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Oxygen: Modified Delivery System: Advantages (Read 3609 times)

Bob Johnson

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Oxygen: Modified Delivery System: Advantages
Feb 3^rd, 2013 at 10:48am

Pain Med. 2013 Jan 31.
Demand Valve Oxygen: A Promising New Oxygen Delivery System for the Acute Treatment of Cluster Headache.
Rozen TD, Fishman RS.
Department of Neurology, Geisinger Health System, Wilkes-Barre, PA, USA.

Abstract
OBJECTIVE.: To show that demand valve oxygen is an effective acute treatment for cluster headache and to compare this oxygen delivery technique with standard cluster headache therapy of continuous flow oxygen. METHODS.: Single-center, open-label, two-period, two-treatment crossover design, pilot study was used. Subjects treated with one of two sequences: first, headache treated with continuous flow oxygen (100% oxygen at 15 liters per minute), and subsequent with demand valve oxygen, or vice versa. Treatment began when pain was at least moderate. Subjects taught a specific breathing technique for demand valve oxygen that included initial period of hyperventilation. Primary end point was headache response (moderate-to-very-severe pain reduced to mild or none) after 30 minutes of treatment. RESULTS.: Three subjects completed the trial, while a fourth completed demand valve oxygen only. All had chronic cluster headache. All subjects treated with demand valve oxygen became pain-free (time in minutes: 15, 19, 6, 8). Three of four had no recurrence within 24 hours. Demand valve oxygen reduced cranial autonomic symptoms in all and resolved them in two subjects. For continuous flow oxygen, two of three subjects became pain-free (20, 10 minutes). Continuous flow oxygen reduced but did not eliminate cranial autonomic symptoms. Continuous flow oxygen had higher recurrence rates. No adverse events noted with either treatment. CONCLUSION.: Demand valve oxygen appears to be an effective acute treatment for cluster headache. All subjects became headache-free. Time to pain freedom was fast (average 12 minutes). The small number of study subjects does not allow a direct comparison of efficacy between demand valve oxygen and continuous high flow oxygen.

Wiley Periodicals, Inc.

PMID:23369112[PubMed]

Bob Johnson

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Guiseppi CH.com Moderator CH.com Alumnus Offline San Diego to Florida 05-16-2011 Posts: 12063 SAN DIEGO, CALIFORNIA USA Gender:	Re: Oxygen: Modified Delivery System: Advantages Reply #1 - Feb 3^rd, 2013 at 1:14pm Great article Bob. I'm a demand valve man myself and I swear by that thing. Joe
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Mike NZ

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Re: Oxygen: Modified Delivery System: Advantages
Reply #2 - Feb 3^rd, 2013 at 1:32pm

Great to see more work in this area, although the low number of subjects in the study will impact how significant the result is seen as being.

What does surprise me however is that the time to being pain free is 12 minutes, which is significantly longer than what a lot of people report here for either demand valve or high flow rates (25lpm or higher). I'd have thought that they should, with the technique they are using, match times around 5 minutes or so.

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Re: Oxygen: Modified Delivery System: Advantages
Reply #3 - Feb 3^rd, 2013 at 3:51pm

Mike, the problem was in how the test was run. They waited until the pain was at a "moderate level." For me, if I wait until the beast is fully entrenched....what they probably refer to as a moderate level....my abort times would be substantially longer. I hit the 02 as soon as the tingle in the eye and the tugging on the back of the neck start. In 6-8 minutes beasty is gone.

Joe

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Re: Oxygen: Modified Delivery System: Advantages
Reply #4 - Feb 3^rd, 2013 at 6:28pm

Bob,

Thanks for posting this abstract. When I spoke with Dr. Rozen in October of last year, he wasn't sure if he had collected sufficient data to submit an article on his pilot study and have it accepted. It appears he obtained one more study participant and that was sufficient...

Hopefully, Royce Fishman will be able to provide CH.com with the full text of Dr. Rozen's pilot study now that it's been published.

Those of you who have followed the saga behind Dr. Rozen's study, know that Michael Berger and I had it in the planning stage in 2007 and that Royce, Michael and I helped obtain the funding to make this pilot study possible.

The wonderful part of all this is we now have the results of a cluster headache study, published on oxygen therapy at flow rates much higher than 15 liters/minute, by one of the top neurologists in the US. This can and will start making a difference in how neurologists treat people with this disorder...

Now that Dr. Rozen has published the results of his pilot study, I'm no longer bound by my agreement with him not to disclose the details of the pilot study of this method oxygen therapy that Michael Berger and I conducted 2007-2008 with 7 CH'ers.

The study protocol that Dr. Rozen used in his pilot study is similar to that used in the RCTs for StatDose Imitrex (sumatriptan succinate injections). Both protocols called for only one dose (or application of oxygen therapy). These studies were both interventional, non-randomized and open label in design.

Dr. Rozen's demand valve pilot study and the StatDose Imitrex RCTs also used a similar primary outcome measure of percent pain free by 30 minutes, but collected data on all actual abort times. Dr. Rozen's pilot study also used an active comparator (oxygen therapy at a flow rate of 15 liters/minute).

you can read the entire protocol and secondary outcome measures used in Dr. Rozen's pilot study at the following link:

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The rationale for the similar protocols was to provide an apples to apples comparison of the effectiveness of these two acute treatments of cluster headache.

The protocol that Michael and I used in our pilot study was somewhat different in design and intent. We encouraged participants to start this method of oxygen therapy at the first indication of a cluster headache.

In contrast, Dr. Rozen's protocol had the CH'er wait until the pain was moderate before starting the demand valve therapy. There are many of us here at CH.com who will tell you this is a sure recipe for much longer abort times.

We had participants use oxygen therapy at flow rates that support hyperventilation using either an oxygen demand valve or 0-60 liter/minute regulator equipped with an O2PTIMASK™ kit.

The O2PTIMASK users followed a sequence of flow rates consisting of 30 seconds each at 25 liters/minute, 40 liters/minute, and 60 liters/minute before returning to 40 liters/minute and staying at this flow rate until the abort. Participants collected abort time and pain level data on every cluster headache for 8 weeks.

Both applications of this method of oxygen therapy are based on the procedures I developed in 2005 and both are equally effective.

In 2007, Michael and I modified the procedures I developed in 2005 to work with oxygen demand valves and regulators provided by Royce Fishman, who was working for Linde LifeGas at the time. Dr. Rozen's pilot study used the exact same demand valve method of procedure.

The basic procedure requires the cluster headache sufferer to hyperventilate with 100% oxygen until they experience respiratory alkalosis with symptoms of paresthesia, and to continue hyperventilating at a high enough rate to maintain these symptoms until the abort to a completely pain free state.

All seven cluster headache sufferers (one woman, six men; one episodic CH'er, six chronic CH'ers) consulted with their PCP or neurologist before participating in this pilot study.

Participants were also allowed to use a bailout or escape abortive like an imitrex StatDose injection after 30 minutes if needed and at any time during the attempted abort if they felt they would be unable to continue with this method of oxygen therapy due to pain. Participants were also allowed to use prescribed cluster headache preventative medications and any other medications prescribed for other medical conditions.

Although the use of cluster headache preventatives may have had a slight influence, the results we obtained from this method of oxygen therapy were so stunning, it's unlikely the use of preventatives was a factor.

Ten CH'ers started our pilot study. Two episodic CHe'rs reached end of cycle after less than 10 days and dropped out. Another chronic CH'er dropped out of this pilot study due to an unrelated medical condition.

In all, seven CH'ers completed the 8 week study collecting data on 367 aborts using oxygen therapy at flow rates that support hyperventilation.

366 of these attempts resulted in a pain free abort prior to 30 minutes (25 minutes) for a raw efficacy of 99.7%. The average abort time for the 366 aborts was 7 minutes for cluster headaches ranging in pain levels 3 through 9 on the 10-Point Headache Pain Scale.

We included the one failed abort in the efficacy calculation in order to maintain objectivity. What happened was the CH'er went out for a walk and got hit five minutes from home and his oxygen...

When he returned home, he found his wife had gone shopping and locked all the doors. He didn't have his keys so he finally had to break a window to get to his oxygen...

By then his cluster headache had reached 10 on the 10-Point headache pain scale. He started this method of oxygen therapy and stayed with it for 30 minutes before using a StatDose injection of imitrex.

The following chart illustrates a plot of the actual abort times:

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You'll find a black and white version of this chart in the patent Michael, Royce and I submitted to the USPTO on the Demand Valve Method of aborting CH in June of 2008. This application was published in 2010 and the patent issued in March of 2012. See the following link for more details on this patent:

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As you can see in the chart above, we also used oxygen therapy at a flow rate of 15 liters/minute as an active comparator.

However, after the first pilot study participant completed collecting abort data at 15 liters/minute and started collecting data on the demand valve method of oxygen therapy, we found the dramatic reduction in abort times made possible with this new method of oxygen therapy were so significant, it made use of oxygen therapy at a flow rate of 15 liters/minute appear cruel and inhumane in comparison. Accordingly only 35 aborts were logged at a flow rate of 15 liters/minute. No other participants were asked to collect abort data at this flow rate.

Our study protocol, with abort data collected on every abort over an 8-week period, also made it possible for us to discover the direct relationship and positive correlation between time to abort and cluster headache pain level. The protocol used by Dr. Rozen, could not have discovered this phenomenon.

As you can see, higher cluster headache pain levels require longer abort times. The message here should be clear... starting oxygen therapy at the first indication of an attack will result in shorter abort times... or the longer you wait, the higher the pain level and the longer it's going to take to abort.

Even though this method of oxygen therapy requires significantly higher oxygen flow rates than traditionally prescribed, the seven participants in this pilot study averaged 25 aborts (min=19, max=30) from an M-size oxygen cylinder holding 3995 liters of oxygen.

At an average cost of $30 for an M-size oxygen cylinder refill before insurance, the average cost of oxygen consumed during each abort was $1.20.

Given the abort times between a StatDose of imitrex and the Demand Valve Method of Oxygen Therapy are not significantly different, cost per abort becomes a discriminator. Moreover, when you factor in the potential side effects from sumatriptan succinate and limitations on it's use compared to none for this method of oxygen therapy, there's a clear advantage to using oxygen therapy at flow rates that support hyperventilation as the first abortive of choice while at home, at work, or during local travel in your car.

One of the most significant findings of both pilot studies deals with the role of CO2 in cluster headache pathogenesis (triggering) and abort mechanisms. To date, there's been no mention or discussion of CO2 or its role in any scholarly paper or RTC results published on cluster headache.

In short, hyperventilating with 100% oxygen blows off CO2 faster than it's being generated by normal metabolism. This enables a very rapid and significantly greater level of vasoconstriction resulting in cluster headache abort times three to four times shorter than breathing oxygen at a flow rate of 15 liters/minute.

I'll be submitting an article with the complete findings, results and analysis of our pilot study of oxygen therapy at flow rates that support hyperventilation in the near future. Once it's published, I'll post a copy here at CH.com.

As always, I'll continue to answer questions on oxygen therapy as I have all along since joining this forum in 2006.

Take care,

V/R, Batch

« Last Edit: Feb 4^th, 2013 at 3:00am by Batch »

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Marc

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Re: Oxygen: Modified Delivery System: Advantages
Reply #5 - Feb 3^rd, 2013 at 8:39pm

Forgive me – perhaps I’m a bit slow. I’m still trying to understand the mystique of breathing through a demand valve versus breathing through a conventional valve. When I joined this site in 1999, O2 was well known as a great abortive. Linda eventually convinced me to try really high flow O2. I found that around 45 lpm, the bag on my mask kit doesn't over inflate and it didn’t go flat - it's in balance. And it works like I couldn’t believe!

Then, gradually the reports about demand valves moved from being a nifty convenience to “studies are being done to prove how much better they are.”

I understand the O2 supplier/insurance company/under-informed doctor hurdles of "too much O2 is dangerous" nonsense, but all of us already know better than that. Breathing O2 at a miniscule 15-20 lpm vs O2 being sucked fast and furiously through a demand valve? Umm ......don't need a study to answer that one. But that’s comparing apples to oranges.

Perhaps someone smarter than me, can help me understand the gains achieved by breathing the identical amount of O2 through one valve type vs. another........... Exactly what is the magic?

Marc

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Re: Oxygen: Modified Delivery System: Advantages
Reply #6 - Feb 3^rd, 2013 at 11:11pm

For me, it dramatically conserves my oxygen. I exhale, cough to clear the lungs completely, breathe in a full breath of 02, then hold it for up to 30 seconds. For people who abort like me, it conserves your 02 as a demand valve only delivers when you inhale, does nothing in between. On an E-Tank I average about 300 pounds per abort. Your mileage of course may vary! Wink

Joe

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Batch

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Re: Oxygen: Modified Delivery System: Advantages
Reply #7 - Feb 4^th, 2013 at 2:25am

Hey Marc,

You've been using oxygen therapy at flow rates that support hyperventilation all along so you're well aware how effective it can be with very short abort times.

The same goes for Joe, me, and many other CH'ers using either a demand valve, a 0-60 liter/minute InGage™ regulator from flotec or a rig like yours.

The point here is we're not your average CH'er and there are only a handful of neurologists who not only understand the benefits of this method of oxygen therapy, but also dare to prescribe it.

In publishing the results of his pilot study, Dr. Rozen has taken the first positive step in this area by alerting his fellow neurologists to the existence of a far more effective method of oxygen therapy with significantly shorter abort times...

Moreover, this method of oxygen therapy should prove effective with CH'ers who are intractable to oxygen therapy at flow rates ≤15 liters/minute.

You and I can flap our lips and quack like the Aflac duck until the cows come home about the effectiveness of the oxygen therapy method we use... and we'll never have the kind of impact Dr. Rozen is going to have on neurologists treating our disorder when they read his study results...

I suspect part of your confusion may stem from the use of the active comparator also used in Dr. Rozen's pilot study... (oxygen therapy at 15 liters/minute with an O2PTIMASK™ kit... not a demand valve)

I developed the procedures for the demand valve method of oxygen therapy as well as the training video DVDs Dr. Rozen provided to each particpant in his pilot study. His pilot study participants also received hands-on training using the demand valve method of oxygen therapy and the O2PTIMASK™. I know... because I drove up to Wilkes-Barre and spent a day training the trainers on both methods of oxygen therapy.

Each study participant had to demonstrate a level of competence with both procedures before they were sent home to abort an actual cluster headache using an oxygen flow rate of 15 liters/minute with an O2PTIMASK kit and abort a second cluster headache using the demand valve method of oxygen therapy.

I can assure you the demand valve method of oxygen therapy evaluated in Dr. Rozen's pilot study used flow rates that support hyperventilation. This procedure is equivalent to a sequence of 25 liters/minute, 40 liters/minute and 60 liters/minute for up to 30 seconds each to ensure the user reaches respiratory alkalosis with symptoms of paresthesia before lowering their respiration rate to a lung ventilation tidal flow equal to an oxygen flow rate of 40-45 liters/minute until the abort.

If your overlook the expense of an oxygen demand valve and regulator equipped with a DISS check valve fitting... which we think will be eventually covered by medical insurance if this method of oxygen therapy is included in the standards of care recommended treatments for cluster headache... the demand valve method of oxygen therapy offers several advantages.

1. As there's no oxygen flow from an oxygen demand vale until the user generates a demand by attempting to inhale, this device helps conserve oxygen... A constant flow oxygen regulator would continue to flow if you fell asleep before turning off the cylinder supply valve... It happens...

2. PCPs and Neurologists don't need to specify an oxygen flow rate if the demand valve method of oxygen therapy is prescribed.

3. Dosage is controlled by respiration rate. Accordingly, there's no need to be reaching for the regulator to change flow rates as the user huffs and puffs his or her way to an abort...

Moreover, can you imagine the explosive IBS experienced by the bureaucrats at CMS, their Oxygen DME stooge contractors, and the obamacare medical insurance bean-counting droids at the IRS upon reading an Rx for oxygen therapy calling for oxygen flow rates of 25, 40 and 60 liters/minute? That could get real ugly... lots of greenhouse gas too...

In short, we can't sell the use of constant flow regulators at flow rates of 25 to 60 liters/minute or at any flow rate in between as a standard of care CH abortive to neurologists, payers, providers and most of all to the big government bureaucrats at CMS... There's just too much build-in bias, push-back, and the all too frequent use of the word "NO" as a first response.

You need to understand that the bureaucrats and bean counters at CMS (Centers for Medicare and Medicaid Services... i.e., Big Government) have already refused coverage for oxygen therapy to Medicare beneficiaries like me suffering from cluster headache...

Moreover, when the idiot bureaucrats at CMS/HHS and mindless droid bean-counters at the IRS drive all the private medical insurance companies out of business making government provided obamacare the only payer and health care provider... you can kiss oxygen therapy with compressed oxygen as a cluster headache abortive goodby forever... They want to kill the use of LOX systems too...

In the mean time... we need to foster the notion of a better mousetrap... like use of the demand valve method of oxygen therapy as a safe, effective and economical abortive for cluster headache that works very rapidly...

We also need to speak soto voce about constant flow regulators and oxygen flow rates above 25 liters/minute... Big Government already has super computers surfing all the blogs and your email.

Even your medical records are no longer private. HHS is already badgering your healthcare provider and insurance company (payer) for electronic access to your medical records and insurance billing data...

Remember... elections have consequences...

I hope this clears up the confusion and intent. If not... I'm sure you'll let me know...

Take care,

V/R, Batch

« Last Edit: Feb 4^th, 2013 at 4:28am by Batch »

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Mike NZ

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Re: Oxygen: Modified Delivery System: Advantages
Reply #8 - Feb 4^th, 2013 at 3:22am

Thanks for the reply Joe. For my CHs they tend to go from zero to moderate / higher pain over about 30 seconds, so for my CHs there isn't a delay for the pain to build before I hit my O2, I just get on it ASAP after it starts, which is what will help with the 5 min or less aborts (plus 25lpm, the optimask and hyperventilating).

Batch, another great post packed full of info. I'm still learning!

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wimsey1

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Re: Oxygen: Modified Delivery System: Advantages
Reply #9 - Feb 5^th, 2013 at 7:58am

Marc, for me a demand flow valve works better because I don't have to worry about deflating the 3 liter bag. Regardless of when I get on the O2, my CH ramps up quickly and I breathe rapidly and deeply from the start. Even at 25lpm I empty the bag and have to wait for the next breath. Not with the demand flow valve. The O2 is there, as much as I want, as fast as I need. blessings. lance

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Marc

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Re: Oxygen: Modified Delivery System: Advantages
Reply #10 - Feb 5^th, 2013 at 8:56pm

Lance,

I fully understand the mechanics and Batch just made it clear to everyone else. Your example is why I've been saying that 25 lpm isn't high flow. I have yet to meet anyone who can deflate a 3 liter bag faster than I do. But, a simple regulator that puts out REALLY high flow will outrun even a demand valve if needed.

Pete made a point about falling asleep. As a regular visitor to the land of "real K10's" I grant that one!

Other than that, it takes virtually NO effort to adjust the flow to match my breathing rate - which varies between 20 lpm and 60 lpm with NO waste, NO deflated bag. You can't get better than that in terms of performance. (convenience, yes)

Batch: That's what I was hinting at - I get it. It's all about getting around the hurdles of the medical/insurance/political system. A study that says that "it works better" will eventually get accepted as mainstream treatment - eliminating the whole 15 lpm argument with folks who don't know better.

After spending a whole lot of hours holding a mask on other sufferers faces with welding O2 feeding a 3 liter bag: I push them with instructions to "try to empty the bag 5 times in 20-30 seconds - keep breathing the O2 at a slower rate for 15 seconds - then do the 5 super deep breaths again" - "Now do it again, but try harder and faster!" A demand valve wouldn't give them a visual target to shoot at, because they don't understand what a DEEP breath really is until later)

The look on their faces and the streaming tears become indelibly etched in your memory.

Sure, demand valves are a great convenience and they will save O2 if you fall asleep. I just don't want anyone to sufferer because "demand valves work better."

For those of us that have been there, avoiding even one minute of a true K10 is waaaay more than just important.

Marc

« Last Edit: Feb 5^th, 2013 at 9:00pm by Marc »

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Re: Oxygen: Modified Delivery System: Advantages
Reply #11 - Feb 6^th, 2013 at 5:19pm

Marc.

LOL... You and I are in violent agreement on the effectiveness and benefits of oxygen therapy at flow rates that support hyperventilation... no matter how administered.

The first point of my last post in this thread, although likely clouded by too many words, was that Dr. Rozen's published study results on the demand valve method of oxygen therapy are eventually going to make a difference in the way neurologists treat patients with our disorder.

The second, and more important point is the results of Dr. Rozen's pilot study of the demand valve method of oxygen therapy represent one of last opportunities to express its benefits as medical evidence... to the neurologists who treat us... We need them on board asap.

As such, we need to fully support this method of aborting cluster headaches... Send a copy of the abstract to your neurologist.

To give you an idea what we, as cluster headache sufferers, are up against from the likes of big government bureaucrats... read the following ruling from CMS (Centers for Medicare and Medicaid Services) when challenged by the leadership of the American Headache Society to overturn their non-coverage ruling on oxygen therapy as an abortive for Medicare beneficiaries suffering from cluster headache...

Their decision, refusing coverage for the home use of oxygen therapy as a cluster headache abortive follows:

"CMS has determined that the evidence does not demonstrate that the home use of oxygen to treat cluster headache improves health outcomes in Medicare beneficiaries with cluster headache (CH). Therefore, we determine that home use of oxygen to treat CH is not reasonable and necessary under §1862(a)(1)(A) of the Social Security Act (the Act)."

Read the following link and weep:

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;

You must understand the people who made this finding are big government bureaucrats and bean counters, not practicing physicians.

They know nothing about clinical medicine, but are determined, as representatives of the ruling class uber liberal politicians in the politburo, to deny you insurance coverage for oxygen as a cluster headache abortive... a gas that comprises 20% of our atmosphere.

Now let me show you a most expertly worded and passionate reclama to CMS to reconsider its decision on this most egregious and absurd finding that's devoid of any real medical evidence... It's a long read, but worth your time...

It was made by Dr. David Dodick, President, American Headache Society...

"November 7, 2010

Louis Jacques, MD
Director, Coverage and Analysis Group
Center for Medicare Management
7500 Security Boulevard
Mail Stop S3-02-01
Baltimore, MD 21244

Re: Home Oxygen Therapy for Cluster Headache

Comments on Proposed Decision Memo
CAG-00296R

The American Headache Society strongly opposes CMS’s proposed decision of October 8, 2010 which would limit Medicare coverage for home oxygen to cluster headache patients enrolled in future clinical trials.

We urge CMS to reconsider this decision, and we reassert our unequivocal position that oxygen therapy is both indicated and necessary for many cluster headache sufferers.

Indeed, it is the only available therapy appropriate for most Medicare patients suffering from this dreaded condition.

The proposed decision turns the concept of “evidence-based medicine” on its head, producing a result that denies relief to patients in the most compelling circumstances:

• It discounts the unequivocal findings of prior studies on the grounds of methodological imperfections, making hopes for “better” evidence the clear enemy of “good” and sufficient evidence.

• It discounts more than 40 years of successful use in clinical practice. To characterize that experience as merely “promising” totally ignores the enormous benefit this therapy has afforded to innumerable patients. And it ignores the fact that the evidence supporting most other items and services routinely covered by CMS is also based on successful clinical practice, not randomized trials.

• It ignores the fact that oxygen is the standard of care for these patients and is taught as such in every medical textbook and peer-reviewed publication on the subject of cluster headache treatment.

For physicians to withhold this therapy, absent contraindications in a particular
patient, would likely be construed by many as unethical, and perhaps by others as actionable.

• It introduces a classic “red herring” by suggesting that there are safety issues with oxygen requiring further research in the elderly population. Of course oxygen will be contra-indicated for some elderly patients. That goes without saying and is equally true of countless pharmacological and other therapies for which Medicare provides undisputed national coverage, while relying on the clinical judgment of practitioners to withhold those services where they are medically contraindicated.

An appropriate penicillin antibiotic may not be given to a patient with a penicillin allergy, and beta blockers are not appropriate for severely hypotensive, bradycardic, or asthmatic patients.

Similarly, oxygen therapy would not be appropriate for a patient with severe obstructive pulmonary disease or related pulmonary ailments, but is nonetheless effective and necessary in the larger group of elderly patients with cluster headache, those without contraindication to oxygen.

These clinical judgments are made by headache specialists every day with respect to a wide range of therapies used in both elderly and non-elderly populations.

• Contrary to CMS’s assertion that it has used the earlier public comments to “inform” its decision, it appears that the Agency has totally ignored those comments which were uniformly supportive of broad coverage.

• Contrary to the assertion that CMS has not received any “expert opinions” (other than the public comments, which it has ignored), and with all due modesty, the American Headache Society represents the established experts in this field of care.

That expertise informed our initial request for a national coverage policy, and that expertise has been made readily available to the Agency.

We urge CMS to reconsider its proposed decision in light of what we believe is virtually unanimous expert opinion in favor of broad coverage.

At least as troubling as the factors noted above, if not more so, is the fact that the path forward suggested in the proposed decision memo is a veritable blind alley. CMS proposes further research comparing NBOT with a “clinically appropriate comparator.” Such research in the elderly population is unacceptable for both practical and ethical reasons.

• To perform a study with greater, or exclusive, involvement of the elderly population that uses an active comparator against oxygen requires the use of a constricting drug, such as a triptan or an ergot derivative, as the only possibly effective comparator. These drugs are generally contraindicated in the elderly.

Indeed, package inserts on leading brands indicate that these drugs are not recommended for the elderly. See for example this statement with respect to Imitrex by injection, taken from the manufacturer’s Prescribing Information:

“Geriatric Use: The use of sumatriptan in elderly patients is not recommended because elderly patients are more likely to have decreased hepatic function, they are at higher risk for CAD, and blood pressure increases may be more pronounced in the elderly (see WARNINGS: Risk of Myocardial Ischemia and/or Infarction and other Adverse Cardiac Events).”

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(page 14). (Emphasis added)

To design a new study around these drugs would thus impose an unethical, and thus unacceptable, cardiovascular and cerebrovascular risk on Medicare patients willing to participate in the research project.

Indeed, with appropriate disclosure of these risks, it seems unlikely that patients would be willing to participate.

CMS’s decision to cover oxygen therapy only for Medicare patients enrolled in a clinical trial compounds the ethical problem, since those who might enroll despite the risks of randomization might well be doing so only in the desperate hope to gain access to a treatment that CMS otherwise denies them.

Alternatively, so many potential trial participants would need to be barred from the study that any study results would be applicable only to a pre-selected group of low risk Medicare patients, and by design, would not be generalizable to the Medicare patient population at large.

• To do a study with a greater enrollment of the elderly population using oxygen vs. a placebo is also ethically unacceptable. Randomization to placebo is generally considered ethical only in cases where there is no known effective treatment or standard of care. Otherwise, patients would be denied treatment for a treatable condition, with the attendant risks and suffering, for the sake of research unlikely to meet the high burden of proof needed to change practice.

Since strong evidence already exists to support the use of oxygen therapy, and randomization to placebo would leave extremely painful attacks untreated, a research trial against placebo is unethical and unacceptable.

• Clinicians have few treatments to abort a cluster headache in any population, and of the few we have, the only one that is largely safe and largely effective in the elderly population is oxygen.

To demand more and “better” studies in these circumstances smacks of comparative effectiveness research at the expense of the most vulnerable of patients. The most likely outcome of such a course is that no study will be done, or will be deferred for many years.

Meanwhile, patients needlessly suffer despite the availability of an eminently “reasonable” and for these patients clearly “necessary” therapy.

To summarize, and with all due respect to your staff, the proposed decision gives clinicians and researchers no option that seems ethically sound or reasonably practical. There is strong evidence to support the administration of oxygen to elderly patients with cluster headache, and it represents the only feasible treatment to relieve this severely painful condition for most Medicare patients. It would be limited to use in patients without contraindication to oxygen, and it has been the treatment of choice for over 40 years by experts in this condition.

We see no reasonable basis for denying coverage.

Respectfully submitted,
David W. Dodick, MD
President
American Headache Society"

CMS blew off the logic in this well-written reclama and made the non-coverage determination anyway... As a result, we medicare beneficiaries, have no coverage for oxygen therapy to stop the pain of our cluster headache disorder.

If a prestigious medical organization like AHS is unsuccessful in arguing these big government bureaucrats out of a stupid coverage determination... what can we as individuals do?

In case you haven't connected the dots by now, or realize where all this is leading... here's a clue... It's not good and you're not going to like it...

Obamacare is the law of the land. By it's intended design, it will drive private medical insurance companies out of business.

When this happens... and it will... by law, big government will become the only medical insurer.

At that point wage earning families will pay $20,000 a year (the latest CBO and IRS estimate) for this mandatory medical insurance... or pay a fine... If they don't, one of the 1,600 new IRS agents hired to enforce obamacare will not come to see them, but he will wipe out checking and savings accounts and put a lien against anything of value... like homes, autos...

As if that's not bad enough... Big government droid bureaucrats already have a big panel evaluating the cost effectiveness of all prescribed medications to improve health outcome. They want all your health records and that of your healthcare provider to see what's being prescribed and for what.

This big panel is called the Federal Coordinating Council for Comparative Clinical Effectiveness Research. It's mission is to set policy that will eventually decide who will be treated for what, with what, and on what basis.

This council and the big computers needed to crunch all the health record names and numbers were funded by the $900 Billion Dollar Stimulus a.k.a. Porkulus legislation passed into public law in 2009.

Connecting the last dot...

As the cluster headache disorder has no known cure... by their logic, the big government bureaucrats will consider imitrex and DHE only provide symptomatic relief and therefore cannot improve the health outcome... so they will not cover their expense. If you want these medications... you'll need to pay for them out of pocket.

Elections have consequences... You decide.

Take care,

V/R, Batch

« Last Edit: Feb 6^th, 2013 at 5:26pm by Batch »

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