An interesting video and script from MedScape recently discussed a troubling trend in clinical research regarding gastrointestinal (GI) cancers. According to John L. Marshall, Associate Professor of Medicine at Georgetown University, in Washington, DC, all of the major research in this area over the last five years “has been led by Europeans, performed by Europeans, and usually with European patients.”
As the Chief of the Division of Hematology-Oncology and Director of Clinical Research at the Lombardi Comprehensive Cancer Center further noted, that although the work on colorectal, gastric, pancreatic, and hepatocellular cancer has all been outstanding, it’s just all been done by European investigators. As a result, “they are really taking the lead in this clinical research world, and being led by a very vibrant group of clinicians and translational researchers.
Consequently, Dr. Marshall went on to ask viewers why this kind of research has become so significant in Europe. In looking for the answer, he described his recent experience attending a three day meeting in Barcelona with 3500 people in attendance. He noted how “there were fabulous speakers, remarkable content, and people from all over the world, but not the United States.”
He found it particularly interesting that this meeting had been in existence for about 10 years, and it started a year after a similar meeting started in the US. Despite its early age and “the same basic organizing committee, the same basic program,” the meeting in the U.S. that was held last year “had fewer than 100 people attend.”
Accordingly, Dr. Marshall determined that one of the major factors causing such a disparity is that the rules outside the US “are not nearly as strict around industry support.” For example, all of the people who went to the meeting in Barcelona were brought there by pharmaceutical support.
While critics of such support, especially here in the US, claim that it can influence people’s practice, they often ignore the significant impact the funding brings. For instance, “that money enabled a huge group of people, young and old, to come and gather and really drill down on these important new clinical research issues.” The funding “educated a large number of people throughout the world; not the US doctors.”
The problem is, as Dr. Marshall correctly puts, is that US doctors are not going to meetings at ASCO [American Society of Clinical Oncology], or for many of the meetings in the US because “they’re not engaged.” Moreover, doctors are “so busy worrying about their practices, and frankly they’re unwilling to pay their own money to go to these meetings.”
As a result, Dr. Marshall called this trend “a dumbing down of the US oncology.” This means that while the US has “become very basic and very simple, the rest of the world is challenging and trying to move cancer medicine forward.” Since the US has “become complacent and happy with what we’ve got,” he asserted that a “shift” is necessary to come up with better answers in the US to progress in treating cancer.
Part of this shift, according to Dr. Marshall, means “actually fighting back against restrictions” that impede our access to commercial support.”
Another way to shift American medicine is through innovation, but as Dr. Marshall points out, “our clinical research has not been very innovative over the last several years,” largely in part because of the strict limitations on industry funding. Such a disruption to our clinical research is problematic because “when our investigators from cooperative groups submit clinical trials to our regulatory bodies, there’s a very conservative approach at our regulatory bodies so that they’re saying no, we can’t do those kinds of clinical trials.” This kind of approach makes the US not “really willing to push the envelope” on research.
If the US does not change its current trend, and begin to “push the envelope,” we will lose valuable research such as the “I-SPY 2 clinical trial for breast cancer,” which although it “took the moving of mountains to do, in the end it was the right kind of clinical trial to do.”
Another obstacle the US faces is that we have become “so conservative and so careful about what we’re doing that we’ve lost sight of where we’re headed.” What the US needs to be doing is educating our doctors the way other countries are, which includes using commercial support to help bring together thousands of experts. If we continue to eliminate commercial funding, how are we going to educate our doctors and “allow innovation in a medical world that so desperately needs new ways of thinking?”
Since “our European colleagues have already figured this out, and they’re leading the way,” it should be clear for policymakers that restrictions on industry have led to the decline in our ability to compete with the world in areas like cancer.
Ultimately, as Dr. Marshall puts it, “we’ve got to decide: are we just going to watch and consume what they produce, or are we going to get back in the game and play as leaders in the medical community?”
Because we owe it to our patients and future generations of doctors and oncologists to give them better opportunities and chances at survival, the obvious answer should be that we are going to get back in the game and play as leaders in the medical community.
The best way to do this is by fighting against the restrictions on commercial funding that have let our country fall so far behind and gaps in care continue to grow, because strengthening those partnerships and collaboration will help make America leaders once again.