There are a lot of things going on at the troubled Food and Drug Administration right now that could have a profound impact on the future of diabetes care, but most of us patients never hear about them. And that’s a damn shame. Because we stand at a crossroads.
You may or may not be aware that the Obama Administration is about to appoint a new FDA Commissioner. The politics and personal leanings of this new leader could provide a complete change in the FDA’s modus operandi, or just more of the same, according to outspoken Michigan Congressman Bart Stupak, who says: “Current senior FDA employees are too close with the industries they regulate, creating a question of who they are working for.” Correct.
And here’s why you should be concerned, as a person with diabetes:
1) One of the most prominent candidates for new FDA Commissioner is a certain cardiologist Dr. Steven Nissen. He’s a long-time past member of the FDA’s CardioRenal Advisory Panel and a brash industry critic who was at the center of the Avandia scandal. He’s currently on record as saying: “We already have enough diabetes drugs that lower blood sugar, so why do we need any more?“ So he’s implying that older drugs like metformin and sulfonyreas are all anyone with diabetes needs? The fact is that new drugs and new technologies have a huge potential to prevent complications and extend and improve life with diabetes, so why stymie progress in drug development?
2) The FDA is indeed dragging its feet on new drug approval. They held an ill-publicized informational meeting in July to gather input into what should be required to get new diabetes drugs approved. Dr. Nissen was one of the experts invited to present, and — according to Rebcca Killion, a diabetic and the panel’s one and only patient representative — he made a strong case that pharma companies should be required to present additional detailed data on all new diabetes drugs submitted for approval suggesting that they do not increase the risk of cardiovascular disease. While this sounds innocuous, forcing drug developers to rigorously jump through even more hoops puts an arguably uneccessary cost and logistical burden on them, which could chill the development of new diabetes drugs and do very little for patient safety in the long-run.
3) As a result of that meeting, the FDA actually issued a letter across the pharma industry calling for the additional research on cardiovascular factors prior to evaluation of any new diabetes treatments. This has already had a chilling effect, in that Amylin’s new long-acting version of Byetta (LAR) (a once-weekly injection for Type 2 diabetes) and Novo Nordisk’s liraglutide (a once-daily injection also for Type 2) are held up at the starting gate for FDA approval.
4) Approval of new diabetes technology is also being hindered. Here are some recent examples of treatment options currently NOT available to US patients due in large part to the FDA’s “very conservative stance,” according to the analysts at Close Concerns, publishers of diaTribe:
- A new pump with a low blood glucose sensor being developed in the UK. It automatically turns off insulin delivery when blood sugar levels get dangerously low. It will be submitted to the EU regulatory body and will likely be available to patients in the UK will sometime next year. Why is this pump not being developed in the US? No one will say officially, but we constantly hear that Washington is so risk-averse that it probably wouldn’t approve this pump or would hold it up for a long time.
- Symlin is another drug from Amylin that has been used successfully to reduce glycemic variability (in particular, high blood-glucose levels after meals — the trickiest time for most of us). It’s currently approved for both Type 1 and Type 2 patients who use mealtime insulin, but a clinical trial recently provided evidence that its also effective for Type 2 patients who currently use basal insulin only. This could be a pwerful treatment for many, but the FDA struck it down without even providing a reason. The data from the trial was published in the journal Diabetes Care, showing no safety issues. According to Close Concerns, the FDA won’t return phone calls asking why Symlin hasn’t been approved for this use.
The diaTribe group summarizes the issue this way:
“With a growing diabetes epidemic and under 50% of patients meeting treatment goals, it is clear that the current treatments are not enough. Many of the drugs available now have safety and tolerability issues, and we lose hope of replacing these with better alternatives. Diabetes is a chronic progressive disease which currently is managed, not cured. Breakthrough therapies which could slow, stop, or cure disease come from innovation. We need to accelerate, not brake, innovation.”
So What’s A PWD to Do?
I’m currently working with Kelly Close of Close Concerns/diaTribe and Manny Hernandez of TuDiabetes to create a campaign that we, the Diabetes Community, can rally behind. It’s somehow going to involve asking you all for signatures, so get prepared for that. Want to get more involved in this Call-to-Action? Let the three of us know what ideas you may have.
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** UPDATE 12:50 pm **
The Health Care Blog announced a survey on “Who Should Obama Pick for FDA Commissioner?” today. Check it out to peruse the full list of candidates, and who appears to be in the lead currently.
Back in March 2008, I responded to the FDA’s “Draft Guidance for Industry on Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention” and said exactly the same thing. While it’s nice to have others joining me in reaching this conclusion, it would have been nicer to have you join me back then!
[...] more here: The FDA in Transition: Diabetes Treatment at Risk Mail this [...]
While its all well and good to have a petition and to voice concern about a rumored appointee, it would be best if you and the rest of the diabetes advocacy community actually indicated preferable candidates and detailed why they meet your criteria.
Yes, the FDA a broken, like many of your government agencies, and one of the outcomes of this dependence on inappropriate industry relations is trusting the pharma industry too much. There are legitimate reasons to demand more study on new drugs and technology.
The evidence for this is how frequently we have after-the-fact studies proving certain pharma products to be dangerous or have previously unstated side effects, complications or interactions. Why? Because in the same process that is slow to approve compared to other countries, is a process that allows big pharma to hire testing agencies that are not independent enough to deliver unbiased results.
Be careful in advocating that you don’t listen to the gripes of pharma companies as fact instead of opinion with a profit motive.
Go to http://www.change.gov and put it in the health care discussion. Be sure to highlight the fact that diabetes disproportionally hits people of color.
I usually agree with you….not this time.
We DO need more info on how new diabetes drugs affect us regarding ,but not limited, to cardio and cancer affects. Recent issues with byetta(Pancreatitis),januvia(cancer), avandia(cardio), and actos(bone) only reinforce this. We do have a significant numbers of drugs that are safe to help us control our blood sugar(insulin,metformin,byetta in some cases) without taking additional risks on new drugs with MINIMAL additional benefits that most likely increase cardiovascular and cancer risks. Drug companies should PROVE significant increases in control and minimal risks before approval. I am not saying that we should stop research or development of MEANINGFUL new drugs. We should stop approval of the latest risky new drugs that provide very little, if any, additional control just because drug companies need a new line of drugs, because their older ones are now available in generic form.
Amy–count me in. I agree with you that we need to rally. There are lots of us. We need to raise our voices. We can VOTE.
All this talk of new drugs to TREAT diabetes, both 1 and 2. I say screw that, all this accomplishes is to make the drug companys go from billionaires to trilliionalres. I WANT WORK DONE ON A CURE. Nothing else matters.
I’m with Rich… we need *more* safety testing, not less.
The type 1 and type 2 forms of diabetes are two distinct diseases, even for the insulin requiring Type 2′s. I would submit that you should leave Type 2′s alone and focus on what you know the type 1 form of the disease. You and Kelley Close et al have no idea what type 2′s go through.
It’s interesting how you mention Dr Nissan and how he is a front runner for FDA Commissioner. I’m in Cleveland and know a fair few doctors here and since Dr Nissan is head of cardiology at the Cleveland Clinic those doctors know a lot about him. The Avandia scandal was the most publicized case but he was also weighing in heavily on the recent Vytorin/Zetia study in much the same way he did with Avandia. Several doctors have mentioned that the reason for his input on both of these has nothing to do with patient safety but more to do with raising his profile and getting himself into that FDA Commissioner role and since the Clinic is rated #1 for cardiology a) they feel that they are the authority on that and anyone who disagrees is wrong and b) the media will push whatever they say as gospel with no effort from them.
There is a lot wrong with the current diabetic treatment methodologies. On one hand A1C is important. On the other hand post prandial is more important but not necessarily reflected in the A1C.
Meanwhile diet can accomplish as much or even more than these so-called modern drugs. I’m reminded of the chimps who know to eat a certain plant leaf when they feel indigestion. They can’t go to the clinic but seem to do just fine in the wild on their own.
To Scott: please don’t be bitter. If I’ve learned anything, it’s that one blog post does not a campaign make. You really need to contact folks directly and shake their tree a little. So we’ve woken up to this issue now – that’s good news, right?
To Stephen: that was rather snarky, and I think you’re wrong there.
Everybody else: please keep the input coming
hey there…wow great dialogue. A couple thoughts to build on the above. A number of drugs might lower A1c but not all reduce variability -it would be nice to have both. And, since side effects can make taking drugs hard, I do think the same A1c drop and fewer side effects is a positive – it makes it easier to keep moving ahead! If some drugs lower A1c impressively but are hard for patients to take, then we need to either improve education or create alternatives. To Amy’s point, we just don’t want alternatives removed. A balance is needed where safety is paramount and where innovation is valued.
Clearly things can be improved if over 8 million people (type 1 and type 2) are struggling with A1cs that are above the recommended level in the US alone. Some type 1s and type 2s could benefit from better products and if a federal agency is limiting the development unnecessarily behind the scenes, that doesn’t make me feel great about the next decades. We want great safety testing done in a smart, balanced, way. Risk can be assessed in a sensible way, by doing the right trials, but not by driving away development of tools that could help us. The FDA patient rep has emphasized this herself and I think it would be great to rally around her and the idea of improved tools to manage our diabetes.
Scott we super appreciate that you were the one out there early!!!!!! This is the case yet again and big time thanks from me : >. I have to admit I didn’t think it would get as dire as it has. Companies are moving AWAY from investing in diabetes – again, a call for balance would be great by my view.
And about Dr. Nissen – he has done a lot of impressive work in his career. But, he doesn’t seemlike the best person to lead the agency at a time when someone truly visionary about diabetes could really move our diabetes cause forward, someone who really understands the disease from a patient perspective and has had lots of experience with the challenges.This could be an incredible opportunity to help usher in someone who really understands diabetes and to communicate with them regularly about our thoughts and needs.
Plenty of doctors regard type 2 as a disease that results from unhealthy lifestyle choices. One of my clinic preceptors remarked to me that a half hour of exercise a day would do type 2 diabetics more good than all the drugs on the market. So I’m not surprised by Dr. Nissen’s comment.
I will have type 2 diabetic patients in the future, so of course I want the best therapies available to them.
Being type 1, I am very tired of hearing the blanket term “diabetes epidemic.” These days I don’t volunteer that I have diabetes, or call myself diabetic, precisely because I am tired of all the rampant misconceptions.
I want someone appointed who #1) recognizes the difference between the two types of diabetes and #2) will specifically address the needs of each type separately, in terms of drug approval, stem cells research, etc.
Amy, thanks for your response, but I think you mistake my response to be bitter, and that wasn’t what I was trying to imply, rather we lost a terrific opportunity by our failure to respond when the issue was first raised. Back in March, we had the opportunity to comment on the FDA’s proposed guidance documents (which I did personally), but today, we’re trying to approach this retrospectively. There is power in numbers, but its a lot harder to stop a wheel in motion than it is to prevent the wheel from moving in the first place!!
Hey Scott,
This is far from over. We’d definitely like your assistance making some noise here.
This is a strange post. I would have thought diabetic people would want more drugs based on proper science, with transparent information and based on honest research.
Who benefits from scientific fraud and science/data which cannot be scrutinized? To criticize Nissen is to fail to understand anything of rthe problem facing medicine.
Aubrey
Hi Aubrey,
That’s a strange comment coming from someone who is surely aware that fraud and misconduct often come from within the system itself.
To understand our concerns, please read this post carefully:
http://closeconcerns.typepad.com/close_concerns_weblog/2008/12/problems-at-fda-prompting-slowdowns-in-development-should-patients-accept-this-.html
Thanks!
Great dialogue. Any thoughts on the diabetes drug being developed by AtheroGenics, a Georgia company that is in bankruptcy proceedings (due primarily to the credit crunch) that has an anti-oxidant drug (AGI-1067) in phase 3 trials for type-2 diabetes? The drug was initially being developed as a cardiovascular treatment. As such, it had a large phase 3 trial that ended in March of 2007. AGI-1067 “failed” on the primary endpoint in that trial, but still showed interesting outcomes including reduced strokes, heart attacks and cardiovascular deaths, plus there was significant lowing of blood sugar as measured by HbA1c among the 2,000 or so diabetics in the study group (who where already on state-of-the-art care for diabetes), and a significantly lower number of patients with metabolic syndrome that became diabetic during the trial. And due to the HbA1c reduction, about 30% more diabetics getting AGI-1067 than placebo achieved their treatment goal on this measure.
With these interesting results the company retooled and began to pursue a diabetes indication for AGI=1067 (probably as an add-on to existing therapy). Notably, due to the large cardio-related trial, the drug already has an established cardio safety profile that probably meets the FDA’s new threshold for cardio safety.
I suspect that the AGI-1067 experience informed the FDA’s deliberations. Here’s a drug that showed actual improvements in hard endpoint outcomes (not just reduction in HbA1c, but reduced strokes, etc.), and reduction of new-onset diabetes when compared with a placebo. Perhaps this is what FDA is looking for in new diabetes drugs, not just a secondary measure such as lowered HbA1c. Thoughts?
i want the best therapies available to them.