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Province halted drug-safety research: lawsuit


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The B.C. Liberals, which receive "major" political donations from pharmaceutical companies, suddenly halted drug-safety research that could have meant big financial losses for drug companies, alleges a new lawsuit filed Monday against the provincial government.

The allegations are contained in a lawsuit filed in B.C. Supreme Court in Victoria by William (Bill) Warburton - the fifth person to sue the Ministry of Health over a scandal in its pharmaceutical services division. Last year, seven people lost their jobs and several researchers - including Warburton - lost access to key health data, which was used to investigate possible harmful side-effects from some prescription drugs.

Four of those fired health employees - including Warburton's wife, Rebecca - have filed wrongful-dismissal lawsuits. Two union employees have filed grievances. The seventh person, a PhD co-op student who was fired three days before his work contract ended, was found dead in December.

The ministry has released few details about its investigation. In interviews before the election campaign began, Health Minister Margaret MacDiarmid said she found the case "troubling" due to allegations of inappropriate sharing of data and said the RCMP had been notified.

Bill Warburton's lawsuit goes further than the other four in alleging a link between powerful pharmaceutical companies and the termination of the employees.

"Warburton's research ... included investigation of harmful side-effects, including mortality, and risk assessment of drugs purchased by the Province through its programs, and had the potential of disrupting financially significant payments to large pharmaceutical companies," says the lawsuit.

The allegations have not been proven in court.

"The Liberal Party was receiving significant contributions from these drug companies, and the Province was eliminating drug safety programs that could cause restrictions on sales of the products of these drug companies ... and these actions includ[ed] ending drug analysis programs such as that of Dr. Warburton and of the Therapeutics Initiative at the University of British Columbia."

The NDP has made the Therapeutics Initiative an election issue, by making a campaign promise to bring back the drug-review agency if elected to form government.

In court documents filed in response to the other four wrongful-dismissal lawsuits, the ministry has alleged the drug researchers - including Warburton and his wife Rebecca, the former co-director of research and evidence development at the ministry's pharmaceutical services division - had inappropriately shared data. There has been no public indication the data included the names of any patients.

The province began its investigation in March 2012, and later in the year notified Warburton that his access to ministry data was revoked. Warburton, a health economist, had signed a contract to access the data to study several outcomes, including the "impact of atypical antipsychotic medications on patient health outcomes."

Warburton's lawsuit denies the ministry's claims that he attempted to obtain improper access to certain provincial data.

He claimed the ministry's investigation was "flawed" and conducted by "inexperienced investigators," and that press releases issued by the ministry about the scandal were defamatory.

"The Province's acts against Dr Warburton are part of a bad faith program by the Defendants to end the investigation of harmful effects of drugs which risk leading to diminishing payments to their political contributors, and constitute misfeasance in public office as the Defendants were aware that their deliberate acts against Dr. Warburton were illegal and would likely harm him," the document says.

The ministry has not yet filed a response in court.

lculbert@vancouversun.com

© Copyright © The Vancouver Sun

http://www.vancouver...7172/story.html

This is why corporate donations MUST stop. Shame on you Liberals. How many lives have you negatively affected now? Wow, just wow. :sadno::picard: Let the spin fest begin.

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Researcher suing B.C. government over privacy breach scandal

A researcher in Victoria is suing Health Minister Margaret MacDiarmid and the province over their handling of a health data privacy breach last summer.

Dr. William Warburton says the province defamed him in statements made after it was determined that at least 38,486 B.C. residents had their medical information compromised by a group of researchers.

The B.C. Ministry of Health said health information of B.C. patients was saved on USB sticks and improperly shared three times in October 2010 and June 2012.

Warburton, 59, holds a doctorate in economics and had a contract with the Ministry of Health to perform complex data analyses on reported adverse drug reactions in patients.

His contract was terminated last summer, and he says the government unfairly accused him of improperly using provincial health data.

hi-stock-prescription-pills-4col.jpgDr. William Warburton's contract with the Ministry of Health was to allow him to evaluate the impact of atypical anti-psychotic prescription medications on patient health outcomes. (iStock)

In a civil claim filed in B.C. Supreme Court Monday, Warburton said at the time his contract was terminated his research was on the effects of atypical anti-psychotic medications on patient outcomes.

Warburton claims he was going to work with data gathered on the use of drugs such as aripiprazole, quetiapine, olanzapine, risperidone, ziprasidone, paliperidone, and clorzapine.

Warburton alleges that at the time of the privacy breach scandal, the Liberals were receiving significant contributions from drug companies — in some cases, from the same companies whose medications were part of the province's drug plans.

Warburton also alleges that the province was eliminating drug safety programs that in place, could limit sales.

His claim states that by terminating his contract, the province damaged his reputation, caused him to lose $100,000 in revenue and the ability to generate other business in similar research.

The Ministry of Health says it plans to respond to the suit in the next three weeks.

None of the claims have been proven in court. http://www.cbc.ca/ne...-warburton.html

Busy, busy liberals. :picard:

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The law suit arises from this - and it began the auditor general’s office relaying an anonymous complaint about contracting irregularities and inappropriate research practices in the ministry’s pharmaceutical services division.

It would appear the Ministry of Health undertook immediate action upon determining the misuse of private medical data may have taken place. The matter was referred to both he RCMP and the BC Privacy Commissioner with whom the Minstry of Health has been working closely.

This affair should reflect credit on the government.

The B.C. government announced Thursday it has suspended all drug-related research and fired four of its employees as part of an investigation into the alleged misuse of confidential medical information.

“I can’t really overstate how deeply troubled I am by this,” Health Minister Margaret MacDiarmid said Thursday.

“What we believe has happened is that individuals have gone outside of the rules around taking data and using data with respect to research in the area of drugs.”

On Thursday, The Vancouver Sun reported that seven government employees had been suspended without pay, and that agreements with two contractors had been dropped.

MacDiarmid said four of those employees were fired Thursday, and that three others remain suspended.

She said her ministry has suspended $4 million in drug-related research contracts, including work being done at both the University of B.C. and the University of Victoria.

“This is research that we contract with certain research entities, and that has all been stopped for the moment until we’re sure going forward that no health information is being shared inappropriately,” she said.

The government announced it has also suspended all data sharing with drug and evidence development researchers.

Other measures include:

• approval by a deputy minister for all spending by the pharmaceutical services division (see sidebar);

• tightening of policies on the awarding of contracts to universities;

• hiring an independent consultant to review and enhance data security measures.

MacDiarmid took over as health minister in a cabinet shuffle Wednesday and said she was shocked to hear of the allegations.

“My reaction was disbelief,” she said, adding the investigation was the first thing she was briefed on upon her arrival.

“I continue to be deeply troubled and disturbed by this.”

MacDiarmid said it appears the misuse of data was limited to unauthorized research, but noted the investigation is still seeking to determine exactly what information was accessed.

“It is my understanding that it was personal data, that it is regarding medications, but that there is personal data included in that,” she said.

“As far as we can understand it was used for research where it wasn’t initially given for that purpose. We don’t know if it was being used for anything beyond that,” she added, saying the ministry has forwarded information to the Information and Privacy Commissioner.

MacDiarmid said the investigation is also looking into allegations of undeclared conflicts of interest.

“It would appear that some of the people that were involved had relationships with others that would put them into a conflict that wasn’t declared,” she said, adding a family relationship was among the issues.

...

The ministry began its recent investigation in May after the auditor general’s office relayed an anonymous complaint about contracting irregularities and inappropriate research practices in the ministry’s pharmaceutical services division.

The ministry has since involved the RCMP, and last month provided the force with the preliminary results of its internal investigation.

MacDiarmid said the ministry hopes to pass more information to police later this month.

The RCMP would not provide any details Thursday. “Until we have reviewed the information we are not in a position to provide comment,” said RCMP spokesman Sgt. Duncan Pound.

In a press release Thursday, government said its internal investigation “examined contracting and research grant practices between ministry employees and researchers at the University of British Columbia and the University of Victoria.”

On Thursday, both schools said the Ministry of Health informed them on Wednesday afternoon of the allegations and the action being taken by government.

UBC spokeswoman Lucie McNeill said that because the university learned of the allegations so recently, it is too soon for authorities to determine whether any disciplinary action is necessary on the part of the university.

Representatives of both universities were unable to say how many researchers were involved or their area of health research. Both said they will cooperate fully with the ministry investigation.

New Democratic Party critic Doug Routley said the allegations raise serious questions, especially as so little is known about what took place.

“This is a fairly significant breach if it’s already led to the firing of four employees [and] there’s a potential RCMP investigation,” he said, calling the lack of public information about the case “disconcerting.”

http://www.vancouversun.com/health/Exclusive+health+ministry+suspends+workers+over+privacy+breach/7197204/story.html#ixzz2SetnqdKR

And in early January:

The personal-health data of millions of British Columbians has been accessed without proper authorization, and in the most serious cases, the provincial government says it will notify 38,486 individuals of the breaches by letter.

Health Minister Margaret MacDiarmid made the announcement as part of an ongoing investigation into research-grant practices between ministry employees and researchers at the universities of B.C. and Victoria.

MacDiarmid said that during three separate instances in October 2010 and June 2012, the health information was saved on USB sticks and shared with researchers or contractors without the proper permission or protocols.

MacDiarmid said the data did not include names, addresses or financial information, but it wasn't supposed to be shared with other health researchers.

Also included was data from Statistics Canada's Canadian Community Health Survey, including information on the mental, physical and sexual health of individuals, as well as their lifestyles and the use of health services.

“We don't have any evidence at all that any of this information was used for any purpose other than health research. There is minimal if any risk that this information that would be used in a way that would be harmful to these individuals.”

MacDiarmid said her ministry decided to write the letters following discussions with the Office of the Information and Privacy Commissioner.

http://www.cbc.ca/news/health/story/2013/01/14/bc-breach-health-data.html

And this:

STATEMENT

For Immediate Release
Jan. 14, 2013

Statement from B.C. Privacy Commissioner regarding

data breaches at the Ministry of Health

VICTORIA
– B.C.’s Information and Privacy Commissioner Elizabeth Denham issued the following statement regarding privacy breaches at the Ministry of Health:

“On Sept. 11, 2012, in response to notice of alleged data breaches by the Ministry of Health, I launched an independent investigation into disclosures of personal data by the Pharmaceutical Services Division of the ministry. My authority to conduct such an investigation is mandated by the
Freedom of Information and Protection of Privacy Act
.

“My office’s investigation includes the instances of unauthorized disclosures of health data confirmed today by the minister, but also includes a broader review of the ministry’s data-handling practices in relation to research.

“Our investigation will be complete in the coming weeks, and we will be issuing a public report with findings and recommendations.”

The Commissioner will not be making any further comment on this matter until the Office’s public report is released.

Media Contact:

Cara McGregor

Manager, Communications and Public Education

Office of the B.C. Information and Privacy Commissioner

250 217-5535

http://www.oipc.bc.ca/news-releases/1489

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Seems Margaret's up to here chin in crappy employees. But this total disregard for public safety by halting drug testing for side effects just to repay her Pharma Brib, I mean sponsors is typical of this out for themselves only govt.

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And as noted...

While B.C. residents spend about $2.6 billion annually on prescriptions, this province has the lowest per capita drug costs in Canada. Fans of the Therapeutics Initiative argue it has contributed to keeping these costs down in B.C.

http://www.vancouversun.com/fears+pharma+influence+would+reinstate+funding+drug+safety+research/8351894/story.html#ixzz2SjGcFpeE

That would seem to be a fact based counter to the claim of "Big Pharma" controlling prescription drugs.

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