Educated Acceptance
France’s population is slightly less than that of California and Texas combined. That means the nation’s myeloma patient community is roughly one-fifth the size of its counterpart in the United States, translating into annual numbers of more than 7,000 newly diagnosed and at least 42,000 French patients.
Most are treated by physicians affiliated with the Intergroupe francophone du myélom (IFM). These connections translate into treatment strategies that include possible participation in an IFM-directed clinical trial. And this means the IFM can usually complete studies much faster than other cooperative groups around the world. An estimated 60-80% of eligible patients take part in trials, as compared to 3-8% in the United States.
Low participant numbers in clinical trials participation rates in the United States have been an issue in cancer advocacy since the first day I worked in myeloma. Go to any cancer policy meeting and it’s a sure bet clinical trials will come up at some point – how important they are, how more has to be done to increase participation – especially for Black and other underserved populations. Pharmaceutical companies set targets for trial recruitment and created incentives to increase participation and address disparities. Yet little has changed.
I asked Jean-Luc Harrousseau why he thought this was the case. He took a few seconds. “I think there are three reasons.”
“The first one is that in the United States patients are treated in university and referral hospitals or in private practice hospitals, which rarely include patients in clinical trials. In France, the majority are referred and treated in public and university hospitals.
“The second reason is, as I said, almost all centers treating myeloma patients are members of the IFM. So, the investigators decide together the protocol, they adhere to the protocol, and then they are able to convince their patients that is the right choice.”
In the United States, he said, a physician would present a range of treatment options and the ultimate decision lies with each patient. “A patient can say, oh, I’m a little bit nervous about high-dose therapy, I would prefer low-dose therapy. In France, patients don’t ask these kinds of questions. ‘No doctor, I trust you, if you think it’s a good question, then I accept.’ The majority of patients accept.”
Not out of deference, but out of inherent confidence in the recommendation of their physicians. Some, a minority of patients, still decide against participating for personal reasons.
“And the third one is that in the United States, and in Germany as well, patients have access to new drugs very rapidly. Once FDA approval has been obtained, insurance can reimburse in the United States. In Germany it’s almost immediate, six months after EMA approval. It’s a very rapid thing. In France, there are very long discussions with the HAS.” And then, like everywhere in the world, it comes down to money, noted Harousseau, putting his regional president hat on for a moment.
“We do not have enough money to pay for innovation in all specialties; Covid vaccinations, anti-obesity drugs, a new immunotherapy for melanoma or lung cancer, myeloma treatment, and so forth. Patients say, ‘wait a minute, since we may have to wait – two, three, four years – before having access to the drugs, the only way to have new drugs is to participate in clinical trials.
“So there are cultural and very practical reasons.”
Culturally speaking, general French and American perceptions of patient – physician interactions are fundamentally different. When I first worked in France in 2006, I asked the daughter of one of Harousseau’s patients, who was active in patient advocacy, to take a look at the French translation of the IMF patient handbook and let me know what she thought. It was helpful, she said, but one section about seeking second opinions was alarming.
“You cannot question the opinion of the doctor,” I recall her telling me, “in France, we trust our doctors. It would be highly insulting to go to another doctor.” I jumped to the wrong conclusion. For years. Because I was analyzing the situation from the wrong vantage point.
I had been overly influenced by the experiences like that of a European support group leader who became a close personal friend. His physician told him that if he got a second opinion, there was no reason to come back. I’ve heard variations of this theme many times. That’s what I heard when my French friend critiqued the patient handbook, but it’s not what she said.
My American viewpoint did not allow me to understand what she was saying until many years later. I had the conviction that a second opinion in myeloma was gospel. That’s what we Americans did. We believe in patient choice, being an educated consumer, and ultimately making the decisions about ourselves, or so I had been told and led to believe. An educated patient is a healthier patient. Period.
There is, however, a middle ground upon which there is no compelling urge to keep up with the latest myeloma research. One in which a physician and patient can communicate about what they must immediately address. There are many ways of being an educated patient without having it dominate one’s life.
Plus, I could never reconcile high clinical trial participation rates in France with low ones in the United States. During the years I was preaching this, clinical trials participation rates in the United States barely budged.
Why? A major part of the answer, I believe, could be found in Harousseau’s practical reasons.
French and American approaches to health care are just plain different. In the United States, access to medical treatment in the best, most appropriate ways for each disease, depends on the quality of insurance, geographical accessibility, and absence of bias – cultural, educational, social, economic – in diagnosis and treatment. Add a large number of uninsured patients, who are generally treated too late and sporadically, if at all, in emergency rooms. And if knowledge is scarce, as it was for myeloma almost through the 20th century, it doesn’t matter as much how good everything else might be.
Moreover, American medical treatment is a diffuse, complex web of public and private hospitals, clinics, and offices seemingly impossible to classify. Familiar names like MD Anderson Cancer Center and the Mayo Clinic have created de facto affiliations and networks to include facilities far-off from the locations of the home facility. Every large cancer facility engages in strategic outreach in surrounding areas. Yet, according to some estimates, as many as 80% of all American myeloma patients don’t consult with a specialist during the course of their disease.
If they really wanted to know about myeloma clinical trials, they could go to SparkCures to get information in plain English as well as support to explain anything. They would learn about the various healthcare networks and generally join one of three major oncology cooperative groups: the Alliance for Clinical Trials in Oncology (Alliance), ECOG-ACRIN (ECOG), and SWOG. Each has a myeloma committee. Before jumping to the conclusion that a single entity would be better, remember, just based on size alone, the United States could theoretically support five IFM-sized groups.
Virtually every French citizen is medically insured and has access to medical care and a university or public hospital if referred. Myeloma (and precursor condition) patients are referred to hematology departments, almost all of which have at least one staff working with the IFM, which offers support, organizes education and networking meetings, and keeps its members up-to-date on clinical trials and the latest news on myeloma research and treatment.
It is unknown how many American myeloma patients are treated by physicians with cursory knowledge of the latest developments, or who may treat one to a small handful of myeloma patients over a year or even a career. But experts believe they may be treating the majority of patients. The odds of them learning about clinical trials are likely close to zero.
Harousseau’s comment about money and costs reveals more than a bit of the governing official in him who knows difficult choices about budgets and people have to be made. France is one of twenty-seven member nations of the European Union (EU). There is mixed authority between the EU and its member nations. While the European Medicines Agency (EMA) serves the same role in drug approval that the United States Food & Drug Agency (FDA), it is up to each member nation to decide on health budgets for its citizens. And budgets determine access.
As head of the Haute Autorité de santé (HAS), the national agency providing health recommendations to French policymakers in government, Harousseau understood the limitations imposed by budgets. Not having coverage approved created incentives for patients to participate in clinical trials in order to have a chance of accessing new treatments. And they knew if they didn’t, they would get the best standard of care available.
Before judging, remember every nation has policies restricting access in some way. If an individual can’t pay for an approved therapy, it doesn’t really matter. In the United States, access is rationed by types of insurance, geographical proximity to care, and a myriad of other factors. Trying to untangle the various threads of American health care providers – the mix of physicians, clinics, insurance, and so on – into a meaningful whole is impossible.
Not so with France and the IFM if you’re a myeloma patient. Once in the system, it sets off a sequence of events, from diagnosis to developing treatment strategies linked to possible clinical trials to having tissue samples and other information add to the data of the IFM’s database maintained by Herve Avet-Loiseau in Toulouse.
Harousseau’s practical reasons provide more evidence why patients “trust” their physicians “and the majority of patients accept.” It does not mean they follow blindly. They are informed about what they need to know and ask questions. Outcomes for French patients are as good or better than patients anywhere while their experiences are translated by the IFM into studies impacting myeloma care worldwide.
Photo: Detail, The Boulevard Montmartre on a Winter Morning, Camille Pissarro (1897), The Metropolitan Museum of Art, New York