To Approve or Not to Approve?

In January, we wrote about the tightening of standards by the Food and Drug Administration (FDA) in its approval of new drugs for Type 2 diabetes (see “FDA: Stifler or Savior?”). When the FDA made this change, its main concern was whether new drugs increased the risk of heart disease, in light of a 2007 study that linked the drug rosiglitazone (brand name Avandia) with an increased risk of heart attack. The leader of that study, Steven Nissen, MD, of the Cleveland Clinic, was a major proponent of the new FDA guidelines.

Now, a prominent diabetes drug may be held up because of a different risk. The new drug by Novo Nordisk, liraglutide, has been associated with thyroid tumors in tests of rats and mice. While Novo Nordisk claims there is no evidence that the drug increases the risk of thyroid tumors in humans, earlier this month an FDA advisory panel of outside experts split its vote 6-6 on whether the tumor evidence should prevent liraglutide from being approved. The FDA can now decide whether to approve liraglutide or to request additional studies.

Advertisement

Liraglutide shows many potential advantages over existing drugs for Type 2 diabetes, including weight loss and the need to take it only once a day. It is in the same class of injectable drugs, GLP-1 agonists and analogs, as exenatide (brand name Byetta).

What do you think — how cautious should the FDA be when a problem is found in animal but not human trials? What should the FDA do when its advisory panel is evenly divided? And knowing what you know, how would you feel about taking liraglutide? Leave a comment below!

  • iowndvc

    Is there a rule that says the answer has to be so rigid, can’t they conditionally approve it and require additional tests maybe an independent sudy. As Sally said above it may just be a matter of tweaking an ingredient or it may be nothing at all. If this new drug is as helpful as I have heard lets GETTER DONE. Maybe the phrase “trust but verify” applies here

  • Karl J Biniarz;

    There is no question that any revolutionary new drug will be “shot” by existing drug producers since they will not wish to give up their dominating position…. no matter how many people in the interim will lose their fight with diabetes. What we need to do is put the final test on each of the drugs mentioned on a ‘super’ fast track with the FDA for approval to save humans from this terrible illness that kills so many in a year worldwide. Well………who has the gumption to tell the drug lords that their goose will be cooked sooner or later so they better get on the band wagon and create a new drug themselves that will do the job better and stop us from becoming totally dependent on “their” product; a product that actually does nothing for the cure and makes you totally dependent on the lords (of the drug that is). In the meantime, when someone invents a new drug, find out who is behind stifling it from becoming a household word with the diabetics!!!! It is a shame how many people are killed that way each year. K. Biniarz, Tigard, Oregon

  • lbrecka

    i’d take it. I don’t have a thyroid. It was removed because of thyroid tumor .

  • sally smart

    The FDA should demand more tests looking at the thyroid itself and what in the drug could be causing the problem. Maybe one of the ingredients could be removed or altered.
    I would love to see a drug like this come available if it is all that they say it is, so the company should be willing to make the testing available if they are so sure it can do what it is supposed to do.

  • LadyLlanowar

    I think that more testing should be done with a closer look at the potential of thyroid tumors in humans. I don’t think that testing on animals should restrict what is approved for humans, because DNA for animals and humans is significantly different and the way drugs and other things react to humans won’t be the same as they react to animals. If they really want to help people they should do another major test with human subjects and see what happens. If this drug is as good as they say, they should do everything in their power to get this drug approved. I have family with Type 2 Diabetes and I would love to see them be able to take less medication and not gain weight from it.

  • Nancy

    My understanding of drug test is that the mice are given 100+ times the dose to speed up the results. In this case the drug should be approved on a trial basis and if problems occur withdraw the drug at that as the drug may be very useful for people.

  • TK

    I agree with Sally that more thyroid testing should be done regarding this new drug and the pros and cons of its use. However,it seems that whenever more testing is required that the results are a long time coming. This new drug sounds like it would certainly be a positive answer for Type 2 diabetics. Let’s get this done ASAP!

  • myrtrose

    There is no way I’d ever take this drug, even with further testing. If they find out it actually does cause tumors 20 years later it’ll be too late. I know my medication is effective and safe. The benefits of weight loss and once a day dosage do not make it worth risking a tumor. I need to lose weight and as a diabetic I need to be watching my diet and exercising…not relying on a drug.

  • Police

    I would try the drug.

  • Trudy

    Where there is smoke…..even thought we are not rats..etc. If there seems to be a problem, try and look for an alternative, don’n approve a drug and ‘lets hope for the best’, just take AVANDIA for example.

  • luckyfela1

    I use Byetta now, and have seen a pronounced drop in my blood sugar with twice daily use at 10 mcg.

    plus I take 2000 mg glucophage daily.

    I’m in control but would like to see new medications that would make it just once a day.

    however, I’m not ready for any new medication unless it has been thoroughly tested.

  • aneyjo

    It seems like the rick of heart problems because of being overweight would be greater that the risk of thyroid tumors. I’m sure more testin will br done before approval.

  • andurian1

    I have stopped taking new drugs. Everytime I have been put on one its bad, so I wait and watch.

  • cthompsonma

    I would check carefully on the trials for human use. Anything that would help diabetics lose weight is worth a try.

  • JSoonerman

    I’ve read the other comments and find myself torn. I am a type 2 diabetic and for about two decades, so I’ve seen a lot come and go over time. Yes, it is discouraging that Big Pharmaceuticals have shown to be more focussed on making Big money than in finding good cures. It’s discouraging that Big insurance has taken such abuses and led to preventative cost and other measures to keep other than generics from some of us who have found success with other than generics. Personally I would like to be able to utilize glucose monitoring equipment which would help me see a better bg picture than what I get with periodic finger punctures and test strips. I realize that practice is miles ahead of what was available before its time, but I detest the continuous punching of holes in some of the most sensitive tactile areas and so often to attempt to get a good overall picture. Hence I often refuse or forget to do so. I keep thinking that there has to be a better way, but medical officials are very slow to endorse such new practices which would be less invasive. Perhaps a better question (getting back to the specific question of the Flashpoint would be, if you knew that you’d get a tumor in 10 or 20 years, would you still want to go ahead and take the medication? I believe there are some who would, and many who wouldn’t. If you don’t perceive a small potential as being ANY potential for you, you tend to move forward with risky behaviour because you see only the more immediate possibility for reward. Then if bad things happen later, let’s all sue Big Pharma for doing this to us. Come now, let’s not keep thinking we can always have it both ways, and only for our benefit. Even if it does get approved, doesn’t mean you’ll be able to afford it or that your insurance will approve it over something else they will claim works just as good or better that’s cheaper for them…

  • monicaqw

    Isn’t it likely that Byetta has the same issue? I take Byetta, and I would not stop because of some low level possibility of a tumor later on. And I would love to take it only once a day or once a week. Get it on the market with a warning, and let people decide for themselves whether to take the risk. Just require that the company monitor the outcome of people who choose to use the drug. The bad effects of uncontrolled glucose spikes are a certainly, not a low level possibility.

  • Concerned

    Dear Sirs,
    I’m sorry but why is it that when an individual has a serious health problem, that providing a drug that marginally helps this problem and the side effects can sometimes cause worse problems. This just adds additional problems to this family. However, it is apparent that the FDA is more concerned about the pharmacutical companies than they are the patients! The “green-back” dollar is the “Big” bottom line!

  • Phantom

    better conclusions please, is it safe for the general human population. Thank You.

  • maranatha

    I think they should approve it and let doctors and patients know potential risks and let them decide.

  • cbieber

    Need more testing. Got enough to deal with without putting myself in a tumor threat.

  • Forrest

    Type 2 Diabetes in India and China is expected to increase dramatically (by over 100 million cases) in the next ten years. There is a tremendous push to find effective treatment strategies that can be MARKETED as opposed to stategies that can be mobilized (like dietary and exercize modification).
    Hold off on the prescription strategy until the evidence of safety/danger is really apparent!