The fact that Medtronic Inc., a leading medical device manufacturer, paid Dr. Timothy Kuklo $800,000 over the past three years is not as disturbing as the fact that Kuklo falsified and exaggerated the benefits of the company’s Infuse bone graft in scientific medical journals. Making matters worse, Kuklo stands accused of forging the signatures of medical co-authors.
The ethical quandary in this case has real life implications for the rest of us. This isn’t some ivory tower academic falsifying reports to justify a bloated consulting salary. Kuklo’s conclusions and writings promote a product that doctors around the country will rely upon to heal and restore health. The false claims can actually end up injuring patients. The scientific community that publishes these medical journals also suffers collateral damage from Kuklo’s behavior.
Presently, Congress is holding hearings regarding medical device safety. They’re trying to determine whether the FDA needs more regulatory power. While they’re investigating this issue, they also need to establish some basic groundrules concerning scientific research and the remuneration of the researchers. It seems to me that a researcher whose task it is to research a drug or medical device can’t be compensated by that same drug company or medical device company. There’s an inherent conflict of interest. The payment naturally predisposes the researcher to look favorably upon the drug or medical device.
If medical journals, doctors, and the community at large are to place their confidence in this research, the research itself must be beyond reproach. These conflictual relationships have to stop. Perhaps the establishment of an independent funding source that is operated apart from the companies would work.