In recent months, The New York Times, The Journal of the American Medical Association, and other media have been reporting on the discoveries of, concerns about, and implications of relationships between doctors and drug/device manufacturers. It should be clearly understood that I do not infer that such disappointing alliances can have the same level of consequences in dental implantology as they might in cardiology, neurology or even orthopedics. In addition, since all of the root forms currently available are included in the FDA's 5-10K classification, there is no question about their qualities, characteristics, or reliability. However, there have been reports that some pharmaceutical products and medical devices have been responsible for deleterious effects. A few of these are the delamination of some early HA coated dental implants, the cardiac complications of Vioxx, and the instability of several acetabular components of total hip prostheses. If there are legitimate problems in regard to these products, adjudication is offered by our courts by using a variety of remedies. One of the significant factors considered when arriving at just decisions is the integrity of the research and the legitimacy of the researchers. Were the published reports based on good, peer-reviewed science? Were they tendered by scientists who were unencumbered by financial or other rewards from the manufacturers or sponsors? Did the publications in which their work appeared insist upon disclaimers? These requirements are as necessary as they are admirable. We, as readers and users, depend on them because they affect our professional behavior, influence our purchases, have a significant impact on our finances, and build prejudices that may alter the outcome of the treatment, therapies, and well being of our patients.
Some of the disappointments noted in magazines and newspapers are eye openers:
A New Orleans orthopedist accepted a grant of $175 000 to serve as a consultant to a knee manufacturer. As a result, his hospital purchased only that prosthesis, overpaid for them, and deprived his residents from being exposed to other products.
A New York internist accepted a large grant from a drug manufacturer to lecture on its products' off-label benefits. A recent indictment alleges conspiracy.
Country-wide orthopedists were evaluated by an overview agency regarding the factors that influenced their choices of total knees. Gifts, outings, and myriad other perks played major roles despite the fact that four equally acceptable products (dePuy, Stryker, Wright, Zimmer) varied in price from $1465 to $5736.
The business complex has been paying large fees to clinicians to lecture to potential investors on the benefits of certain medicines or other forms of therapy.
The Justice Department has issued subpoenas to a number of orthopedic device manufacturers to seek information about financial ties between themselves and the surgeons who use their devices.
In Burlington, Vermont, a former medical school professor pleaded guilty to obtaining a federal grant using fabricated statistics. He may have to serve 5 years in prison and pay a fine of $250 000. An article published in The New York Times in 2005 by Barry Meier, stated that a group of leading medical journals were planning “to stop the publishing of clinical trials unless the test had been registered at its outset in a public database.” Editors, it was maintained, released headline-making good news with more enthusiasm than they did with inconclusive or negative results.
Several manufacturers have actually forged contracts with medical centers which permit them to dictate what information may or may not be published.
On the other hand, there have been instances in which positive recommendations might have seemed too overt. Instead, some drug and device makers are actually paying doctors to criticize their rivals' products, subsidize the writing of negative reports and demean the benefits of generics that may be much cheaper and equally effective as the far costlier proprietaries.
The drug industry spent billions of dollars last year (NYT, Jan 24, 2005), wooing prescribers with grants, gifts, trips, greens fees, and Cuban cigars.
If all implants are equal, if all sutures and scalpels perform with even results, if a $90 implant works as well as a $300 implant, I suggest that the surgeon purchase the less expensive one and send the difference to UNICEF. Do not be influenced by ads or speakers, by junkets or dinners, by grants or cash. Choose the products and the methods you are convinced will serve your patients best.
This journal will make its contributions to ensure accuracy and truth. We will eschew the acceptance of advertising that makes unsupported claims, refuse to publish reports and articles that are not verified by current science or which fail to reveal the details of financial relationships among authors and sponsors.
As practitioners in whom the public places great trust, and, in fact grants the license to ply our skills, we must always exercise the highest level of ethics in selecting materials, devices and techniques.
A. Norman Cranin, DDS, DEng, is Editor-in-Chief of the Journal of Oral Implantology