Canada OKs 'liberation therapy' trials (AFP)

OTTAWA (AFP) – Canada will fund clinical trials for a controversial multiple sclerosis treatment that targets blocked neck veins, Health Minister Leona Aglukkaq announced Wednesday.

"Patients and their families have been calling for funding of a clinical trial on a treatment to unblock veins," the minister said in the foyer of the House of Commons.

"Our government had been clear that we are prepared to fund a clinical trial but only when there was sufficient medical scientific information to support proceeding safely."

She said a scientific working group established by the government last August recommended proceeding with the trials after reviewing seven ongoing studies looking at "chronic cerebrospinal venous insufficiency" and its link to MS.

The Canadian Institute of Health Research plans to establish terms for the clinical trial. Afterward, the government will launch a call for applications to conduct the trials.

MS is an autoimmune disease that affects the brain and spinal cord, impairing vision and speech and muscle control, leading to tremors, spasms and chronic pain.

Italian researcher Paolo Zamboni theorized in 2008 that it could be reversed by unblocking neck veins using balloon angioplasty.

According to his theory, malformed blood vessels caused increased iron deposits in the brain that triggered the autoimmune response.

Many Canadian MS patients have sought the so-called "liberation treatment" abroad, as it is not offered in Canada. Some reported vast improvements in their mobility while others experienced little or no alleviation of symptoms.

Surgeons in Medtronic trials omitted results: report (Reuters)

NEW YORK (Reuters) – Surgeons conducting clinical trials to test a Medtronic Inc bone-growth protein used in spine surgery, some of whom got at least $62 million from the company, failed to report serious complications in their research papers, the Wall Street Journal reported.

Fifteen of the surgeons got at least $62 million from the company over the past decade, the paper said, citing an analysis of Medtronic documents and disclosures on the company's website.

A new study in the Spine Journal said serious complications including cancer, sterility, infections, bone dissolution and worsened back and leg pain, occurred in 10 to 50 percent of patients who were administered Infuse or a sister product in 13 clinical trials funded by Medtronic and conducted by the surgeons between 2000 and 2010, the Wall Street Journal said.

These complications weren't reported in research papers the surgeons wrote on those trials, even though the papers were peer-reviewed, the study said.

A U.S. Senate committee is investigating whether surgeons who were paid consulting and other fees by Medtronic failed to note the complications of Infuse.

The company last week said the three main side effect concerns raised by the committee are listed as warnings on the product labels, as approved by the U.S. Food and Drug Administration.

In a statement, Omar Ishrak, Medtronic's chief executive, on Tuesday said the Spine Journal study does not raise questions about the data Medtronic submitted to the FDA in the approval process.

"Based on that data, we strongly believe that the safety profile reported to the FDA and summarized in the product label support the safe use of rhBMP-2 for the identified indications," he said. The company will continue to investigate questions surrounding researchers' potential conflicts of interest and refine policies as needed, he said.

A company spokesman declined additional comment.

(Reporting by Lynn Adler; Editing by Lisa Shumaker)