Another email pleading for “Compassionate use”.

From: Joyce and Herbert Stein [mailto:fabrik@bellsouth.net]
Sent: Friday, September 06, 2013 12:20 PM
To: Jonathan Blum, Deputy Administrator Director - CMS; Madam Secretary Kathleen Sebelius
Subject: How long does it take for bureaucrats to act responsibly and effectively?

Dear Mr. Blum,

I shall not go away.

I shall continue to kneel before you.  I am rightfully begging to have you people correct the moral injustice and negligence you continue to perpetrate against these implanted VNS Therapy patients by not covering their health care needs.  I am again asking for either of your signatures to a document for “Compassionate use” for these patients.

Additional Cyberonics sits by of absolutely no help to me or these patients caught up in this Catch-22.  The CEO, Mr. Dan Moore has not responded to my last email (August 16, 2013) to him refuting his contention that paying for the study subjects replacement prosthesis stated in his company’s document “Lifetime Reimbursement Guarantee” violates the “kickback statue”.  Nor has he to the best of my knowledge attempted in any way to contact the VNS depression patients to inform them of our advocacy for “Compassionate use”.

Despite all the obstacles in my path, slowly but surely, my message and advocacy apparently is being heard.  I just received and once again copied and pasted below another response from another depression patient giving me permission to share her pleas and life experiences.  I strongly believe that none of these life experiences that I have shared with you compute or are figured anywhere in the data you “medical team” might be reviewing and yet these are facts.  These are facts affecting the very lives of the people that the FDA and CMS are supposedly mandated to protect, care for and serve.  This life experiences has proven to be effective and cost savings to our health care system for this group of patients formerly unresponsive to conventional therapies.  The former costs to maintain these people through ineffective conventional therapies are astronomical.  100% of the patients opting to continue with the therapy have obtained favorable responses and efficacy. 

Are you and your “medical team” comprehending the significance of that data?

How can you continue to stand by ineffectively given me bureaucratic speak while delaying and watching and literally forcing these people one by one return to the agony, pain and hell they’ve suffered for decades when there is this treatment that has effectively and safely given them a reasonable quality of life?

Have you no real compassion and understanding of the hardships you’ve created and continue to perpetrate?

Joyce and Herbert Stein

1008 Trailmore Lane

Weston, FL 33326-2816

(954) 349-8733

vnsdepression@gmail.com

http://www.vnstherapy-herb.blogspot.com

http://vnstherapy.wordpress.com/

Julie Ottaviani	11:52 AM (18 minutes ago)
to me

My name is Julie Ottaviani and I am a VNS Implant !00% success story.  Seven and a half years ago I stood in front of panel upon panel of judges and appeal members telling my story of why this treatment needs to be covered.  I now need a new generator and I can feel the black hole of depression descending upon me.  I am the mother of 4 children.  Two boys and two girls.  The youngest two, my daughters were robbed of having a real mother by this horrible disease. Always in the hospital, suicide attempts, or I would just be sleeping in my room and they would ask why is Mommy so sad?  Why is Mommy crying all the time? Did we do something wrong?  On Jan 12,2006 I was implanted with the VNS Implant for TRD depression.  It was a desperate attempt by my doctor to save my life which I had tried to end many times.  My youngest daughter Ashley was 3 years old and Sara her sister was 5.  After the implant was turned on and adjustments were made the improvement was almost instantaneous. I will never forget the day I woke up after the last adjustment and for the first time since I could remember I thought something is different.  Then I knew, I felt happy, I felt alive, I felt like laughing.  My girls came running into the bedroom because they heard me and we all jumped on the bed wrestling.  Ashley who was 3 said Mommy's back, Mommy's back.  And Sara went running to get her brothers yelling Mommy's all better, look she's all better.  The tears of joy were running down my face and it felt good.  Now it is time for a new generator and I feel the sadness descending. Ashley is 18 and a senior in high school.  She is terrified of losing me again.  I'm trying hard to keep a smile on my face but she knows what's coming.  Sara says I can see it happening Mom.  I come home and your sleeping just like when I was little.  They are angry that the doctors just won't give me what I need, they are right.  It's not fair to give children their Mother back for 7 years and then tell them that's all you get it's over, we're taking her away again.  Please, for myself, Corey, Adam, Sara, Ashley my beautiful granddaughter Trinity, give me a chance to see them grow.  Pass Compassionate Use

Sincerely,
Julie Ottaviani
11 Alexandria Drive
Blakely, Pa  18447
570-604-3043

Julie Ottaviani
julieottaviani@aim.com

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"Lifetime Reimbursement Guarantee for All TRD IDE Study Patients"

YAHOO! FINANCE

Financial News Press Release                                                        Source: Cyberonics, Inc Cyberonics Announces Closure of Investigational Device Exemption (IDE) for Treatment-Resistant Depression (TRD), Lifetime Reimbursement Guarantee for All TRD IDE Study Patients and $15 Million TRD Indigent Care Program Wednesday January 18, 8:00 am ET HOUSTON, Jan. 18 /PRNewswire-FirstCall/ -- Cyberonics, Inc. (Nasdaq: CYBX - News) today announced that FDA recently approved its request to officially close Investigational Device Exemption (IDE) G980099 covering all pre-market studies of VNS Therapy(TM) in chronic or recurrent treatment-resistant depression including the D-01 pilot study, the D-02 Pivotal Study and the D-20 Treatment IDE. No additional depression studies under an Investigational Device Exemption are currently underway or being planned by Cyberonics. To ensure that all TRD IDE study patients continue to have access to VNS Therapy, Cyberonics also announced today that it is providing a lifetime reimbursement guarantee to all study patients and VNS Therapy service providers, whereby Cyberonics will provide reimbursement for VNS Therapy services at standard rates in the event that third party payers deny post-approval coverage to patients in the D-01, D-02 and D-20 studies. Lastly, Cyberonics also announced a $15 million TRD Indigent Access Program, similar to its B.J. Wilder Therapy Access Program in epilepsy, to provide indigent Americans with TRD access to VNS Therapy. Cyberonics will provide up to 200 VNS Therapy Systems per year over a five year period in this program to qualified patients through experienced hospitals and trained psychiatrists. "Cyberonics' mission is to improve the lives of people touched by pharmaco-resistant epilepsy and treatment-resistant depression," commented Robert P. ("Skip") Cummins, Cyberonics' Chairman of the Board and Chief Executive Officer. "Official closure by FDA of all TRD studies conducted under an Investigational Device Exemption, the lifetime reimbursement guarantee for TRD IDE study patients and the $15 million TRD Indigent Access Program will facilitate accomplishment of that mission by providing more Americans with TRD access to the first and only FDA-approved treatment option for their lifelong and life-threatening illness. "All Americans with TRD should have access to VNS Therapy for its FDA-approved indication," continued Mr. Cummins. "Although over 85 different third party payers, including 19 different Blue Cross/Blue Shield plans, United Healthcare, CIGNA, Aetna, Humana and several regional Medicare carriers have to date granted at least one American with TRD access to VNS Therapy (http://www.vnstherapy.com/depression/hcp/ReimbursementIns/casebycase.aspx ) and several State Medicaid programs now have the same coverage policy for both epilepsy and depression, all Americans with TRD do not yet have the same immediate, universal access to VNS Therapy that Americans with pharmaco- resistant epilepsy have had for at least the past five years. The combination of FDA approval, FDA's Summary of Safety and Effectiveness, the official closure by FDA of all VNS Therapy TRD investigational studies, the rapidly building body of peer-reviewed evidence and post-approval appropriate use and favorable patient outcomes should convince all third party payers that VNS Therapy, the first and only treatment specifically developed, studied, approved and labeled for TRD, should be a covered benefit as indicated for fully-informed use. Lack of access to the only FDA-approved treatment option for TRD can, unfortunately, have tragic implications for Americans and their families. Cyberonics was recently made aware of one person with three children who had suffered from treatment-resistant depression for over 25 years who committed suicide following a VNS Therapy coverage denial by a major private payer. Cyberonics has taken the unprecedented steps with its lifetime reimbursement guarantee for study patients and its $15 million TRD Indigent Access Program, to ensure that study patients and indigent Americans with TRD have fully informed access to VNS Therapy. We continue to work diligently with all third party payers to provide them with all the information they need to follow our lead and give Americans with health insurance suffering from TRD the same universal access to VNS Therapy that Americans with epilepsy have had for over five years and that Cyberonics is now providing to TRD study patients and indigent Americans with no insurance. "Official closure of the TRD IDE confirms that VNS Therapy for its approved indication for use, is neither experimental nor investigational," concluded Mr. Cummins. "Studies under an Investigational Device Exemption are done to demonstrate the safety and effectiveness of devices for a proposed indication for use. We have no plans and there are no FDA requirements for Cyberonics to conduct further depression studies of VNS Therapy as an investigational device for its approved indication. Consistent with the post-market requirements of the majority of device approvals over the past five years, Cyberonics is required by FDA to conduct post-market studies. In our case, we originally planned, and were subsequently required by FDA's approval order, to conduct a dosing study and long-term patient outcome registry to elucidate the optimal dosing, predictors of response and long-term outcomes of patients treated with post-approval VNS Therapy. Similar to our track record in epilepsy, Cyberonics' post-approval TRD development plan goes well beyond the FDA approval requirements and includes mechanism of action research and several clinical studies all within the TRD approved indication for use. The purpose of these post-approval studies is to facilitate fully-informed use of VNS Therapy for the approved indication consistent with our mission to improve the lives of people touched by TRD." ABOUT VNS THERAPY AND CYBERONICS Cyberonics, Inc. was founded in 1987 to design, develop and market medical devices for the long-term treatment of epilepsy, depression and other chronic treatment-resistant disorders using a unique therapy, vagus nerve stimulation (VNS). Stimulation is delivered by the VNS Therapy System(TM), an implantable generator similar to a cardiac pacemaker. The VNS Therapy System delivers preprogrammed intermittent mild electrical pulses to the vagus nerve in the patient's neck 24 hours a day. The Company's initial market was epilepsy, a disorder characterized by recurrent seizures. Epilepsy is the second most prevalent neurological disorder. The Cyberonics VNS Therapy System was approved by the FDA on July 16, 1997 for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. The VNS Therapy System is also approved for sale as a treatment for epilepsy in all the European Economic Area, Canada, Australia and other markets. To date, more than 32,000 epilepsy patients in 24 countries have accumulated over 94,000 patient years of experience using VNS Therapy. The VNS Therapy System was approved by the FDA on July 15, 2005 "as an adjunctive long-term treatment for chronic or recurrent depression for patients 18 years of age and older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments." As part of FDA's approval order, Cyberonics is required to conduct a 450- patient post-market dosing study and a 1,000- patient, five-year patient outcome registry. For more information on VNS Therapy for treatment-resistant depression, including the contraindications, warnings and precautions, see the Physician's and Patient's Manuals and other information at http://www.cyberonics.com or http://www.vnstherapy.com or call 1-877-NOW 4 VNS FREE The VNS Therapy System has been approved for sale in the European Economic Area and in Canada as a treatment for depression in patients with treatment- resistant or treatment-intolerant major depressive episodes, including unipolar depression and bipolar disorder (manic depression) since 2001. VNS Therapy is at various levels of investigational clinical study as a potential treatment for anxiety disorders, Alzheimer's disease, chronic headache/migraine and bulimia. The Company is headquartered in Houston, Texas and has an office in Brussels, Belgium. For additional information please visit us at http://www.cyberonics.com . SAFE HARBOR STATEMENT This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. These statements can be identified by the use of forward-looking terminology,            including "may," "believe," "will," "expect," "anticipate," "estimate," "plan," "intend," and "forecast," or other similar words. Statements contained in this press release are based upon information presently available to us and assumptions that we believe to be reasonable. We are not assuming any duty to update this information should those facts change or should we no longer believe the assumptions to be reasonable. Investors are cautioned that all such statements involve risks and uncertainties, including without limitation, statements concerning epilepsy patients maintaining universal access to VNS Therapy, TRD patients gaining access to VNS Therapy through case-by-case approvals or national coverage policies, TRD patients gaining similar insurance coverage for VNS Therapy services as Americans with epilepsy and/or Cyberonics' funding or completing post-approval TRD studies. Our actual results may differ materially. For a detailed discussion of these and other cautionary statements, please refer to Cyberonics' most recent filings with the SEC, including its Form 10-K for the fiscal year ended April 29, 2005 Source: Cyberonics, Inc. Document published January 18, 2006

TMS may bring remission in bipolar depression

 

Adult Psychiatry

TMS may bring remission in bipolar depression

By: BRUCE JANCIN, Clinical Psychiatry News Digital Network

06/18/13

HOLLYWOOD, FLA. – Transcranial magnetic stimulation shows promise in highly treatment-resistant bipolar depression, a small observational study suggested.

Most studies of transcranial magnetic stimulation (TMS) have focused on treatment of major depressive disorder, the indication for which this noninvasive device therapy has Food and Drug Administration approval. TMS also is under study for the treatment of headaches, as well as for improvement of the negative symptoms of schizophrenia.

Yet little work has been done on TMS for bipolar depression, even though a pressing need exists for new treatment options for this often highly disruptive mood disorder. Antidepressant medications are often ineffective or can trigger a switch to a manic or hypomanic episode, Dr. William S. Gilmer noted at a meeting of the New Clinical Drug Evaluation Unit sponsored by the National Institute of Mental Health.

Dr. William Gilmer

He reported on 10 patients with bipolar II disorder and 4 who met criteria for bipolar disorder not otherwise specified. All had complicated nonpsychotic depression. All were refractory to and/or intolerant of multiple antidepressant agents during their current episode; indeed, the patients had previously been on a mean of 6.4 antidepressant drugs during this episode, which had already lasted more than 18 months in 9 of 14 cases. Four patients were previous nonresponders to ECT. None of the subjects had bipolar activation symptoms such as grandiosity, nocturnal alertness, or agitation at baseline, according to Dr. Gilmer, associate professor of clinical psychiatry and behavioral sciences at Northwestern University, Chicago.

After an extended period during which he attempted to optimize the participants’ medications, including reducing benzodiazepines and increasing mood-stabilizing drugs if necessary, all patients underwent high-frequency TMS at 10-Hz over the left dorsolateral prefrontal cortex 5 days per week according to the standard procedure using the NeuroStar device marketed by Neuronetics.

Nine of 14 patients achieved a clinically meaningful antidepressant response to TMS, as defined by at least a 50% reduction in scores on the Quick Inventory of Depressive Symptomatology (QIDS-16 SR) from an initial mean baseline of 18.9. A mean of 24.6 sessions was required. Four patients achieved and maintained remission, as defined by a QIDS-16 SR score below 6; this required a mean of 24.8 TMS sessions, followed by a taper phase.

Two of the four previous nonresponders to ECT achieved full remission on TMS, and a third had a significant response.

Although there were no study dropouts, seven patients experienced bipolar activation symptoms during TMS therapy that required drug therapy. Of note, four of five TMS nonresponders experienced clinically significant activation symptoms, compared with just three of nine TMS responders. Thus, the emergence of activation symptoms during TMS may turn out to be a predictor of poor outcome. This is a possibility warranting further study in controlled trials aimed at establishing optimal TMS treatment parameters in bipolar depression, the psychiatrist suggested.

Dr. Gilmer is on the speakers’ bureau for Neuronetics.

Vitals

Major finding: Nine of 14 patients with highly treatment-resistant bipolar depression achieved a clinically meaningful antidepressant response to transcranial magnetic stimulation, including 4 who reached and maintained remission. Two of the four in remission were prior nonresponders to ECT.

Data source: This observational study was a naturalistic case series with no control group. Patients had been unresponsive to and/or intolerant of a mean of 6.4 antidepressant medications during their current episode of bipolar depression, which had been ongoing for more than 18 months in nine cases.

Disclosures: Dr. Gilmer is on the speakers’ bureau for Neuronetics, which markets the transcranial magnetic stimulation device used in the investigation.

http://www.clinicalpsychiatrynews.com/news/adult-psychiatry/single-article/tms-may-bring-remission-in-bipolar-depression/930235d48a44184b9395b8e5a3325f29.html

Deep Brain Stimulation: Evidence Based Science or Wishful Thinking?

By Natalie Timoshin, Managing Editor | May 28, 2013

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I have a friend whose nephew received a diagnosis of late stage cancer about 9 months ago—everyone thought (but didn’t say) his chances for survival were slim. After stem cell transplantation, he’s just marked 100 days of being cancer free.

Cancer outcomes like this make me optimistic for the future. Deep brain stimulation (DBS) might be another reason to feel optimistic about the future.

One of my favorite sites on the internet is Ted Talks. I don’t spend a lot of time on the internet, but I do have a few favorites (eg, New York Times, Psychiatric Times, the National Gallery of Art), and Ted Talks tops this list. The topics are varied and I learn something new every time: I recently learned how to tie my shoelaces so that they don’t untie and had my future brightened by Andres Lozano, MD, PhD, who talked about Parkinson, depression, and ways that their processes might be turned off.

Because of new imaging techniques and advances in our understanding of neurophysiology, neurological and psychiatric disorders are increasingly being recognized as disorders of circuit functions in the brain. Using techniques such as DBS, neurosurgeons are able to pinpoint malfunctioning circuits and to recalibrate them. DBS is very precise—the electrode is inserted through the skull and into any area of the brain to deliver electricity.

Dr Lozano is chief of neurosurgery at the University of Toronto, where he and his team are studying the use of DBS to turn brain circuits on and off, depending on the circuits’ role in certain disorders (eg, movement, mood, memory). In his presentation on Ted Talk, Lozano describes the case of a little boy with dystonia who is no longer able to stand or walk and whose prognosis is dismal—he will be progressively more disabled and his chances of survival are nil. Dr Lozano and his team used DBS to suppress the circuits in his brain responsible for movement. Three months later the boy is walking. As a young adult he is living a normal life and going to university.

Both pharmacological and psychotherapeutic modalities are used to treat MDD, yet 10% to 20% of patients with depression do not respond to treatment. PET scans have shown that areas of the brain responsible for motivation, drive, and decision making are impaired in patients with severe depression, and the sadness center is overactive. After six months of continuous DBS, the sadness center is turned off, and the circuits responsible for motivation, drive, and decision making have made a comeback.

Similar positive results were seen when DBS was used in patients with early Alzheimer disease. Healthy brains use 20% of the body’s supply of glucose—as Alzheimer disease progresses, glucose utilization shuts down. Dr Lozano and his team wanted to know if this “power failure” could be reversed. They placed DBS electrodes in the Fornix area of the brain and looked at what happened to glucose consumption. After one month, areas of the brain that had stopped using glucose had resumed consumption. The implications seem to be that not only can DBS modify symptoms but that the technique can help repair damaged areas of the brain as well.

Is DBS evidence-based science or wishful thinking? What do you make of the different brain stimulating techniques? Is there reason for my optimism? Can I continue to believe that my golden years will not be plagued by memory loss and cognitive decline?

Oh, my friend’s nephew . . . he celebrated by getting engaged!

http://www.psychiatrictimes.com/display/article/10168/2144438