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Editorial: Conflicts delay new drug rules

A setback has occurred in the effort to combat B.C.’s fentanyl crisis. Health Canada has been forced to delay the introduction of new prescribing guidelines for heavy-duty painkillers.

A setback has occurred in the effort to combat B.C.’s fentanyl crisis. Health Canada has been forced to delay the introduction of new prescribing guidelines for heavy-duty painkillers.

It has been known for some time that opioids such as oxycontin and fentanyl should not be given to patients with long-lasting disorders. The risk of addiction is too high.

But some physicians still overuse this class of drugs, in part because the treatment guidelines are years out of date. That increases the leakage of prescription opioids onto the street.

The federal ministry recognized the problem in 2015, and asked a panel of experts at McMaster University to come up with a tighter standard of care. But no sooner were the guidelines complete than it was discovered that some of the panelists had potential conflicts.

Specifically, six of 13 specialists on one of the advisory committees had ties to the drug industry, as did one of the authors who wrote the final report. Yet the rules laid down by Health Canada were clear: No one linked to big pharma was to take part in drafting the guidelines.

As a result of this revelation, the federal government placed the project on hold and ordered an independent review. McMaster apologized and promised to clarify its rules for disclosing conflicts of interest.

It is uncertain whether the review will change the final shape of the guidelines. The expert panel received enough external input that its recommendations will probably stand up.

The harm lies in the delay that will occur in circulating the new advice to physicians.

The larger question is how this could have happened. McMaster has one of the most respected medical schools in the country. How could such a basic error occur?

Part of the problem lies in the tangled web that exists between the drug industry and university research staff. Pharmaceutical firms frequently contract with faculty members to conduct drug trials and other forms of work. This is considered acceptable as long as the researchers have freedom of action, and their relationship is declared.

But the industry has a long history of offering incentives to physicians in exchange for promoting its products. Until recently, these might include paid vacations at exotic locations, fishing trips, expensive cruises and the like.

The more crass forms of inducement are now prohibited in Canada. Doctors may not accept gifts that are offered in the expectation of a favour in return, such as agreeing to prescribe a company’s brand-name drug.

But there are numerous other involvements that still look much like a conflict of interest.

One of the physicians on the McMaster panel had accepted paid speaking engagements at industry events, and served on advisory boards for various firms. Among those companies was Purdue Pharma, which manufactures oxycontin — one of the drugs studied by the panel.

And this is the dilemma. On the one hand, exclude every faculty member with connections to the industry, and you would struggle to assemble a viable research team. On the other hand, allow participation in industry-sponsored activities, and you create at least the perception of a conflict.

The 91Ô­´´ Medical Association has tried to deal with this problem by issuing guidelines for interactions between doctors and drug firms. Unavoidably, however, it is impossible to foresee or define every possible form of relationship.

The industry continually comes up with new forms of inducement, and as a result, much is left to the judgment of individual physicians.

Let’s hope the independent review of opioid guidelines wraps up quickly. There is no simple cure for the epidemic of overdose deaths, but halting the overprescription of these drugs is an essential part of the solution.