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Have We Killed Clinical Research?

“…I have always depended on the kindness of strangers.”  — Blanche DuBois in Tennessee Williams’ play A Streetcar Named Desire

Years ago when I began my medical training, I recall enrolling patients for clinical research. In cardiology, there were a myriad of questions that needed to be answered, especially in the area of defining which medications were best to limit the damage caused by a heart attack.

Patients routinely participated in large, multi-center prospective randomized trials to answer these questions. It was routine for them not to charged for participating in the trial — the drug(s) and additional testing would be funded by the company whose drug was being studied. Patients enrolled willingly, eager to help advance science and perhaps, in some small way, their fellow man. It never dawned on me in those early days why hospitals and research centers were so eager to promote research.

Like many things in our profession, research centers realized that these studies could make money. There are always additional expenses required to perform these studies and research centers wanted to make sure they were not left holding the “cost bag” for these trials, so they would pad their budgets for both the “direct costs” of performing the trial and a bit more for “indirect costs” that funded their offices and utilities and perhaps to offset the losses carried by other slow-to-enroll trials.

This strategy worked. Research centers, working earnestly, helped recruit patients by marketing their cutting edge researchers to the populous. Patients came in droves since there was no additional cost on their part to participate. Research centers got additional “indirect” funds from the drug companies to grow. More research was conducted, more patients recruited, and everyone benefited.

Until the costs of healthcare grew.

About 2001, research was getting expensive for companies. Back then, I noticed a subtle shift occur in the funding of clinical research by the medical device industry. I was involved in Medtronic’s Insync trial that tested the first biventricular pacemaker for the treatment of heart failure. As a young electrophysiology researcher, I was stoked — this was exciting new and unproven territory for pacing therapy to venture.

But I remember how the Insync trial budget was formulated because it was quite different than I had remembered with other clinical trials. In this trial, part of the study was completely funded not by the company, but rather a portion of the trial was paid for by the patient’s insurer. This was perfectly legal, we were told, since the large companies had to gain approval from our government via the FDA to allow such a payment strategy. Also, insurers were required to pay for clinically-indicated pacemakers.

So, since dual chamber pacemakers were already approved for reimbursement by insurers and the “only” new portion of the implant procedure was the placement of a new left ventricular lead, the patient would not be charged for any of the new equipment, and their insurer would “only” be charged for a “regular” dual-chamber pacemaker (mind you, for a pacing therapy that was unproven at the time).

Technically, patients still did not have to bear any additional cost of their involvement in the trial and everybody was happy. With this new trial budget strategy now firmly in place, we had, in effect, “relied on the kindness of strangers” (the patient’s insurer) to help fund the company’s research. No one seemed to notice this shift, and certainly no one minded, since everybody won: the patient got the device, the research center got paid, and the company, too, could even make a little money to offset their expenses in the process.

Naturally, there was a desire for research centers to recruit more and more trials to grow their prestige in the community. Small companies would use research protocols to gain marketshare in competetive hospital accounts using, in part, this patient-subsidized budget strategy. Worse, they would create new add-on trials only marginally relevant for the same growth strategy even after devices were FDA-approved.

Fast forward 10 years to our current era…

With the growing cost of healthcare being offloaded by insurers on the backs of patients, patients have seen their insurance deductibles rise. Employers are finding they can no longer provide “Cadillac plans” to their employees due to costs, and instead move to insurance programs that are less encompassing in an effort to control costs to their employees. As a result, some patients even have “lifetime caps” limits on their insurance. Consequently, patients have become keenly aware of the costs of providing their healthcare.

I have noticed that patients are increasingly reluctant to participate in clinical research. Perhaps this is because they understand the relationship between ANY healthcare and THEIR expenses. They know that their insurers might not cover the experimental parts of research trials and are concerned that they’ll be left holding the bag. After all, defining where the lines are drawn between what is paid for and what is not in clinical trials is nearly impossible with our current cloudy hospital billing schemes.

Peter Orsag, the White House budget director, has promised comparative effectiveness research will lead us to the promised land of healthcare cost containment. But given what I see, because patients are footing an increased portion of their healthcare tab already, do we really think enrolling patients in these trials will be easy going forward?

Reality always trumps the spin in Washington. Unless we see better transparency of costs from all of parties making money in clinical research, we’ll never have the patients enrolled to bring any of these trials, comparative or not, to fruition.

-WesMusings of a cardiologist and cardiac electrophysiologist.

*This blog post was originally published at Dr. Wes*

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One Response to “Have We Killed Clinical Research?”

  1. I agree with most of this thoughtful analysis, that the costs have overrun our capacity to conduct clinical trials. Another factor, though, may be many patients’ progressive loss of trust in their physicians and the medical system.

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