Alberta rushed $10-million grant, eliminated ethical oversight, for unproven health program

Six days before Alberta Health rushed to deliver a $10-million grant to a private alternative-health foundation, the ministry abruptly changed the grant's purpose, eliminating the need for ethics approval for what experts say was a human-subject experiment on thousands of Alberta seniors.

On Dec. 23, 2013, former Progressive Conservative health minister Fred Horne approved the funding to Pure North S'Energy Foundation to expand an unproven, alternative "wellness" program, ultimately to more than 7,300 seniors.

Horne made the decision against the advice of officials from several ministries who had determined the Pure North program was not adequately supported by scientific evidence, could not prove the incredible health and economic benefits it claimed, and could cause adverse health effects in participants. The officials also said no funding should be granted without an ethical review of the entire Pure North program.

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"Current research supplied by Pure North is unpublished in peer reviewed medical journals," states an internal Alberta Justice document dated Aug. 28, 2013, less than four months before Horne granted the funding. "It is unclear if the results are clinically significant and lead to better health outcomes."

Horne did not respond to interview requests over the past several weeks.

University of Alberta political scientist Jim Lightbody, an expert in public governance, said there are "tried and true" methods for governments to independently determine whether funding a particular project is valid. That includes substantiating the benefits claimed by the organization requesting funding.

"That is why there are guidelines; that is why there is a competitive process (for funding)," Lightbody said. "And it would seem that there was an end run - consistently - around any attempt to apply that kind of standard testing to this kind of operation."

Pure North collects health information

Pure North is the private foundation of multi-millionaire Calgary philanthropist Allan Markin, the former chairman of energy giant Canadian Natural Resources Ltd. He declined repeated interview requests from CBC News.

The foundation targets vulnerable populations such as the homeless, addicted, seniors and Indigenous people in such places as homeless shelters and on reserves. Its various health programs offer high-dose vitamins and minerals, lifestyle counselling and, in some cases, treatments to remove heavy metals from participants' blood and mercury-amalgam fillings from their teeth.

None of its alternative treatments are supported by conclusive science.

Pure North collects detailed medical information from its participants, including blood samples, and has built a "mega-database" to which university researchers have been provided access.

The foundation, however, insists it is not conducting research but instead gathers data to gauge the efficacy of its program. Its spokesperson, Stephen Carter, told CBC News the information provided to researchers is simply a "secondary" use of that data.

Carter also claims Pure North has many studies that prove the effectiveness of its program. He said 50,000 people have participated in the program without any safety issues.

Tim Caulfield, director of research for the University of Alberta's Health Law Institute, said if the government had consulted him on whether the Pure North program should be funded, "I would clearly say no.

"I don't think there is any evidence to support, for example, the high doses of vitamin D," he said. "Yes, there is interesting research going on. But there is no evidence to support the funding of this kind of level for this kind of service."

Irregularities in funding agreement process

Thousands of pages of internal government documents obtained by CBC News reveal numerous irregularities in how Alberta Health came to provide the funding to Pure North, including that:

- For more than a year, the Pure North funding request had been classified, and internally analyzed as a research project. Documents show the research project was supported by then-premier Alison Redford. But the documents contain no explanation for why the ministry abruptly changed the grant's purpose on Dec. 17, six days before Horne signed the funding agreement.

- The change from health research project to an expansion of Pure North's existing seniors program meant Pure North was not required to obtain independent approval from a research ethics board for its activities.

- The final grant agreement did not contain any detailed project budget, clear description of the program Pure North would offer to seniors, or specific targets the foundation had to meet.

- The $10-million grant was inexplicably rushed. "We need to execute it this week," Health chief delivery officer Glenn Monteith told colleagues in a Dec. 17, 2013 email entitled "Urgent meeting." A colleague, Lorraine McKay, issued the directive in an email. "10 million (dollar) grant Pure North - right now. To foundation's efforts to support seniors' initiatives. High level - one year, one time," she said, adding, "bolt in some description material" for the grant.

- A senior Health official personally walked the ministry's payment request to ATB Financial in downtown Edmonton on Dec. 24, the day after the grant agreement was signed.

- Pure North's funding was not "gated" or paid in instalments, based on demonstrable performance measures. Instead, Alberta Health gave Pure North the entire $10 million up front, which some academic researchers say is extraordinary.

- The documents contain no discussion of the potential liability for the Alberta government should Pure North's program cause any of the adverse health effects senior officials had previously identified. In a review of the Pure North program a year after the program started, Alberta's chief medical officer of health warned of potential liability for the province "should things go wrong."

Pure North spokesperson Stephen Carter acknowledged the request for funding started as a research project, but the focus eventually changed to an established program targeting seniors.

"The Government of Alberta, and Alberta Health in general, isn't interested in funding research projects," Carter said. "They're interested in funding health care for Albertans. So they decided to shift the project and we agreed to shift the project to providing direct health care."

Internal documents, however, show that immediately after Pure North received the funding, Markin began seeking access directly through health minister Fred Horne to anonymized patient data from Alberta Health Services. Markin wanted access to the data so university researchers could assess the efficacy of the recently funded seniors program.

Internal documents show Pure North made repeated requests for funding to the Alberta government, which continued after the NDP assumed power in May 2015.

The program for which Pure North had received the $10-million grant ran for 15 months, ending in March 2015.

As part of the funding agreement, the foundation had to submit both a financial report and a brief progress report every three months. When Pure North submitted its final progress report in late May 2015, it asked for another $4.5 million to continue one part of the program for seniors with special health needs.

"No convincing data" to support claims

In response to the funding request, Alberta Health ordered a review of the Pure North wellness program. Two of three reviewers agreed there was no convincing data to support the claim the program would achieve the health benefits claimed by Pure North. The third reviewer thought a more rigorous review of the program would be needed to either confirm or contradict the foundation's claims.

Two reviewers also raised concerns about the quality of evidence supplied by Pure North. They said much of it was self-reported by participants, there was no evidence any benefits were specifically attributable to the Pure North program, and changes to measures of chronic disease didn't appear large enough to be clinically relevant.

"Placebo effects are very common with nutritional supplements and there are concerns that the program may be overstating the benefits of the supplements, enhancing the placebo effect," a summary of the two reviewers' findings states.

Carter insisted the program was a success. As proof, he cited a study conducted by Herbert Emery of the University of Calgary's School of Public Policy.

Emery's study found participants who stayed in the program for two years significantly reduced their visits to emergency rooms and hospitals, saving the system $276 for each Pure North participant.

But all three independent reviewers found a serious problem with how Pure North calculated savings for the health-care system. They said Pure North told the ministry each client cost the program between $1,280 and $2,300 a year.

When Pure North performed its cost-saving calculations, it "used a cost of $500 per year per client.

"It is unclear how the program could be offered at a dramatically lower cost while maintaining the same results," the reviewers' summary states.

"Based on the absolute reduction in hospital visits (2 per cent), we would need to treat 50 people to avoid a single hospital visit," the review's summary states. "Even using the $500 figure, the program cost would be $25,000 in order to save $1,107 in acute care costs."

Two reviewers said the documentation supplied by Pure North didn't support further investment by the government. The third reviewer couldn't make an evidence-based recommendation but felt a more formal review was warranted "due to the pressing need for community-based health promotion in the province."

NDP Health Minister Sarah Hoffman turned down Pure North's request for further funding of the seniors program based on advice from ministry officials.

In an interview, Hoffman said she had no knowledge of how Pure North came to get the funding from the former Conservative government.

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