Author Advances Damaging Myth About Diabetes
By James S. Hirsch
Jim Hirsch, diaTribe contributor and bestselling author, weighs in on a damaging diabetes myth:
“They’re never going to cure diabetes, because there’s too much money in it.”
This article prompted a letter of complaint from Dr. Denise Faustman, printed below, followed by responses from Jeffrey Brewer and Mr. Hirsch.
I was diagnosed with type 1 diabetes 40 years ago, and I can’t tell you how many times I’ve heard someone say that or words to that effect. It’s understandable. Diabetes is big business, and as the drugs and medical devices have become more sophisticated and expensive each year – and as more people are diagnosed each day – diabetes itself becomes an even bigger business. In the United States, about $200 billion a year is spent in direct costs for diabetes, including hospital and emergency care.
Hence the conclusion: In the view of frustrated patients, family members, and loved ones, there’s just too much money to be made in this disease for a cure to ever be found. Powerful corporate interests will see to that. Even worse: Conspiracy theorists believe that the companies that profit from diabetes are actively thwarting a cure. Or as one person told me, “Eli Lilly has the cure in its vault, but it won’t let it out.”
I was recently listening to NPR and heard the writer Elisabeth Rosenthal discuss her new book, “American Sickness: How Healthcare Became Big Business and How You Can Take It Back.” The title captures her central theme, that health care in America has been compromised by corporations that have their put their financial interests ahead of all else. Profits trump patients. During the NPR interview, she described how health care companies stand to earn more from therapies than from cures.
“If you’re a pharmaceutical company and you have a problem like diabetes,” Rosenthal said, “if I invented a pill tomorrow that would cure diabetes – that would kill a multi-billion- dollar business market. It’s far better to have treatments, sometimes really great treatments . . . [that] go on for life. That’s much better than something that will make the disease go away.”
She appeared to be saying that this multi-billion-dollar industry preferred treatments over cures to maintain the viability of the industry, and that the companies were aligned against “a pill . . . that would cure diabetes” because that pill would jeopardize their business.
In other words, they’re never going to cure diabetes, because there’s too much money in it.
Rosenthal holds an MD from Harvard Medical School and was trained in internal medicine. She was also a long-time reporter for the New York Times and is now editor in chief of Kaiser Health News. Did she really believe that diabetes would be cured if not for these self-interested, mercenary companies?
I read Rosenthal’s book, and to make her case about why we don’t have a cure, she offers a mini-profile of Denise Faustman, a controversial researcher at Harvard Medical School and Massachusetts General Hospital who is trying to cure type 1. I know Faustman well, as I wrote about her at length in my book about diabetes, “Cheating Destiny” (2007). In 2001, Faustman reversed type 1 diabetes in mice by using an inexpensive vaccine, but when she sought funding for human trials, pharmaceutical companies rejected her request because, she said, the companies couldn’t make money from her proposed cure. Faustman also sought grants from the JDRF, which was founded with the specific mission to cure type 1 diabetes, but the JDRF has also repeatedly turned down her applications.
Faustman ultimately raised the money, first from the Iacocca Foundation and then from other donors, and she is now running Phase II clinical trials (and still raising money).
Rosenthal uses Faustman’s experience – specifically with the JDRF – as evidence that financial interests are undermining the search for a cure. During the 2000s, the JDRF began “venture philanthropy” efforts, in which the nonprofit formed partnerships with companies to develop therapies designed to ease the burden of the disease. If successful, these investments could also generate revenue for the JDRF, which could then be used for additional ventures and partnerships.
But in Rosenthal’s telling, these investments betrayed the core mission. “Fund-raising, rather than curing disease,” she writes, “often seemed like the first metric of success.”
She takes aim at Jeffrey Brewer, a successful internet entrepreneur who in the 2000s got involved in the JDRF after his son was diagnosed with type 1 diabetes. Brewer was the driving force behind the organization’s Artificial Pancreas Project, which began in 2006, and he was appointed the organization’s CEO in 2010. Brewer pushed the JDRF to broaden its mission to include treating and preventing type 1 diabetes, and he also advocated for joint ventures, including those with giants such as Medtronic and BD. The result, according to Rosenthal, is that “by 2013 JDRF research grants hit a ten-year low . . . while non-research grants increased. Dr. Faustman’s work didn’t make the cut.”
The juxtaposition is clear. The JDRF has been funneling money to corporate titans while starving researchers. As Rosenthal sees it, even at a nonprofit dedicated to curing type 1 diabetes, that search has been sacrificed on the altar of profits.
Rosenthal didn’t interview Brewer, but I did. He left the JDRF in 2014 and founded Bigfoot Biomedical, which is essentially trying to complete the work begun by the Artificial Pancreas Project, using technology to improve the lives of patients.
Brewer bristles at the criticism that the JDRF has betrayed its roots by supporting corporate efforts to develop better therapies. It’s a false choice, he says. We can’t simply fund research, for a cure or anything else, without also supporting strategies that bring that research to market. Whatever its motives, corporate America is not our enemy but our partner.
“It’s all about how do we get something done for patients,” Brewer says. “Scientists make discoveries, companies make products. A cure will eventually come from a company. If you don’t understand that, you don’t understand our society.”
Or as I would say: Banting and Best discovered insulin, but Eli Lilly saved millions of lives by mass producing it.
Brewer talks about diabetes not as an entrepreneur or an executive but as the father of a type 1 son (who is now in his early 20s). Brewer notes that “no chronic disease has ever been cured,” and he estimates that over these decades (the JDRF was founded in 1970), the NIH and the JDRF combined have spent $5 billion to find a cure. . . and we have no cure. It made sense to him, and to me (I also have a type 1 son), that instead of putting all of our dollars in moonshot cures, we also invest in therapies that could make life safer and better today.
What good is a cure, years down the road, if your kid doesn’t make it through the night?
Regarding Faustman, Brewer also turned down her request for money, as had his predecessors, because he found her research unconvincing. I happen to like Faustman. In the staid science world, she’s an unconventional thinker, she’s doing experiments that no one else is doing, and she’s devoted her life to the cause. She also ruffles feathers because she promotes her work and attracts publicity. Flamboyance is not admired in science, and some of the attacks against her have been personal and unfair. But her larger problem, and the reason the JDRF has rejected her requests over the years, centers around the reproducibility of her research and the overall soundness of her work. Count me among those who are rooting for Faustman, and if she cures type 1 diabetes, the JDRF will have egg on its face. But in her book, Rosenthal misleads readers into believing that the JDRF rejected Faustman out of some vague desire for financial gain, when it was really about the science.
Rosenthal also reprimands insulin makers for their high prices and faults medical device companies for selling products that deliver incremental gains at ever-higher costs. Fair enough. Insulin prices are too high, and in the past couple years, the companies have been rightly criticized by patients, providers, and even U.S. Senators for not making their product more affordable. From my perspective, the pace of innovation, for pharmaceuticals or medical devices, is never sufficient for the dollars we spend. But any assessment of these companies has to at least acknowledge that they have engineered a revolution in care. I know it because I’ve lived it. Compared to 10 years ago let alone 40 years ago, the insulins are purer and more stable. The glucose meters fit in the palm of your hand. The insulin pumps can be worn discreetly. The CGMs make severe hypoglycemia all but a memory. In time, everything will be run off your smartphone or some similar device. The Artificial Pancreas isn’t here yet, but it’s happening.
Rosenthal visited the Friends for Life convention at Disney World in Orlando. Founded by Jeff Hitchcock, this convention is specifically for kids as well as their parents and grandparents. I’ve attended the event several times with my own family, and it’s one of the best run, most meaningful activities on the diabetes calendar. Rosenthal acknowledges that the kids have a joyous time, but then she takes us to the exhibition hall and describes a game for the kids, in which they must answer a question written on a white board: “What Is Your Wish for the Future of Diabetes?”
The kids write: “A cure.”
Rosenthal finds cruel irony in the response. “Almost all of the dozens of exhibitors and sponsors who help underwrite the conference are focused on something else: selling ever-costlier treatments and supplies.”
Actually, the exhibition hall is one of the best parts of the conference, as it’s where we go to learn about new products – from high-tech stuff to stylish carrying cases – that we use each day. But according to Rosenthal, the companies were only there to take our money. Who knew?
Every industry has greedy bastards, but should we condemn en masse those who work in diabetes? I’ve spoken to plenty of executives, sales reps, and researchers, and most of them understand the hardship of this disease, the frustration, the occasional despair, even the tears. Call me sentimental, but if a cure were discovered, most of those who work in diabetes, I believe, would gladly find another line of work.
What makes Rosenthal so odious is her complicity in propagating one of the most damaging myths in diabetes. There’s too much money in it for there to be a cure. Rosenthal has too many credentials to be dismissed as a crackpot, so maybe, just maybe there really is a pill – as she told NPR – that could be invented to cure this disease. . . except, of course, that pill would then vaporize a multi-billion-dollar industry.
To believe that is to sharpen your anger about all the forces surrounding diabetes, to codify disillusionment, to deepen your own cynicism about the future. To live each day with diabetes, or to have a child with it, is to understand anger, disillusionment, and cynicism. We don’t need fictitious screeds or baseless polemics to give us even more reason to feel dismayed or overwhelmed.
Here’s the truth about type 1 diabetes. It occurs when the immune system mistakenly destroys a body’s insulin-producing beta cells. A cure, at minimum, requires “re-educating” or “re-wiring” that immune system – an inscrutable ocean of white blood cells – so it doesn’t turn its deadly fire on its own body. Even if that hurdle is cleared, the body would still have to restore or replenish the beta cells that have been destroyed. We don’t have a cure because the immune system is too powerful, too complex, too resistant to human intervention, for mere mortals to master.
That doesn’t mean we give up. The search continues and breakthroughs will occur. But until then, we should continue to support initiatives, therapies, and products – even those tainted by profit – that allow us to live better, healthier lives.
Letter from Dr. Denise Faustman:
Jim Hirsch’s “Damaging Myth About Type 1 Diabetes” diaTribe column, which was written in response to Elizabeth Rosenthal’s recent book and makes my research the focal point of his argument, uses outdated and inaccurate statements about our research that we would like to correct. I have not heard from Mr. Hirsch for more than a decade. I am happy to be included in any conversation that involves innovation in healthcare, but feel it is reasonable journalistic practice to check your facts and make sure your sources are current and in context.
First, my colleagues and I never applied to the pharmaceutical industry for funding for the BCG clinical trial. We are moving forward with a generic vaccine, which is outside the business model for profit companies; that does not mean we are in opposition to the pharmaceutical industry, although it has been positioned by many that we are. I would have welcomed the opportunity to correct that misconception had Mr. Hirsch contacted me. Second, while the JDRF has denied multiple funding requests for the BCG clinical trial including last year, we never applied for funding during the tenure of Mr. Brewer as CEO. If Mr. Brewer conducted a private review of our work, it was without our knowledge, consent or the scientific details of our project. We did meet with Mr. Brewer twice in 2011 after he joined the JDRF and hoped he would reverse the prior administration’s rejections for partial funding of the clinical trial, the last of which included instructions to “not apply again.” In our 2011 meetings with Mr. Brewer, he cited a variety of political issues within the JDRF and reluctance to fund a clinical trial in the wake of the JDRF’s expensive anti-CD3 trial failures. The political history of the JDRF and our BCG clinical trial program is well documented by many sources, but probably no better than Mr. Hirsch’s own book, “Cheating Destiny.” Mr. Hirsch’s implications of a scientific basis for Mr. Brewer’s comments are entirely unsupportable and is inconsistent with even the JDRF’s past and current scientific reviews of our program, which Mr. Hirsch read as part of the background research for his book. Lastly, there is broad scientific consensus for testing BCG in autoimmune diseases: dozens of independent labs confirmed our mouse models, large government-funded trials with thousands of patients are currently underway in Europe and Australia, epidemiological studies have shown the impact of one and two BCG vaccinations on type 1 incidence, and multiple clinical groups have shown BCG can halt autoimmune disease. Most recently the mechanism is now even coming into focus through our work and a global team of BCG researchers from academia and industry that convene every two years to share ideas on BCG and autoimmunity. We convene our third meeting in October and will show how BCG may create a host effect with our immune system that has been lost in our transition to modern health and agricultural processes, a version of the hygiene hypothesis. Mr. Hirsch is well within his rights to debate health care costs and diabetes, but his tangent about the science behind our BCG research is misinformed.
Response from Jeffrey Brewer (President and CEO of Bigfoot Biomedical):
In her letter, Dr. Faustman fundamentally misrepresents my interactions with her during my tenure as CEO of JDRF. While she did not apply, in those years, for support through the normal grant-application process, she did request funding, and she did ask JDRF to support her trial. Dr. Faustman did so in emails that I still have as well as in-person, in the presence of multiple JDRF scientists. As a parent of a child with T1D, I welcomed a chance to meet with Dr. Faustman. I desperately wanted her to have the answer for my son. It was also my job as CEO of JDRF to make sure no stone was unturned in pursuit of a cure and that only objective and rigorous scientific review should determine funding for Dr. Faustman’s project.
The entire purpose of meeting with Dr. Faustman during the two visits she references was to understand her research and to determine whether JDRF could support her existing trial or fund another related initiative. We did not conduct a "private review" of her work. The review was conducted in front of her with my team. Scientists who specialize in her field then made recommendations, and those scientists had concluded that the claims by Dr. Faustman for the efficacy of BCG were at odds with our understanding of the science and were without justification based on the clinical data she presented. It is not uncommon for scientists to see things in their own work that 3rd party review does not validate.
I never told Dr. Faustman that political issues had affected JDRF's assessment of her work, but rather the precise opposite. I told Dr. Faustman and her colleague, Russell LaMontagne, that I couldn't care less about the politics or personalities and was only focused on whether JDRF’s funding of her research was justified by the results of her work to date, and whether her request had equal or greater merit than the other research opportunities that were currently under evaluation by us. To suggest anything otherwise is a categorical misrepresentation of the record. I never mentioned JDRF’s previous funding of Anti-CD3 as having anything to do with what she was proposing to us. To make such a claim is not only false but bizarre.
I regret that Dr. Faustman distorts her interactions with me while I led JDRF. I will continue to wish for her success on behalf of everyone with T1D. I hope she proves me wrong. Unfortunately for all of us, Dr. Faustman’s distortions of the facts combined with her attack on the integrity of anyone who disagrees with her have demonstrated why she has engendered the very resistance that she so resents.
Response from James S. Hirsch:
Dr. Faustman seems to believe my article was about “innovation in health care” and “health care costs and diabetes.” Those are certainly important topics, but my article had nothing to do with them, nor did my column include any “inaccurate” or “outdated” statements. Regarding Dr. Faustman’s specific claim that she “has never applied to the pharmaceutical industry for funding for the BCG clinical trial:” While researching my book on diabetes, both Dr. Faustman and her supervisor at Massachusetts General Hospital, Joe Avruch, told me that pharmaceutical companies had rejected her requests to fund BCG clinical trials, and I wrote that in “Cheating Destiny” (2007). Elisabeth Rosenthal, in “American Sickness” (2017), quoted Dr. Faustman directly that pharmaceutical companies refused to fund her BCG clinical trials. I can understand why Dr. Faustman wants to defend her research, but why she wants to walk-back her previous comments on her relationship with drug companies is a mystery to me.