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)

Portugal drug law show results ten years on, experts say (AFP)

LISBON (AFP) – Health experts in Portugal said Friday that Portugal's decision 10 years ago to decriminalise drug use and treat addicts rather than punishing them is an experiment that has worked.

"There is no doubt that the phenomenon of addiction is in decline in Portugal," said Joao Goulao, President of the Institute of Drugs and Drugs Addiction, a press conference to mark the 10th anniversary of the law.

The number of addicts considered "problematic" -- those who repeatedly use "hard" drugs and intravenous users -- had fallen by half since the early 1990s, when the figure was estimated at around 100,000 people, Goulao said.

Other factors had also played their part however, Goulao, a medical doctor added.

"This development can not only be attributed to decriminalisation but to a confluence of treatment and risk reduction policies."

Portugal's holistic approach had also led to a "spectacular" reduction in the number of infections among intravenous users and a significant drop in drug-related crimes, he added.

A law that became active on July 1, 2001 did not legalise drug use, but forced users caught with banned substances to appear in front of special addiction panels rather than in a criminal court.

The panels composed of psychologists, judges and social workers recommended action based on the specifics of each case.

Since then, government panels have recommended a response based largely on whether the individual is an occasional drug user or an addict.

Of the nearly 40,000 people currently being treated, "the vast majority of problematic users are today supported by a system that does not treat them as delinquents but as sick people," Goulao said.

In a report published last week, the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) said Portugal had dealt with this issue "in a pragmatic and innovative way."

Drug use statistics in Portugal are generally "below the European average and much lower than its only European neighbour, Spain," the report also said.

"The changes that were made in Portugal provide an interesting before-and-after study on the possible effects of decriminalisation," EMCDDA said.