Comparative Effectiveness - why are some so afraid?

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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. Among other ideas, 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 to the HHS/NIH fund is comparing the effectiveness of medical treatment Vs. stents, drug eluting, bioresorbable or otherwise...

Why?

I am almost at the point where I am ready to conclude stenting is an ineffective, expensive 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 of the stents and the drugs they "elute".

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:

http://uk.reuters.com/article/healthNewsMolt/idUKTRE51H7D020090218

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?

NO!

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.

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...

Why?

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:

http://uk.reuters.com/article/healthNewsMolt/idUKTRE51H7D020090218

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?

NO!

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.

Medical Device Innovation! : Arthrocare is now rebranding to Art-no-care!

[Click on Post Title for Link to External Article]

Innovations in medical devices have been happening at hitherto unknown magnitudes of time and quality. The time for medical devices to join the banking sector in defrauding the American Public seems to have finally arrived! How, you say?

1. The FDA:

The Bush administration, in well measured tactical moves has rendered the FDA a nearly useless joke (except of course it's the dead Chimpanzee cartoon kinda joke - the kind that no sane person would laugh at). Want to know more?

Read This!

Now, regulations both necessary and otherwise don't exist. You know what happens when there is less regulation?

More "innovation" in medical devices!

2. The Supreme Court:

Give a bunch of extremely old people with outdated ideas and extremely untalented people John Roberts the chance to do what they please and say what they please for life and you have reduced "Democracy" to "Ironic Drivel".

Last year, this was very helpful in creating something so entertaining that Tyler Perry, Stephen Colbert and their like have to kiss it's ass - this was called "Pre-emption".

With this tad bit of innovation, now you the patient cannot sue a company for a medical device that the FDA has already "approved". Yes, you are right, the very same FDA that is totally weak, engages in all kinds of unethical duty dodging...

Yes, you cannot sue if in fact the device malfunctioned, did not do what the labeling suggested it was going to do, or if in fact, the device killed you or a "loved one".

Who else laughed so hard that their stomachs hurt?

Careful there, your stomach ache medication may have side effects including death, permanent disability, loss of self esteem, feelings of suicide...

3. The Slapstick Entertainment Commission, er., SEC:

If you thought the FDA was a joke, wait till the SEC comes to investigate. You know, how in Hollywood movies the cops and the army always show up after the trouble is over (unless they caused it of course!), and the hero has tackled all the thieves, alien monsters and so on....who told you that was fiction?

4. More Tools to help innovation? - Democrat Nominees for HHS, FDA or any government position you can name

Let's see. There is this certain subspecies among humans. They love taxing you. Any excuse is enough. Are you rich? Are you wealthy? Are you a business? Are you none of the above?

Doesn't matter. They will tax you!

Except...they won't pay.

Come on, whoever followed what they preached?

Won't believe me? Go look up "Daschle", "Geithner", "The husband of a labor secretary nominee" on the Googles and see for yourself!

With friends like these in Government, who needs the GOP and their fear of comparative studies? (Yes, they don't like the idea!)

Meanwhile, if you are a medical device company looking to "innovate" alongside the aegis of "Art-No-Care" and others, here are a few tips:

1. Don't worry about the FDA. As long as you fill paper work, you will get a 510(k) - heck you might even get a PMA approval.

2. Tell your sales folks to ignore "approved uses". Tell them to sell the medical device for any use that pleases them. If convicted, only the sales guys go to prison. You can even take your company name out of the mention in court papers!

3. Hire lawyers whose dads work in the federal judiciary system. This way, you can use the son to get the dad to dismiss any cases, pre-emption or otherwise. The dad can always deny even knowing his son had a job!!

(See my previous blog post, if you can't believe your eyes and ears about 2 and 3).

4. When in doubt, be assured that pre-emption will protect you! Do you fear that the Obama administration will ever do something about it? Fear not!

How come you say? Well, for one, they are not very different from the Bush Administration - they just sided with them (and against your right to know) on White House emails. How different do you think they are going to be? Change is only for Washington - not much else.

For another, Obama will never appoint a HHS secretary. Or he may, and it would be too late anyway. Heck he hasn't responded to FDA scientists who lamented about the FDA and later pleaded that they were being persecuted.

5. Ignore audits, the SEC and other regulations. If anything, it will be years before the SEC investigates. By the time the agency would be busy with one of two possibilities - either the administration (and the party that administers said administration) would have changed, or the SEC itself would be re-branding, because the last name did not work out! And you would be far away.

Who cares if you have to re-state revenue figures for a whole decade in the past? As long as you can cook up the numbers for the next 90 days, it's good enough! Be practical.

Meanwhile - Yay! Innovation. Enjoy! There are absolutely no barriers or regulations or rules of law that will stand in your way.

Art-No-Care just proved it.....

How many weird medical device stories did you read this week?

As a note, I was quite sick and I am finally back...to report two really weird medical device stories that I myself came across this week. To say the least, I have no idea what to make of them, so maybe you can help me out here.

Link1: Of Medtronic, Judges and their sons...

Link 2: Stryker's "amazing" tact to distance itself from it's own sales reps

Let's take the first story.

First, off sorry about the weird, expensive, unpopular anti-Obama Republican haven journal Wall Street Journal link. It is the only one reporting the story as far as I can tell....I learned this story myself first from the SmartBrief summaries. I dug up news.google and found nothing anywhere else. If you find another place reporting this, please let me know. It's not just the thin reporting that wins this story weird points...

Okay, so maybe Medtronic itself doesn't have much to do with it. I really suspect it though. For both the judge and the lawyer to not know their personal relationship and fiduciary compounded with judiciary relationships with Medtronic...well, gets slightly edgy, doesn't it?

The Judge can't have it both ways - this is not a Perry Mason "The Judge who did not know" story. This is "Either the Judge is stupid or dishonest" story.

Well, isn't this all just a ploy by the plaintiffs? Yeah, maybe..

Isn't it simply wrong then?

Do you think stealing consumers of their rightspre-emption is right?

Like I said, I don't care what Medtronic thinks or puts out in its vehement press releases. They probably have very little to do with this nonsense (other than, maybe paying some incredibly incompetent law firms).

I want someone to scrutinize this "Judge" Kyle. Because in the race to nominate people in public positions who lack self-awareness, he might have joined the likes of Merkel, Judd Gregg and the entire set of House Republicans....

And, now to move on to the second strange "medical device" "weird" story of the week.

Okay, so what was Stryker trying to do here? Play the harp or whatever as its sales reps burned in the courts?

Why is it so weird?

Well, for one, the name of the employer of the sales rep prosecuted is mysteriously missing. So is the "medical device" that was sold deceptively. (Until reporters had to do a lot of "court document" digging.) Why the secrecy?

What is the big idea?

So, they will convict the guy, but not disclose to the tax-paying public what medical device was misused and under the auspices of which employer?

Did we all undergo some weird time-space transformation into some middle eastern country in the 16th (or 21st, doesn't matter) century?

How is it possible that in this day and age, companies can wash their hands off employees they were supposed to discipline and regulate? How is it that even the medical device that was inappropriately marketed is not disclosed?

Am I the only one feeling a chill down the spine?

Talking of spines - can we rely on the devices designed by any one of the ............... er, orthopedic device makers out there?