Posts Tagged ‘FDA’

Washington University in St. Louis Shocks Pregnant Women

Sunday, March 19th, 2017

Mark Wrighton, the Chancellor of Washington University in St. Louis (WUSTL), wrote in the Spring 2017 Washington magazine, “One of the [Leading Together fund raising] campaign’s priorities is to advance human health.”

This is a laudable goal, but it is belied by the University’s strong support of the psychiatric industry and the reprehensible actions of psychiatrists on the university payroll.

The WUSTL interest in Electro Convulsive Therapy (ECT) and other harmful psychiatric “treatments” [Repetitive Transcranial Magnetic Stimulation (rTMS), and Vagus Nerve Stimulation (VNS)] is not superficial, it is widespread throughout the psychiatric department, and is a primary area of education for medical students.

Approximately 150,000 people get ECT every year in the US, with 2,000 shock treatments being done every year by WUSTL psychiatrists at Barnes-Jewish Hospital. Complications after treatment usually increase with the age of the patient; small surprise there. WUSTL psychiatrists say that, “ECT is considered a safe treatment modality in pregnant women in whom a number of medications may be associated with risk to the fetus.”

“The main inpatient psychiatry facility has 48 beds and is divided into three locked units — intensive care floor, step-down floor and a geropsychiatry floor. The units are located on the 15th floor of the main Barnes-Jewish teaching hospital and are closely integrated into all of the specialty care inpatient units (e.g., surgery, internal medicine, neurology) of the hospital. The 15th floor also houses an ECT suite where approximately 2,000 treatments are done each year.”

Medical Residents are trained in these procedures. “A major emphasis of our program is intensive clinical training underscoring diagnostic skills, somatic treatments including psychopharmacology, ECT, and experimental procedures such as rTMS and VNS.”

“Residents evaluate patients referred to the Treatment-resistant Depression and Neurostimulation Clinic and work on the ECT service at Barnes-Jewish Hospital, providing ECT consults to the inpatient psychiatric services and to outpatients referred by their outpatient psychiatrist.”

These procedures are subjects of intensive research. “Faculty and staff of the Department of Psychiatry at Washington University School of Medicine conduct federally funded and industry-sponsored research through the Center for Mood Disorders.” — These procedures include ECT, TMS, and VNS.

Dr. Charles Zorumski says, “Our clinical studies are examining the benefits and risks of electroconvulsive therapy (ECT) in various groups of patients with psychiatric disorders, including the use of ECT as a maintenance therapy.”

Dr. Pilar Cristancho boasts that she won an award in 2008 at the Philadelphia Psychiatric Society, 6th Annual Colloquium of Scholars for “Electroconvulsive Therapy for treatment of severe major depression during pregnancy.” She also conducts research for Transcranial Magnetic Stimulation on pregnant women.

Dr. Michael Jarvis expresses his interest in “suicide and treatments for significant psychiatric illness such as Electroconvulsive Therapy and Transcranial Magnetic Stimulation.”

ECT can cost between $300 and $2,500 per session, there is apparently no set standard; a primary cost driver would be how much hospital support is required for the patient. With eight as the average number of treatments per patient, this means a course of ECT treatment will cost between $2,400 and $20,000. Medicare allowed charges are roughly $88 per session.

A TMS patient will usually have 20-30 treatments, typically in the range of $400-500 per session for a total cost of about $15,000.

The cost of implanting a VNS device is approximately $30,000 and up.

Predictably, the psychiatrists of WUSTL insist that ECT is safe and effective. Realistically, would you stick your finger in an electrical socket on purpose? Let alone your brain?

A prominent constitutional attorney was presented with a Human Rights Award at the 48th Anniversary celebration of the mental health watchdog, Citizens Commission on Human Rights (CCHR). The event, held in Los Angeles on March 4th, included hundreds of guests from around the world honoring the awardees for their work in the field of mental health reform. Among his accomplishments, Constitutional attorney Jonathon W. Emord is currently challenging the U.S. Food and Drug Administration‘s (FDA) bizarre and dangerous proposal to reduce the risk classification of the electroshock treatment (ECT) device, which would make the brain-damaging procedure more widely used, including endangering children.

In accepting the award, Mr. Emord said, “ECT devices are a throw-back to an age of primitive torture, of ignorance and barbarism, where bludgeoning those with depression and psychoses into a lack of consciousness and awareness was considered therapeutic. This past year CCHR has done more than any other organization to fight against FDA’s indefensible proposal to make Electroshock Therapy devices far more available for psychiatric use, a move that would expand the horrors and compound the problems facing patients in need…Electroshock must be banned.”

Click here for more information about ECT and other horrifying psychiatric treatments.

Remembering Carrie and Debbie

Friday, January 6th, 2017

We are sincerely grieved at Carrie Fisher’s death December 27th from heart failure. When we read that Carrie Fisher suffered a heart attack December 23rd on a plane flight from London to Los Angeles, we were shocked.

Fisher as Princess Leia was just 19 years old when she began shooting “Star Wars.” By the time she was 21 she was doing LSD in an attempt to self-medicate. In 2011 she confessed to Oprah that she had electroshock therapy every six weeks, since the antidepressants were not entirely effective in dealing with her mental issues, suffering memory loss as a result. She was hospitalized in 2013 for so-called bipolar disorder, and she was still taking psychotropic drugs and getting ECT.

One can only assume such treatment continued into present time, so it is now hardly shocking that she has suffered a heart attack as well. The amazing part is her resilience. All those drugs and electric shocks through the years, in a normal person, may well have been fatal far sooner.

Any benefit one claims for ECT, no matter how famous one is, has to speak only for a person’s innate strength, since ECT, as well as psychotropic drugs, is patently damaging.

A cursory review of over 200 psychotropic drugs shows that every one has potential adverse effects of heart attacks or other heart-related problems. During ECT, the heart rate is severely impacted, either speeding up or slowing down dramatically. Most deaths reported during or immediately after ECT are cardiovascular in nature.

And now, the FDA wants to reclassify ElectroConvulsive Therapy machines to exempt them from clinical testing if they are similar to machines currently being marketed, which effectively means they do not have to be demonstrated as safe and effective.

Frankly, the FDA should simply ban outright the use of psychotropic drugs and ECT machines as being dangerous and harmful.

We are doubly saddened by the passing of Debbie Reynolds, Fisher’s mother, just a day after Fisher’s death. Debbie Reynolds was recognized for her decades-long commitment to various charities, including the mental-health organization The Thalians, a group of entertainment professionals who support mental health care issues. Reynolds was among the founders of the Thalians charity group in 1955, and was the Thalians’ third president. A mental health center at the Cedars-Sinai Medical Center was named after the organization. It closed in 2012 and the Thalians now raise funds for veterans with mental health issues in association with the UCLA Medical Center. Honor the memory of both Carrie and Debbie by working with CCHR to continue to bring sanity to the mental health care profession.

Passage of the 21st Century Cures Act

Saturday, December 17th, 2016

If you contacted your Senators and Representative about the dangers of the 21st Century Cures Act, thank you very much.

Unfortunately it passed — 392 to 26 in the House, and 94 to 5 in the Senate.

While some of the $6.3 Billion funded by this legislation is not controversial and may even be beneficial, a large chunk of the money will go to fund suicide-prevention programs, mental health services for children, and programs for court-ordered psychiatric outpatient treatment. It reinforces current laws that require insurers to treat mental illness as they do any other illness in terms of benefits (“parity“). And it creates a new position in the US Department of Health and Human Services called the Assistant Secretary for Mental Health and Substance Use for coordinating mental health programs across the federal government.

The bill also lowers the regulatory bar of the Food and Drug Administration,  which may result in less safe and effective products reaching the market by putting less emphasis on clinical trials, which has caused some critics to label it the 21st Century Quackery Act. The FDA insists it will not compromise safety and efficacy; but they have already shown their fake reliance on safety and efficacy by approving psychotropic drugs and trying to make it easier to approve electric shock machines.

How concerned should we be? Very concerned. Proliferation of coercive and abusive mental health “care” by the current psychiatric industry is a waste of lives and funding.

Instead, here is what we should be doing:
1. Mental health hospitals must be established to replace coercive psychiatric institutions, where appropriate medical diagnostics and treatments can be performed. Proper medical screening by non-psychiatric diagnostic specialists could eliminate more than 40% of psychiatric admissions.
2. Establish rights for patients and insurance companies to receive refunds for harmful and abusive mental health treatment.
3. Clinical and financial audits must be done for all psychiatric facilities to uncover and correct fraud and abuse.
4. All mental disorders in the DSM should be validated by scientific, physical evidence.
5. Abolish mental health courts and mandated community mental health treatment.
6. Citizens groups and responsible government officials should work together to expose and abolish psychiatry’s hidden manipulation of society.

Risky Business of Sleep Drugs

Saturday, March 5th, 2016

Risky Business of Sleep Drugs

After reading about the dangers of sleeping pills in the February 2016 edition of Consumer Reports magazine, we thought you might like to know something about that.

Some psychotropic drugs are prescribed as sleeping pills. Trazodone, an antidepressant, is often prescribed off label as a sleeping pill. Benzodiazepines such as Valium are also prescribed as sleeping pills. Other examples are Ambien (an anti-psychotic), Lunesta (an anti-anxiety drug), and Sonata (another anti-anxiety drug).

These have all the potential side effects we have come to associate with psychiatric drugs — including violence, suicide, addiction, and so on.

The latest sleeping pill fad, touted as “the new insomnia drug”, is Belsomra (generic “suvorexant”). It is classified as a “sedative-hypnotic” which means it is a central nervous system depressant; it alters brain chemistry by targeting a neurotransmitter called orexin.

Belsomra is manufactured by Merck, Sharpe & Dohme Corporation, and was approved by the FDA for insomnia in August of 2014.

Guess what? This drug carries the same warnings as other psychotropic drugs; it may cause memory loss, anxiety, confusion, agitation, hallucinations, depression, addiction, and thoughts of suicide — all this along with its own special side effects: inability to move or talk, sleep-walking, sleep-driving, and drowsiness lasting through the next day.

Here is what Consumer Reports has to say about Belsomra: “…people who took a 15- or 20-milligram dose of Belsomra every night for three months fell asleep just 6 minutes faster on average than those who took a placebo. And those on Belsomra slept on average only 16 minutes longer than people given a placebo. Such small improvements didn’t translate to people feeling more awake the next day, either. Instead, more people who took Belsomra reported that they felt drowsy the next day than those who took a placebo.”

“Because of the limited benefits and substantial risks of sleeping pills, Consumer Reports’ medical experts advise that sleep drugs should be used with great caution.”

“Merck spent $36 million on TV ads for its new drug Belsomra from Aug. 1 to Nov. 24, 2015, making it the second most advertised Rx drug in that time frame, according to iSpot.tv. The ads note that Belsomra is the first drug to target orexin, a chemical that plays a role in keeping people awake. But Belsomra doesn’t work much, or any, better than other sleep drugs. And because it’s new, little is known about its long-term safety.”

One take-away here is that even if a prescription drug is not advertised or prescribed for psychiatric reasons, if it messes with the brain’s neurotransmitters and has all the same side-effects as a psychiatric drug — well, you must get the picture by now.

The Consumer Reports article goes on to discuss non-drug sleep alternatives at some length; it is a good and helpful read.

When your doctor prescribes a drug, it is good practice to ask questions so you can give your full informed consent. These are some example questions you can ask:

1. What is the evidence for the diagnosis?
2. How does the treatment affect the body?
3. How does the treatment affect the mind?
4. What unwanted effects may occur?
5. Is it approved by the FDA for this condition?
6. What is known and not known about how safe it is and how well it works?
7. What are the alternatives, including the option of no treatment?
8. Does the doctor or the clinic have a financial interest in pushing the diagnosis or treatment?

Another Day Another Anti-depressant (Again)

Thursday, February 25th, 2016

Another Day Another Anti-depressant (Again)

On July 10, 2015, the U.S. Food and Drug Administration approved Rexulti (brexpiprazole, an atypical antipsychotic) tablets to treat adults with so-called schizophrenia and as an add-on treatment to an antidepressant medication to treat adults with so-called major depressive disorder. We are now starting to see the TV ads for this.

Rexulti is manufactured by Tokyo-based Otsuka Pharmaceutical Company Ltd. and its partner Lundbeck. It might be marketed as a replacement for Abilify (aripiprazole), although clinical trials for its usage to treat ADHD were discontinued, likely due to lack of efficacy. It is still a new drug that has not been tested over a long-term in a real-world population.

Rexulti and other such drugs have a Boxed Warning alerting health care professionals about an increased risk of death associated with the off-label use of these drugs to treat behavioral problems in older people with dementia-related psychosis.

The Boxed Warning also alerts health care professionals and patients to an increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants.

It has the same pattern of debilitating side effects as any other antidepressant or antipsychotic, including addiction and suicidal thoughts and actions. The most common side effects reported by participants taking Rexulti in clinical trials included weight gain and an inner sense of restlessness (akathisia), such as feeling the need to move.

Rexulti is being touted as producing less akathisia, restlessness, and insomnia than other drugs, but it is important to be skeptical of this marketing due to the fact that clinical trials reported all of these side effects. Like all antipsychotics, Rexulti will likely have severe withdrawal symptoms.

While the way Rexulti works is completely unknown, it affects serotonin, dopamine, and norepinephrine neurotransmitters in the brain; and this effect is called a “serotonin-dopamine activity modulator”. Messing with neurotransmitters in the brain without really understanding how they work is serious business; we don’t recommend it. In any case, we can guarantee that this chemical-in-the-brain-based hypothesis is bogus. Full Informed Consent should be your watchword.

Rexulti was studied in two 6-week clinical trials of 1,054 patients aged 18-65. The patients selected for the studies took another antidepressant for at least 8 weeks. Twenty patients discontinued participation due to adverse reactions.  The incidences of akathisia and restlessness, and some other side effects, increased with increases in dose.

We must recognize that the real problem is that psychiatrists and other medical practitioners fraudulently diagnose life’s problems as an “illness” and stigmatize unwanted behavior as  “diseases.” Psychiatry’s stigmatizing labels, programs and treatments are harmful junk science; their diagnoses of “mental disorders” are a hoax – unscientific, fraudulent and harmful. Taking such damaging drugs as Rexulti prevents people from finding out what is really wrong and fixing that.

CCHR believes that everyone has the right to full informed consent. FIND OUT! FIGHT BACK!

Another Day Another Anti-depressant

Thursday, January 28th, 2016

Another Day Another Anti-depressant

The New Year brings us another harmful psychoactive antidepressant – Brintellix (vortioxetine hydrobromide).

The mechanism of the antidepressant effect of vortioxetine is not understood, although it is theorized to be related to serotonin in the brain.

It has the same pattern of debilitating side effects as any other antidepressant, including addiction and suicidal thoughts and actions.

Developed by the Danish company H. Lundbeck A/S and marketed by Takeda Pharmaceuticals, it is an SSRI (selective serotonin reuptake inhibitor) drug. It was approved by the U.S. Food and Drug Administration in September, 2013. Its sales to date have not been inspiring, possibly related to its initial review by the National Institute for Health and Care Excellence (NICE) in the U.K. which said, “there was no convincing evidence to show that vortioxetine was any more or less effective than other antidepressants.”

Lundbeck and Takeda are making a new push to increase sales by submitting additional clinical trial data to the FDA and to NICE. You may now start seeing TV commercials for it. Don’t be fooled; there has been no change in the drug itself or its devastating withdrawal and side effects.

We must recognize that the real problem is that psychiatrists and other medical practitioners fraudulently diagnose life’s problems as an “illness” and stigmatize unwanted behavior as  “diseases.” Psychiatry’s stigmatizing labels, programs and treatments are harmful junk science; their diagnoses of “mental disorders” are a hoax – unscientific, fraudulent and harmful.

CCHR believes that everyone has the right to full informed consent.

FIND OUT! FIGHT BACK!

S.2388 Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2015

Saturday, January 16th, 2016

This bill, S.2388, introduced in the U.S. Senate by Senators Ted Cruz (R-TX) and Mike Lee (R-UT) on 12/10/2015, has been referred to the Committee on Health, Education, Labor, and Pensions (HELP).

Its stated purpose is “To amend the Federal Food, Drug, and Cosmetic Act to provide for reciprocal marketing approval of certain drugs, biological products, and devices that are authorized to be lawfully marketed abroad, and for other purposes.”

Essentially what this Act would provide is that if a drug, biological product, or device is approved for use in another country, then the U.S. Food and Drug Administration (FDA) would approve it for use in the United States without it having to go through the entire FDA approval process.

While we applaud the Senators for desiring to reduce the inherent bureaucracy of the FDA, we cannot help but notice that this would open the door for marketing various harmful psychiatric drugs and devices without satisfying the usual FDA requirements for safety and effectiveness.

The Act also authorizes an outreach campaign to encourage the sponsors of such products that are potentially eligible for reciprocal marketing approval to request such approval.

We think this Act deserves to be amended to explicitly exclude psychiatric drugs, and devices such as transcranial magnetic stimulation, vagus nerve stimulation, deep brain stimulation, or any other electric shock or magnetic wave device designed to interfere with the brain.

Please contact your U.S. Senator and the members of HELP to express your viewpoint regarding S.2388.

MedWatch Consumer Protection

Tuesday, September 8th, 2015

MedWatch Consumer Protection

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

For immediate release:
Contact Sheila Matthews, Cofounder AbleChild (203) 253-0329
Westport, 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 15th District.

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.


FDA MedWatch Adverse Event Reports:
http://www.fda.gov/Safety/MedWatch/
1-800-FDA-1088

The New “Female Viagra” is an Antidepressant

Saturday, August 29th, 2015

The Food and Drug Administration (FDA) has just approved (18 August, 2015) the drug Addyi (generic flibanserin) which is misleadingly being touted as the “Female Viagra.”

But unlike Viagra, which affects blood flow to the male genitals, Addyi, the “pink Viagra” for women, is all about messing with their minds: it’s an antidepressant drug and there are some very serious, even life-threatening adverse reactions.

While most would agree that it is insulting and demeaning to suggest women suffer from a mental illness because of a lack of desire to participate in a sexual act, the use of dangerous mind-altering drugs to allegedly increase a woman’s sexual desire is simply a continuation of the FDA and APA’s (American Psychiatric Association) history of pathologizing normal female behavior and it is a disservice to women, not a mental disorder. This fraudulent diagnosis, Hypoactive Sexual Desire Disorder (HSDD), appears in the DSM-4 (Diagnostic and Statistical Manual of Mental Disorders), and as Female Sexual Interest/Arousal Disorder in DSM-5.

Because of the severity of the potential side effects, and to get around the complaint that many patients are being given psychotropic drugs without full informed consent, this drug can only be dispensed by certified prescribers using a Patient-Provider Agreement Form about the risk of serious side effects.

Two hundred sales representatives from Sprout Pharmaceuticals are targeting obstetricians and gynecologists, as well as psychiatrists and primary care physicians.

Clinical trials had a very large placebo effect; 38% of placebo patients indicated improvement. One suspects that there are many natural alternatives without the risks of psychotropic drugs.

Flibanserin was originally developed as an antidepressant before being re-purposed for the treatment of so-called HSDD. It messes with the levels of dopamine, norepinephrine and serotonin in the brain. No one really understands how it works.

Read more about this drug by clicking here.

Read more about full informed consent here.

Human Rights Concerns with the Helping Families in Mental Health Crisis Act of 2015

Saturday, July 18th, 2015

Human Rights Concerns with the Helping Families in Mental Health Crisis Act of 2015

Congressional Rep. Tim Murphy (R., PA) originally introduced the Helping Families in Mental Health Crisis Act (H.R.3717) in 2013. Not to be outdone by H.R.6 the 21st Century Cures Act, he has reintroduced it to this year’s Congress as H.R.2646 the Helping Families in Mental Health Crisis Act of 2015.

Rep. Murphy is a psychologist, and a staunch supporter of “mental health care” as defined by the psychiatric and psychological industries; not to mention the pharmaceutical and insurance industries.

Official Title of the Act: “To make available needed psychiatric, psychological, and supportive services for individuals with mental illness and families in mental health crisis, and for other purposes.”

The Act creates a new position in the Department of Health and Human Services – an official to be known as the Assistant Secretary for Mental Health and Substance Use Disorders. (As if we need another bureaucracy in the psych industry.)

The Act creates more funding for psych-based “treatments.”

The Act expands the bureaucracy surrounding “parity in mental health and substance use disorder benefits” under Medicare and Medicaid.

The Act provides for grants in early childhood intervention and treatment programs, and specialized preschool and elementary school programs.

The Act provides for grants in “Assisted Outpatient Treatment” programs.

The Act requires states to have a law that enforces court-ordered involuntary mental health treatment for the “mentally disabled” if the state want to receive certain federal funding.

The Act expands mental health training for primary care physicians.

This isn’t even half of the proposed legislation.

The Act spends lots more money on “suicide prevention” all up and down the entire educational chain, from elementary school through college.

The Act establishes an entirely new bureaucracy called the “Interagency Serious Mental Illness Coordinating Committee.”

Of course, the Act also expands the availability of and insurance coverage for psychiatric prescription drugs, as well as lifting limits on Medicare payments for inpatient psychiatric hospital services.

The Act expands the Community Mental Health Care programs.

The Act increases funding for the National Institute of Mental Health.

And even that’s not all the Act does to strengthen the already fraudulent and abusive psychiatric mental health industry.

CCHR Supporters should really consider contacting their Congressmen to express their opinions about this affront to rationality.

Let us know when you contact your Congressmen about this, and any response you may receive.