Shoddy research, deadly results

A microbiologist examines MRSA plates.
A microbiologist examines MRSA plates. Centers for Disease Control and Prevention

China recently announced that research fraud may be considered a capital crime, punishable by death, when it leads to approval of dangerous drugs that result in the deaths of patients.

This news was all but dismissed by journal editors on medical listserves as a sign of an oppressive totalitarian regime. But is it unethical for any government institution to recommend the death penalty for someone who knowingly, for profit or job advancement, promotes a gambit which needlessly results in fatalities, sometimes in the thousands?

Although many consider the death penalty too extreme, many patient advocates believe that appropriate and commensurate penalties should be imposed upon one who knowingly uses tainted data to promote a product that harms patients or leads to their deaths. Would such unethical behavior causing death be tolerated in any other industry without severe sanctions or prison?

How bad is the problem? The blog “Retraction Watch” estimated that in China 40 percent of the research is not valid. The United States and Europe are not much better.

Dr. Richard Horton, editor of The Lancet, a premier medical journal, has said, “The case against science is straight forward: much of the scientific literature, perhaps half, may simply be untrue.” He blames “studies with small sample sizes, tiny effects, invalid exploratory analyses and flagrant conflicts of interest, together with an obsession for pursuing fashionable trends of dubious importance.”

The Journal of the American Medical Association recently devoted an entire issue to conflicts-of-interest in medicine. Conflicts of interest taint not only the researcher, but also the editorial processes which allow these articles to be published.

This problem is of paramount importance. Research is the foundation for treatment protocols and health policy. A murky fog has descended over what works and what does not.

For example, look at our efforts in reversing the superbug epidemic. These problems appear to be worsened by unscrupulous profiteers promoting interventions and attempting to pack research laboratories, editorial offices and governmental advisory committees with individuals possessing significant conflicts-of-interest.

Federal policy advisers must declare these conflicts. But this declaration does not eliminate them. The excuse for their inclusion on policy committees is that their expertise outweighs their conflicts-of-interest. But isn’t a tainted opinion from an influential and famous person even more dangerous than one from someone less well known?

For example, research involving the control of MRSA (Methicillin resistant Staph Aureus) has become muddled. Much of our policy has concentrated on hand washing. Hand washing should be viewed as very important but a back-up measure for containment of these dangerous bacteria, since health-care workers should not have these superbugs on their hands in the first place. If they do, there is a problem in containment and control.

Some of the basic hand-washing research appears to overstate its benefits. This is supported by the experience of the National Health Service in England. Several years ago, the NHS instituted a massive hand-washing campaign to reduce infections, along with a surveillance and isolation (search and destroy) strategy for the superbug MRSA.

Over several years, the NHS was able to cut MRSA infections by more than 50 percent. Hand-washing enthusiasts used this as a testament as to how handwashing can control infections. However, this decrease was only observed in the resistant strain which was part of the search and destroy campaign, and not in the more common methicillin-sensitive Staph Aureus.

In the U.S., the Department of Veterans Affairs Hospitals had similar results using surveillance and isolation, with an over 80 percent reduction in MRSA infections.

One would think that this would lead to widespread adoption of search-and-destroy strategies. But it did not.

A new strategy, daily bathing of all patients with an antiseptic, chlorhexidine, did become popular. However, a Reuter’s investigation raised questions about both the basic research demonstrating this protocol’s effectiveness and the product’s safety. The strategy failed to control a MRSA outbreak at the lead researcher’s hospital. Nonetheless, the protocol is being used in more than 60 percent of hospitals.

The U.S. private health-care system is following the path of least resistance, hoping the emphasis on inexpensive hand hygiene programs will be enough to reverse this epidemic, rather than making the hard and expensive investment needed in infection control.

Real infection control includes testing and isolation of patients, appropriate staffing of infectious disease nurses, and providing adequate cleaning staff who are trained and have time to thoroughly clean patients’ rooms. Only then will we be able to stem the tide of this epidemic.

Kevin Kavanagh of Somerset is a retired physician and board chairman of Health Watch USA.