First, a small mea culpa. It is ever so much easier to paint with a very broad brush, than to pick and choose. I realize there are GOOD doctors, there are GOOD researchers and there are GOOD medical educators. Actually, there are some good pharmaceutical products and some (almost ethical) pharmaceutical companies. There, now. I’ve apologized . . . nevertheless, I still contend that some of the above (who blacken ALL of the above when they behave so egregiously) are worthy of my ‘anti’ sentiments.

I merely criticize Lilly because they were first, and set the model. You state that human insulin is “the gold standard.” Take a look at the application submitted to the patent office by Lilly’s own researchers, where they admit the problems with their “new insulin” and compare it to the “gold standard” of basal insulin–Beef Ultralente. (Ahhh, how times and semantics change.)

Lilly can state (and the FTC agree) that they did not break anti-trust laws or engage in monopolistic behavior. But at the time they introduced rDNA human insulin, they were the major supplier of ANIMAL insulin (in the U.S. Squibb had already disappeared from the U.S. insulin market.) You may contend that they did NOT manipulate the market, but when husband was first encouraged to use the “latest and greatest” Lilly product, and declined, his doctor warned him that “the handwriting is on the wall. I’ve been told that Lilly is going to remove all animal insulins from the market.” WHICH THEY DID–and which Novo mirrored, one product withdrawal at a time.

Unlike Pfizer’s Exubera, diabetics currently still have a few choices (albeit far fewer than a decade ago). I fear that were Exubera a Lilly product, diabetics might expect that same kind of treatment. As patents expire for Humulin, Humalog, etc., and IF Lilly (as the hypothetical owner of Exubera) found the market were not rushing to embrace its new inhaled product–they would simply remove alternatives from the market! Unfortunately, for Pfizer, they do not have the luxury of such manipulation for this product.

You state that the data isn’t in to support Exubera’s claims. Neither did the data (even 4-5 years after its introduction)support human insulin need or superiority.

I am anti-Lilly. Not only my husband, but countless other diabetics who felt better, who achieved better release curves, who appreciated the predictability and uniformity of a wide range of natural insulins have been denied freedom of choice. UK, Australia, Canada, Germany, France, Switzerland, Poland, still provide a choice for their patients; the only “choice” for U.S. diabetics who cannot or choose not to use rDNA synthetic insulin (or analogs) that ARE NOT “just like the human body makes”, is to navigate a cumbersome PERSONAL IMPORT regulatory process. For all intents and purposes, each order of needed or desired product is subject to confiscation by DHS; can be held indefinitely, regardless of time/temperature concerns; and requires planning months in advance of need to secure the medication.

I don’t know how I didn’t think of this earlier with your anit-Lilly bent. I know you believe Lilly somehow manipulated everyone in the world to use their unproven unknown recompbinant insulin.

If it were really that easy don’t you think that Exubra, Pfizer’s inhaled insulin would have taken off. There is no bigger giant in pharma than Pfizer, on the surface an inhaled insulin sounds like the answer to a big chunk of diabetics problems. But the data isn’t there and no one can really justify using the new insulin. I am sure Pfizer wishes they knew the Lilly insulin manipulation secret, but the secret is in the data. And for Exubra the data isn’t there.

So I guess everyone should pick a side - do you want large trials with more data or do you want small trials so pharma can’t “buy docs”.

Everything in this life is a trade-off.

Melody, I understand that insulin is your hot button like SSRI’s for Lisa, but come on! I think the long term results of Humulin looks pretty good and is the gold standard. How come you don’t rail on Novo like you do Lilly. I believe they produce synthetic insulin as well.

So let me get this straight, pharma sponsors large trials to pay docs, but then they don’t collect the data? BTW when a big “primary care” type drug is tested, many more sites than not are community. These are not KOL’s, but docs interested in advancing medicine. I have been involved in more than a couple and there is absolutely no one around for me to influence out in the country.

Docs are compensated for enrolling and treating/following patients. But honestly if a doc wanted to make money, he would stick to what he is good at and does on a daily basis. Trials slow you down, honestly. Maybe some have figured it out better than I have, but I would be better off running my practice in a normal fashion.

As you know all of the clinical trial stuff goes thru the proper channels before starting a trial - so no one for example is paying me $10k/patient to try out a new community acquired pneumonia drug. Instead for example, I scoped patients for a PPI trial. I got $3000 per patient for 4 visits and 2 scopes. This is actually about on par for what I would receive from Medicare. The patiet recieves free med and scopes and actually gets better care than they would have - at no cost to them. Plus I now have to mess with clinical monitors, mountains of paperwork, etc. So, if I were smart and just worried about my check, I would say forget it. But if you want to contribute to medicine you do what you feel is right.

I know it is much easier to think that all docs and drug companies are crooked, but some of are trying to do the right thing and get painted with a broad brush.

Take a look at Sid’s post above - he is absolutely correct when it comes to the p’kinetics of AEDs. If you don’t understand that post - you shouldn’t be in the arguement.

Again, I will state I have never used Vioxx, Bextra, Ketek or any of the new wonder drugs. So I am not in pharma’s pocket, I just actually read the literature.

You state: Also clinical trials are expensive. A large phase 3 trial of 6,000 people on average costs $100 million. That is a large phase 3 trial. How big do you want clinical trials, 1 million+ patients?

How much of this expense goes to pay doctors for “enrolling” patients? And the “large phase 3 trials”—are they the norm, or the exception. As I looked back at the original application submitted to the FDA by Eli Lilly for rDNA human insulin—THE FIRST BIOTECH DRUG submitted for approval, and approved—the data indicated there were actually 6 trials. Tthe smallest trial comprised 6-12 patients; and the largest (most ‘meaningful’) had slightly more than 200. This, to me, is astounding. An unproven technology with no long-term data (of course) was given the green light with data collected from such a minute base!

Pharma may have changed their strategy, and may now finance ‘large phase 3 trials’—but somehow I believe they may be driven by more than data collection and efficacy/safety concerns. If they can compensate a few key opinion leaders for enrolling significant numbers, and acquiring predetermined answers, they can be reasonably certain there will be a substantial ROI.

Now that is something we can agree on. LOL!

If you have time take a biostats class. You would then understand why you have to have similar groups with certain conditions excluded in order to determine the effects of the drug. No, many people have additional conditions, and that is why post marketing reporting is important. But it is too difficult to account for all the confounding variables if you just take a random sample of people. Also clinical trials are expensive. A large phase 3 trial of 6,000 people on average costs $100 million. That is a large phase 3 trial. How big do you want clinical trials, 1 million+ patients? The FDA has a huge balancing act - speed and cost versus absolute safety. Best bet is to not take a new drug for the first couple of years if possible.

If you think that clinical trials for innovator products are too small, take a look at generics. They have on average a bioavailability trial of 12-20 people and only look to see that blood levels are “close”. So if you think large phase 3 trials are too small, think about the generic trials and how easy it would be to get bad data.

Innovator companies spend billions on research, while generic companies like Teva are half lawyers, who start poring over patents the moment the NDA is submitted. Who are the greedy ones here? The innovators or the leeches?

I am willing to admit that some in the FDA may “bend” the science to help their pharma cronies. But to characterize the entire agency that way would be wrong. [Another 4 years of Bush-type Republican leadership, however, may make a liar out of me!]

Science also does not speak with one voice. Equally “scientific” data, I am sure, has been put into evidence on both sides of Vioxx trials, for example.

Still, if you are truly looking for links between cause and effect, the proper application of the scientific method is the only way to go. Unless, of course, you believe that snow is caused by cold weather because you only see it snow when it is cold. That’s anecdotal evidence for you!