Is "New" Always Improved?

By Barry B. Sheppard, M.D.

The cherry tree outside of Peninsula hospital is in bloom. This is one of the perennial harbingers of spring that impinges on my awareness, and with spring come ideas of change. Spring is the season associated with rebirth and renewal and reassessment of things and the opportunity to improve one’s life or even the world at large.  I have come to wonder of late, however, whether “new” is always “improved.”

In the sixties and seventies the presence of TV became ubiquitous in America. One result of this was that we were barraged by advertising campaigns touting the wonders of a multitude of products. Products of proven worth were frequently upgraded, and we were urged to go out and buy the “new and improved” iteration. Somewhere along the line we also became brainwashed into thinking that those two modifiers were inseparable, i.e., that new was always improved.

In certain arenas of medical care, modernity correlates highly with improvement. This is especially true in diseases where we currently have no good alternatives. An excellent example would be the treatment of AIDS in the ’80s and early ’90s when the disease was universally fatal and any new breakthrough held the promise of an improvement over what was otherwise certain death. In that setting it was even appropriate to rush prospective drugs through an abbreviated evaluation by the FDA in hopes of providing some succor to the dying.

Modern medicine, however, does have a few claims to successful treatment of disease, and perhaps the greatest of these have been the successes enjoyed in the treatment of cardiac disease; treatments so successful that death secondary to heart disease may drop below death from cancer this year, a heretofore unimaginable circumstance. Operating in such an arena, one has to be sure that a new modality does not simply cause less discomfort or have fewer side effects or less morbidity than its predecessor, but it must prove itself to be at least as efficacious. Before you say, “Duh, of course the new product is as efficacious as the old,” let me relate a cautionary tale.

A couple of years ago one of the leading valve manufacturers decided to make a simple improvement on its artificial heart valves. Since prosthetic valve endocarditis carries a 70 percent mortality rate, the company decided to make its valve resistant to infection. A slight adjustment was made to the valve by impregnating the sewing ring with silver to give it an antibacterial quality. Of course any new heart valve has to go through rigorous testing using in vitro models and animal models, and for U.S. approval a valve frequently needs a track record of proven efficacy in human trials done elsewhere. In this case, however, a simple modification was proposed in the brand most frequently implanted in the U.S. Laboratory, and tests indicated that this improvement in the tried-and-true valve should give it measurably better antibacterial properties. A large cooperative trial was initiated to prove this desired quality, but simultaneously the valve was put into widespread use in hospitals nationwide. Within months, however, the oversight committee monitoring the endocarditis study noted a much higher incidence of paravalvular leak in the study patients implanted with the new, improved valves. The incidence became so high that the study was closed, and subsequently all of the improved valves were recalled across the country.

In retrospect it isn’t so amazing that a sewing ring treated in a fashion that makes it bactericidal might have a negative impact on the growth of new tissue cells. The FDA had not demanded trials carefully measuring the complications of the new valve because this was just a simple modification of a valve with the best track record of all artificial heart valves. The government assumed equal efficacy. The government trusted the valve manufacturer to provide a new product that improved on the old. The improvement (whether or not the valve had a lessened risk of endocarditis) became moot when the valve proved to be less reliable than its unimproved predecessor.

I suspect that the American public is even more susceptible to errors of assumption than the U.S. government, and I suspect that risk is even greater if the new item promises better cosmesis or less discomfort. We as physicians are the stewards of quality. In the profession of medicine, a policy of “let the buyer beware” is not morally conscionable. For example, as a surgeon I have to be convinced that a new bypass operation provides the same graft patency, protection from subsequent MI, or return of angina, and carries no greater risk of neurologic injury or renal impairment than the old one before I recommend it to my patients. And I need to test that conviction down the road with a measured assessment of the results of that procedure in my hands against the results obtained with the old-fashioned approach. Only then is the “new and improved” iteration fully acceptable as an option, regardless of its impact on our “market share.”

A recent study documented the correlation between advertising dollars spent on certain drugs and their likelihood of being prescribed in lieu of less expensive, older, and equally efficacious alternatives. Despite any hue and cry from the public, we are responsible for protecting our patients from corporate greed and from themselves. As financial pressures impacting our practices increase, so too will the pressure to shirk our responsibility to our patients increase.

So this spring as the cherry blossoms remind me of renewal and change, they will serve as a reminder to me to “renew” my pledge to my patients to protect them from change unless it is change for the better.