Saturday, February 28, 2009

Comparative Effectiveness - why are some so afraid?

[Click on Post Title for Link to External Article]

The Premise
One of the main reasons why I used to be an avid supporter of Hillary Clinton's Presidential Campaign was her Healthcare policy. She was an early champion of comparative effectiveness and now President Obama has solidified that into the final version of the signed stimulus bill.

My Proposal
The first study I would propose the HHS/NIH fund is comparing the effectiveness of medical treatment Vs. stents, drug eluting, bioresorbable or otherwise...


I am almost at the point where I am ready to conclude stenting is an ineffective, inexpensive treatment. I am not there yet, but everything I read and analyze, seems to take me in that direction.

For almost every study that involves stenting, there's a ruse - a blame is placed on something external. The real ugliness is hidden - it is almost proven now that in almost every situation stents are useless when compared to good old medical management.

And now device manufacturers and the coating manufacturers are in nexus trying to "study" and "prove" the effectiveness.

They could be no farther from what appears elsewhere:

Here is one that demonstrates that "late stage stenting", that is doing the procedure several days after the patient has had an attack is not effective:

I am betting, and you can count on it, that the stent manufacturers are going to come out and blame patients for "waiting" before getting treatment. We all know that this is not the case - not when we just looked at the results from 447 patients.

Why are device and drug manufacturers scared?
It is not simply because they are scared that their particular device/drug would be named the expensive and ineffective one.

Testing comparative effectiveness was their responsibility and they chafed on it - with the FDA's obsequious assistance.

Remember, and understand, in case you didn't know - comparative effectiveness studies are only new to the United States, since lobbyists have effectively (this, they are effective at) blocked efforts to launch such studies. Elsewhere it has been practiced for quite a while. Look at the UK for example.

Yes, one of the folks quoted in NY Times states rightfully that none of the other countries that have performed comparative analysis for years haven't figured out an effective mechanism yet. Okay, all I am saying is that it is a great opportunity for US leadership in this area then, now that we have $1.1 bn to spend on it.

What is the current state of studies on approved treatments and devices?
The current state of the union, er, comparative effectiveness or even stand-alone effectiveness of devices/drugs is terrible.

Here is what happens:

Evidence to support effectiveness of a certain therapy/drug is primary to CE/FDA certification. So, yes, companies sponsor them quite happily.

However, post-market approval studies are weak - more so for devices than the drugs. This is because of effective policy oversight on the part of who else, your friendly neighborhood FDA.

Whither ethics?
There is no question that ethically every device manufacturer should be invested in post-market follow-up at much higher levels of diligence.

At the detriment of profits? Isn't this just expensive?


After all, every device manufacturer wants to keep expanding device use, refining the device, fight for and retain reimbursement codes and rates.

All of this should be based on sponsored studies, monitoring and so on - which costs money yes.

Instead, they spend it on lobbyists, firing off workers and buying up competitors and smaller players - simultaneously (oh you know I am taking another dig at 'you know who').

So, when they won't even study the effectiveness of their own drugs/devices, do you think these masters of the universe will succumb to comparative studies voluntarily?

"Rationing Treatments" and "Government Intrusion"
Yes, I am sure ideologically you have a problem with the government deciding what you deem to be necessary treatment - except it was already proven ineffective and expensive.

Why, then should you still vote for that treatment?

This is where the drivel sounded off by idiots like Rush Limbaugh doesn't hold. Large government may not be your thing. You may love being Conservative.

Good, pay for your own treatments.

The vast majority of the public on the other hand simply doesn't know. If you quizzed them many of them would probably be surprised that comparative effectiveness studies are not being done right now. They would have assumed that.

They (me included) needed for Obama to do this.

Still Not Convinced?

Here is a real-world example. A certain subset (large) of breast cancer patients that do not respond effectively to chemotherapy. Following chemotherapy, there is a huge risk that "chemo brain" effects may lead patients to suffer from reduced mental alertness and other consequences.

Now add on top of this the fact that many patients will not even benefit from chemotherapy!

Genetic studies are being developed to find out which patients will respond to chemo and which ones wont. This will help patients who don't respond well to this treatment save themselves from the treatment. This is a subset of the type of results comparative studies would result in.

In the absence of these types of studies, drug and device manufacturers can keep merrily entreating Doctors to keep prescribing treatments that may be not only useless but harmful treatments.

Combine this with unscrupulous DTC ads, and the FDA's uselessness (aka, instead of banning the YAZ ads outright, they added a very confusing layer of message to customers), and you have yourself a lot of wasted money and unhealthy, dissatisfied patients.

Are Comparative Studies Risk-Free for the consumer?

No. Here are some risks I have thought of. I am sure there are more I am missing:

1. Is $1.1bn enough? How will it be distributed? We haven't seen a plan. Will NIH ensure that grantees will not have any ties to companies that make the drugs/devices they study?

2. Apparently the money is available for "many years". How many years? What will happen when the money runs out?

3. How will treatments and drugs that require studying be prioritized? We know the HHS will have authority over this. But who specifically? And what will be their logical course to action?

4. A certain portion (again we don't know how much) of the money available will be used to review data from studies previously conducted - well, what with the problems we have had with greedy study leaders having issues with disclosing "conflicts of interest", how do we know how many of them are reliable? Even without these issues, how many studies will have reliable data that can be used to make effective analyses?

Trust me, I am no fan of meta-analysis. Just do one on half a dozen of the "coffee does this to your body" studies out there..

So, yes, the current plan for Obama's proposal is virtually non-existent.

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