- Joined
- Sep 20, 2016
- Messages
- 1,802
- Reaction score
- 502
The discussion about "evidence" based medicine has been quite intriguing to me on these forums. I often see posters like "101N" who keep crying about the lack of "evidence" for certain types of procedures such as LESI due to the "need" for perfectly randomized placebo controlled studies including meta-analyses confirming efficacy before they are "proven", which can only be done by authors they deem appropriate (such as Chou). Basically, setting up a strawman level of evidence that doesn't exist anywhere else in medicine, as I will argue below.
The scrutiny the mILD procedure has received from CMS due to neurosurgical opposition really brought this home to me.
It seems like a level of scrutiny is applied to some of these procedures far in excess of the biggest cost drivers in medicine including procedures (cardiac, neurosurgery/ortho "back" surgeons, general ortho, etc) and pharmaceutical companies.
The mILD procedure is literally being forced to undergo many prospective randomized trials by CMS before approval. Compare this with many other procedures that have been much larger cost generators for Medicare that appear to increase every year , which have actual evidence proving they don't work for the vast majority of patients they are used on.
Kypho, RF, ESIs, etc will have more positive evidence for them than the procedures listed below that are FAR more expensive for CMS.
Examples below include:
100 billion dollar cardiac market (stents and CABGS)
A) Stents have basically NO evidence for any mortality benefit for >95% of cases where they are used for "stable CAD" rather than an acute MI.
One of many articles below confirming this fact:
http://circinterventions.ahajournals.org/content/5/4/476.long
The vast majority of studies prove there is NO evidence that stents work at all for stable CAD patients, especially compared to conservative medical therapy (Statins, ACE, etc)
B) CABG has no evidence for almost any patients outside of LMA disease with depressed EF compared to medical therapy
http://www.nejm.org/doi/full/10.1056/NEJM197709222971201
There are literally articles back from the 1970s until present showing the vast majority of CABG procedures offer no benefit compared to medication therapy, This is particularly true recently with newest medication therapies.
Only a handful of studies show some very SLIGHT mortality benefit for LMA disease with decreased EF
C) Most EP Ablation treatments have no evidence of mortality/morbidity benefit over conventional medication management in >99% of stable AF patients, yet cost 10s of thousands of dollars for each procedure.
Back Surgery World
A) Fusion surgery for Stenosis, DDD, Disc Herniation with radiculopathy: has literally no evidence to prove efficacy and plenty of evidence against it.
Hell, even most workman comp studies show that fusion causes increased disability and increase narcotic usage compared to CONSERVATIVE therapy such as PT, injections, medications, etc.
http://www.ncbi.nlm.nih.gov/pubmed/20736894
http://www.ncbi.nlm.nih.gov/pubmed/26709561
All independently done trials through workman compensation show increased disability and increased narcotic usage with decreased return to work status for fusion surgery used for ANY diagnosis.
B) Laminectomy surgery for Stenosis:
Only the SPORT trial shows any benefit for stenosis, which is SHORT term with a limited cohort of patients. The study was also performed by surgeons who have a financial interest in keeping the procedure going (compare this to the critique of "mILD")
Furthermore, the study only showed benefit in ONE level stenosis for a short period of time, with far less benefit for 2 or 3 levels of stenosis.
There are almost no other studies that show efficacy past 6 months for laminectomy.
Compared to CMS demands on the mILD procedure
Here are the makers of BMAC (who incidentally NOW HAVE MORE EVIDENCE for efficacy for treatment of DDD when compared to fusion surgery) showing yet another study confirming that Ortho spine surgeries just don't work:
http://www.regenexx.com/spinal-stenosis-surgery-questions/
Yet here CMS continues to pay 10s of billions more for this than conserative care.
Orthopedic World:
Biggest issue are arthroscopic surgeries for meniscus repair (100s of thousands/year) with MANY studies now confirming they have no benefit.
Rotator Cuff surgeries have surprising few studies confirming any benefit.
Pharma world:
Most recent cancer drugs that cost 10s of thousands have no evidence for any mortality benefit yet cost 10s of thousands per year.
http://www.cbsnews.com/news/cost-of-cancer-drugs-60-minutes-lesley-stahl-health-care/
Good expose that shows many CA drugs that have been approved by FDA over the last 15 years provide NO benefit in terms of mortality.
Lyrica is the biggest money making drug for Pfizer at the moment. It provides marginally better benefit than placebo and nothing really over Neurontin.
Lyrica costs 700/month with very little benefit proven in studies.
Antidepressant drugs such as Abilify are big sellers with marginal evidence only shown in industry supported trials.
I think this constant ridiculous standard we need for "evidence" that is applied by guys like 101N is getting tiresome and needs to be called out.
Let the games begin!
The scrutiny the mILD procedure has received from CMS due to neurosurgical opposition really brought this home to me.
It seems like a level of scrutiny is applied to some of these procedures far in excess of the biggest cost drivers in medicine including procedures (cardiac, neurosurgery/ortho "back" surgeons, general ortho, etc) and pharmaceutical companies.
The mILD procedure is literally being forced to undergo many prospective randomized trials by CMS before approval. Compare this with many other procedures that have been much larger cost generators for Medicare that appear to increase every year , which have actual evidence proving they don't work for the vast majority of patients they are used on.
Kypho, RF, ESIs, etc will have more positive evidence for them than the procedures listed below that are FAR more expensive for CMS.
Examples below include:
100 billion dollar cardiac market (stents and CABGS)
A) Stents have basically NO evidence for any mortality benefit for >95% of cases where they are used for "stable CAD" rather than an acute MI.
One of many articles below confirming this fact:
http://circinterventions.ahajournals.org/content/5/4/476.long
The vast majority of studies prove there is NO evidence that stents work at all for stable CAD patients, especially compared to conservative medical therapy (Statins, ACE, etc)
B) CABG has no evidence for almost any patients outside of LMA disease with depressed EF compared to medical therapy
http://www.nejm.org/doi/full/10.1056/NEJM197709222971201
There are literally articles back from the 1970s until present showing the vast majority of CABG procedures offer no benefit compared to medication therapy, This is particularly true recently with newest medication therapies.
Only a handful of studies show some very SLIGHT mortality benefit for LMA disease with decreased EF
C) Most EP Ablation treatments have no evidence of mortality/morbidity benefit over conventional medication management in >99% of stable AF patients, yet cost 10s of thousands of dollars for each procedure.
Back Surgery World
A) Fusion surgery for Stenosis, DDD, Disc Herniation with radiculopathy: has literally no evidence to prove efficacy and plenty of evidence against it.
Hell, even most workman comp studies show that fusion causes increased disability and increase narcotic usage compared to CONSERVATIVE therapy such as PT, injections, medications, etc.
http://www.ncbi.nlm.nih.gov/pubmed/20736894
http://www.ncbi.nlm.nih.gov/pubmed/26709561
All independently done trials through workman compensation show increased disability and increased narcotic usage with decreased return to work status for fusion surgery used for ANY diagnosis.
B) Laminectomy surgery for Stenosis:
Only the SPORT trial shows any benefit for stenosis, which is SHORT term with a limited cohort of patients. The study was also performed by surgeons who have a financial interest in keeping the procedure going (compare this to the critique of "mILD")
Furthermore, the study only showed benefit in ONE level stenosis for a short period of time, with far less benefit for 2 or 3 levels of stenosis.
There are almost no other studies that show efficacy past 6 months for laminectomy.
Compared to CMS demands on the mILD procedure
Here are the makers of BMAC (who incidentally NOW HAVE MORE EVIDENCE for efficacy for treatment of DDD when compared to fusion surgery) showing yet another study confirming that Ortho spine surgeries just don't work:
http://www.regenexx.com/spinal-stenosis-surgery-questions/
Yet here CMS continues to pay 10s of billions more for this than conserative care.
Orthopedic World:
Biggest issue are arthroscopic surgeries for meniscus repair (100s of thousands/year) with MANY studies now confirming they have no benefit.
Rotator Cuff surgeries have surprising few studies confirming any benefit.
Pharma world:
Most recent cancer drugs that cost 10s of thousands have no evidence for any mortality benefit yet cost 10s of thousands per year.
http://www.cbsnews.com/news/cost-of-cancer-drugs-60-minutes-lesley-stahl-health-care/
Good expose that shows many CA drugs that have been approved by FDA over the last 15 years provide NO benefit in terms of mortality.
Lyrica is the biggest money making drug for Pfizer at the moment. It provides marginally better benefit than placebo and nothing really over Neurontin.
Lyrica costs 700/month with very little benefit proven in studies.
Antidepressant drugs such as Abilify are big sellers with marginal evidence only shown in industry supported trials.
I think this constant ridiculous standard we need for "evidence" that is applied by guys like 101N is getting tiresome and needs to be called out.
Let the games begin!
Last edited: