6 Responses

  1. Scott
    Scott September 5, 2008 at 11:05 am | | Reply

    All of this comes from the FDA’s reliance on HbA1c as a “surrogate” for improved patient outcomes, rather than a true long-term measure of any new drug’s effectiveness. Earlier this year, the FDA concluded after several open solicitations for input and meeting with the Cleveland Clinic’s Dr. Steve Nissen that the use of “surrogates” had lead the agency to approve a number of drugs which did not improve patient outcomes, but merely lowered blood glucose levels — which by itself is not a guarantee of improved outcomes. Today, the FDA is FINALLY moving more cautiously and we’re finally starting to see some of that outcome. Novo has been on overdrive with press releases and mis-representative data (for example, recently, the company admitted that liraglutide DID cause cases of pancreatitis, but the company tried to spin things by noting that it was, in their words, “not a statistically significant increase”). The reality is that these changes are long overdue, for too long, regulators have allowed the needs of the drug industry take precedence over the need for protecting patient safety. We can hope regulators make Novo’s approval much more difficult, as it will really change the mode of operation for an industry which has learned to selectively disclose facts to gain approvals, but in fact, provide only marginal incremental patient benefits.

  2. Glucoholic
    Glucoholic September 5, 2008 at 5:26 pm | | Reply

    This is unfortunate. So many have really high hopes for this drug. One of the reasons I’ve always tried not to get too upset about the price of drugs is the hope that quality is job one, but more and more of these cases make me think that marketing is job one.

    In addition, the FDA’s involvement in the markets and the corresponding price elevation from supply control seems to be a total waste since the quality that is supposed to result from that involvement seems to be waning.

  3. Sharod Broadhead
    Sharod Broadhead September 7, 2008 at 5:28 am | | Reply

    I initially thought the article was optimistic but its final discussion was quite pessimistic. too bad!!!

  4. Hans
    Hans September 7, 2008 at 1:09 pm | | Reply

    The opulent menus of sugar meds some doctors use to prescribe their diabetics (just read some forums – I do not want to know what else they must take for the rest of their ailments) before they top them with Byetta sort of curls my toenails. – Looks like at least “some” health professionals don’t read and respect med specifications, doesn’t it?

  5. Medical Grand Rounds 4.51
    Medical Grand Rounds 4.51 September 9, 2008 at 3:43 am |

    [...] Diabetes Mine has an interesting commentary on the politics of drug approval at Byetta Fallout Hits Novo Nordisk (That Pancreatitis Scare) [...]

  6. Kathy
    Kathy September 10, 2008 at 8:42 am | | Reply

    I must say that when I first started on Byetta I was a bit concerned but when I started to lose weight I hailed it as a GREAT medication – BUT I was also getting very sick every time I injected it (2x’s a day) After 4 months of being “sick”, throwing up every day – I became very ill and had become so dehydrated and my BS numbers blew up to over 500 when I was finally put in the hospital. Very scary situation and it amazed me that my doctor did not even question that the side effects of the Byetta had caused this.
    I stopped takking it and thankfully from being so sick I had lost a little over 20lbs and my BS levels had dropped. I no longer take Byetta and feel great, no more stomach pain and nausea. I did try going back on it recently but after the FIRST injection I was sick right away!
    I feel the drug companies are putting out these new “wonder” drugs and hailing all the great benifits of them LONG before they have been tested long enough. People should not die before the public heeds the warnings of the dangers of these drugs.

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