Show 1299: Is Evidence-Based Medicine an Illusion?

In our nationally syndicated radio show this week, we consider the strengths and shortcomings of evidence-based medicine. Compared to the alternatives–basing medical care on opinion or tradition–evidence-based medicine sounds like a great idea. As currently practiced, however, it falls far short of its potential.

What Is Evidence-Based Medicine?

Philosopher and bioethicist Leemon McHenry describes the ideal of evidence-based medicine. Randomized controlled trials are the gold standard of evidence-based drug research. However, they don’t always tell us what we want to know. Sometimes that is because researchers design them specifically to help the drugs being tested show up at their best, downplaying side effects. Unfortunately, that benefits the drug company who pays for the trial, but it doesn’t forward the cause of public health.

Where Is the FDA?

Many people assume that the FDA is busy testing medications to see whether they are safe and effective. In actuality, the FDA reviews data from the trial sponsor. As a result, medication manufacturers exercise a great deal of control over what the FDA knows. Needless to say, that also has a major impact on the data available for doctors and patients as well.

What Is the Illusion?

When it comes to drugs, too often marketing masquerades as research. One example is a common practice in which a drug company employee prepares most of the report on a drug trial, and the academic who is its official author gives it a minor tweak or two. Dr. McHenry describes the efforts that pharmaceutical manufacturers expended in disguising suicidal thoughts and behaviors associated with antidepressants by calling them “emotional lability.” That sounds a lot less threatening, and it took the FDA quite a while to require black box warnings regarding suicide on SSRI and SNRI antidepressants.

Sue the Manufacturers?

Quite a bit of Dr. McHenry’s information comes from his work with a law firm. In the course of a lawsuit, drug companies may have to reveal information that they would otherwise keep secret. Why doesn’t the threat of litigation discourage misleading behaviors? Essentially, says McHenry, the manufacturers calculate even the expense of a large lawsuit as part of the cost of doing business.

Can We Restore Evidence-Based Medicine?

Evidence-based medicine is a good idea. How can we restore the practices behind it so we can all trust the evidence it produces?

Dr. McHenry has a few suggestions.

1. Don’t let the firms test their own drugs. Testing should be conducted by an independent, objective entity, separate from the manufacturer and from the FDA.
2. Cultivate independent funding for drug research. When pharmaceutical firms no longer sponsor the lion’s share of investigations, the public will have much better access to the evidence.
3. Make unpublished and abandoned trials available for analysis. That reduces the “cherry-picking” effect.
4. When firms are found in violation of the law, currently they pay fines. Instead, or in addition, the executives responsible for the company during that violation should face imprisonment. Very few companies or boards of directors would consider that a simple cost of doing business.

This Week's Guest:

Leemon McHenry, PhD, is a bioethicist and Emeritus Professor of Philosophy at California State University, Northridge. He is the author, with Dr. Jon Jureidini, of The Illusion of Evidence-Based Medicine: Exposing the crisis of credibility in clinical research.

Disclosure: Dr. McHenry is a research consultant for the Los Angeles law firm, Baum, Hedlund, Aristei & Goldman. It is through the law firm that he became aware of the problems with evidence based medicine and worked with Dr. Jureidini.