharmacist hired by Shoppers to produce an electronic inventory of drug risks told the Toronto Star the company didn’t want to “frighten” consumers by including rare but serious side effects on its printouts for the public.


Shoppers patrons who take Diane-35 are instead advised to watch out for headaches, tender breasts, menstrual pain, swelling and a lowered sex drive.
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The family of Marit McKenzie, 18, a first-year university of Calgary student who died after suffering four cardiac arrests, a massive pulmonary embolism and brain hemorrhaging in late January, is seeking $85,000 in damages and legal costs. That is the maximum allowable in Alberta for such a loss.


“Shoppers was negligent in providing sufficient information to Marit regarding the warnings and risks associated with taking Diane-35,” states the claim, which was filed last week in a Calgary court. It also argues that Shoppers should have told McKenzie to stop using the drug three to four months after her acne cleared, a protocol recommended by the manufacturer to reduce the likelihood of side effects.


The McKenzie family’s legal claim states that Shoppers has a “duty to provide accurate, current and pertinent information” about the risks and warnings associated with the medications its pharmacists dispense and that the company did not fulfil this duty.


The allegations have not been proven in court.


Lana Gogas, a spokeswoman for Shoppers, said the company could not comment on the legal claim. Shoppers has not yet filed a statement of defence.


The drug information Shoppers distributes to its pharmacy customers is supplied by a Quebec company that has held the contract for more than 10 years.


“We restrict to a maximum of six side effects on all drugs,” explains Raymond Chevalier, the president of Les Consultants Vigilance Santé, which is based just outside of Montreal. The information is poured into an electronic database that is accessed by Shoppers stores across the country.


“We select the most prevalent, the ones most likely to occur, the ones the patient can identify . . . The purpose here is not to frighten anyone,” said Chevalier, who is also a pharmacist.


Bruce McKenzie, an architect in Calgary, says he would rather be afraid if it meant saving his daughter Marit’s life.


In the weeks before her death in January, Marit McKenzie had grown increasingly anxious about her physical condition. She was constantly tired, easily winded and found it difficult to concentrate. After her death, Bruce McKenzie and his wife, Susan, discovered that these symptoms were outlined on the patient information sheets for Diane-35 that were handed out at other pharmacies, including Safeway and Calgary Co-Op. The Toronto Star also found this information on the drug information sheets distributed by Walmart, Loblaw and Rexall pharmacies.


1 drug, 3 stories: What pharmacies are telling patients about Diane-35


Shoppers Drug Mart (PDF)


Walmart (PDF)


Loblaw (PDF)


The week before her death, Marit McKenzie complained to her family doctor, but her condition was chalked up to school-related stress. Routine blood work was ordered but it came back normal, the Star learned after interviewing Dr. Dubravka Rakic, who prescribed Diane-35 to McKenzie.


Several days later, after suffering four cardiac arrests, a pulmonary embolism and bleeding in the brain, McKenzie was pronounced dead in hospital on Jan. 28, 2013.


She became the 13th Canadian woman, and the eighth younger than 21, whose death has been unofficially linked to Diane-35 in Health Canada’s adverse reaction database. Since the majority of her organs were donated immediately, there was no formal autopsy. A hospital pharmacist filed the adverse drug reaction report listing Diane-35 as the suspect cause of her death. McKenzie had been taking it for just over a year.


The drug, which is approved by Health Canada as a short-term treatment for severe and otherwise untreatable acne, has been the subject of three federal warnings since 2002 that addressed the elevated clotting risk. The warnings also emphasized that Diane-35 should not be used as an oral contraceptive. Health Canada is now trying torein in off-label use for the hormone-based pill with help from the manufacturer, Bayer, which has launched an education campaign for doctors.


Shoppers, though, does not appear to be helping on that front either.


Its information sheet for Diane-35 calls the drug a “hormone-based contraceptive.”


“I didn’t notice that myself,” Chevalier told the Star by phone from Repentigny, Que. “We’ll recheck that.”


Dr. Barbara Mintzes, a drug researcher based in British Columbia who has investigated the off-label use of Diane-35, worries that the additional drug information provided by pharmacies may create a false sense of security.


Consumers may reasonably assume the pharmacy’s patient information leaflets, which are often written in easy-to-understand language, is a “Cole’s Notes” version of the dense product monographs supplied by manufacturers.


Gogas of Shoppers says the sheets “are designed to provide patient-friendly information in order to educate the patient on the medication they are taking and help them manage their condition.” They “are not an alternative to a product monograph.”


“We’re not replacing the discussion that a doctor should have had with his patient before prescribing this drug, covering the side effects and risks and contraindications,” Chevalier says.


Rakic told the Toronto Star she was unaware the federal government had issued any advisories about Diane-35 when she prescribed it for McKenzie.


Nearly 500,000 prescriptions were written in Canada for Diane-35 or one of its two generics last year, according to IMS Brogan data supplied by Health Canada.


The relatively new practice among pharmacies to supply additional printed information to consumers is not mandated by any professional group.


Shoppers was one of the first retailers to provide its customers with drug information sheets. The practice dates back to the company’s launch of HealthWATCH in the late 1990s.


“There’s nothing from the college requiring they do this,” says Lori DeCou, spokeswoman for the Ontario College of Pharmacists.


“There is a standard practice to which we hold pharmacists accountable, which has to do with counselling,” she says. “A pharmacist is required to ensure their patient understands the medication they’re being prescribed.”

Saturday, December 14, 2013

Election fraud finding by Federal Court points directly at Conservative Party: The Federal Court has found .




Election fraud finding by Federal Court points directly at Conservative Party



The Federal Court has found in no uncertain terms that widespread election fraud took place during the 2011 federal election. The ruling clearly states that "there was an orchestrated effort to suppress votes during the 2011 election campaign by a person with access to the [Conservative Party's] CIMS database."

"This Federal Court decision is a major indictment of the Conservative Party of Canada," says Garry Neil, Executive Director of the Council of Canadians. "Either senior leaders of the Conservative Party were directly involved in election fraud or they were astoundingly negligent in securing access to their voter database. Illegal or incompetent -- just like in the Senate scandal."

The Council of Canadians is calling on the Conservative Party to make public the list of everyone who had access to the national CIMS database and authority to make a decision to launch such a campaign, as well as turning the information over to the Commissioner of Elections and the RCMP. The Council argues that anything less at this point would be a cover-up.

"The use of the Conservative Party's CIMS database to attack democracy and the deepening scandal around Nigel Wright, Mike Duffy and the PMO both reflect the determination of this regime to avoid accountability at all costs," says Council of Canadians national chairperson Maude Barlow.

The Council of Canadians notes that the non-cooperation, obstructionism, and attempts to derail the Federal Court case by the Conservative Party makes it look like Prime Minister Harper has something to hide.

"The Prime Minister needs to answer some serious questions," says Barlow. "Did Harper authorize the use of CIMS for voter suppression? If not who did? The Federal Court has found that CIMS was used for extensive election fraud. It's now up to Conservative Party to tell Canadians who did it."




The Council of Canadians is consulting with the applicants and lawyers as they consider an appeal to the Supreme Court of Canada. If these consultations conclude there is a chance the Supreme Court could overturn the Conservative MPs' narrow victories, the Council would pay the necessary legal fees.

The organization is calling on Canadians to donate for that purpose at http://canadians.org/democracy247.

Key excerpts from the Federal Court decision

[184] ... there was an orchestrated effort to suppress votes during the 2011 election campaign by a person with access to the CIMS database.

[244] I am satisfied that is has been established that misleading calls about the locations of polling stations were made to electors in ridings across the country, including the subject ridings, and that the purpose of those calls was to suppress the votes of electors who had indicated their voting preference in response to earlier voter identification calls.

[245] ... I am satisfied ... that the most likely source of the information used to make the misleading calls was the CIMS database maintained and controlled by the CPC, accessed for that purpose by a person or persons currently unknown to this Court. ... the evidence points to elaborate efforts to conceal the identity of those accessing the database and arranging for the calls to be made.

[246] I find that the threshold to establish that fraud occurred has been met by the applicants.

[253]... I don't doubt that the confidence rightfully held by Canadians has been shaken by the disclosures of widespread fraudulent activities that have resulted from the Commissioner's investigations and the complaints to Elections Canada.

[256] [the voter suppression] calls appear to have been targeted towards voters who had previously expressed a preference for an opposition party (or anyone other than the government party)

[261] ... it has seemed to me that the applicants [supported by the Council of Canadians] sought to achieve and hold the high ground of promoting the integrity of the electoral process while the respondent MPs engaged in trench warfare in an effort to prevent this case from coming to a hearing on the merits.

[262] Despite the obvious public interest in getting to the bottom of the allegations, the CPC made little effort to assist with the investigation at the outset despite early requests. I note that counsel for the CPC was informed while the election was taking place that the calls about polling station changes were improper. While it was begrudgingly conceded during oral argument that what occurred was "absolutely outrageous", the record indicates that the stance taken by the respondent MPs from the outset was to block these proceedings by any means.

Thursday, December 12, 2013

Conservative Brand Slipping.



The Conservatives are facing a cooler reception from Canadians as they head home for the holidays, with new poll numbers suggesting a significant drop in the party's brand strength in traditional strongholds.
According to the Nanos Party Power Index, the Tories are losing ground to the NDP and Liberals in Ontario and the Prairies — key battlegrounds in the next federal election.

"Stephen Harper and the Conservatives built their majority and their successful kind of resurgence on the Canadian political field in the West," said Nik Nanos, president and CEO of Nanos Research. "Fast forward through this session — not a great time for the Conservatives."

Nanos Research releases a new Party Power Index score each week. It's a combination of measurements of federal party brands based on questions about the parties and the leaders, scored on a scale between zero to 100 for each party.​

In the prairies, Conservatives have dropped 12 points since MPs returned to Parliament on Oct. 16. The Tories maintain the lead with a score of 54, but the Party Power Index shows the Liberals and NDP closing in with scores of 52 and 47, respectively.

These numbers are based on random telephone (cell and land-line) interviews with 197 voters in the Prairie provinces using a four-week rolling average ending Oct. 18, 2013, and Dec. 6, 2014 and are accurate to within 7.1 percentage points, 19 times out of 20.

"The Tories can't afford to lose more here because, you know what, if the Prairies start to unravel for the Conservatives, it won't be good news in the rest of the country," Nanos told Power & Politics host Evan Solomon.


In Ontario, the Nanos numbers reveal significant gains for the New Democrats. Though they still sit in third place with a score of 48, the NDP have gained six points. In comparison, the Liberals fell six points and the Tories dropped four.

These results are based on random telephone (cell and land-line) interviews with 300 voters in Ontario using a four-week rolling average ending Oct. 18, 2013 and Dec. 6, 2014, accurate to within 5.7 percentage points, 19 times out of 20.

Which leader would make the best prime minister?

The polls also show NDP Leader Thomas Mulcair enjoying a lift from the fall session of Parliament. He's the only leader who has gained favour among Canadians in the past few months, according to the latest Nanos tracking numbers.

On the question of which major party leader would make best prime minister, Stephen Harper and Justin Trudeau are in the lead with close scores of 27 and 26, respectively. However, those scores reflect decreases of four and six points.

With a score of 20, Mulcair has seen a four-point increase in his personal brand.

"Two lumps of coal for Harper and Trudeau and a little bit of a Christmas bump for Tom Mulcair coming out of the last session," said Nanos.

These tracking numbers are based on random telephone (cell and land-line) interviews with 1,000 Canadians using a four-week rolling average ending Oct. 18, 2013 and Dec. 6, 2014, accurate to within 3.1 percentage points, 19 times out of 20.

Nik Nanos digs beneath the numbers with CBC News Network's Power & Politics to get to the political, economic and social forces that shape our lives. Recognized as one of Canada's top research experts, Nanos provides numbers-driven counsel to senior executives and major organizations. He leads the analyst team at Nanos, is a Fellow of the Marketing Research and Intelligence Association and a Research Associate Professor with SUNY (Buffalo).
NOTE: This story has been edited from an earlier version that, due to an editing error, incorrectly referred to party "support." In fact, the Nanos Party Power Index is based on a combination of measurements from questions about the federal parties and their leaders to gauge the strength of the parties' brands.

Wednesday, December 11, 2013