Financing for medical research has always been a challenging affair. The growth of the pharmaceutical and device industry, combined with FDA requirements, has spawned the growth of a huge clinical research enterprise. This enterprise, although somewhat essential in order to translate medical knowledge into drugs and devices that can be used to directly benefit patients, has, from a scientific point of view, the distinct limitation that it is profit-driven. Despite the fact that much medically important information is generated in this research arena, the fact remains that the questions asked, and the answers reported are inextricably tied to the financial well-being of the study sponsor.
One can readily begin to understand how such vested interest could impact research. Suppose for example, the manufacturer of a given medication determined that the use of this medication in patients who had suffered a heart attack, could lower mortality by 25%. Assuming that the difference met statistical criteria for significance and the study was appropriately conducted, we might very appropriately be encouraged by this finding. However, let us further assume that the baseline mortality for post-MI patients in this study population was 8%, and, with the use of the medication mortality dropped to 6%. Therefore, the real decrease in mortality was only 2%. This means that 50 people would need to be treated with this medication in order to save one life and 49 would derive no discernible benefit, despite being subject to whatever side effects the medication brings.
The next most important and logical fact to research would then be how to distinguish the one patient who will benefit from the 49 who will not. However, given that research is an extremely expensive enterprise, why would the manufacturer pursue this additional line of research that could potentially drop their market share by 98%? And suppose there was another medication which might prove to be equally effective; why would a manufacturer expend hundreds of thousands of precious research dollars and risk finding out that their product has no incremental benefit? If research revealed no significant reduction in mortality, why would manufacturers make the extra effort to be certain that these findings were published in a peer-review journal, rather than attempting to bury to the information in an internal corporate graveyard?
So where can we look for scientifically-driven research? Traditionally, our academic medical centers were a rich source of information in this regard. However, the financial exigencies of funding for academic medical centers have placed severe limitations on the “extra” dollars available to support a research effort which might have no opportunity for bringing dollars into the university. The National Institute of Health (NIH) has also served an important role in medical research through its 27 centers, 18,000 employees and investment of over $28 billion in medical research through some 50,000 competitive grants to some 325,000 researchers across the country. Although scientifically-driven, there are several limitations to this vital research pipeline. First of all, despite its size, the demand is much greater than the supply and the NIH has, in recent years been able to fund only 12-17% of the grant requests that it receives. Secondly, as a public trust giving large awards, it must necessarily be somewhat risk averse, thus placing innovative approaches or untested researchers at a distinct disadvantage. However, there may unfortunately be a third element emerging which will constrain the traditionally scientifically-oriented NIH agenda. Health care in America has become increasingly unaffordable. As the government is apparently assuming an increasing rather than decreasing role in protecting the access to care, it will sooner or later have to constrain costs. The government now becomes an “interested” party to the research, whose funding decisions will necessarily need to address its financial interest, not completely unlike the necessity of private industry to protect their financial interest. We may perhaps be seeing the tip of this iceberg in the somewhat radical recent reversal of recommendations for breast cancer screening in women.
In this increasingly financially constrained environment, the importance of independent research organizations such as the Florida Heart Research Institute assumes an ever increasingly critical role. Although small in size, the unique focus of FHRI on innovative pilot projects, as well as our commitment to scientific integrity, distinguishes our efforts as one of the few islands of scientifically driven research. You can depend on FHRI to be the leader in unbiased scientific advancement in an increasingly tempestuous sea of financial uncertainty and mounting political pressures.
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