We must protect guidelines against undue influence

In recent columns and press releases, I've talked about efforts toward meaningful reform of the physician payment system and of the current medical liability climate. I would like to raise a different issue that undoubtedly will receive much more attention soon.

Depending on one's point of view, it is usually painted as taking the best care of patients by following currently accepted evidence-based guidelines (then translating these into performance measures), or the interference of government and others into the practice of medicine. We are appropriately engaged and vigilant about these two dichotomous ways of approaching guidelines and comparative effectiveness research and have written about those in recent weeks.

There is another threat we need to be extremely vigilant about, namely undue influence on the development of guidelines themselves. What has received a lot of attention are cost concerns that could interfere with the doctor's ability to prescribe the best care for the patient. We have years of experience in dealing with private health insurance plans in this regard. But I am talking about a different sort of influence that is even more insidious; i.e., conflict of interest in developing those guidelines.

Evaluation of scientific evidence should be unbiased, free of political pressure and untainted by conflict of interest. Establishing guidelines for medical practice should be the province of those most trained to evaluate scientific evidence, which includes medical specialty societies.

When controversy about the best treatment exists, scientific evidence and clinical trials can bring clarity and help for patients and their physicians. The dilemma comes when those who stand to gain from the guideline itself try to influence how it is written.

Here is an example that does not pass the "smell test": a pharmaceutical manufacturer financed the workshop meeting expenses where experts were to write the guidelines for septic shock. No surprise that the drug made by the manufacturer was written into the guidelines. Maybe it would have been anyway, but the undue influence potential was called out in the Oct. 19, 2006 New England Journal Medicine. The safeguards against industry influence in that meeting were described in an article in the December 2006 Surgical Infections, but the perception damage was done.

Imagine if the guideline then gets translated into a performance measure, where the physician is being evaluated for quality purposes and perhaps for pay-for-performance. Getting a drug or device written into a performance measure is worth its weight in gold -- far more than an army of drug reps deployed throughout the country to detail physicians in their offices. So we all have to be very careful not to become pawns to any group that stands to profit from the outcome of the guideline.

There is another powerful sort of influence that whips up interest and exerts pressure on the way we practice, and sometimes we fall victim to this influence ourselves. The best example of this was seen in the public pressure to use autologous bone marrow transplants in treating women with advanced breast cancer. Despite weak evidence, physicians, patients and lawyers pressured health insurance companies to cover this treatment approach. It took years to find out that the treatment was ineffective. Conviction and hope are not synonyms for evidence.

At a symposium where I spoke some months ago, patient disease advocacy groups proudly announced that their organizations were almost completely funded by one or another pharmaceutical company, and that all of their travel expenses were covered by the companies as well. Needless to say, these patients with very real and difficult diseases had been convinced by their sponsors that any attempt to evaluate the effectiveness of drugs scientifically was a smoke screen for withholding lifesaving drugs from them. The conversation was the most anti-science one I had been in for a long time.

We need to be very concerned about politicians who try to legislate "good medical practice." That is the province of the profession. It should not be a political football or a response to emotional appeals, however well-intentioned. As one state legislator put it after she was lobbied to support patients who wanted a certain type of treatment that was not based in evidence (in fact, it was contradicted by evidence), "If you don't do what they want, they treat you like a monster."

So be alert to well-meaning groups and politicians who try to create legislation or regulation to "protect" doctors' ability to treat patients as they choose. While the intent sounds appealing, it is a really, really bad way to establish good medical practices. As one of my colleagues said, "Having state legislatures decide what is and is not an appropriate treatment option for a given clinical condition is intruding into clinical decision-making and is wrongheaded."

Now, we all know that individual patients may have characteristics, risk factors, preferences or beliefs that lead a physician to deviate from an established scientific guideline for good reason. This can and should be documented. Otherwise, there is nothing that separates us from quacks. State medical boards have an established role in regulating the practice of medicine to protect the public from fraud, misconduct and abuse. Those regulatory bodies need to recognize that guidelines are not prohibitions against alternative approaches, but are thoughtful, careful, evidence-based road maps to aid physicians in evaluating and treating patients.

Breakthroughs in medicine do not occur by following guidelines; we know that. But we can do better by doing our best to follow where the evidence leads us. We take our role as scientifically trained professionals very carefully. We also know that balancing risk and benefit should always be done in evaluating treatment options with the patient's best interests and well-being as the goal.

These pressures will not go away. Therefore, we must engage constructively and work closely with our specialty societies to ensure that clinical effectiveness is not defined by legislation or political negotiation and influence. We must also engage our students and our colleagues in support of the bedrock principles of our profession. This is not an issue to ignore, because if we can't handle this, how will we handle the tougher issues that are sure to come as a result?