Jul 25, 2013

BC doctors need unbiased info on prescription drugs


As a family physician, I need to be sure that each medication I prescribe has good evidence behind its use for my patient’s diagnosis, concurrent medical conditions, and demographic. This isn’t as straightforward as it sounds, because good evidence isn’t always easy to find.

In an often polarized culture of illness and suffering in which some patients take pride in avoiding medication use and others desperately search for a cure, it’s important for patients and physicians to have real conversations about risks and benefits. With increasing access to a motley collection of online information, my job of critical appraisal and patient education is growing ever more important. In this context it’s important to know where physicians get their information.

To complement Clinical Practice Guidelines of varying utility, my go-to sources are three academic organizations I know of in Canada (Bugs and Drugs based in Alberta, RxFiles based in Saskatchewan, and the Therapeutics Initiative at UBC) with no affiliations to the pharmaceutical industry, whose mandates are to provide unbiased and up-to-date information to physicians on appropriate and safe prescribing. BC’s own Therapeutics Initiative (the TI), funded by the provincial government, is on the chopping block. We should demand that it be sustained. Let me explain why.

As a family physician, the Therapeutics Initiative does more than provide me with gold-standard prescribing information that I pass on to my patients. It promotes regular, face-to-face learning opportunities for health providers of all stripes to critically think about medication prescription. When I leave their sessions, I do so with a feeling of relief that I am better equipped to practice evidence-based medicine, and confidence in the therapeutic options I can offer patients henceforth. On a policy level their work impacts my practice too. The Therapeutics Initiative provides the government with the unbiased facts needed to choose worthwhile drugs for our provincial Pharmacare plan, and avoid adopting drugs with dangerous side effects, or with inflated or unproven efficacy. They don’t study cost-effectiveness of medications, only safety. So my patients covered by Pharmacare (or those whose extended benefit plans cover Pharmacare benefit medications only) know that they are getting drugs that are safe, and that work. However such organizations, beneficial on both a clinical and policy level, are rare in the landscape of pharmaceuticals. Let me give you a sense of the landscape.

If I follow the path of least resistance to prescribing information, I get a free lunch, and a one-on-one update from a pharmaceutical company rep who delivers a glossy hand-out with a narrow view of data that always has their drug coming out on top. Although medical schools don’t always excel at enforcing conflict of interest policies, I was taught to keep away from these slick and persuasive encounters. So that’s what I do. It requires resistance. Drug reps are everywhere.

The next easiest option is the CPS manual: a massive blue book that is a familiar sight in most doctors’ offices. Every year I get it in the mail, for free. I go to my PO Box and dutifully sign “Return to sender.” And every year they send it again. Why? Its content is supplied by the drug manufacturers; it’s no more than a hefty accumulation of the information provided in the glossy pamphlets mentioned above. At a recent seminar organized by the Therapeutics Initiative, the Canadian Medical Protective Association cautioned me that if I prescribe based on this information, errors in my prescribing that harm patients would not be defendable in court, because this information is not filtered through the academic lens required to identify safe prescribing practices.

When I finished medical school, I dedicated a year to public health research. I first naively accepted a job at a research firm that promised high pay and great learning opportunities. My first assignment was to use my MD credentials to “convince my colleagues” to take part in a Phase IV marketing study that was having a hard time recruiting physician offices to participate. The study would provide free medication to patients, and study the acceptability of the drug to patients. I didn’t see the benefit to patients of this study, besides access to free samples that might bias their perspective on acceptability, but I had to pretend. I couldn’t do it. My second assignment was to design a study that would show that a drug could be useful for some indication – anything, so that it could sell in North American markets after not being approved for its same use in European markets. “You must be able to find an indication for this drug in Canada,” they said to me. I quit this job after one week.

These stories represent the challenge that physicians face in finding bias-free evidence for good prescribing. We are mired in this challenge, and we depend on academic groups like the Therapeutics Initiative for the academic lens through which we are professionally obligated to look for safe, evidence-based prescribing practices. I don’t want to berate pharmaceutical companies for providing my patients with medications that can extend and improve their quality of life. But I admonish the practice of finding as many patients as possible to sell drugs to, whether or not the evidence exists for the use of the medication.

Given that the pharmaceutical industry tries its hardest to build cozy relationships with doctors, so too have they been cozying up to the BC government. And although the government denies withdrawing funding and support for the TI, that is exactly what is happening. The government has been slowly eroding funding for the TI over the last 2 years, including defaulting on the contract that promised TI funding through June 2013. UBC has filled the gap for the last nine months, but the future of the TI is grim with a lack of financial support, even though funds would be recovered many times over by avoiding the prescription of unproven or dangerous drugs and the complications that result.

My first responsibility as a physician is to do no harm. But the reality is that harm is done both by adverse reactions to prescription medication, and also lack of access to needed medications. The true science of medicine is getting the right medication to the right patient. That is what the TI does.

Patients who are suffering are easy targets for miracle solutions, and that’s the exactly the picture that drug manufacturers try to paint of their medications. That’s what happened when Pfizer paid $2.3 billion in fines for civil and criminal allegations that they illegally promoted drugs for use that wasn’t supported by medical evidence. Similarly, arthritis sufferers were enlivened to try something new in Vioxx until it was clear that the medication was causing deadly heart attacks and strokes. This disaster caused Merck to pull the drug from the market after concealing the magnitude of the risk in their initial research. Prior to the withdrawal of Vioxx, the TI correctly forecasted this risk, recommending that it not be adopted as a Pharmacare benefit and protecting many BC residents from these devastating side effects.

But let’s not dwell in fear. Many medications are beneficial to patients. But we need to know what kind of benefit they offer. How much of a benefit? A benefit for what type of patient? The seller is not the right person to ask. The right person to ask is an impartial academic organization like the Therapeutics Initiative that looks at relative versus absolute benefits, and harms, of medications. This helps doctors to see what we actually know, and how that differs from what the drug companies are trying to show.

There are several reasons why I need this reliable, impartial evidence – especially in a culture in which more medical attention, and thus intervention, is often sought. When my patients are hoping for a cure for their pain and suffering, it is difficult for them to evaluate the risks and side effects of a treatment. Our yearning for a cure for arthritis, MS, cancer, and many other devastating health problems causes us to look more favorably towards benefits of medications, and less to risks; it’s what doctors and patients both want to hear. That’s also why medical journals publish studies that show positive results, not negative ones.

Another reality of medical practice is that many of the drugs coming onto the market, such as those for cholesterol and diabetes, are for the prevention of future complications. In these situations, patients can suffer more from the side effects of the medication than from the condition itself. Evidence is also constantly shifting about how aggressively we need to treat these conditions in the first place. Other new medications, such as those for depression or anxiety, are competing with multiple drugs already on the market that treat the same condition, and shockingly few studies compare them head to head. In addition, one in ten Canadians can’t afford to pay for prescription drugs. In the context of growing income inequality in BC, I must also ensure that a new medication for my patient is worth the money spent on it instead of on food, rent, or other necessities.

Given irrefutable pharmaceutical industry bias that saturates our information sources, physicians and governments need organizations like the Therapeutics Initiative to make safe decisions about pharmaceuticals. Yet the government is cancelling funding for the TI as they simultaneously take no more than superficial steps towards reducing the exploding costs of pharmaceuticals in this province. It is time we stop blaming seniors for escalating health care costs in Canada and acknowledge that rising pharmaceutical costs are the leading cause of health system unsustainability. And then let’s do something about it. Let’s get the patients who we know will benefit access to the medications they need through a national pharmacare strategy that can save us up to $10 billion dollars annually. It’s about using smart evidence and safe practices to do what works in health care: getting patients the drugs that work while avoiding harm, and saving money.