A life changing treatment is out of reach for MS patient

A life changing treatment is out of reach for MS patient


Patient denied insurance coverage

Thomas James, WUSA 1:05 p.m. EDT July 24, 2014

In this case, Jennifer’s insurance company informed the doctors right before the operation, that they would not pay for the DBS because it was brought on by MS, leaving Jennifer to struggle with the tremors.


WINCHESTER, Va. (WUSA9) — 30 year-old Jennifer Crane sits patiently in her doctor’s office waiting for an exam. She seems rather relaxed as her doctor entered the room. He asks her to hold out her hands, as he grabs her hands, they shake. He asks her to use her arm to push his forearm, she has to exert her whole body to do so. She cannot hold a pen, and her legs are so stiff she can barely walk.

Jennifer has Multiple Sclerosis, but unlike many MS patients, she doesn’t have a lot of pain. Her main symptom is tremors, those tremors keep her from doing most things that come easy to all of us. They also cause her to be homebound, she had to leave her job with FEMA and as a paramedic.

Crane says, “My eyes shake, because I have tremors and I shake so much my eyes actually shake so sometimes watching TV, it’s like the TV is going like this (she moves her finger up and down) and that kinda gives me headaches.

She met Dr. Mark Landrio of Neurologic Associates in Winchester, VA. He recommended a procedure called Deep Brain Stimulation, or DBS to stop the tremors.

Dr. Landrio says, “That would allow her to feed herself, to dress herself better, to be able to walk more steady without tremor in her legs.”

Its a procedure in which electrodes are placed inside the brain and connected to a pacemaker. This sends electrical pulses to the brain that block what causes the tremors.

Dr. Landrio says, “It’s been approved by the FDA all the way back to the late 1990s for the essential tremor and early 2000s for parkinson’s disease. It’s also used for mood disorders and obsessive compulsive disorder, so hardly a new therapy. It’s been shown to work in tremors for quite some time. It hasn’t been studied in MS proper, but not all MS patients have tremors as dramatic as Jennifer’s. But the underlying cause is not dis-similar.”

Dr. Landrio believes Jennifer is a good candidate for DBS, But since the tremors are caused by MS that became an issue with her insurance provider.

Sometimes insurance carriers will not pay for a procedure if there aren’t enough formal long-term studies to show it’s medcially necessary or effective.
In this case, Jennifer’s insurance company informed the doctors right before the operation, that they would not pay for the DBS because it was brought on by MS, leaving Jennifer to struggle with the tremors.

But in a statement from America’s Health Insurance Plans, an organization that represents insurance companies, they say “health plans want to make sure patients get the care they need. Coverage decisions are based on medical evidence about patient safety and effectiveness of treatments.

We also spoke to Jennifer’s medical provider and they reiterated the same, saying “clinical (health) outcomes with this technology have not been shown to produce results at least equivalent to other approaches.”

Dr. Landrio says, “Given the current environment with insurance companies it didn’t entirely surprise me. But given the severity of the tremor that perturbed me some. So oftentimes it makes it quite difficult to get the right treatment for the patient.

For now, Jennifer and her mother Brenda say they will appeal the decision. Out of pocket, the DBS procedure would cost them $150,000.

When asked if they can afford the procedure, Jennifer replied, “No, there is no way either me, my mom, no, there is no way.”

The Crane family will appeal the decision by their insurance company.


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Should the Cyberonics VNS Implant Device be Recalled by the FDA?

Should the Cyberonics VNS Implant Device be Recalled by the FDA?

Chad Points

by Chad Points cdp@denenapoints.com


Board Certified Personal Injury Trial Lawyer, One of Founding Partners, Denena & Points, PC

Comments (0)

The Houston medical implant injury lawyers at Denena and Points believe that a look at the available literature on the device would probably lead you to say, “Yes.” Actually, your look at the data would more likely lead you to wonder why the device was ever approved at all.

The Cyberonics Vagus Nerve Stimulator (VNS) device is a surgically-implanted apparatus comprising a generator and wires ending in leads coiled around the Vagus nerve in the throat. The device generates periodic electrical pulses to stimulate the nerve. The frequency of the pulses can be adjusted using a computer.

The original purpose of the device was to provide treatment for patients with epileptic seizures that had not responded to other forms of therapy. Cyberonics itself warned against implanting the device in patients less than 12 years of age, but “off label” implants in these younger patients are apparently common. However, when complications, injuries, or deaths occur in these young patients receiving off-label implantation of the VNS device, the adverse effect gets chalked up to user error.

Our Houston medical implant injury lawyers emphasize that any surgical implantation procedure involves risk. The VNS device, due to its implantation in the throat near the carotid artery and jugular vein and the main juncture of the body’s central nervous system into the brain, entails especially high risks. And complications involving nerve damage, vascular damage, and damage to the larynx have been frequently reported.

Furthermore, many physicians say the device is useless, perhaps even actively harmful, and there is insufficient data to indicate that it’s effective for its intended uses. Significantly, Medicaid/Medicare consistently refuses to pay for VNS implant procedures, and insurers generally are reluctant to foot the massive bill for a device that has not been proven effective and is linked to thousands of injuries and deaths.

The federal MAUDE database, a data aggregation system for reporting adverse events linked to medical devices, shows more than 10,000 deaths, injuries, and malfunctions linked to Cyberonics’ VNS device. Many of those reports are vague, making it hard to pin down the precise cause of death or injury. And many of the deaths are classified as SUDEP, sudden, unexplained death in epilepsy. Between May and December 2004 alone, 500 adverse events occurred. And the year 2002 lists 1,414 adverse events.

Cyberonics’ own website details the high risks from malfunctions of the implant. “Device malfunction could cause painful stimulation or direct current stimulation. Either event could cause nerve damage. Patients should be instructed to use the Magnet to stop stimulation if they suspect a malfunction, and then to contact their physician immediately for further evaluation.” Other possible adverse effects include vascular damage, onset of sleep apnea, damage to the larynx, increased frequency of seizures, and SUDEP. Are any of these possible effects worth the risk for a device that has not been proven effective? Studies conducted by Cyberonics that show a reduction in seizure frequency generally indicate that real reductions only kick in after two or three years of using the device. And our Houston medical implant injury lawyers point out that some studies show little difference in seizure frequency compared to patients receiving other, or no, treatments. Continue to Part 2 to learn about the dangerous effects of the VNS device when used on patients with TRD, treatment-resistant depression.



Ongoing Problems with Cyberonics Implantable Vagus Nerve Stimulator

Tony Denena

by Tony Denena amd@denenapoints.com


Board Certified Personal Injury Trial Lawyer, One of Founding Partners, Denena & Points, PC

Comments (0)

Continued from Part 1. The Houston medical device injury attorneys at Denena and Points report that the FDA’s own teams of scientists recommended against approving Cyberonics’ VNS device to treat depression. Yet Cyberonics won that approval in a way that resulted in Congressional scrutiny, and its website still lists instructions and warnings regarding implantation of the device into depression patients. That open description of potentially dangerous use of the product to treat TRD could be construed by patients desperate for relief as evidence that the device is effective for such treatment.

Yet medical literature provides case studies linking implantation of the VNS device to the onset of or worsening of psychosis in patients. In effect, treatable depression becomes dangerous psychosis requiring institutional confinement.

FDA approval of the device for such use was somewhat irregular, if not downright shady. The VNS device received its initial approval for use in treatment-resistant epilepsy patients in 1997. Dr. Daniel Schultz, then in charge of the FDA approval process, personally signed off on the approval of Cyberonics’ VNS device for use in TRD (treatment-resistant depression) after an entire FDA panel of physicians, managers, and scientists recommended against the approval. Our Houston medical device injury attorneys note that Schultz later resigned from the FDA by mutual consent with the FDA Commissioner.

Even while Dr. Schultz was going against the FDA panel to approve the device, reports of injuries, deaths, and malfunctions linked to it were mounting. And the FDA itself, perhaps in an example of the left hand not knowing what the right hand was up to, saddled Cyberonics with one of its serious warning letters, often the prelude to a recall. But a true recall has yet to emerge against the VNS device. The letter contained more than 30 serious allegations against Cyberonics and its VNS device. Cyberonics addressed the issues over the course of many months, getting the FDA to close the file on the warning shortly before Dr. Schultz issued his approval.

The FDA panel of scientists, physicians and managers had taken more than a year, 15 months actually, in reviewing Cyberonics’ application to use the Vagus Nerve Stimulator to treat depression. The reviewers found that the company simply didn’t have enough data to support such use of the device. And what data there was did not support the thesis that the device was effective against TRD. One reviewer wrote that approving the application would be like “approving an experimental product.” Our Houston medical device injury attorneys emphasize that the FDA teams repeatedly recommended against approving the device for use in TRD patients, yet those recommendations repeatedly got overridden by FDA officials.

Further adverse events resulted in another FDA warning letter to the company, as well as the Senate investigation relating to safety, efficacy, and the startlingly irregular approval process, as well as a false claims lawsuit. But the product still has not been recalled from the market. After a Class II recall in 2011, the FDA approved a “redesign” that put the VNS device back in play. We note that aClass II recall only suggests a minor danger, despite the ongoing reports of injuries and deaths linked to the product. It is a Class I recall that alerts the public to the danger of death and serious injury. And a Class I recall would seem more appropriate for the Cyberonics VNS device given the more than 10,000 adverse event reports linked to its implantation.

The Houston medical device injury attorneys at Denena and Points wonder just how many more deaths, injuries, and malfunctions will be needed before safety regulators, responsible for ensuring the public’s health and safety recognize the dangers posed by this device and remove it from the marketplace. Click the link to read about the 2011 Cyberonics Class II recall.



Class 2 Device Recall VNS Therapy Aspire HC Generator and VNS

Class 2 Recall
VNS Therapy Aspire HC Generator and VNS

Date Posted
November 18, 2011

Recall Status1
Terminated on August 20, 2012

Recall Number

Recall Event ID

Premarket Approval
PMA Number

Product Classification
Stimulator, Autonomic Nerve, Implanted For EpilepsyProduct Code LYJ

VNS Therapy Aspire HC Generator and VNS, Model 105 Cyberonics, Inc. 100 Cyberonics Blvd., Houston, TX 77058 For implantation in humans to treat Epilepsy and Depression.

Code Information
Model 105, VNS Therapy AspireHC Generator

Recalling Firm/
Cyberonics, Inc
100 Cyberonics Blvd
Houston, Texas 77058-2069

For Additional Information Contact
Brian Olin, Ph.D.
281-228-7323 Ext. 223

Manufacturer Reason
for Recall
The devices are being recalled because the output current delivered to the vagus nerve is less than the design intent and there is a potential charge imbalance at the lead cathode and generator-can during stimulation.

FDA Determined
Cause 2

Cyberonics sent a Field Safety Alert on August 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The firm decided to recall and initiated contact with implanting facilities in the United States on 08/15/2011. A Field Safety Alert was delivered on 09/19/2011 to implanting facilities. Customers were instructed not to prescribe AspireHC pulse generators for implant until Cyberonics resumes shipment of AspireHC pulse generators that have the issue remedied. Cyberonics recommends that physicians continue their current practice of titrating programming parameters for patients implanted with an AspireHC pulse generator to achieve appropriate clinical outcomes, paying particular attention to report of: Lack or loss of efficacy Pain, inflammation, swelling/edema in the neck area; and/or Patient perception of stimulation or muscle twitching in the area surrounding the implant. Cyberonics recommended routine systems diagnostic testing to aid in device and patient monitoring. Physicians may contact Clinical Technical Support at 866-882-8804 or via email at clinicaltechnicalservices@cyberonics.com. For questions regarding this recall call 281-228-7323.

Quantity in Commerce
340 units

Worldwide Distribution – USA including TN, TX, IL, OH, FL, CA, CO, OR, AZ, NY, PA, MO, NJ, WI, OK, MI, ID, KY, IA, MA, NE, GA, LA, NY, and Norway.

Total Product Life Cycle
TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.

PMA Database
PMAs with Product Code = LYJ and Applicant = CYBERONICS, INC.

Page Last Updated: 07/24/2014

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U.S. Food and Drug Administration

10903 New Hampshire Avenue
Silver Spring, MD 20993
Ph. 1-888-INFO-FDA (1-888-463-6332)
Email FDA





Dear Messieurs Chad and Denena,

It is only just recently that I came upon your essays relating to VNS Therapy to which I would like to take this opportunity to briefly comment and respond to distortions.

By way of background I am a very long-time support person and health care advocate/activist of more than 50 years to my spouse who formerly suffered for some 36 years with MDD (Major Depressive Disorder) with 9 suicide attempts notched in her medical history. I am also a former board member, president and facilitator of a local chapter of DBSA and a Florida State appointment as a Guardian Advocate.

The first point I would like to address is your statement and seeming confusion:

“Furthermore, many physicians say the device is useless, perhaps even actively harmful, and there is insufficient data to indicate that it’s effective for its intended uses. Significantly, Medicaid/Medicare consistently refuses to pay for VNS implant procedures, and insurers generally are reluctant to foot the massive bill for a device that has not been proven effective and is linked to thousands of injuries and deaths.”

Contrary to your statements and misunderstandings, from my research and readings, I find physicians and more current study results both for epilepsy and depression acknowledging the benefits and safety of the therapy for some of the most difficult to treat patients. Apparently you are confusing Medicaid/Medicare payment policies when applied to depression as to those for epilepsy patients. Epilepsy patients are receiving medical health insurance coverage.

On the other hand in a decision rendered May 4, 2007 CMS (Centers for Medicare and Medicaid Services) has denied health insurance coverage for the depression indication and the private insurers followed suit. Thereby and for the first time placing a group of patients with implanted medical devices in a “Catch-22” with health insurance but being denied the coverage.

In a more recent decision of June 3, 2014, U.S. Administrative Law Judge, Troy Smith has ruled that a depression patient implanted prior to the May 4, 2007 CMS decision is entitled to Medicare/Medicaid health insurance coverage:


Which in my opinion this decision should then set precedence for all the volunteer study subjects and depression patients implanted prior to the May 4, 2007 decision wanting to continue the therapy that may need legal assistance especially when confronting the private insurance carriers as well as Medicare/Medicaid.

I shall also point out to you through my efforts and advocacy CMS has agreed and arranged an informal procedure and staff to help the Medicare/Medicaid depression patients obtain care and replacement coverage.


Furthermore I can easily debate with you and shoot holes in many of your premises and statements but my efforts are more importantly directed to helping my spouse and others maintain wellness and long-term stability contrary to your presentation. My spouse has been almost continuously depression free for the past 14 years which I and her physician attribute to VNS Therapy.

Where you folks as a law firm can be beneficial and possibly obtain cases is helping to represent those study subjects and depression patients who were negligently, egregiously, immorally and stupidly etc. denied care and replacement by not being grandfathered into the 2007 thereby placing them in a “Catch-22” situation and who wish to continue the therapy and are still trying to obtain coverage from their existing health insurance carriers.

Should you have any interest in possible referrals or would care to discuss this matter further, please contact me.



Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733




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Low field magnetic stimulation may offer immediate relief for patients with depression


Low field magnetic stimulation may offer immediate relief for patients with depression

By Tina Shah, Tech Times | July 23, 1:01 PM


Van Gogh depicts depression

Researchers at Harvard Medical School and Weill Cornell Medical College discovered that a single treatment of low field magnetic stimulation produced mood-elevating effects in depressed patients.
(Photo : Vincent Van Gogh (Wikipedia Commons))

Depression affects every part of a person’s life-how he or she thinks, behaves, interacts with other people-and the diagnosis of clinical depression can sometimes require long-term treatment. Combinations of medication and counseling can often help a person through the disorder.

Other treatment options include electroconvulsive therapy (ECT) and transcranial magnetic stimulation (TMS). ECT sends electrical currents through the brain and TMS sends magnetic pulses to the nerve cells that regulate mood and depression.

However, these treatments often take weeks to produce a full response. Researchers have been searching for a way to immediately produce mood-elevating effects. It seems that a lucky accident may have led researchers at Harvard Medical School and Weill Cornell Medical College to an answer.

The researchers found that low field magnetic stimulation (LFMS) produces the desired effects.

The researchers, led by Dr. Michael Rohan, were conducting an imaging study of healthy participants when they found some of the parameters that seem to induce the response of antidepressants. They went ahead and made an LFMS device that would send low strength, high frequency electromagnetic waves to the brain and tested it on depressed patients.  According to Rohan, LFMS uses only a fraction of the strength of the magnetic fields in TMS and ECT but produces a higher frequency.

63 depressed patients were given the LFMS treatment. In a randomized order, some patients were given a real treatment and some were given a fake in which the electromagnetic fields were deactivated.

“An immediate and substantial improvement in mood was observed in the patients who received real LFMS, compared to those who received the sham treatment. There were no reported side effects,” said a statement.

The results show that this method, as well as the designed device for delivering it, might be effective in helping depressive patients find relief immediately, such as in emergency situations.

The study was published in the journal Biological Psychiatry. The editor of the journal, Dr. John Krystal, explains that the finding that weak electrical stimulation can alleviate depressive symptoms is quite surprising, but the case that Rohan and colleagues make is “compelling” and should be further studied.

Rohan’s study only administered a single LFMS-treatment to patients, so additional studies are already underway to determine the effects of multiple treatments. Other aspects of the treatment that will soon be researched include how long lasting the effects of the treatment are, and what other parameters produce the best LFMS response.


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Study: Trying harder makes it more difficult to learn language

Study: Trying harder makes it more difficult to learn language

Tuesday, 22 July 2014

When it comes to learning languages, adults and children have different strengths. Adults excel at absorbing the vocabulary needed to navigate a grocery store or order food in a restaurant, but children have an uncanny ability to pick up on subtle nuances of language that often elude adults. Within months of living in a foreign country, a young child may speak a second language like a native speaker.

Brain structure plays an important role in this “sensitive period” for learning language, which is believed to end around adolescence. The young brain is equipped with neural circuits that can analyze sounds and build a coherent set of rules for constructing words and sentences out of those sounds. Once these language structures are established, it’s difficult to build another one for a new language.

In a new study, a team of neuroscientists and psychologists led by Amy Finn, a postdoc at MIT’s McGovern Institute for Brain Research, has found evidence for another factor that contributes to adults’ language difficulties: When learning certain elements of language, adults’ more highly developed cognitive skills actually get in the way. The researchers discovered that the harder adults tried to learn an artificial language, the worse they were at deciphering the language’s morphology — the structure and deployment of linguistic units such as root words, suffixes, and prefixes.

“We found that effort helps you in most situations, for things like figuring out what the units of language that you need to know are, and basic ordering of elements. But when trying to learn morphology, at least in this artificial language we created, it’s actually worse when you try,” Finn says.

The findings support a theory of language acquisition that suggests that some parts of language are learned through procedural memory, while others are learned through declarative memory. Under this theory, declarative memory, which stores knowledge and facts, would be more useful for learning vocabulary and certain rules of grammar. Procedural memory, which guides tasks we perform without conscious awareness of how we learned them, would be more useful for learning subtle rules related to language morphology.

“It’s likely to be the procedural memory system that’s really important for learning these difficult morphological aspects of language. In fact, when you use the declarative memory system, it doesn’t help you, it harms you,” Finn says.

Still unresolved is the question of whether adults can overcome this language-learning obstacle. Finn says she does not have a good answer yet but she is now testing the effects of “turning off” the adult prefrontal cortex using a technique called transcranial magnetic stimulation. Other interventions she plans to study include distracting the prefrontal cortex by forcing it to perform other tasks while language is heard, and treating subjects with drugs that impair activity in that brain region.


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Migraine treatment innovations still have ways to go

Migraine treatment innovations still have ways to go

Stephanie M. Lee
Published 3:02 pm, Saturday, July 19, 2014


Dr. Robert Cowan, head of the Stanford Headache Clinic helps migraine patient Nancy Mikhael, who is getting three rounds of Botox injections as part of her treatment. Photo: Leah Millis, The Chronicle

Dr. Robert Cowan, head of the Stanford Headache Clinic helps migraine patient Nancy Mikhael, who is getting three rounds of Botox injections as part of her treatment. Photo: Leah Millis, The Chronicle

Dr. Robert Cowan, head of the Stanford Headache Clinic, administers a Botox injection to migraine patient Nancy Mikhael, 31, of San Jose. Photo: Leah Millis, The Chronicle

Dr. Robert Cowan, head of the Stanford Headache Clinic, administers a Botox injection to migraine patient Nancy Mikhael, 31, of San Jose. Photo: Leah Millis, The Chronicle


Few sensations are as grating as a head-splitting, nausea-inducing migraine that just won’t disappear.

When aspirin and Advil aren’t strong enough, patients often turn to the class of drugs called triptans, the prescription medicine DHE or even opioids. But these treatments do not work well in everyone and may have dangerous side effects.

So biotechnology companies, including one in San Mateo, are developing alternatives in an attempt to treat some of the 36 million Americans who suffer migraines. Also on the market are two head devices that use magnets or electricity, one of them developed at facilities in Sunnyvale.

The migraine market in developed countries will grow to nearly $5.4 billion in 2022, predicts the Decision Resources Group. “The unmet need is pretty strong,” said Bethany Kiernan, a senior director for the health care market analysis firm. “Having a therapy that can either work to a greater extent in a larger percentage of the population, or that can better serve those patients that are currently underserved, has a real advantage in this market.”

Universal relief may be a long way off, however. This month, a panel of California clinicians voiced support for Botox, the wrinkle-smoothing shots that are also approved to treat chronic migraines, defined as severe headaches at least 15 times per month.

At the same time, the doctors were skeptical about the two new head devices.

“These are all promising things, but we still know so little about what’s actually going on,” said Dr. Robert Cowan, director of Stanford University‘s Headache Clinic. “How come two different people get hit in the head the same way, one of them gets a lump in the head that goes away in few days or a week, and the other gets chronic headaches that never go away for the rest of their life?”

Seeking cause

Scientists are still trying to understand the exact causes of migraines. Labrys Biologics in San Mateo has been developing a drug that tries to prevent chronic and episodic headaches by binding a protein to a neuropeptide thought to play a role in migraines. In June, Israeli drug giant Teva Pharmaceutical Industries said it would acquire the company for up to $825 million.

But the field has seen some high-profile flops. Last year, Allergan spent nearly $1 billion to acquire a new, inhalable migraine drug, only for the Food and Drug Administration to reject it out of safety concerns.

Allergan also owns Botox. In 2010, the cosmetic injections won approval to treat adults with chronic migraines. Current therapy recommendations call for injections every three months.

Compared to no treatment at all, Botox seems to have small benefits in some patients, the California Technology Assessment Forum agreed this month. The panel of physicians reviews medical issues three times a year.

The group was not as convinced of the merits of SpringTMS, a handheld device that delivers a brief pulse of energy, or transcranial magnetic stimulation, to the back of the head. It is supposed to generate magnetic fields that interrupt abnormal electrical activity associated with migraines.

The device won federal approval in May and is made by eNeura Therapeutics, whose headquarters are in Baltimore and whose research and development facilities are in Sunnyvale. CEO David Rosen said the product may appeal to the estimated 10 to 15 percent of migraine patients who are not eligible for drugs or other treatments.

“It would make sense for a specialist to consider use of the device and prescribe use of the device for patients who don’t have any other treatment option,” he said. “What are you going to do for these people besides say, ‘I don’t have a treatment option for you?’ ”

But the panel decided there was inconclusive evidence to demonstrate the SpringTMS was better than standard treatments. Patients in one study reported some relief after using the device, but other measures, such as whether patients became less sensitive to light and sound, did not significantly differ from the placebo users.

“There really was no difference between the device and a sham stimulator,” said Dr. Rita Redberg, a cardiologist at UCSF, who sided with the majority of the panel. It was “just putting something on your head and thinking you were being treated for migraines.”

The panel was similarly skeptical of Cefaly, a $449 headband designed to deliver electrical impulses to nerves that transmit migraine pain. Approved in March, it is supposed to be worn for 20 minutes each day to reduce the frequency of migraines – but the panel found the supporting evidence inconclusive.

Few options

At the same time, the group acknowledged that many patients lack viable options. The popular migraine drugs known as triptans, for example, temporarily narrow blood vessels, an effect that makes them off-limits for people with coronary artery disease and other vascular conditions.

Frustrated patients often seek out opioids in the emergency room, but opioids can be dangerous. In a year, the panel estimated, 20,000 patients in California develop chronic migraines because of opioid overuse, and 3,000 become addicted. So the demand for safe and effective alternatives is urgent.

“Headache care is 50 years behind things like diabetes and cancer,” said Cowan, the Stanford doctor, who was an adviser to the panel. “It just hasn’t had the attention, hasn’t had the funding, in order to get to the answers we need.”

Stephanie M. Lee is a San Francisco Chronicle staff writer. E-mail: slee@sfchronicle.comTwitter: @stephaniemlee


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"Compassionate Use" for VNS Therapy Depression Patients…

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Friday, July 11, 2014 2:02 PM
To: Madam Secretary Sylvia Matthews Burwell, United States Secretary of Health and Human Services
Subject: “Compassionate Use” for VNS Therapy Depression Patients…

Dear Madam Secretary Burwell,


Do you happen to know what kind of cake this is?  If by chance you don’t it is a Seven Layer Cake somewhat reminiscent of the bureaucracy I’ve encountered these past seven years since one of the agency’s, CMS now under your stewardship, through their ignorance, intellectual arrogance, stupidity or downright forgetfulness denied medical insurance coverage to volunteer study subjects and patients implanted with a medical prosthesis after the FDA approved the device, another agency now under your stewardship.

Pick the appropriate word for what the brain-trust at CMS committed; immoral, egregious, unconscionable, unfathomable, half-assed, incomplete, thoughtless, negligent, criminal and/or plain stupid.

One or all terms might be apropos but what we have after 7 years since the decision to deny was rendered is additional negligence and the seven layer cake.  This negligence and layers of bureaucracy could quickly and simply be remedied by the stroke of your pen.  A document issued and signed by you for “Compassionate Use” eliminates the current band-aide attempt to remedy what should have been considered and included in the decision of May 4, 2007.

You might be too young to know of the sign on former President Harry Truman’s desk read, “The Buck Stops Here.”  Isn’t it time for the same? 

I shall quote your message to me, once again:

“Thank you very much for your e-mail.  Our ability to deliver impact depends on your input.  I very much appreciate that you’ve taken the time to write, and will be sure to share your message with the most appropriate member of my team for review. 

This Department belongs to the American people, and what you have to say matters to all of us.   As we advance our mission of providing Americans with the building blocks of healthy and productive lives, we never lose site of the fact that ultimately, you are “the boss” – and everything we do is on behalf of everyday Americans who work hard, take responsibility and rely upon the outcomes and services this Department provides.

To deliver impact and move our mission forward, we are guided by three central tenets: delivering results for the American people on a wide range of important issues; strengthening the relationships that drive progress; and building strong teams with the talent and focus that our challenges call for, and our fellow Americans deserve.

Working together, we can strengthen the foundation of a stronger middle class, a more prosperous economy, and healthier communities.

Thank you again for your message.

Sylvia Burwell


I hope your message was truly meaningful of your sincere thoughts and not simply public relations speak.  You are “the boss” of your agencies.  After 7 years of inexcusable inaction exercise your executive authority and make the decision to do the right thing for this small American group of patients.  Don’t waste time by sharing my “message with the most appropriate member of my team for review” as you stated.  Instead take action and stop fostering the “Seven Layer Cake Syndrome”. 

U.S. Administrative Law Judge Troy Smith saw the injustice by ruling for one patient.  Now you too can remedy the issue for all these patients.  Take action!

Sign the document now for “Compassionate Use” and give these Americans “the building blocks of healthy and productive lives” that you are espousing.



Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733







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Important information…

From: Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Tuesday, July 08, 2014 10:59 PM
Subject: Important Information…

To the VNS patients and their attending physicians,

1:00 PM today I participated in a teleconference with CMS.  The discussion I was told is “off-the-record” although I could share one particular very important piece of information and then I’ll share my thoughts and opinions of the teleconference.

As you already know Kathleen Sebelius and Jonathan Blum had resigned their positions with their respective agencies.  Ms. Amy Larrick has been moved to a higher position within CMS and will no longer be the contact person at CMS for the VNS patients so please delete any information pertaining to Amy Larrick.

The first step to obtaining replacement is described in my posting link entitled:

Expediting the VNS replacement surgery for the depression patient.

Kindly substitute Courtney Turner’s name anywhere you read “Amy Larrick”.  Should one encounter any obstacles then read the below listed information.

The new contact at CMS, so please mark your records accordingly, for any VNS patients for Depression initially implanted prior to May 4, 2007 is:

Ms. Courtney Turner

Telephone: 410-786-4593  

Any implanted depression patient needing assistance must be prepared to supply the following information when contacting Ms. Courtney Turner:

One’s Full Name  

Telephone number

State of residence

Be prepared to share any other pertinent information relating to one’s case, if requested.


I have been advised that Ms. Turner will make every effort to expedite each case on a case by case basis although some patience on the part of the applicant will also be required as Ms. Turner is apparently the sole staffer assigned to this undertaking.

I more or less firmly expressed my frustration and exasperation during the conference as to why after all this time a written or “Compassionate Use” document could not be issued, once and for all.  What I came away with is my continued belief and impression that the government is inundated with bureaucracy, upon bureaucracy, department upon department, committee upon committee and the wonderment in my mind that anything can ever be accomplished.  If the government were a private enterprise in my opinion; they’d be bankrupt by now through their inefficiencies, convoluted organizational management and questionable qualification of their so called medical experts.

I also indicated during the conference call that I shall not let up in my advocacy and campaign to formally right this egregious wrong as I direct my emails to Madam Secretary Burwell in the hope she gets completely fed up with me and whether she personally signs or directs one of her subordinates to sign a formal directive to cover the health insurance for these patients.

In any event and under the circumstances I was left with the impression despite all the negatives in my mind they are making their best efforts, under the circumstances, to accommodate the medical insurance needs of the VNS Depression patients.



Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733




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