As reported in the Wall Street Journal, and other sources, Eli Lilly made the decision to terminate their development program for inhaled insulin. This follows two other companies who have taken similar steps, NovoNordisk a few weeks ago, and Pfizer's dropping Exubera after it had been out on the market (which I put on my "worst" list for 2007). Only one small company (Mankind in California) is left trying to bring inhaled insulin to market.
When Pfizer pulled Exubera, it did so for financial reasons; since not enough prescriptions had been written. Lilly, who was finishing up studies to get their drug approved, stopped the drug not for safety reasons, but similar concerns that their drug would not do well. Specifically,
this decision is not a result of any observations during AIR Insulin trials relating to the safety of the product, but rather was a result of increasing uncertainties in the regulatory environment, and a thorough evaluation of the evolving commercial and clinical potential of the product compared to existing medical therapies.
The key word here is "regulatory environment," which basically means that they were concerned whether or not the FDA would approve the drug, or if approved would be restricted in the way they were able to promote it. If they state that there were no safety concerns, then why would they think the FDA might not approve their drug easily? How might they be restricted in their promotion?
Here's the issue: Vioxx was a great example of how we need to look very carefully at safety before, and more importantly after a drug has been approved. The problem may be that we have gone too far. The political and heightened media scrutiny of the FDA and drug companies may be in part to blame for a needed drug not coming to market. As I have posted recently, the FDA now plans on releasing safety concerns to the public earlier and more frequently, even if they are not sure that a safety problem truly exists. Remember all the media attention regarding Avandia? Do you remember the headlines when the FDA concluded "there is not enough evidence to indicate that the risks of heart attacks or death are different between Avandia and some other oral type 2 diabetes treatments?" (You probably don't, because there really were no head lines-good news doesn't really sell). I had also posted about the NIH stopping the intensive treatment in the ACCORD study for diabetes. Though the study showed an increased risk of death in the intense treatment arm, both groups had a death rate that was much lower than usual, and the difference was 3 deaths per 1000 patients. I wonder if the the ACCORD study would have been discontinued prior to events like Avandia and Vioxx?
Pfizer's Exubera failed for three reasons: 1) it first targeted endocrinologists instead of primary care physicians who were the best candidates to prescribe the medication 2) the device was significantly larger then most inhaled products and 3) they were pressured by the FDA not to minimize lung safety issues, when 2 years worth of data showed non clinically meaningful lung problems. Had that 3rd barrier not been there, and had Pfizer launched the product differently, Exubera might have been a best selling drug. I had many patients very upset when Pfizer pulled the plug.
Type 2 diabetes is a growing epidemic in our country. Of the 20 million or so patients estimated to have type 2 diabetes, only about 12 million received treatment, and of those only slightly more than one third have their sugars under good control. A study showed that for patients on more than one diabetes pill, doctors often wait up to 3 years with sugars very poorly controlled before adding insulin. Of those patients not controlled on more than one drug, fewer than 20% got the insulin they needed. Why? Because patients don't want to be on insulin. One thing has to do with the fact that for many patients, taking insulin means they have a serious disease, and not just something they need to take pills for. Secondly, is the obvious injection part which inhaled insulin overcame. Thus, inhaled insulin (even in a large inhaler) was a major breakthrough, that we will never likely see in the near future.
It is very easy to criticize the pharmaceutical industry for making too much money advertising expensive products to doctors and patients. Similarly, it is very easy to fault the companies every time an undiscovered side effect is reported. The media has done an excellent job at this. However, it is harder to admit to that a profitable pharmaceutical industry is necessary in order to see innovative products. In addition, if the FDA (due to its intense recent scrutiny) is going to be overly cautious about every side effect, companies may choose not to develop products which huge potential gain for many because of some minimal side effects to a few.
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5 comments:
"The political and heightened media scrutiny of the FDA and drug companies may be in part to blame for a needed drug not coming to market."
Ridiculous. Do you think Eli Lilly will not field new products due to scrutiny? They would go out of business. Either the safety was not there or the required profit margin was not there. Business is business.
Yes, business is business, but my point is that things have gotten trickier. It is likely true that some products in the past may have been pushed too quickly (Vioxx), but I think the pendulum may have shifted too far in the other direction. Since there is no public data on the Lilly product, other than they said it was safe, I will use Exubera as an example. Exubera was delayed for about 2 years because the FDA was concerned about declines in lung function. There was a small, but not very meaningful declince in the lungh function of patients taking Exubera. After two years of looking at hunderds of patients, the studies showed that this mostly inconsequential decrease in lung function was seen soon after starting the medication, didn't get worse, and resolved after stopping the medication. However, when the FDA approved Exubera, one of the caveats was listing that patients should all get lung function testing before starting Exubera. Unlike an EKG machine, most primary care physicians do not have lung function testing machines in their office (though they should), thus requiring a referral to a testing center that had this or to a pulmonologist. This caveat caused physicians to question the safety of the drug, and remained a barrier to starting Exubera on a patient, which is likely one reason the product was not as successful as Pfizer thought it would be. It is very possible or even likely that the Lily product had the same lung function issue, and though their drug was possibly equally as safe as Exubera, Lily didn't see that a big enough profit would be made if they anticipated the FDA would apply these same restrictions.
Is mannkind corporation inhaled insulin trials still alive? Will they seek FDA approval?
I am not aware that Mankind has dropped the project. In addition, the home page of their website (http://www.mannkindcorp.com/) has a picture of their inhaled insulin device displayed prominently. Thus, it would appear they are still committed to their product.
I am one who participated in the Pfizer study and can't say enough good things about their product. It was very predictable and as long as the appliance was maintained, it worked perfectly. I truly think Pfizer made a big mistake in not trying different avenues to offer the inhale. As far as the FDA (fat dumb arrogant), they should be pulling this same kind of pressure on the drugs that are causing serious problems, not those that can make life easier for us diabetics.
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