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Tag: MedWatch

Minnesota Reaches Out to AbleChild to Discuss New CT Law 1-800-MedWatch on “Prescription Drug Container Bill”

On Thursday July 9th, at 7 pm Eastern time, AbleChild will be a guest on TS Radio Show with Marti Oakley.

Marti Oakley is a talk show host with a focus on state and national legislation. This is not the first time media has reached out to AbleChild regarding liberty in mental health.

This broadcast will focus on the recently passed “Prescription Drug Container Bill” that incorporated an AbleChild amendment to include the 1-800-MedWatch consumer reporting phone number directly on the containers. AbleChild will also discuss the legislative impact of the aftermath of Sandy Hook.

Senate Bill 28 “The Prescription Drug Container Bill” unanimously passed both the Connecticut House of Representatives and Senate.

The AbleChild amendment makes it mandatory for all generic prescription drug containers to carry the 1-800-MedWatch telephone number on the container.

MedWatch is a drug safety reporting system made available to consumers to allow direct reporting of Adverse Drug Events to the Food and Drug Administration (FDA).

This is a first-in-the-nation legislative action to provide this important consumer 1-800-MedWatch number directly on a prescription drug label, and a landmark win for consumers in Connecticut.

Connecticut Consumers Need Some Avenue of Relief in Mental Health

As is typical of “crisis management” by elected officials, the Connecticut legislature responded to the Sandy Hook tragedy without full knowledge of the facts of the incident with ill-advised mental health recommendations that do nothing to protect consumer rights.

In April of last year, the Task Force to Study the Provision of Behavioral Health Services for Young Adults, established pursuant to Public Act 13-3, put forth yet-to-be-approved mental health recommendations that, for all intents and purposes, would institute cradle to grave mental health diagnosing, yet provided no avenue for consumer input.

In other words, the public may be subjected to extremely intrusive mental health services, but will have no way to voice opposition to possible inaccuracies and wrongs committed by the service providers.

For example, the Task Force writes on page xi, number 45, that “…given the current understanding of mental illness to be a biological disease.” This is just wrong. The fact is there is no scientific/medical data to support this statement for any psychiatric diagnosis, including ADHD, depression, schizophrenia, or the alleged bi-polar disorder. Believing in, and having proof of, a psychiatric “disease” is two very different things.

However, regardless of the misinformation provided by the Task Force about what is and isn’t a mental “disease,” the recommendations, if instituted, do not provide consumers the ability to hold service providers responsible. What transpired between Nancy Lanza and the Yale Child Study Center actually is a good case in point.

Recall that Nancy Lanza sought treatment services for Adam Lanza at the Yale Child Study Center beginning in October 2006 – six years prior to the shooting incident. As part of the “treatment” provided, Adam was diagnosed by Yale as suffering from a “profound Autism Spectrum Disorder” and “obsessive compulsive disorder” and then was “treated” with the mind-altering antidepressant, Celexa.

Nancy Lanza “immediately” called the service provider at Yale Child Study Center, complaining about what she believed to be serious adverse reactions to the psychiatric drug. Specifically, Nancy Lanza advised Yale that Adam was “unable to raise his arm” and attributed this adverse reaction to the drug Adam had been prescribed.

Rather than take Lanza seriously and consider that the drug may be implicated in the adverse drug event, the Yale clinician “attempted to convince Nancy Lanza that the medication was not causing any purported symptoms which Adam might be experiencing” and labeled Lanza as “non-compliant.”

Was Nancy Lanza provided information about the Food and Drug Administration’s (FDA) MedWatch System? No. Had Lanza been provided this basic adverse drug reporting information, at a minimum, the FDA would have been given important information in the event of a future drug review.

Additionally, was Lanza advised by Yale Child Study Center that she could file a complaint with the Connecticut Department of Public Health (DPH)? The record makes no mention of providing any such information.

And, to add insult to injury, there is the case of Dr. Paul Fox, Adam Lanza’s longtime psychiatrist who, ironically, six months prior to the shooting incident at Sandy Hook, voluntarily surrendered his license to practice in New York and Connecticut and destroyed his patient records prior to fleeing the U.S. to live in New Zealand.

Despite destroying all of his patient medical records and, in the case of Adam Lanza, Fox destroyed those records almost two years too early, there is absolutely no recourse. A clear violation of Connecticut State law, but no action is prescribed to deal with such flagrant violations. No fines, no penalty, nothing.

Dr. Paul Fox and even the clinicians at Yale Child Study Center are proof that consumers need an avenue of relief. AbleChild believes that lawmakers have a responsibility to provide some level of protection to consumers, especially in light of the overwhelming number of mental health recommendations being considered.

Particularly important is the recommendation listed on page xi, number 44, where it is the intent to scale up “Assertive Treatment Programs that provide aggressive outpatient services, shy of forced medication…”

Clearly the intent of the Task Force recommendations is to severely ramp up mental health “treatment,” which almost always includes psychiatric medication. Nowhere in these recommendations are suggestions for legislative measures that will provide consumers some avenue of relief, alternative treatment options, or information about reporting adverse reactions to prescribed drugs.

Ablechild takes exception to the increased mental health recommendations on a number of levels, including the fact that, given the numerous problems surrounding the mental health “care” Adam Lanza received, the State obviously cannot enforce the laws already on the books. Increasing mental health services without consumer protections in place certainly cannot be called responsible legislative action.

Is Sandy Hook Father Asking the Wrong Questions?

In a recent article in the pressherald.com, father of Sandy Hook victim Avielle Richman, Dr. Jeremy Richman, is looking for answers, saying “we’re scientists. We ask ‘why’ for a living.” So one can only wonder why he’s failed to ask the questions that scream for answers.

As the father of one of the victims of the 2012 Sandy Hook shooting, Dr. Richman is on a broad, all encompassing mission to understand the workings of the brain of those who commit violent acts. Clearly this is a noble cause. But Ablechild cannot help but wonder what action Dr. Richman has taken to understand the murderous behavior of his child’s killer, Adam Lanza.

Specifically, it is well known that Ablechild sued the state of Connecticut in order to have Lanza’s medical/mental health records, autopsy and toxicology reports released for public review. Ablechild was denied this request as the state randomly concluded the non-profit was “not a stakeholder.” Ablechild believes that we all are stakeholders.

But it seems impossible that the state would deny a request by the family of one of the victims. Clearly the Richman’s would be considered “stakeholders.” Did Dr. Richman contact Ablechild to lend his support in these efforts? No. Has Dr. Richman ever requested that the state release this important information? Ablechild is unaware of any of the victim’s families requesting this information be made public.

It is no secret that Lanza had mental health issues. The problem, though, is that the State Police investigation of the shooting incident provides no information about Lanza’s mental health “treatment” after 2007 – five years prior to the shooting.

The public is aware that Lanza was “treated” at the Yale Child Study Center for OCD and was prescribed two antidepressants – Celexa and Lexapro – experiencing serious adverse reactions to both psychiatric drugs, as reported by his mother. But that was five years prior to the shooting.

What mental health “treatment” did Lanza receive after his “treatment” at Yale? It seems unrealistic that this grieving father would initiate this daunting brain campaign without having investigated every possible lead for answers about the man who killed his daughter.

After all if Lanza had been receiving mental health “treatment” prior to the shooting that consisted of psychiatric drugs, that information may be useful in understanding Lanza’s violent behavior. The Food and Drug Administration (FDA) has placed “Black box warnings” on all antidepressants as they may cause suicidal ideation and a host of other adverse reactions, including mania, psychosis and hallucinations.

Prior to the shooting was Lanza prescribed one or several psychiatric drugs to “treat” his OCD? Nobody knows. This information has not been made public. Has Dr. Richman made an effort to meet with Peter Lanza to glean information about Adam’s mental health “treatment?”

As a neuroscientist who has worked with pharmaceutical companies, Dr. Richman cannot ignore the fact that psychiatric drugs may actually cause violent behavior and, thus, information about Lanza’s mental health “treatment” may actually help understand his violent behavior. Failing to request specific, detailed information about Lanza’s mental health history seems odd.

Furthermore, has Dr. Richman, or any of the victim family members, requested information about the sealed, stamped envelope found in the Lanza home addressed “for the Young Students of Sandy Hook Elementary School?” Does Dr. Richman, or any of the victim families, know what was inside that envelope? Have the family members questioned the State Police about how the DNA of a convicted offender from New York was found on that envelope, while Adam and Nancy Lanza’s DNA was eliminated?   Do the family members wonder why, out of thousands of pieces of paper removed from the Lanza home, this particular envelope was fingerprinted and tested for DNA? What made this piece of evidence so important?

Additionally, has Dr. Richman, or any family members, questioned the State Police about the oddities of the ballistics report. For example, have any the family members raised questions about the weapon used to kill Nancy Lanza – the Savage Mark II rifle? Testing revealed the weapon has no fingerprints or DNA from Adam Lanza, but does have DNA for some unknown person.

Dr. Richman’s desire to understand the workings of the human brain of those who commit violent acts is a noble cause, but one cannot help wonder why Dr. Richman, and the other family members, appear to have no interest in the mental health records of the man who killed their loved ones or, for that matter, the ever increasing number of oddities in the official investigation of the shooting.

Ablechild believes these are basic questions that may help provide the answers that Dr. Richman is seeking and, also, make sense of the millions of dollars that were immediately appropriated by the State Legislature for increased mental health services.

 

 

Ablechild April 2014 Update

“Never underestimate the power of a few committed people to change the world, it is the only thing that ever has.”

 Dear Ablechild Members:

We’ve been busy and April proved to be a very rewarding month for Ablechild. We’re so pleased to have the opportunity to bring you up to speed on our efforts on your behalf.

We began the month with Ablechild, Co-founder, Sheila Matthews, attending the April 2nd Autism Awareness Day in Stamford, Ct., where Matthews was able to meet other like-minded people and gather support for Ablechild’s MedWatch System legislative language.

Matthews and New York Ablechild, Co-founder, Patricia Weathers, also attended the April 5th Connecticut Citizens Defense League (CCDL) “Rally at the Capitol,” in Hartford.  Matthews and Weathers manned a table to distribute information about Ablechild’s efforts to elicit support for the MedWatch System legislative language.

Continuing our push to gain support for the MedWatch System, Ablechild was invited to be a guest on two radio shows in April.  First, on April 10th, in response to the horrific stabbing incident in Pennsylvania, Ablechild’s Matthews was interviewed by national radio host, Jonathan Emord of “Truth Trials” radio, where Matthews discussed the possibility of psychiatric drugs being involved in the violent act and the need for MedWatch education via the non-profit’s legislative efforts.

Matthews also was a guest on the Mike DeRosa radio show in Connecticut, WWUH 91.3 FM on April 14th.  DeRosa and Matthews discussed the recent spate of school violence and again Matthews brought the issue full-circle by discussing the need for MedWatch education within the state and discussed in depth Ablechild’s legislative efforts to make this happen.

Throughout the month Ablechild published several articles related to mental health/drugging issues, including an op-ed requested by the distinguished mental health website madinamerica.com, titled Legislator’s Rush to Implement Increased Mental Health Services Based on No Data from Shooting at Sandy Hook. Ablechild also published New York’s “unsafe” ActState Child Advocate Still Investigating Sandy Hook Shooterand Ablechild Warns of Clinical Trial “offers” to Low-Income Families.  We hope all our members will click on each of these links and read this important information.

In our continuing efforts to get MedWatch education language inserted into legislation, on April 25th, Ablechild met with State Senator Markley and Representative Steinberg.  Both lawmakers were very supportive of Ablechild’s efforts and have offered their assistance with the legislative language when the new legislative session begins. Ablechild will work with both lawmakers over the Summer months to insure that we hit the ground running for the next legislative session.

Finally, Ablechild is so pleased to report that our annual fundraising event, the Spring Fling Raffle, was a huge success. We were pleased that so many of our friends and members attended the event at Venture Photography in Greenwich on April 24th.  And, we were even more gratified when the winner of the gift basket, George Papadopoulous, graciously “paid it forward,” donating the $300.00 Salon KIKLO beauty services gift to an Ablechild member.

While April was very busy and rewarding, we anticipate that May will be equally challenging. As always, we appreciate our Members continued support, which allows us to do the work on your behalf for you and your families. We always welcome your feedback and look forward to knowing your thoughts on issues of importance.

The Ablechild Team

 

 

 

New Information About Adam Lanza’s Mental Health Treatment Reveals Multiple Drugs

New information regarding Sandy Hook shooter, Adam Lanza, has recently been made public, adding to the already growing list of questions surrounding the Newtown shooting incident and Connecticut’s subsequent rush to increase mental health services.

With the March 10th release of The New Yorker article, “The Reckoning: The Father of the Sandy Hook killer searches for answers,” by Andrew Solomon, serious questions have been raised about the State Police investigation and the statements provided by personnel of the Yale Child Study Center, where reportedly Lanza was last treated.

The Reckoning author, Andrew Solomon, reports the following:

“Kathleen Koenig, a nurse specialist in psychiatry at Yale, gave some follow-up treatment. While seeing her, Adam tried Lexapro, which Fox had prescribed. Nancy reported, “on the third morning he complained of dizziness. By that afternoon he was disoriented, his speech was disjointed, he couldn’t even figure out how to open his cereal box. He was sweating profusely…it was actually dripping off his hands. He said he couldn’t think…He was practically vegetative.” Later the same day, she wrote, “He did nothing but sit in his dark room staring at nothing.”  Adam stopped taking Lexapro and never took psychotropics again, which worried Koenig. She wrote, “While Adam likes to believe that he’s completely logical, in fact, he’s not at all, and I’ve called him on it.” She said he had a biological disorder and needed medication. “I told him he’s living in a box right now, and the box will only get smaller over time if he doesn’t get some treatment.”

Remember that, until 2007, Lanza’s primary psychiatrist was Dr. Paul Fox who, in 2012, accused of having sexual relations with his patients, surrendered his license to practice medicine in New York and Connecticut, destroyed his records and moved to New Zealand.

Now Solomon is reporting that Dr. Fox had prescribed the antidepressant, Lexapro, and reportedly was working with the Yale Child Study Center’s Kathleen Koenig on Adam’s case.  Nancy Lanza apparently was very concerned about what appeared to be an adverse reaction to the mind-altering Lexapro and wrote copious notes about Adam’s behavior while on Lexapro.  More importantly, Solomon is reporting, apparently based on information gleaned from his extensive interviews with Peter Lanza, that Adam never took psychotropics again.

This important information does not jibe with the information Yale’s Kathleen Koenig provided to investigators and made public in the State’s Police Report of the shooting incident. Most importantly, the public only now, 15-months after the fact, is being made aware of a second psychiatric drug prescribed to Lanza and a second adverse reaction.

Five days after the shooting incident, investigators interviewed Kathleen Koenig. According to the police summary of Koenig’s interview the following was revealed.

“Koenig prescribed medication: Celexa – antidepressant/anti-anxiety.”

“Koenig recommended Adam Lanza participate in follow-up visits.”

“Koenig described Nancy Lanza’s response to her recommendations as “non-compliant.”

“Specifically, immediately after prescribing a small dose of Celexa to Adam Lanza, Koenig received a phone call from Nancy Lanza which reported her son was “unable to raise his arm.” Nancy Lanza was reporting her son was attributing this symptom to the medication. Nancy Lanza stated due to her son’s symptoms, he would be discontinuing use of the medication. Koenig attempted to convince Nancy Lanza that the medication was not causing any purported symptoms which Adam Lanza might be experiencing. However, Nancy Lanza was not receptive to Koenig’s reasoning. Nancy Lanza missed at least one scheduled appointment (unknown date) and failed to schedule subsequent appointments for Adam Lanza. Koenig did contact Dr. Paul Fox and agreed that his behavioral-based therapy would remain the primary course of treatment for Adam Lanza. She stated that Adam Lanza never returned for follow-up visits.”

According to the State Police Report, Koenig acknowledges that she had prescribed Adam Lanza the mind-altering drug, Celexa, and that Nancy Lanza had “immediately” reported what she believed to be serious adverse reactions to the drug. This is where it gets interesting.

If Lanza never returned to the Yale Child Study Center for follow-up visits and Koenig believed Nancy Lanza was “non-compliant,” when was the Lexapro prescribed?  Based on Solomon’s reporting it certainly appears that the Lexapro had been prescribed while Adam was being treated at Yale, yet the Lexapro incident apparently was not reported to investigators by Koenig.

Additionally, Koenig was advised on two occasions that Lanza had adverse reactions to psychiatric drugs prescribed to him – the Celexa and Lexapro. Why was information about the adverse reaction to Celexa provided to State investigators and not the adverse reaction to Lexapro?

On both occasions, when confronted with Nancy Lanza’s report of an adverse reaction to a drug, Koenig apparently pooh-poohed these concerns stating, “he had a biological disorder and needed medication,” and she “attempted to convince Nancy Lanza that the medication was not causing any purported symptoms which Adam Lanza might be experiencing.” Ultimately, it seems that Koenig labeled Nancy Lanza “non-compliant,” when in reality it appears this mother was acting responsibly.

One has to wonder how informed Koenig is when it comes to psychiatric drugs.  First, there is no medical/scientific evidence to support Koenig’s claim that any psychiatric disorder is “biological.”  Secondly, the information provided by Nancy Lanza about the adverse reaction to the Celexa actually is one of the serious side effects of the drug – “stiff, rigid muscles.” Adam had complained that he could not lift his arm. And Nancy Lanza also told Koenig that Adam was “sweating profusely.” This also is an adverse side effect of Lexapro.

Unfortunately, Solomon did not provide information in his article about the date the Lexapro was prescribed.  However, because Solomon wrote that “Adam stopped taking Lexapro and never took psychotropics again, which worried Koenig,” we can assume that it was during the time that Adam was receiving treatment at the Yale Child Study Center.

Based on the fact that Adam did not “participate in follow-up visits” to the Yale Child Study Center after the Celexa incident, then the above information seems inaccurate. According to Koenig’s statement to police, Celexa was the only drug that Adam received and that was the end of the relationship with the Yale Child Study Center.

Beyond the fact that the data provided by Solomon about Koenig’s statements appears to be contradicting the State Police Report, what also becomes abundantly clear is that Koenig appears to be completely unwilling to accept, as real, Nancy Lanza’s reports about the medication.  Koenig does not recommend discontinuation, nor does she recommend that the adverse reactions be reported to the FDA’s MedWatch drug reporting system.

More bizarre, though, given that the Yale Child Study Center appears to be pivotal in Lanza’s mental health care, is that Dr. Ezra Griffith (a psychiatrist) of Yale University was chosen by Connecticut Governor Dannel P. Malloy to sit on the Sandy Hook Advisory Commission, which is tasked with making recommendations about mental health care in the state. Furthermore, the Yale Child Study Center testified before the Advisory Commission.  Is this not a serious conflict of interest?

Nevertheless, the point is, of course, that there is a problem with the information about Adam Lanza’s mental health care.  Specifically, when did Adam Lanza stop taking psychiatric medication? In fact, what medications had Lanza been prescribed throughout his life?  Why has no information about Lanza’s mental health for the last five years of his life been made public? Did Nancy Lanza uncharacteristically decide to stop providing mental health treatment for Adam after his negative experience at the Yale Child Study Center?

No one knows. And that is why all of Lanza’s mental health records need to be made public. Until that time, more information about Lanza’s mental health treatment and prescribed drugs will surely leak out. In the meantime, though, important mental health decisions, affecting the entire country, will be made by lawmakers.

As often is the case when it comes to these tragic school shootings, lawmakers irresponsibly act first then, maybe, consider the facts later.  What Ablechild is learning, though, is that the “facts” of this incident keep changing, making it all the more important for the public to demand absolute transparency of all information regarding Lanza’s mental health records.

It is no secret that almost immediately Lanza’s mental health treatment was questioned.  Specifically what mental health disorder(s) did he suffer from and what “treatment” and medications had been prescribed over the course of his life.

Given that most of the psychiatric drugs available at that time had not been approved for children and that they also carried serious FDA “black box” warnings for serious behavioral adverse reactions, these questions are not unimportant.

In fact, without this information no governing body can responsibly claim the need for “increased mental health services” based on the shooting incident at Newtown.  Without knowing Lanza’s mental health history, lawmakers are subjecting the public to unnecessary and costly mental health services with zero information to support the action.

 

 

 

 

 

“ON THE AIR” Ablechild kicks off in CT then goes National for MEDWATCH AWARENESS

On February 14, 2014, Ablechild was interviewed on WGCH 1490 AM, Greenwich, Connecticut. Ablechild left immediately after that interview to the Capitol in Hartford, Connecticut to educate lawmakers on the MEDWATCH “adverse drug” reporting system.  Ablechild distributed to every State Representative and Senator a copy of the “MEDWATCH” form  along with suggested language to incorporate into law “the ensured access” for the consumer on their right to report “adverse drug events” to the FDA.  Take a listen, below:

Tony Savino
News Director
WGCH 1490-AM
71 Lewis St.
Greenwich, CT. 06830


After our effort in Connecticut, Ablechild reached out Nationally.  We did our first exclusive interview on the National radio show, Republic Broadcasting System with Deanna Spingola, where Ablechild discusses the Sandy Hook, Newtown Investigation, our legislative efforts, and fielded questions from callers throughout the United States, as well as a call from Canada!  Take a listen:

Ablechild Guest on Republic Broadcasting Network with Deanna Spingola

Federal MedWatch System Rejected in Connecticut Public Safety and Security Committee

Federal MedWatch System Rejected in Public Safety and Security Committee

 Ablechild’s legislative efforts to bring awareness to consumers of Connecticut about the Food and Drug Administration’s (FDA) MedWatch System have been shot down before ever getting off the ground. It is an odd story, but one that seems to be standard operating procedure for the state’s legislative body.

On Tuesday, February 18th, Ablechild co-founder, Sheila Matthews, drove thru a snowstorm in order to personally testify before the Public Safety and Security Committee regarding two legislative measures: an Amendment, which would include training law enforcement personnel about the existence, and availability of the MedWatch System, and also a new bill requesting that February 14th of each year be recognized as MedWatch Awareness Day.

Ablechild also submitted the two requests electronically prior to the 18th and checked in with the Committee clerk prior to the public hearing.  Ablechild was assured its request was received prior to the deadline of 2/20 for Committees to raise bills.

Ablechild was advised by the Public Health Committee that the appropriate committee for such legislative requests would be the Public Safety and Security Committee.  Apparently there is some kind of legislative shuffle happening in Connecticut because the reason provided to Ablechild for rejecting the two legislative measures was because the legislation “should have been filed with the Public Health Committee.”

But that isn’t the only oddity. Ablechild was shocked to learn that, despite going to great lengths to be present for the public hearing on February 18th, its testimony was mysteriously missing from the committee’s website – not so much as a mention of Ablechild’s appearance before the committee. Upon inquiring about this “lost testimony,” Ablechild was told that, basically, accidents happen. What are the odds that Ablechild’s testimony for both legislative measures would go missing?

The bigger question, though, is what part of Ablechild’s legislative Amendment is not concerned with Public Safety?    SB 98 would provide training to law enforcement as part of the “drug detection and gang identification process…”

The reason behind SB 98 is backwash from the tragedy at Sandy Hook.  Everyone is concerned about safety in schools because of the deadly incident, but few realize that Nancy Lanza reported to the Yale Child Studies Center that Adam Lanza was experiencing an adverse reaction to a drug prescribed to him.  Despite raising legitimate concerns, Yale did not provide Nancy Lanza with information about how to report the adverse event to the FDA.

The MedWatch System is set up by the FDA in order to allow consumers the opportunity to report adverse reactions to prescription drugs. Given that 70 million Americans currently are taking prescription mind-altering drugs (many of those live in Connecticut), and the Centers for Disease Control and Prevention (CDC) reports that a staggering 27,000 unintentional overdose deaths are ascribed to prescription drugs, wouldn’t the committee take this information into consideration as a Public Safety issue?

The MedWatch System is about Public Safety.  The reporting of adverse drug events plays a huge part in ensuring that the public is safe from drugs that may be harmful and this information can only be obtained if consumers are aware of the MedWatch System.

While Ablechild is shocked by the committee’s blatantly sloppy mishandling of its testimony, the larger issue is the committee’s unwillingness to consider legislation that actually may protect public safety, especially in light of the fact that there is no funding request associated with either piece of legislation.

Seems like a no-brainer.  Training law enforcement about a federal drug reporting system that, if used, could help saves lives and at no cost to the state.  Thanks to the short-sightedness of the committee, its inability to recognize what could have been a win-win for the state and consumers, this important legislation has been relegated to the trash bin.

Not surprisingly, though, the pharmaceutical-funded National Association of Mentally Ill (NAMI) did not experience the “accidental” loss of its testimony nor was it rejected for consideration. NAMI, and other like organizations who submitted testimony to the committee, are fighting for increased access to mental health (prescription mind-altering drugs) in an already over-prescribed market, while Ablechild is committed to providing informed consent and MedWatch would have been a step in the right direction of protecting parental informed consent.

While Ablechild was willing to work with other organizations to help ensure public safety, it appears that SB98 does nothing to ensure parents rights and, therefore, Ablechild is unable to support this legislation.

 

Ablechild Submits Legislative Requests in Public Safety and Security Committee

Ablechild Submits Legislative Requests in Public Safety and Security Committee

In response to Governor Dannel P. Malloy’s announced funding in the state’s mental health budget, Ablechild has introduce two pieces of legislation with the Public Safety and Security Committee, that would provide informed consent and consumer access to the FDA’s MedWatch adverse drug event reporting system.

It is no secret that prescription mind-altering drugs are linked to a number of violent incidents across the country. It also is no secret that the use of psychiatric drugs is increasing at startling rates. For example, currently 70 million Americans (one in five) is taking a mind-altering drug.

In 2010, alone, more than 250 million prescriptions for antidepressants were written for Americans and ten percent of high school children are prescribed prescription psychiatric drugs to “treat” ADHD. The Center for Disease Control and Prevention (CDC) has suggested that there is a greater risk posed by prescription drugs than illicit substances.

As is well known, Ablechild sued the State to obtain Adam Lanza’s mental health records and toxicology report in order to learn whether Lanza had been prescribed psychiatric drugs and whether those drugs may have played a role in his violent behavior.

Although the state refused to make public Lanza’s mental health records and complete toxicology report, what is known is that Lanza had at least been prescribed the antidepressant, Celexa, in 2007. Immediately after taking the Celexa, Nancy Lanza reported to the Yale Child Studies Center that she believed Adam was having an adverse reaction to the drug.

Despite Nancy Lanza’s concerns about the drug, mental health practitioners at Yale did not make Lanza aware of the FDA’s MedWatch System in order that she could report the adverse event, nor is there any information provided in the State Police Report of the shooting that Yale made any effort to report the adverse event to the FDA.

Ablechild has submitted to the Public Safety and Security Committee an amendment to Raised S.B. 98 to include training of the MedWatch System to security personnel. The amendment would make it mandatory to provide verbal and written information to parents of children who are flagged in the drug detection and gang identification process.

Ablechild’s second legislative request to the Public Safety and Security Committee is to make February 14th of each year MedWatch Awareness Day, which would acknowledge the important role the MedWatch System plays in protecting the health and well-being of the State’s consumers.

“Both of these legislative measures,” said Ablechild co-founder, Sheila Matthews, “are an important part of informed consent.  This is about public safety, and it’s about making sure that parents know that they can directly report adverse drug events to the FDA. The system is completely private and there is no cost associated with it.”

“Less than one percent of the actual adverse drug events are reported to the FDA,” explained Matthews “because people are not aware that the system exists.” “These legislative initiatives,” said Matthews, “would be a great help to Connecticut consumers and, ultimately, help the FDA decided when action needs to be taken on a drug.”

Both legislative requests have been sent to the Public Safety and Security Committee and Ablechild looks forward to the upcoming public hearings to gain support for the measures.

 

 

Will The Governor Include MedWatch Training To Proposed Mental Health Initiatives?

Will The Governor Include MedWatch Training To Proposed Mental Health Initiatives?

Sandy Hook Shooter Proves Need For Inclusion

In an apparent response to the 2012 Sandy Hook Elementary shooting, Connecticut Governor, Dannel P. Malloy, has announced increased funding in the state’s mental health budget. Why?

If shooter, Adam Lanza, had been a product of the state mental health system there may be some evidence to back up such broad changes, and this increased spending may make sense. But, to date, there is no evidence that Lanza received any state mental health assistance.

In fact, based on what little information has been made public about Lanza’s mental health treatment, it appears that, beyond school recommendations to the family, the father’s private insurance was used and the family did not depend on state sponsored benefits.

Of course, the last publically known mental health treatment Lanza received was from the Yale Child Study Center, which, oddly enough, provided information to investigators about an adverse drug event Lanza was experiencing from the prescribed antidepressant, Celexa.

According to the State Police investigation of the shooting, Yale Child Study Center Registered Nurse, Kathleen Koenig, prescribed Celexa to Lanza and was “immediately” contacted by Nancy Lanza, who reported that her son was “unable to raise his arm.”

Did Koenig recommend discontinuation of the antidepressant?  No. In fact, Koenig told police investigators that she tried to “convince Nancy Lanza that the medication was not causing any purported symptoms which Adam might be experiencing.”

Koenig’s response seems questionable.  First it is important to point out that Celexa has not been approved for use by children, so the prescription was written “off-label” when Adam was 15 years old.  More importantly, though, the “serious side effects” include: “call your doctor at once if you have a serious side effect such as: very stiff (rigid) muscles.”

To the layman, it doesn’t seem out of the realm of possibility that Lanza, unable to lift his arm, may have been experiencing one of the serious side effects of the antidepressant.  In fact, a quick perusal of the internet reveals many reports of similar complaints associated with Celexa.

Is it possible that Koenig was unaware of the specific side effects associated with Celexa?  Did Koenig review the possible adverse side effects of Celexa before providing her medical advice?

Koenig further reports to investigators that “Nancy Lanza was not receptive to Koenig’s reasoning,” and that Nancy Lanza “missed at least one scheduled appointment…and failed to schedule subsequent appointments for Lanza.”

Again, given Koenig’s response to Nancy Lanza regarding what very likely could be a serious adverse reaction to the psychiatric drug, is it so tough to understand why Nancy Lanza decided to end her son’s relationship with the Yale Child Study Center?”

It is interesting to note, however, that investigators do not mention whether Koenig reported this adverse drug event to the Food and Drug Administration’s MedWatch System. Nor do investigators mention whether Koenig advised Nancy Lanza that she could report the adverse event to the FDA herself.

Ablechild believes that the MedWatch System is an important, no-cost, tool that is necessary for the FDA to make safety recommendations and post warnings to consumers about drugs. In an effort to provide consumers with this important information, Ablechild is lobbying State lawmakers in an effort to have information about the MedWatch System made part of any new mental health training among educators and mental health care workers.

Given that the Yale Child Study Center receives state mental health funding, it seems appropriate that Governor Malloy might consider it important for organizations, such as the Yale Child Study Center, be made aware of the availability to consumers about the MedWatch System.

It’s only speculation, but it would appear that Nancy Lanza’s reporting of the adverse drug event her son was experiencing was a perfect time for an organization, such as Yale Child Study Center, to take advantage of the FDA’s MedWatch System.

 

 

 

 

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