Diabetes may be a widespread disease for which millions of people need treatment, but a new analysis finds that developing new medicines has been a risky proposition for drug developers.
How so? Here are a few key findings:
Only 1 in 13 investigational diabetes drugs that entered clinical testing from 1995 to 2007 ultimately received regulatory approval, compared with 1 in 8 for all investigational drugs, according to a recent analysis by the Tufts Center for the Study of Drug Development.
The likelihood that a diabetes drug entering clinical testing would make it to late-stage testing was about 13 percent, compared with 21 percent for all drugs. But the chances of approval for a diabetes drug that entered late-stage testing was 60 percent versus 56 percent for all medications.
“There is a lot of demand (for new treatments), but this is a challenging market,” said Joseph DiMasi, director of economic analysis at the Tufts Center, which is funded, in part, by drug makers. He noted that a high percentage of medicines for which testing began after 2007 would still be in development, so outcomes could not be captured.
To be sure, the findings underscore trends that have been fairly noticeable over the past few years, although the analysis appears to be the first attempt to very specifically quantify shifts seen through the prism of regulatory approvals.
Analysts say the most important challenge for drug makers that is reflected in the report continues to be the regulatory approval process, which has grown more demanding in the wake of a controversy in 2008 over the heart risks of a widely used diabetes drug.
At the time, a meta-analysis determined the Avandia pill, which is sold by GlaxoSmithKline, was responsible for an increased risk of heart attacks and strokes. This prompted the FDA to place tight restrictions on Avandia and require other drug makers to run additional tests for similar heart risks, which makes the process more uncertain, although the agency later reversed course and lifted the curb on the Glaxo pill after reassessing the meta-analysis.
“That (episode) shifted the entire dynamic for getting a drug approved,” David Kliff of Diabetic Investor told us. “The regulatory process has become more onerous since then, and so the risk level associated with new drug approvals is higher than it has ever been. That hasn’t changed.”
And so, the Tufts analysis found that so-called first-in-class approvals for diabetes — which refers to new types of medicines — represented almost 30 percent of all FDA approvals. By contrast, first-in-class drugs for other endocrine disorders — those afflicting the thyroid or pancreas, among others — were 47 percent.
Also, of all new diabetes drugs that were approved by the FDA from 1995 to 2015, 15 percent received a so-called priority review designation — which refers to a speedier review process — compared with about 50 percent for other drugs.
There was at least one bright spot, though. The 61 diabetes and other endocrine drugs approved from 1995 to 2015 accounted for 10 percent of all new medicines approved by the FDA during that time.
This post was updated to note the FDA later reversed course and lifted restrictions on Avandia.
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Ed, great piece. However, you fail to point out that the meta-analysis on Avandia which caused changes to the entire process has since been proven incorrect. The RECORD study initially proved that Avandia was safe, but was discounted because an independent analysis had not been performed. Subsequently, the independent analysis was performed and found the data to be accurate. In 2013, the FDA lifted prescribing restrictions and in 2015, removed the entire REMS program. In other words, the Avandia fiasco was much ado about nothing, but has had long lasting implications including (as you point out in this article) limiting new diabetes drugs in coming to market. Why are these regulatory restrictions still in place when the rationale for putting them in place no longer makes sense?
Dr Smith, I agree that scientifically Avandia was much ado about nothing. But on a personal level it was much worse. It began with a sinister effort by Steve Nissen to secretly tape a meeting with GSK and then going public with the tape. A former boss of mine from pharma was in that meeting and although the meeting produced nothing incriminating there were careers ruined by Nissen. So I’d say it was much ado about something.
Hi Dr. Smith,
Thanks for the note and you’re correct. I overlooked that bit of info and have updated the post to reflect the about-face by the FDA. Sometimes I move too fast for my own good. Appreciate that you took the time to write in.
Regards
ed
My husband was diagnosed with diabetes 2 about 3 months ago. We immediately began using a food plan, and within 2 weeks his numbers went from the frightening 440, down to 100 !!! We added a brisk 1 mi. walk, and eliminated sugar, white flour and white rice, and upped our raw fresh veggies, nuts, and seeds. We switched to coconut, avocado, Hemp and Rice Bran oils, and minimized even their use. He is the picture of excellent health today at the age of 51. His energy is back up to normal, and his skin color is beautiful! We are SO thankful on her site (google ” HOW I FREED MYSELF FROM THE DIABETES ” ) told us about a book to cure diabetes! And THANKS to Sheryl！
Congratulations on 1) your husband’s outcome and 2) exposing the industry’s nasty little secret that with rigorous adherence to a diet and exercise regimen most Type 2 diabetics can reduce or even eliminate their need for medication.
Thanks, Ed. There is also a lot of garbage data out there on so called “cardio protective” effects of some of the newer drugs that attempt to capitalize on the Avandia heart risk data. For the most part these are mandatory safety studies where a chance finding of “efficacy” is really a statistical artifact or clinically insignificant to a physician who understands the literature. Given the whole First Amendment deal I expect to see these “efficacy” findings in DTC ads and as testimony to the idea that you can get pretty much anything published these days. One example is that FDA won’t allow them to claim weight loss efficacy in DTC but you can say they “may help you lose weight”. Yep, if you don’t consume that box of Milano cookies after dinner.
The photo is an insulin pump,not a glucose monitor.
Thanks for spotting that. I corrected the caption.