Happy New Year

"Always bear in mind that your own
resolution to succeed is more
important than any other one thing."


-Abraham Lincoln

"Doctors sued for creating 'Valium addicts'" patients take action after damage is done

VIA the Independent:

"Doctors are being sued for creating prescription drug addicts amid claims they have failed to follow safety guidelines published more than 20 years ago.

Lawyers and medical experts have reported an increase in clinical negligence cases by patients left physically and psychologically broken by "indefensible" long-term prescribing of addictive tranquillisers such as Valium, collectively known as benzodiazepines.

Patients taken off the drugs too quickly, leaving them disabled with pain for months if not years, are also seeking legal redress. Many say they were never told about the dangers of rapid detoxification, which can lead to seizures and even death in severe cases. Doctors have been accused of being "in denial" about the problem.

Experts have warned of a coming flood of legal action against doctors who failed to inform their patients about the addictive nature of some tranquillisers, currently given to millions of people worldwide. They are prescribed to deal with common social and psychological complaints, from exam stress to relationship problems and bereavement."

Watch:Trailer for "OPEN DIALOGUE," an alternative Finnish approach to healing psychosis

Robert Whitaker, author of Anatomy of an Epidemic is featured also in this short trailer.

Psychologists, now Therapists speak out on the DSM-5: the psychiatric 'bible' could promote over-medicating

The American Psychiatric Association has been under increasing scrutiny regarding the upcoming revision of the DSM manual of psychiatric disorder codes and labels. The numbered diagnoses listed are often and most used by insurance companies and doctors for billing purposes. With the revisions being discussed the new DSM 5 has potential for watering down and over generalizing many psychiatric diagnosis as well as medicalizing some human conditions as a result.

America has a problem. Society is in general a quick-fix nation. Americans want easy answers and they don't want to take the time to introspect or heal when they suffer grief, loss and change that happens as a part of being a human being. The medicalization of human emotions and reactions to life events has increased with people seeking treatment from doctors and psychiatrists, they want relief and many find it inside a pill bottle. Though once on the psychiatric medications, unexpected body side effects can result in the patient leaving medications behind, only to find themselves weathering the storm of life itself.

Severe mental illness, I feel has not actually been seen by the general public. The few (of us, myself included as a visitor of my daughter)who have for some reason or other been inside locked psychiatric institutions and hospitals have witnessed the 'real deal' and we have also witnessed the erroneous medicating of some patients. In my years (over a decade) of being inside several locked facilities, I have seen a large spectrum of patients with various diagnosis and I dare say not many were severe.

I feel bipolar disorder is way over-diagnosed, and the ones who are severely manic or depressed are almost being done a disservice by having so many 'bipolar lite' on board using the same drugs and medical model for treatment. It goes both ways. The ones labeled bipolar are many times being medicated with popular antipsychotics many are not actually severe enough in presentation to warrent such potent chemicals.

People talk about the risk versus benefit ratio, and frankly there really is not this discussion in the trenches of locked inpatient wards and units. There is a cookie cutter formula America bases its treatment on for mental illness, and it is the same drugs across the board for many different DSM diagnostic codes and labels. I've seen doctors prescribe Seroquel (antipsychotic) for just about everything. From Borderline to Bipolar, from Schizophrenia, Schizoaffective, to agitated depression.

It seems there is an answer for all of the DSM 5 diagnoses and the same run of the mill pills are the answer. It's rare to find a locked inpatient unit that houses therapists or psychotherapists. It's basically a small craft class, a few outside fresh air breaks a day and most of all it's meds time.

Patients DO NOT for the most part ever discharge OFF of medications from psychiatric hospitals in America. If you enter one off meds sure as hell you will leave on them, and if you entered on meds they will be tweaked, some added you may not need and a laundry list of DX's results in labels, added, and added and added. I've seen it with my own eyes. I 've seen the forced injections. It's all about control of the patient and many patients complain to me they cannot think on the meds. I have seen a few extremely manic, (not many!)patients arrive 'on the ceiling' and within 24 hours walking like zombies, which always broke my heart. Their spirits became dull immediately, and many grow agitated as time passed wanting to 'just go home'.

SALON has an article on therapists revolting against the new DSM 5 which discusses the over diagnosing and potential for over medicating due to the new revision of the psychiatric manual.

There is definitely an uprising happening, and I feel it's what the retired psychiatrist and blog author of 1 Boring Old Man says in his post about the therapists and psychologists speaking out against the revisions. He ponders about how psychiatrists feel, being they are in the profession of 15 minute med checks and 3 day inpatient medication management hospital stays.

True, that is what psychiatry is based on, and in my opinion this entire paradigm and drug-based medical model for psychiatric care is in need of a change and it is not changes within a diagnostic manual that creates more patients and more medicated ones to boot. The pharmaceutical companies will be the profiteers when the labels are watered down. The patients will, in the end suffer the most when dealing with a life event medicated and numbed down, only to go off of the meds and wonder where the hell their lives went.

Happy Holidays

I have had a golden moment in the last couple of weeks, when my daughter greeted me with words I had not heard in ages: "Hi Mom!"

Merry Christmas!

The Boring Old Man blog on the Dan Markingson CAFE Seroquel trial

.."the story of Dan Markinson’s suicide during the CAFE Trial, an AstraZeneca funded Trial designed to show the wonders of their Seroquel after its poor showing in the NIMH CATIE Trial.": Go check it out, as usual he is insightful with a lot more to add to the Dan Markingson suicide trial gone bad.

Transparency & truth: Part 2: Psychiatric Times hosts a doctor's blog post regarding the DSM-5

I started writing this blog as an outlet many years ago as I navigated a mental health system with my daughter that has proven to be a challenge to say the least. The system has an infrastructure that is lacking cohesive care for patients, and the patient is treated with a medication based paradigm and medical model that has become the 'American Way'.

I have, over many years, met hundreds of psychiatric patients within hospital settings as a result of being with my daughter. I can safely say, that many complain about the medications and many tell me they cannot think on antipsychotics. I've witnessed forced injections, heard people sobbing and begging to get out,among many other sad and intense situations.

There are many readers of this blog that are what they describe themselves to be: Psychiatric Survivors. These are the people who have scraped themselves up after being slammed down on psychiatric medications, or who have been locked inside psychiatric hospitals. Many are completely off of medications and successfully living a recovered life off of the medication-based paradigm.

Some write blogs, others leave comments on blogs. Many have and still suffer from the trauma induced upon them by the inpatient time. Many have body damage as a result of psychiatric medication use. Their voices are out there, and need to be heard.

Most of all, these people deserve respect.

They deserve dignity.

They deserve integrity.

They deserve honesty.

They deserve the truth.

Over time, as I wrote here about my daughter I began researching into the depths of how the system worked. It didn't take long to see a connect-the-dots setting that involved a corrupt pharmaceutical industry, with ties to the Key Opinion Leaders of Psychiatry. The information began to flow in with stories of fines from the Department of Justice for illegal marketing of the medications, the stories came in about the KOL's taking undisclosed money from pharmaceutical companies. The information over the years has evolved to become an inside look at how the world of Psychiatry works, and it is not a world that is conducive to the health and well-being of psychiatric patients in need.

Psychiatric patients are vulnerable people. In fact, I believe they are the most vulnerable people in society. They are at their most vulnerable, when they have had a break with reality. I say this based on what I have seen with my daughter. In her time of need, when she was not able to think for herself, or ask for informed consent, are times when she deserved respect, dignity and integrity from her doctors and those around her. She, instead like many others, was victim to lack of informed consent, given forced (against her will, being held down)injections of antipsychotics, and strapped tight to gurneys. Those days are now past. The pain and suffering and resulting trauma has not. She resides in a quiet world most of the time. Verbal days can be mixed with words we do not understand and mixed with memories. Sometimes, tears.

My daughter is a representative of the Psychiatry Survivor. She has survived all of the trauma, and is here. She cannot write or speak in public. I can. I can represent what I have seen on her behalf. I can demand the dignity she so richly deserves. I can hold integrity, truth and honesty high as I do in my daily life.

----

Therefore, I feel I must present a few facts I have discovered that bother me. I'll be honest, it bothers me a lot. I have no agenda or witch hunt intentions. I shoot from the hip with honesty and I can no longer remain silent about what I feel people deserve:

Honesty, truth and integrity.

For the people who leave comments on doctor's blogs, for the readers who do not comment but are directly influenced by a doctor's opinion, for those who look up to doctors and base hope in ones they find who seem to speak to them for some reason. It is with my own burden that I present this about a blogging doctor who I wrote about in my previous post title, and referenced as a Psychiatrist , regarding the Psychiatric Times article on the Criticism of the DSM 5.

The Psychiatric Times describes the author, Dr.Steven Balt as a Psychiatrist, and author of the Thought Broadcast blog.

Another 2011 article by William Heisel has a Q and A with Dr.Balt where he asks:

Q: How could you work as a practicing psychiatrist without finishing your residency?

A: "There’s nothing to keep me from practicing medicine. I do have a medical license and a DEA license and can prescribe medications. But, to work in most settings, you have to have malpractice coverage or be board-certified or board-eligible. At this clinic, I was able to get onto their malpractice policy."

As a result of reading the Psychiatric Times article, I discovered that Balt is a current Psychiatry Resident.

In my opinion, there needs to be a correction on the Psychiatric Times article, stating Balt is a psychiatrist, when in fact it should say 'resident', because patients and readers deserve the truth,honesty and transparency.

As for the transparency and full disclosure on Balt's blog--that is ultimately up to him as to how he portrays himself to his readers and commenters.

----

12.23.11

*Addendum Dr. Steve Balt has responded via email and gave permission to post his reflections on this post, which I appreciate.

" Hi Stephany,

I feel compelled to respond because you and I have communicated regularly in the past, I know that we're on the "same side of the fence" with respect to our views on psychiatry, and you raise some valid points.

First, with respect to the Psychiatric Times article, I had no say in how I was named or cited (or even the picture-- I don't know where they found that!). They asked for contributions offering various viewpoints on DSM-5. I had written a recent blog post which received a lot of feedback (not all positive), and I emailed it to them. They posted it without asking me for my title, disclosures, etc., even though I offered to provide such information.

Second, getting to the major point of your argument-- i.e., that I am a psychiatry resident. That is correct, I'm completing my final six months (out of 4 years total) at UCLA-Kern Medical Center. As you know, I spent three years at Stanford, then took time off to deal with my own personal issues, detailed in Heisel's articles. And while these issues had nothing to do with patient care, they made it difficult for me to find a place to resume my training when I did return to practice.

Nevertheless, I have been fortunate to work successfully in a variety of settings in the last three years. And as you and I have discussed, this has opened my eyes to some of the misrepresentation, pseudoscience, waste, and outright abuse that takes place in everyday psychiatric practice. This was also the impetus for me to start my own blog in 2010. I don't mean at all to suggest that the psychiatrists I've worked with are bad people, but rather that the field is built on such shaky ground and is so ripe for abuse (sometimes inadvertently so) by doctors, patients, and the public-assistance systems in which I have primarily worked in the last four years. Much of what I experience and observe leaves me shaking my head, and I often wonder whether psychiatry is doing any good for the people who come to us for help.

I would never have developed such a strong opinion had I NOT taken time away from a place like Stanford and worked as a psychiatrist "in the trenches." Furthermore, I believe that my own experiences as a patient (with a history of at least five different medications, two long-term treatment programs, and numerous psychiatrists and therapists) give me a certain outlook that I never would have developed as a "mainstream" psychiatrist. Finally, my 2-year relationship (and recent marriage) to a drug rep offers yet another perspective on the overmedicalized nature of my field.

I often comment to my friends that, had I stayed at Stanford, I would probably have become, by now, one of those "key opinion leaders" paid by Pharma to give dinner talks and to speak at meetings like the APA about "new medications in bipolar disorder" or something like that. After all, that's one of the reasons I chose that program for my training.

However, what I've learned in the last 5+ years has been FAR more informative regarding what psychiatry is *really* all about, and, more importantly, what patients experience when they come to someone like me for guidance, support, compassion, and advice. If the fact that I'm lacking six months of residency training means I'm not a "real" psychiatrist, so be it. But I'll constantly stand by what I write, say, and do for my patients, because it seems so rare amongst my colleagues-- especially the more "certified" ones-- and I think my profession is due for a change. "

Steve Balt

Psychiatrist appears to defend the DSM 5 in Psychiatric Times: Editor Ronald Pies thanks Steve Balt

link to Psychiatric Times hosting Dr.Steve Balt's blog post about the DSM-5, "Is the Criticism of DSM-5 Misguided?"which can also be found at Balt's blog Thought Broadcast.

The Editor of Psychiatric Times, Ronald Pies left a comment there:

by Ronald Pies | December 21, 2011 10:12 PM EST

You make some very good points, Dr. Balt--thanks! And, indeed, as several of us have argued in other venues, the issue of (anticipated) inappropriate prescribing or over-use of medication is a problem that should be dealt with through continuing medical education and more stringent FDA labeling--not by preemptive jiggering of our diagnostic criteria, as some have advocated. --Best regards, Ron Pies MD

Which pretty much states, don't mess with our book, naysayers! There's plenty of discussion out there against the DSM5, by Psychology groups and other doctors.

Notice the fully entrenched pharmaceutical ads on that page, for Seroquel, Latuda and Pristiq. Bird's of a feather....

*This article was found via Google search which bypasses the Psych Times log in page.

Amazing story of recovery: "She stays on the phone with me until the dulling numbness of the medication first reaches my mind and I no longer care"

Seroquel was the medication the doctor told Laura Delano to triple the dose, and the doctor remained on the phone with her until it kicked in. This is an amazing story of hope in mental health recovery written by Laura Delano in a series on author Robert Whitaker's Mad in America blog. Laura no longer takes psychiatric medication is not labeled with a psychiatric diagnosis any longer. She tapered off of her last psych med in 2010 and now tells her story of hope.

Brilliant and well done!

J&J has a campaign that is as bad as a cheap romance novel: personalized song for OB tampon shortage

Click here for your personalized apology for the OB tampon shortage and to hear your name in a song and see it in the clouds, and in a seriously sappy song. Oh, and at the end you get a coupon for OB Tampons.

A poignant post from retired psychiatrist where a medication discussion never happened

This is how I think an ideal appointment with a psychiatrist should go. Untangling the person's life situation as an assessment and the patient leaves without a medication prescription...

From the 1 Boring Old Man blog. A doctor who sees that people are human beings, rich with human condition experiences, to be felt and embraced.

Here it comes: spray antipsychotic --Loxapine inhaler by Alexza pharmaceuticals

Adasuve

It's not a pill, it's not a dissolve under the tongue, it's not a patch, it's an inhaler designed for agitated patients with Schizophrenia or bipolar disorder.

Alexza Pharmaceuticals wants your business. Look out involuntary psych ward patients, the injectables forced upon you could have competition.

Study in British Journal of Psychiatry shows positive data, and sponsored by the drug company itself Alexza. That's conflict of interest, and it's to their best interest isn't it?

BMJ.



Respiratory failure a concern of the FDA

Alexza Inhaled Antipsychotic May Pose Fatal Lung Risks, FDA Review Finds- Bloomberg

"Alexza Pharmaceuticals Inc. (ALXA)’s inhaled antipsychotic drug may put some patients at risk for respiratory failure, according to U.S. regulators considering whether to approve the treatment for sale.

While Adasuve is effective as a fast-acting treatment for agitation among patients with schizophrenia and bipolar disorder, it can cause bronchial spasms that may be fatal in people with conditions such as asthma, Food and Drug Administration staff said today in a report. Outside advisers to the agency plan to meet Dec. 12 to evaluate the findings.

Adasuve would be the first product for Mountain View, California-based Alexza. The therapy uses an inhalation device developed by the company to deliver a vaporized form of the antipsychotic medication loxapine to the lungs for rapid absorption into the bloodstream. The FDA aims to decide on the product by Feb. 4.

“It is likely that, even with adequate screening for pulmonary risk factors, some patients will require respiratory support post-dose, and some patients will be at risk for respiratory failure and death,” FDA staff said.

The drug, if approved, should only be administered by professionals who have intubation tubes and ventilators “readily available,” according to the report.

Adasuve failed to win FDA approval in October 2010, because the agency was concerned about risks of pulmonary toxicity, particularly in patients with asthma or chronic obstructive pulmonary disorder."-Bloomberg

Here's the update from the FDA panel December 12, 2011

Adam Feuerstein, Sr. Columnist at The Street

"$ALXA final final vote -- 9 yes, 8 no, 1 abstain. split vote."

Reuters:

December 12, 2011

"U.S. drug advisers recommended approving an experimental treatment from Alexza Pharmaceuticals for calming down patients with schizophrenia or bipolar disorder, but placed restrictions on how the drug should be used.

Advisers to the Food and Drug Administration on Monday voted 9 to 8 that Adasuve should be approved, but only if it is given in a single dose in 24 hours, and with the FDA's safety strategy.

Adasuve caused some breathing problems for patients, especially for those who already had lung issues, and panelists were concerned such patients would not be properly screened in the real world with Alexza's safety strategy.

The FDA usually follows the recommendation of its advisers, and will make the final decision on Adasuve in early 2012."
---

There you have it. Inspite of the respiratory issues, the drug goes to market. Good luck,to those who have a doctor prescribe this inhaled antipsychotic.

Inmate knew of Seroquel side effect, doctor gives it to him anyway: LAWSUIT

Inmate sues Madison County sheriff and psychiatrist claiming psychotropic drug caused diabetes

VIA Madison Record

"A Madison County jail inmate says he developed diabetes as a result of a psychotropic drug given to him while in custody.

Hubert D. Hill filed a lawsuit Nov. 21 in Madison County Circuit Court against the Madison County Sheriff's Office and psychiatrist Dr. Robert Blankenship.

According to the handwritten complaint, Hill was incarcerated in the Madison County jail in August 2008. Prior to that, Hill says he had never been diagnosed with diabetes. During his stay at the jail, Hill says the facility's psychiatrist, Dr. Blankenship, prescribed the medication Geodon. The psychotropic medication is used to treat chemical imbalances in a person's brain that cause mental health concerns.

Hill says he had a bad reaction to Geodon, so Dr. Blankenship allegedly prescribed Seroquel instead. Hill says he expressed his concern about the medicine's possible side effects because he understood Seroquel was linked to the development of diabetes. The former inmate claims Dr. Blankenship ignored the issue.

Hill says he was administered Seroquel regularly and began to gain weight. He says he was eventually diagnosed with Type-1 diabetes.

Hill accuses the Madison County Sheriff's Office and Dr. Blankenship of negligence for not knowing or properly mitigating the side effects of a drug prescribed to an inmate. He is asking for more than $60,000 in damages for medical expenses and court costs.

Hill is representing himself.

Madison County Circuit Court Case No.11-L-1259."

poem of the week

Dust of Snow

by Robert Frost (1923)


The way a crow
Shook down on me
The dust of snow
From a hemlock tree

Has given my heart
A change of mood
And saved some part
Of a day I had rued.

"We’ve paid a high price for stealth from the pharmaceutical industry and we deserve transparency!" - 1 Boring Old Man

"We’ve paid a high price for stealth from the pharmaceutical industry and we deserve transparency!"

Great post by Boring Old Man blogger--"transparency..".

I've asked Dan Sfera, of South Coast Clinical Trials if he can lend some insight to the question(s) the retired psychiatrist has asked in his post regarding trial centers, drug companies and why the trial centers are stealth, in the listings. Read about it at Boring Old Man's blog.

Texas Medical Board Press Release:child psychiatrist Charles Fischer, M.D. suspended

For sexually abusing teenage boys (inpatients) for nearly 20 years.

Nov 22, 2011-TMB suspends child psychiatrist Charles Fischer, M.D.:

"On November 22, 2011, a disciplinary panel of the Texas Medical Board temporarily suspended, without notice, the medical license of Charles Henry Fischer, M.D., after determining that Dr. Fischer's continuation in the practice of medicine constitutes a continuing threat to the public welfare.

The panel found that Dr. Fischer, a child psychiatrist at the Austin State Hospital in Austin, has demonstrated a pattern of sexually abusing teenage boys in his care for inpatient psychiatric treatment over a period of nearly 20 years.

The Board has received information that there are as many as nine patients who have alleged sexual abuse by Dr. Fischer since the first patient report in 1992.

Dr. Fischer, 59, was employed at Austin State Hospital from December 1990 until his termination on November 14, 2011. He has also been employed as a psychiatrist at the Waco Center for Youth, the Southwest Neuropsychiatric Institute in San Antonio, Lutheran Social Services Residential Treatment Center for Girls and Central Counties Mental Health and Mental Retardation.

The suspension remains in effect until the board takes further action."

* Liz Spikol has more on this at the Trouble With Spikol blog

Play Misty For Me: Dr.Charles Nemeroff on the NovaDel Board of Directors: spray Ambien anyone? Zolpimist

Here's the Press release from NovaDel announcing Dr.Charles Nemeroff's seat on the company's Board of Directors. It's a retro look at Nemeroff before the Grassley scandal hit the news.

The press release is a nice bio of the conflicted Nemeroff:

"Charles B. Nemeroff,
M.D., Ph.D., has been elected to the Board of Directors of
NovaDel Pharma Inc. (OTC Bulletin Board: NVDL), a leading formulator of
lingual spray drugs for systemic delivery through the oral musoca.
Dr. Nemeroff serves on the scientific advisory boards of numerous
pharmaceutical companies including Acadia Pharmaceuticals, Astra
Pharmaceuticals, Forest Laboratories, Janssen, Organon, GlaxoSmithKline and
Wyeth-Ayerst.

Since 1991, Dr. Nemeroff has been the Reunette W. Harris Professor and
Chairman of the Department of Psychiatry and Behavioral Sciences at the Emory
University School of Medicine in Atlanta, Georgia. He has served on the
Mental Health Advisory Council of the National Institute of Mental Health and
the Biomedical Research Council for NASA.

Dr. Nemeroff is past President of both the American College of
Psychiatrists and the American College of Neuropsychopharmacology. He has
served as the Editor-in-Chief of the Psychopharmacology Bulletin, Associate
Editor of Biological Psychiatry, and both Critical Reviews in Neurobiology and
Depression and Anxiety. He is currently Editor-in-Chief of
Neuropsychopharmacology.

Dr. Nemeroff has received numerous awards for his research including the
Bowis Award from the American College of Psychiatrists and the Menninger Prize
from the American College of Physicians. In 2002 he was elected to the
Institute of Medicine of the National Academy of Sciences."

Here's how it went in 2009:

"For more than a decade, the scenario I just described played out in a much more obscene way between Dr. Charles Nemeroff and Emory University. At the end of last year Senator Chuck Grassley finished an investigation of Dr. Charles Nemeroff. The conclusions were clear. For years, Dr. Nemeroff wrote positive reviews of drugs from companies like Cyberonics, Glaxo Smith Kline, and Pfizer all the while receiving speaking fees, advertising fees, and other gifts of monies from these companies. All toll, Dr. Nemeroff received about $2.6 million. While he wrote all these positive reviews, he never disclosed his financial relationship with these pharmaceutical companies. In other words, while writing about positively about a drug made by Pfizer, Dr. Nemeroff never disclosed that he was receiving money from Pfizer. Furthermore, emails and other correspondences revealed that Emory stonewalled the investigation and mislead the media about their involvement and Dr. Nemeroff's culpability. Finally, and most damning, once Grassley's investigation wrapped, Emory did remove Dr. Nemeroff from head of his department, Psychiatry, but allowed him to stay on as a professor earning six figures. In fact, Grassley uncovered documents that showed that Emory knew about Nemeroff's conflicts for years and did nothing."-from the Provocateur, Dr. Charles Nemeroff and Emory University's Culture of Corruption.

In the pipeline over at NovaDel is another version of the popular sleep aid Ambien and Intermezzo: Zolpimist which has been approved by the FDA.

Zolpimist™

"Zolpimist™ (zolpidem oral spray) uses NovaDel’s proprietary formulation technology to deliver zolpidem tartrate, which is currently marketed as Ambien®, the leading hypnotic for the treatment of insomnia. NovaDel has announced positive results from its clinical studies comparing zolpidem oral spray with Ambien® tablets. Zolpimist™ has been approved by the FDA for the short-term treatment of insomnia characterized by difficulties with sleep initiation.
Zolpimist™ offers the potential benefit of a faster rise in drug blood levels potentially leading to a faster onset of action, without having to take water.

Novadel's North American licensee is currently finalizing commercialization plans for this new product.

Clinical Studies
The Company has completed three clinical studies comparing Zolpimist™ to Ambien® tablets. The two pivotal studies are described below:

NVD003 – Healthy volunteers with mean age of 29 years

Study NVD003 compared 5 mg and 10 mg doses of Zolpimist™ with comparable doses of Ambien® tablets. Pursuant to FDA guidance in this type of 4-way crossover study, all data were compared to the highest marketed dose, which in this study was the 10 mg Ambien® tablet. Positive results from the study demonstrated that NovaDel’s 10 mg and 5 mg Zolpimist™ achieved bioequivalence with 10 mg Ambien® tablets, the primary standard of reference for this study.

A secondary assessment of the relationship between speed of drug absorption and the attainment of therapeutic drug levels showed 79% of subjects using the 10 mg Zolpimist™ reached therapeutic levels at 15 minutes post-dosing while only 26% of subjects using 10 mg tablets reached therapeutic levels at that time point. The results were statistically significant.

NVD004 – Healthy, elderly volunteers with mean age of 71 years

Study NVD004 compared doses of 5 mg Zolpimist™ to 5 mg Ambien® tablets. The primary objective of the study was to demonstrate comparability/bioequivalence of pharmacokinetics between oral spray and tablet groups.

A secondary assessment of the relationship between speed of drug absorption and the attainment of therapeutic drug levels showed 65% of subjects using the 5 mg Zolpimist™ reaching therapeutic levels at 15 minutes post-dosing while only 19% of subjects in the tablet group reached therapeutic levels by 15 minutes. The results were statistically significant.

Current Status

Zolpimist™ has been approved by the FDA for the short-term treatment of insomnia characterized by difficulties with sleep initiation. NovaDel is seeking a partner for commercialization in regions other than North America.

Zolpimist™ for Middle-of-the-Night Awakenings (MOTN)

Clinical studies have demonstrated that a low dose of zolpidem is effective in treating a sub-set of insomnia patients who wake up during the night and have difficulty falling back asleep. NovaDel has begun development of a lower dose version of Zolpimist™ with the intent of performing clinical trials to demonstrate the benefit of an easy-to-use oral spray form of zolpidem in this important and large patient population."

$$$$$ Way to go, Charlie. This proves that investigations, fines or other sanctions don't mean a damn thing in the pharmaceutical world of KOL's, it IS possible to never be without an income. Anyone want to know how much Nemeroff has invested in the ultimate spray sleep aid?

How about Zolpimist instead of pepper spray?

*Zolpimist 8/22/2011 9:30 AM ET News Release Index

NovaDel Signs Exclusive License and Distribution Agreement with Rechon Life Science AB to Manufacture and Commercialize Zolpimist(R) outside the US and Canada.

Link to corporate presentation of NovaDel's Zolpimist. *note they have a spray version of Viagra too.


Hat tip to Dr.David Bransford for the Board of Directors announcement.

"Seroquel, Abilify,Risperdal, Trileptal,Geodon" listen to the list of psych meds these kids tell you they take

These little kids are on boatloads of powerful pills that most are not approved for their age....and for what? behavior?

Menace to society: Sohail Punjwani, M.D. -- the safety of children is far too important to mince words: Gabriel Myers story

Gabriel Myers fell through the cracks in the foster care and mental health system, and this doctor was in charge of his medications.Sohail Punjwani, MD

Read this warning letter to him from the FDA 2-4-2010

HERE

There is NO excuse.

*in my opinion.

Some studies cause me to wonder about our science stories: "Teen Sex May Affect Brain Development, Study Suggests "

This study is based on HAMSTERS MATING.

Hamsters are the equivalent of teens according to this study

Watch out, you could be a depressed adult if you believe this hamster sex comparison to teens. LOL

Tracking doctors who harm kids with psychiatric meds: Dr. Sohail Punjwani

SATURDAY, MAY 15, 2010

Children at risk: Seroquel & Dr. Sohail Punjwani , Psychiatrist

VIA Miami Herald May 2010

" A Broward doctor reprimanded by the Food and Drug Administration for his drug-prescribing practices is facing accusations in a civil suit that he caused the death of a Weston teen after prescribing an anti-psychotic drug not approved for use in adolescents.

Norma Tringali of Tamarac believes the drug Seroquel, which Dr. Sohail Punjwani prescribed to her son Emilio, played a role in his death seven years ago. Punjwani is the same physician who was treating 7-year-old foster child Gabriel Myers before he committed suicide last year.

Earlier this week, pharmaceutical giant AstraZeneca agreed to pay state and federal government agencies $520 million to settle an investigation into the company's marketing practices, which the Department of Justice said encouraged doctors to use Seroquel for young and elderly people for indications not approved by the FDA."

AND


"The issue relates to these drugs,'' Freedland said. ``The way Dr. Punjwani treated Emilio Villamar and the manner in which these drugs were prescribed is a picture of everything that's wrong with this industry and the relationship between doctors and pharmaceutical companies.'"


VIA AHRP-Alliance for Human Research Protection,Vera Hassner Sharav

Hat tip: Stan, author of Is Something Not Quite Right with Stan-A Mental Health blog.

Further reading:

VIA Furious Seasons April 22, 2009:7 Year Old Boy On Prozac, Zyprexa Combo Hangs Self.

May 12, 2009:Florida Probes Doctor Of 7-Year-Old Suicide.

December 2011

U.K. mental health advocate and author-Bob Fiddaman's blog, ABC news-20/20 Confront the Pill Pushers

Saturday, December 03, 2011

ABC 20/20 Confront The Pill Pushers

"Over the past week or so ABC News in America have been covering the plight of the thousands of children caught in the loop of the mental health system. These children have each had a poor start in life and have been placed into Foster care because, more often than not, they have been abused by their parents or, in some instances, have had to deal with the death of their parents.

Last night ABC's 20/20 rounded off their investigation with a 10 minute special entitledConfronting Doctors [As yet not available on YouTube]. It was, in essence, a pastiche of their two previous specials from Wednesday and Thursday but featured a more in-depth look at the case of 7 year-old Gabriel Myers."

Children deserve better!!

Statement of the American Psychological Association on the DSM-5 Development Process

DSM-5 news: No official position taken by the American Psychological Association

"The American Psychological Association recognizes that there is a diversity of opinion concerning the ongoing DSM-5 development process. Our association has not adopted an official position on the proposed revision; rather, we have called upon the DSM-5 Task Force to adhere to an open, transparent process based on the best available science and in the best interest of the public. In this regard, we appreciate the Task Force's expressed commitment to seriously consider the issues and concerns raised by experts in the mental health field in their deliberations.

We call upon our members (either as individuals or groups) to continue to add their perspectives to enhance the validity and clinical utility of the DSM-5. The American Psychological Association will continue to monitor the revision process and be a strong voice for its transparency."

read the entire statement here

Furious Seasons:August 10, 2009 Liz Spikol Ain't Dead : December 2011 She's baaack!

I thought it would be fun to steal Philip Dawdy's headline announcing Liz' return to blogging back in 2009.

Yes, it's true the original one and only mental health blogger Liz Spikol has returned to her blog The Trouble With Spikol, after a long hiatus while she did other things she will surely blog about.

Here's her new post Okay. Let’s Go Back Into Business., go take a look.

Psychiatrist wants to add Lithium to the water in Ireland as suicide prevention plan

via Irish Times

"Dr Bhamjee said: “A recent article in the British Journal of Psychiatry found the beneficial uses of lithium when it was added to the water supply in parts of Texas.”

He said the Government should consider a pilot project for a town in Ireland where lithium salts could be added to the water in very small doses and examine the results.” He said there was already strong precedent for governments intervening in the operation of public water supply for health benefits by adding fluoride.

Dr Bhamjee said that a community would not get “hooked” on lithium “because the doses would be so small”.

He said: “There are 200,000 people suffering from depression in Ireland and the Government must think of new ways of tackling the problem.”

Fine Gael TD and chairman of the Irish Association of Suicidology, Dan Neville, told the forum the average annual suicide rate in Ireland in the 1960s was 64-65.

He said: “Last year, 483 people died by suicide and if you add the 123 undetermined deaths, the suicide number is over 600.”

He said: “This compares to 212 who died by road accidents, which is itself unacceptable.

“Research shows during international recessions, the suicide rate increases by 25 per cent. Ireland has the fourth highest youth suicide rate in Europe.”

Mr Neville added: “Suicide is the most common death for 15 to 24-year-olds and accounts for more than those who die from cancer and road accidents combined.”

The Limerick West deputy said that the attitude in mental health service towards those with mental health problems should be recovery and not containment."

12 year old speaks before Senate and Congress on psychiatric drugs--foster system

From Fid's blog at Seroxat Sufferers: (read it all there!)

"The Senate sat in stunned silence as they listened to a statement from 12 year-old Ke' Onte Cook. Ke' Onte had been place in care from the age of 6 and a half. He told the panel that he was told that if he didn't take his drugs he would be punished by not being allowed to watch TV. He did not know why he was on drugs or how many he was taking, he could not remember. Ke' Onte also informed the panel that later on he had been diagnosed with Post Traumatic Stress Disorder [PTSD] Insomnia, Depression and Attention Deficit Hyperactivity Disorder [ADHD] during which he could not process thoughts, felt glazed and tired, had stomach aches and a "lights out" mood. He added that he was first prescribed the medications [3 different drugs a day] because he was throwing tantrums and was upset after being taken into State care.

Sen Carper asked Ke' Onte how he managed to get off the medication. Ke' Onte informed him that he sought the help of an Attachment Therapist who talked to him about his history and added that "It helped me to get over the anger." When asked by Sen Carper if he had a message he would like to add Ke' Onte replied, "Medication isn't going to help children with problems, it just sedates them."


Sen Carper concluded that "We need to figure out what works." and told Ke' Onte, "Some good is going to come out of what you experienced."

Bravo brave young man!!

Former PhRMA chief Tauzin earned $11.6 million in 2010 : healthcare reform lobbyist

via Fierce Pharma:

"Ex-PhRMA chief Billy Tauzin caught a lot of flak in 2010 for brokering an $80 billion cost-savings deal with President Barack Obama, helping the administration seal its healthcare reform plans while aiming to stave off further pharmaceutical industry cuts. As it turns out, he was well paid for absorbing the hits.

Tauzin earned $11.6 million in 2010, the year he negotiated that pharma-politico arrangement. That salary put him head and shoulders above the other healthcare lobbyists battling for their interests during the reform fight. Insurance lobbyist Karen Ignagni reaped $1.5 million the same year, while the Chamber of Commerce's Tom Donahue was paid $4.8 million, according to Bloomberg."


Who do you trust?

Senate Hearing on antipsychotic use in nursing homes

Use of antipsychotics in nursing homes Senate hearing

2007 305K medicare claims for antipsychotics...drugs were NOT used for medical reasons

Rx dose was too high or person was on too long....

listen and watch here

watch here

From C-Span

"WASHINGTON, DC
Wednesday, November 30, 2011

The Special Committee on Aging examines the widespread use of these drugs among dementia sufferers, despite FDA "black box warnings" against it as well as a high cost to taxpayers.

David Levinson, Inspector General of the Department of Health and Human Services, released a report on the overuse of antipsychotic drugs which said the two main problems are "overmedication and Medicare pays for drugs it shouldn’t.”

Dr. Jonathan Evans with the American Medical Directors Association said the drugs are used "as chemical restraints.”

Suggested use for antipsychotic are for diseases such as bi-polar and schizophrenia, but atypical antipsychotic are often prescribed “off-label” to dementia patients in nursing homes and assisted living facilities who exhibit symptoms of agitation and other aggressive behaviors, even without a diagnosis of psychosis."

These are antipsychotics: Seroquel, Zyprexa, Abilify, Geodon, Risperdal, Haldol, Melleril