Latimer: Evidence-based medicine: Whose responsibility is it?

Drug development is one example of evidence-based medicine…and it is surprising how easily we take it for granted.

There is a broad consensus among physicians and educated people everywhere that evidence-based medicine is the goal, the gold standard, the ultimate. Evidence-based medicine is based on scientific methodology that allows us to know what works and what doesn’t.

Although it may seem straightforward, truly determining a treatment’s effectiveness can be frustratingly difficult—and can take many years. You only have to look at how often findings are reported in the news based on some new study and then retracted a few years later as new evidence is produced. Dietary recommendations are a good example. Medical practice is under revision on a daily basis as evidence becomes available at an ever-increasing pace.

But where does this evidence come from and who is responsible for generating it?Evidence comes through scientific studies conducted by a relatively small number of people in centres around the world. Drug development is one example of evidence-based medicine that I am very familiar with and it is surprising how easily we take it for granted.

Of course when most of us get ill we want a solution and usually depend on medication of some sort for treatment. Even when faced with a surgical problem there will be anaesthetics, analgesics and possibly other medications involved in recovery. (Of course, surgical procedures themselves are also subject to clinical trial evidence to find the most effective procedure).

Pharmaceutical companies both large and small do most drug development today. They hire physician investigators to design and conduct clinical trials and these investigators rely on volunteers to participate in the studies with the goal of learning whether the treatments work, are better than sham treatments or placebos, and whether they have acceptable side effects.

Right now on clinicaltrials.gov there are about 186,000 clinical trials listed and about 50,000 are active. They require hundreds of thousands of volunteers. Most volunteers in clinical trials find out about the trials either from their physician, if that physician is involved in conducting the trial, or from advertising. Very few physicians are involved in clinical trials and studies conducted around the world show those who are not, seldom talk to their patients about clinical trials or refer them to available studies. Finding volunteers for these trials is one of the bottlenecks in new drug development and one of the biggest expenses involved in launching a new treatment. It contributes to the high cost of drugs.

People who do volunteer usually find it a worthwhile experience and often do it for altruistic reasons. The vast majority say they would do it again and would recommend it to family and friends. Those who don’t volunteer usually say it is because no one told them about the trial. It is not a topic of conversation for most people unless they are faced with a difficult medical problem.

I have been surprised to learn that even health advocacy groups often don’t make their members aware of clinical trials. This could be out of a misplaced, paternalistic attitude or fear of seeming to advocate for a specific treatment or study. This is frustrating to those of us trying to get the word out about ongoing studies requiring volunteers.

Although I have found groups here often don’t participate in raising awareness of clinical research, it is clearly not a universal policy because in some countries advocacy groups are very active in this area. People can be informed without being coerced or without those providing the information being advocates for any particular study.

Sometimes groups say they don’t want to pass on information about trials because the study is being sponsored by a for-profit company. Although that is often the case, there is unfortunately no one else taking on the role of testing and developing new treatments. It would be great if our government funded more clinical research, but realistically we would pay for it through higher taxes. Government is always trying to find ways to partner with private enterprise to reduce cost and investment risk.

In my view evidence-based medicine is everyone’s responsibility. It simply can’t be done without the widespread participation of health care professionals, the public, private industry and those who represent the public in various ways.

 

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