Comments on: A Federally Funded Institute To Compare Drugs?

By: LILLI

LILLI — Mon, 07 Apr 2008 14:25:43 +0000

I cannot support this. Every time the government deceides to help it is not genrally for the public but it is for the medical profession, healthcare industries and hospitals. Just the same with Patient Safety Acts were in name only, but not to do anything with patient safety. Patient Safety was concern for the doctors, healthcare industries, hospitsals, pharmaceuticals being sued. Now, patients that have legtimate medical malpractice case find it difficult to find a lawyer that will represent them. First we must change and put restrictions on our elected officials. Having representatives in congress for more than 46 years is not a good idea. We need to change the corruptiion in our government. New Jersey Clean Election Act also was in name only. Just last week the legislature and Gov. Corzine
reported issues that New Jersey /clean Act is a farce. In fact, New Jersey taxpapers money was wasted on this corrupt program.

By: Atlex

Atlex — Wed, 02 Apr 2008 20:57:28 +0000

Scott for the most part, the health insurance industry does support this. BCBSA, representing the Blues, has been an active supporter. However, they, like others, realize the potential corruption of this concept. The Center could become something like DERP out of Oregon, which is simply an exercise in cost minimization. Or, the Center could get bogged down in an academic exercise that produces little of value. And, there are many other possibilities for corrupting the system–all depending upon the point of view (ie, bias) of who one speaks to. One would hope that the Center would base its work on a robust and acceptable definition of “value”; however, I have my doubts as to whether this is possible.

By: Scott

Scott — Wed, 02 Apr 2008 20:37:30 +0000

Actually, I am surprised that a proposal like this isn’t actively supported by the healthcare insurance industry, since they fund most drug purchases — presumably under the assumption that these substances improve patient health. Having a more “objective” review would help ensure that healthcare providers aren’t unncessarily funding expenditures that do not have proven benefits. Now, what is the official opinion of United Healthcare, Humana, Aetna, Cigna and the other major providers on this subject?

By: Justice in Michigan

Justice in Michigan — Wed, 02 Apr 2008 15:29:43 +0000

I guess it cuts in all directions. As I understand it, SP balked at doing comparisons between Claritin and existing allergy meds because of the anticipation it would lose on efficacy unless you raised the dosage - in which case, it would lose on “doesn’t make you drowsy.”

That may or may not be true in this case. But, in general terms, one comes to the question of what is the proper balance between what sells and what’s true, who is responsible for finding out, and who pays (and in what ways) when we don’t find out.

By: Richard Leff

Richard Leff — Wed, 02 Apr 2008 15:01:09 +0000

This proposal sounds radical but a model already exists. The NCI funds several large cooperative oncology research groups that perform studies based on need assessed by the clinical leadership of the groups. (They also perform some studies spnsored by industry.) They also perform very large national inter-group studies encouraged by the NCI. Some of the studies have included comparisons of 2 approved drugs or different administration regimens and are studies that industry has no incentive to perform. A great example is ECOG 1199 comparing paclitaxel to docetaxel in 2 different administration schedules. A model that would allow the NIH to sponsor independent research by large cooperative groups in other disciplines could only advance patient care.

By: snugpharma

snugpharma — Wed, 02 Apr 2008 13:29:34 +0000

The money would be better spent on increasing the FDA funding to facilitate its mandatory role. That is where the common denominator sits. These government employees with talent deserve a better deal.

By: HorusCat

HorusCat — Wed, 02 Apr 2008 12:16:55 +0000

All,
Sometimes a me-too drug is better, while not being more efficacious, because of dosing convenience or side effects…a good example is Mevacor vs Lipitor…

And OTB is absolutely right–sometimes I can’t figure out where all these drugs cost come from, because industry figures show no one is compliant with their meds!

By: Outside the Box

Outside the Box — Wed, 02 Apr 2008 11:48:55 +0000

And pretty much all of the above comes back to using placebo as it is the only unvarying control.

To be clear, I am wholly against the idea of setting up prospective controlled trials for the purpose of comparing drugs. I think the idea is only workable in disease areas where the disease is non-life threatening (ethical issues), where the safety profiles of the drugs are already sufficiently well established to avoid issues (ethical), where the disease has lots of patients (recruitment, time, cost) and where the effects of products differences can be reasonably balanced (i.e. dose differentials and so forth).

Bob is correct, this has been discussed numerous times over the years all over the world and different solutions have been put in place (ref Australia, UK). For the US market both of these are bad examples because of the different payer systems (both) and the lack of any significant indigenous industry (Australia).

I come back to the original announcement, and it is clear that the real objective here is cost containment. From a healthcare perspective it would be far more interesting to explore the damage done from non-compliance and lack of persistence because I think that there is where we find that the real costs to the economy will be found. What is the point of proving that Crestor is better than Lipitor if patients only comply with their meds for 6-9 months and over half the patients have stopped taking drug entirely within a year?

By: Nathan

Nathan — Wed, 02 Apr 2008 11:05:35 +0000

I think Bob brings up one of the most important points of this discussion: What doses will be compared? In many cases it will be very easy for a company to say “The competition’s drug worked better, but if our drug were given at a truely comparable dose it would have been equivalent or better.” So then you are in a position of having to study multiple doses. We also have 3 or 4 very similar products in a given theraputic area. This quickly becomes an unsolvable problem — do we really study 10-15 subgroups? If so, this becomes either VERY EXPENSIVE (due to clinical trial size) or irrelevant (due to limited subgroup size).

By: Tanin

Tanin — Wed, 02 Apr 2008 02:50:57 +0000

HorusCat,

To a certain extent you are right about this proposal discouraging R&D, however it is more likely to discourage the development of “me-too” drugs than truly innovative therapies.

Also using other countries as a model (Australia etc), if a new drug is found to be no better than an old drug they normally can be reimbursed on a cost-minimisation basis (ie same price or lower than old drug), so the pharma company would recoup some of their research losses from developing the drug