For as long as there has been research to cure diabetes, there have been people who believe that a cure will never happen because treating this disease is simply far too profitable. Those who believe in this so-called "conspiracy theory" are convinced that pharma companies have a vested interest in keeping diabetes around as long as possible because peddling their treatments is far bigger business than a cure could ever be.
We all know that diabetes is a multi-billion dollar industry, including sales of insulin, oral agents and injectibles like Victoza, and medical devices such as insulin pumps, glucose monitors and their pricey test strips, and new continuous glucose monitors. Type 2 diabetes is increasing exponentially, but even type 1 diabetes is growing at a dramatic rate, which means more and more consumers.
The latest flare-up over a possible "conspiracy" occurred in August, when a news article about controversial researcher Dr. Denise Faustman circulated around the diabetes community. In the article, Faustman says that when she approached pharmaceutical companies for funding, she was told "there wasn't enough money to be made in a cure that used an inexpensive, generically available vaccine."
But is that even true?
Certainly, there are legitimate financial considerations these companies' research & development decisions. But does that mean they never work on cure research? Would pharma really sweep a possible cure under the rug to protect their own interests -- especially if it turned out to be a cheap vaccine?
Who's to say?
We decided it would be fascinating to tap some prominent experts in the diabetes community to get their perspective on the "D-conspiracy theory."
Kelly Close, a type 1 PWD and president of diabetes consulting firm Close Concerns, which has analyzed the diabetes industry for over a decade, says, "Many have wondered over time whether there is a conspiracy in which pharmaceutical companies have 'hidden' the cure so that they could profit from insulin, blood glucose strips, and other supplies. I disagree. For starters, there is no evidence to support such a claim. More important, any company that found the cure would be celebrated and immortalized for eliminating an ancient disease. That triumph, that breakthrough, would be worth far more in prestige and honor than any financial gain derived from these products."
Kelly adds, "Besides, diabetes is so prevalent today that rare is a corporate manager who doesn't know someone who has some form of the disease. I think that manager would be more motivated to help his friend or family member than to add a few more dollars to his bonus."
In fact, last year senior investment analyst Sean Farhy wrote a piece on investor blog Seeking Alpha titled, " Is Big Pharma Really Trying to Cure Diabetes?" He shares 10 solid reasons why pharma would not and could not hinder the cure for diabetes, including their inability to silence every researcher who came across a path to a cure, the "carryover benefits" to other diseases, lucrative licensing agreements and the clincher: type 2 diabetes will still exist even with a cure for type 1 diabetes.
That's because, at the end of the day, no matter how similar type 1 and type 2 diabetes look on the outside, they are fundamentally different diseases on the inside.
And if it's all about the products, why do pharma companies even bother supporting cure research at all? The diabetes community is no stranger to non-profit organizations like JDRF teaming up with Pharma (like Sanofi) for such research.
"Sanofi is not just a drug company, it is a healthcare company," says Marc Bonnefoi, Head of the Sanofi North America R&D hub. "What drives the Sanofi R&D teams throughout this process, what drives the whole company for that matter, is a passion to improve patients' lives through better, more targeted therapies. And if there is a possibility of cure, even remote, this is what we aim for."
It sounds so wonderful and sincere, yet I can't help but doubt the motives just a bit. One indelible truth is that pharma is aggressively for-profit, and is always looking for the next big "blockbuster drug." Money can be made from a cure (as the Seeking Alpha article explains), but there's always the issue of how high R&D costs are up-front. Could it come down to a "business decision" that some promising possible cure simply isn't worth pursuing because the exploration phase is so expensive and it may not pan out?
Dr. Camillo Ricordi, Scientific Director and Chief Academic Officer at the University of Miami's Diabetes Research Institute, concurs with Kelly that there is no "conspiracy" related to developing a cure for diabetes.
"What I believe is that the cost of drug development, now well over a billion dollars, and the time required to bring a new molecule to the market (7-9 years) are such that there are careful marketing and financial factors that a for-profit entity must consider in their strategic R&D decisions," Ricordi said.
In a video Q & A with JDRF's president Jeffrey Brewer, he was asked: "Why does JDRF work so closely with industry?" Brewer explains that aside from academic researchers, industry plays an important role in the "pipeline" to a cure. Brewer is a little vague on the specifics, but he explains that JDRF is able to incentivize (obviously, with money) pharmaceutical companies to work on projects that they otherwise wouldn't bother with.
Kelly and Ricordi both shared that there is quite a bit of money going into the development of a cure in the R&D of pharma companies, but that research has always been much slower than the development of new devices and drugs. We can all agree that the development of drugs and devices are painstakingly slow, so you can only imagine how slow a cure will be!
"We estimate that between $3 and $5 billion has been spent on R&D alone in the last year for therapies and technologies that will help us manage diabetes better, and we estimate that many hundreds of millions will keep going toward developing a cure," Kelly said.
Finances have always been a guiding influence in what research is funded and approved. Scientists need to prove why they should continue getting a salary and research dollars from their institution. Many of those dollars are sourced from the government or from pharmaceutical companies. It's an incredibly complicated web of stakeholders and investors. Ricordi says that critics label cure-research focused as "overambitious" or that they have a "high risk of failure" or "not enough preliminary evidence." Tough sell, huh?
Meanwhile, Dr. Ricordi points out: "One patient with diabetes dies every 8 seconds."
FDA as the Bottleneck?
But it looks like pharma's financial priorities aren't the only obstacle. In addition to the extraordinarily complicated biological systems that researchers must understand and then manipulate, there's another complicated system we have to overcome: the FDA.Wordpress class wp-image-60583 is not supportedMarkup
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"There are a series of regulatory, legal and institutional barriers to the development of cures that now make up a formidable wall to the translation of potential breakthroughs emerging from basic science toward clinical trials and their delivery to patients," Dr. Ricordi explains.
Historically, this shift occurred in the 1960s, after the development of the Polio vaccine, when the FDA went from focusing on "safety" to focusing on "efficacy," Ricordi explained.
"While efficacy requirements may delay market approval and commercialization, the aspects that concern me most are those delaying or impeding innovation trials, making it very difficult, if not impossible, for young physician scientists to try to actually cure their patients, trying a novel strategy outside the boundaries of 'evidence-based medicine,'" Ricordi said.
So the real "conspiracy" against a cure could very well be coming from the FDA, which doesn't have a financial stake in keeping diabetes around but does have a vested interest in being extremely risk-averse, i.e. paranoid about approving anything that could potentially harm people. But at what cost?
"Who is accountable for the cost of doing nothing, or delaying approval, or imposing unbearable costs which make most scientists and small entities abandon the hope and battle to fight diseases and try to develop cures?"
— Dr. Camillo Ricordi, on the FDA's role in cure research
"The regulatory agency that once was born to rightly focus on patient safety has evolved into a monster apparatus of such complexity, that now imposes such time-consuming and costly requirements for the development of a new molecular entity or a novel biologic therapy. No one can afford to develop a cure any longer -- or better, very few multinational giants could afford it, if this was in their strategic interest," Ricordi adds.
The American Diabetes Association shared that they are hoping to encourage diabetes research with their new cure-research focused "Pathway to Stop Diabetes" program.
"It takes a radical approach to attracting and retaining brilliant scientists into the field and accelerating their research progress by providing the resources and support for conducting transformative science," a rep from the ADA said in an email. "Programs like these ensure that a future generation of scientists and clinicians will be concentrated on finding a cure for the disease."
Are there things impeding a cure for diabetes? Definitely. There are financial and regulatory considerations, and then there's the whole issue of the complexity of the human body. But is there someone hiding the cure for diabetes? Very unlikely. It just doesn't make sense.