Almost daily we hear stories of breakthrough medical discoveries, ways to advance healthcare and improve the longevity and quality of people's lives through medical research.
Medical research has become a multibillion dollar industry in the United States and is driven like all of healthcare — by money.
Unfortunately, that has led to some problems with how research is conducted and reported, giving rise to controversies ranging from funding problems, to conflicts of interest, to ethical conundrums (such as stem cell research), to FDA approvals for dangerous drugs.
The discussion of healthcare reform must address medical research, because it is tied to money, and as we know, money is the real heart of all healthcare reform discussions.
Funding Shifts
Until a few years ago, the bulk of funding for medical research in the United States came from government sources through the National Institutes of Health and its related agencies. The research was then conducted through universities and government labs, which would apply and be approved for funding for their research. Since the funding came from nonprofit government resources, there were not ways to profit from the research other then by doing the research itself.
In recent years, as budgets in Washington have gotten tighter, however, less and less money has been available for research through government sources, giving rise to more industry-sponsored research. Pharmaceutical and medical device companies to insurance companies and private enterprise (with profit motives) have become major funders of research, giving rise to questions about its objectivity. Further, conflicts of interest are exposed by the media on regular occasions.
Research and Conflicts of Interest
Is it possible for privately funded research to be objective? Yes, of course. That, though, also requires honesty about who is underwriting the research and ensuring that any ties to a profit motive are disclosed.
And that's where the problem is. There have been a number of very public disclosures of conflicts of interest through the media where those who were charged had previously denied those ties. That, of course, leaves questions about how objective the research is, and therefore, whether or not its outcomes can be trusted.
FDA Approvals for Dangerous Drugs
The question about whether or not research results can be trusted then goes to the heart of approvals through the FDA. The FDA can only do its job as well as the information submitted to it, unless we begin to ask the approval system to start second-guessing every submission. That requires more money.
Included in the conflicts of interest discussion is this fact: More than half of the FDA's budget is now funded by the pharmaceutical and device companies it is supposed to regulate. The FDA began to get its funding from pharma, beginning more than 15 years ago, through the 1992 Prescription Drug User Fee Act. Therefore, job security for the people who work at the FDA means keeping its funders — the pharmaceutical companies it is tasked with monitoring — happy. Among those who track FDA approvals, this type of conflict of interest spells approval for drugs and devices that may not be safe.
The approval for Vioxx was a good example. Research showed Vioxx was responsible for the deaths of some patients with coronary disease, but Merck, the manufacturer, covered up that research. When it submitted to the FDA for approval of Vioxx and paid its hefty fee to get that approval hurried through the FDA system, Vioxx was approved and on the market quickly, and patients soon began to die.
FDA's System Leaves No Room for Cost Saving Drug Approvals
One of the ways pharmaceutical companies bolster the FDA budget is through additional fees, which allow their applications to move to the front of the review line. Those fees have become a roadblock for the less-expensive drugs, generics and alternative herbs and supplements that won't ever make enough profit to make the cost of moving their products to the head of the review line worth the price.
Consumers lose, because only the expensive drugs, manufactured by big pharma, are being approved. The FDA does not have enough staff to work on more applications, nor do they have the budget to hire more.
Stem Cell Research
Separate and aside from other problems regarding research that are addressed as part of healthcare reform is the question of stem cell research. Since some stem cells are derived from human embryos, ethical questions are raised and funding is affected. Further, because embryonic stem cells were the first type of stem cell discussed in the general population, most lay people don't understand that other forms of stem cells exist and can be used for research. As a result, any conversation about healthcare reform must focus on the reality of stem cell research and its prospects for helping patients.
Overall, as is true with all aspects of healthcare reform, money from objective sources would fix the problems. Unfortunately, that money seems to become scarcer as time goes on.
