Skip to main content

Tag: MedWatch

AbleChild’s Statement on Informed Consent as it Relates to Covid and Consumer Safety

 

AbleChild has worked diligently throughout the years on informing the public on the importance of Informed Consent and an individual’s right to be given all necessary information (full disclosures on diagnosis, benefits, risks, alternatives) regarding psychiatric drugs and children.  Informed Consent is no less important as it overlaps many different issues and comes back to overall public safety.

Continue reading

FDA Responds to AbleChild’s MedWatch PSA Request for Public Education

Recently, AbleChild requested that the FDA run their own PSA (Public Service Announcement) to educate the public on how to report Adverse Drug Reactions directly to the Agency.  The FDA’s response to our request is shocking, as they state that because MedWatch is a “voluntary” program, there is no need to run the PSA to educate the people on its existence and importance.

Continue reading

FDA’s MedWatch Minute, Where has it been?

AbleChild found a 2016 Public Service Announcement on the Consumer Adverse Drug Reporting System.  One must ask, why hasn’t this been running on TV?  With the billion dollar drug industry advertising on TV, it is amazing that this FDA PSA hasn’t seen the light of day.  This is exactly why we need a urgent call to action to get a MedWatch law passed for the consumers.

We need your help, please take action  Please support our efforts to keep informed consent mission going!

Continue reading

Government Oversight Councils Contribute to Opioid Crisis

The Washington Post reported on July 6, 2017 that there’s a “glimmer of hope” for the devastating opioid crisis that has ravaged our Nation killing close to 180,000 people between 2000 and 2015.  According to the article Opioid Prescriptions Dropped for the First Time in the Modern Drug Crisis, the Center for Disease Control and Prevention reported that the number of opioid prescriptions written between 2012 and 2015 declined by 13.1%. But before breathing a sigh of relief that this crisis may be ending, there still are serious issues:

  1. The prescription rate for opioids is still three times the level it was in 1999 and 4 times what it is in some European countries.
  2. Anne Schuchat, the CDC’s acting director, said that even with this decline in opioid prescriptions, “enough opioids were ordered in 2015 to keep every American medicated around-the-clock for three weeks.”
  3. In 2015 there were more than 33,000 deaths from prescription opioids. 13,000 more people died from heroin overdoses.

If this is considered the first sign of any progress after almost two decades of hopelessness, it is troubling. The fact is questions surround the accuracy of stale statistics being utilized to highlight this “glimmer of hope.”  The wavering light of improvement touted in the article appears to be coming from data that is two years old.  Gary Mendell lost his son Brian to addiction in 2011 and started the anti-drug advocacy group, Shatterproof, to bring more attention to the opioid crisis.  Mendell expressed concern over the CDC’s methods of collecting and analyzing data in the United States, calling it “cumbersome and inefficient.”  AbleChild shares Mendell’s concerns.

According to Connecticut’s Public Health Department website, “Within the realm of public health, mortality statistics are often used as a cornerstone in formulating health plans and policies to prevent or reduce premature mortality and improve our quality of life.” So, what happened?  Why no real progress?

Today, behavioral health “oversight” councils exist in every state.  Federal legislation fuels the councils with mental health block grants that are dispersed to the billion-dollar behavioral health industry.  The outcome of being ruled by behavioral health councils equates to the more money given, the more the crisis grows.  The opioid crisis has been determined to be a behavioral health problem because psychiatry has determined that addiction is a mental illness.  What is odd about this determination is that there is no science to support that addiction is an abnormality of the brain.

Nevertheless, the Behavioral Health Oversight Partnership Council (BHOPC) ultimately reports through the executive branch. The committee members are mental health vendors that sell their products and services to the government to reach consumers. They make recommendations on how the block grant money is spent, actually write the legislation, and are never audited. Obviously this is a clear and present conflict of interest and is deadly for the consumer. Members are not elected and the policies they influence increase their financial bottom line.

The Connecticut BHP Oversight Council current opioid crisis plan is outlined in a vendor’s presentation entitled Project Echo a 3-pronged solution. Simply put, it’s an “Access, Drug, Drug” approach. Missing in all the glossy presentation marketing material is enforcing informed consent for patients on what these drugs really are, the possible side effects, and a lack of access to natural alternatives that don’t involve prescribing more drugs such as Soboxone and Naxolone.

The Council fails to educate the consumer on how and why to report an adverse drug event via MEDWATCH. After all, the FDA uses the MEDWATCH consumer reporting system to regulate the drug companies; one would think this is important for the consumers to have access to during this prescription drug crisis, but apparently not.  Yet, it is difficult to miss the executive branch bootlicking praise of yet another mental health vendor’s experience and knowledge in the field of addiction.

The BHPOC recently welcomed back Lori Szczygiel to re-assume the role of Chief Executive Officer for Beacon Health Options, a prominent behavioral health company. In the presentation distributed by the Council for Beacon, entitled Health Inequity in the Connecticut Medicaid Behavioral Health Services System: A Roadmap for Improvement.  It was shocking to see a clear marketing strategy to target certain racial and ethnic groups in the Beacon “three-pronged plan” with the roadmap rational jargon of “unmet” mental health “needs” of Blacks and Asians in particular. Considering that the “solutions” they are presenting mostly involve prescribing more drugs, it seems dangerous and discriminatory to be singling out any race or ethnicity as a target for treatment.

This would not be the first time a behavioral health provider would use the “bad gene pool approach” to capture more mental health clients for their addictive drug treatment programs. A psychiatrist in Texas made national news explaining to the legislators why children in foster care were given massive psychiatric drugs. The psychiatrist indicated the reason the children were given multiple drugs, off label, was because they were from a “bad gene pool.” AbleChild stood with the NAACP for that psychiatrist to step down. Clearly, this racial and ethnic “Beacon Theory” should be backed up with some science.

The lack of science and accurate data is appalling and must be called out as a major contributing factor in the overall opioid death toll.

 

Landmark Legislation: Consumer Protection MedWatch Phone Number Placed on Generic Prescription Drug Containers in Connecticut

For immediate release: July 15, 2015
Contact Sheila Matthews, Cofounder AbleChild (203) 253-0329
Westport, Connecticut

Landmark Legislation: Consumer Protection
MedWatch Phone Number Placed on Generic Prescription Drug Containers in Connecticut

AbleChild is pleased to announce the passage of Connecticut SB 28, a bill that makes it mandatory for all generic prescription drug containers to carry the 1-800 MedWatch telephone number. This is a first-in-the-nation legislative action to provide this important consumer information and a landmark win for consumers in Connecticut. In February of 2015, AbleChild proposed an amendment to SB 28, taking the unique opportunity to propose this very specific protection on behalf of the consumers.

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).

Information provided to MedWatch, by consumers, provides a unique tool to the FDA by giving the federal agency the ability to identify adverse reactions and monitor prescription drugs. The information collected about adverse reactions is used to determine if FDA action is needed on a specific drug.

According to the FDA, it receives information on less than 1% of the actual adverse drug reactions (ADRs) from the consumers. Prescription drugs are currently responsible for killing more people annually than illegal drugs, and according to Tom Friden, the director of the Centers for Disease Control and Prevention (CDC), “It’s a big problem and getting worse.” Furthermore, according to the Medical Journal of Medicine, prescription drugs are responsible for 291 deaths every day.

Representative David Baram of Bloomfield, co-chairman of the General Law Committee, stated that, “The passage of legislation requiring the MedWatch information to be provided with prescription medications is a positive consumer bill.  I applaud Sheila Matthews for bringing this to our attention and helping us to pass this great consumer protection legislation.  Now consumers will have information on how they can report adverse prescription reactions so the manufacturers can review medication issues, and the FDA can re-evaluation safety concerns.  This is a major consumer protection that will help promote the safe use and manufacturing of medicines that many of us rely on to live productive lives.”

Senator Joe Markley, who also supported AbleChild’s efforts from the beginning said, “I’m delighted at the progress AbleChild has made in getting out the word on MedWatch, which will enhance the conversation on prescription drugs.  Reactions to these drugs differ dramatically, and it’s important that people who have a bad experience have a place to report what happened.  I hope we can do more to let people know about MedWatch, and to make them aware of the problems sometimes associated with certain prescription drugs.”

AbleChild’s amendment received bipartisan support and was unanimously passed on June 1, 2015. AbleChild would like to acknowledge and thank the cosponsors of this important consumer protection legislation, including Senator Joseph J. Crisco, 17th District, Representative Jonathan Steinberg, 136th District, Senator Joe Markley, 16th District, and the General Law Committee Chairman, Representative David A. Baram of the 15thDistrict.

AbleChild also would like to extend our sincere gratitude to the entire General Law Committee staff for their assistance in navigating the often, complicated legislative process.

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.

 

 

  • 1
  • 2