Do you ever wonder how, after making a diagnosis, a physician decides what treatment to prescribe?
General practitioners and specialists alike depend largely on what are called clinical practice guidelines, detailed sets of recommendations on the appropriate treatment for a specific condition.
The guidelines, of which there are thousands for conditions ranging from ingrown toenails to heart failure, are written by committees of experts, most of them physicians.
But who chooses the experts? According to research published in today's edition of the journal Nature, the process has been largely co-opted by pharmaceutical companies. The investigation confirmed what is already widely known -- that the process of clinical guideline-writing is often dubious -- but the extent of the problem is nevertheless shocking.
Nature found that 35 per cent of authors had a conflict of interest, meaning generally that their research funding comes from companies whose drugs they recommend, and 16 per cent of experts own stock in the companies. All told, 70 per cent of panels had members with a financial interest in the guidelines -- and that is almost certainly an underestimate because it includes only those who declared conflicts. Fully half the guidelines examined by Nature did not include any disclosures.
"Trust me" is not good enough.
In some cases, scientific evidence for recommending a specific drug or treatment is irrefutable. But often the data are muddy and experts provide their "best guess" as to what should be done.
When the allegiances of panel members are suspect, so, too, are the guidelines. The groups that produce them argue that industry links do not necessarily lead to biased advice. True. But perception is as important as reality. Right now, it looks like docs are for sale, and that guidelines can be bought.
Most clinical trials of drugs are funded by industry, providing a certain slant from the outset. Drug companies often fund the meetings where the clinical guidelines are hashed out and, in some cases, choose panel members. Drug reps wine and dine the experts and doctors who will be turning to the guidelines in everyday practice.
Is it any surprise that, given such circumstances, most guidelines enthusiastically promote prescribing drugs, almost always brand-name ones? Does the process not bias panel members and reviewers, even subconsciously, to new medications even if they do not have a demonstrated advantage over a generic or alternative treatment?
Guidelines should not be pharmaceutical hagiographies, but sound advice based on a critical analysis of benefits and risks.
These are not trifling issues. Billions of dollars are at stake, as is the health and well-being of patients.
Consider that Vioxx, an expensive painkiller that never worked much better than ibuprofen and proved to be more dangerous, had annual sales of $2.5-billion, thanks to its wonders being touted in all kinds of clinical guidelines.
Look at hypertension treatment guidelines. The best way to bring down high blood pressure is usually to lose weight. The best first-line drug treatment is diuretics, water pills. But the guidelines suggest that beta-blockers, calcium channel blockers, and angiotensin-converting enzyme (ACE) inhibitors and diuretics are all equally effective.
When company-sponsored guideline panels gather, the first order of business is usually to declare that cost is not an issue. In the real world, cost does matter. But taking cost into account doesn't bolster the bottom line for Big Pharma.
To counter the pernicious influence of the pharmaceutical industry, Britain has created an independent, government-funded body called the National Institute for Health and Clinical Excellence to create guidelines. The U.S. National Institutes of Health has also set up a process it uses when there is conflicting evidence about best treatment: Independent panel members with an expertise in analyzing medical data interview expert witnesses and produce final guidelines.
In both cases, industry and industry-sponsored researchers have a role in the process (as they should) but the guideline-making process is more transparent and independent.
Canadian policy-makers need to take some initiative in this area. Clinical practice guidelines are an invaluable tool for health professionals. But the ultimate test of guidelines is that, if followed, the recommendations improve patient outcomes.
Right now, it looks like patient health is taking a back seat to corporate interests. We need a pill to cure that ill -- and quickly.