Posts Tagged ‘Informed Consent’

The Skinny on the Skin Drug

Saturday, June 17th, 2017

We saw a TV commercial recently for the drug Otezla® (generic apremilast), from Celgene Corporation, which was approved by the FDA in 2014 for the treatment of symptoms of moderate to severe plaque psoriasis (skin lesions) and psoriatic arthritis.

Our attention was caught by the statement that Otezla is associated with an increase in adverse reactions of depression, suicidal thoughts, or suicidal behavior. We wondered why, since this drug is not used for psychiatric diagnoses, and psychiatric drugs all have such potential side effects.

The drug inhibits the enzyme phosphodiesterase 4 (PDE4), but the exact way in which it is supposed to work “isn’t completely understood”.

The estimated wholesale price is $22,500 for a year of treatment.

Digging deeper, we find that apremilast is an analog of thalidomide which was primarily prescribed as a psychotropic sedative or hypnotic and which was banned in 1961 for causing disastrous birth defects. Depression is also a common side effect of thalidomide.

In 1998 thalidomide was approved again by the FDA for use in multiple myeloma, a type of cancer, because it apparently had some kind of anti-inflammatory effect. It still is not known how it is supposed to work. Analogs of thalidomide were then developed to try to limit the side effects; an analog is a compound having a chemical structure similar to that of another one, but differing from it in respect of a certain component. Analogs are developed to see if they can improve upon the function of the base drug.

Well, apparently this one side effect — depression — did not get eliminated in the transformation from thalidomide to apremilast.

If someone has been given the full range of pros and cons for a drug or other treatment (i.e. full informed consent), with all applicable alternatives and even the alternative of no treatment, and then decides to take the drug or treatment, they made a fully informed decision. But we know that such informed consent is rarely, if ever, obtained prior to a psychiatrist or other doctor writing a prescription for a psychotropic drug. Click here to learn more about informed consent.

Knocked Out, Paralyzed, and Shocked

Saturday, April 8th, 2017

Electroconvulsive Therapy (ECT), or shock therapy, is a controversial psychiatric “treatment” in which seizures are deliberately induced in the patient with an electrical current to the brain. There are roughly 100,000 ECT sessions given per year in the U.S.

The unproven theory is that somehow a seizure is beneficial; in actual fact, seizures are considered a serious health issue by real medical doctors.

There are several different words used to describe the seizures. “Tonic-Clonic,” or “Convulsion,” or “Grand Mal” seizure, are some of these terms. Tonic means stiffening, and Clonic means rhythmical jerking. Grand Mal is generally associated with epilepsy, so its use is discouraged for ECT seizures.

In the 1500’s seizures were induced by chemical means to treat various mental conditions. At some point it was observed that some agitated people appeared to improve during spontaneous epileptic seizures — at least, they got quieter. In 1939 Cerletti in Italy substituted electricity for chemicals to induce seizures. (See here for more information.)

The severe muscle contractions attendant with seizures was causing bone fractures and dislocations, resulting in the use of neuromuscular-blocking drugs (NMBD) to paralyze the muscles, along with anesthetics to block the pain. In 1951, the introduction of the synthesized NMBD suxamethonium as an alternative to curare led to the more widespread use of ECT since that regimen was less likely to result in broken bones and presumably had less side effects than curare. Suxamethonium has been described as a “perfect poison” for murder, and has been used by criminals in murders.

The ECT seizure lasts about a minute, and is administered two or three times a week, or until the patient’s cognitive side effects become too severe. A seizure lasting more than 5 minutes would be a medical emergency. There is a delicate balancing act to the administration of anesthetic, NMBD, and electricity, since the side effects of improper dosage and current can be a restriction of blood flow to the heart, or heart attack, or hemorrhage of blood vessels in the brain, or loss of vision.

Total paralysis with suxamethonium or another NMBD is not desired, since the attending psychiatrist needs to observe some muscle twitching in order to judge if a seizure is occurring. Total paralysis would also interfere with normal breathing, although intubation would normally be used during ECT.

The appropriate dosage of suxamethonium is difficult to determine; it would likely be adjusted in subsequent sessions based on the parameters of the individual’s response. Suxamethonium has a long list of possible side effects such as: high blood potassium leading to cardiac arrest; prolonged paralysis; slow heart rate; low blood pressue; neuroleptic malignant syndrome, a fast rise in body temperature with severe muscle contractions; skin rashes.

There are other NMBDs which can be used if suxamethonium is contraindicated, although these have their own peculiarities. [Reference: “Neuromuscular blocking agents for electroconvulsive therapy: a systematic review”, Acta Anaesthesiol Scand 2012; 56: 3-16]

All told, it is a complicated procedure, and not one to be suffered lightly. Full informed consent is a must. If you know someone who was abused by electroshock therapy, or who has witnessed such abuse, have them submit an abuse report here.

Off-Label Drug Use May Be Risky

Saturday, February 18th, 2017

The February 2017 issue of Consumer Reports article, “Should Drugs Do Double Duty” says, “Your doctor might give you a drug for a condition that it’s not approved to treat. That’s a risk you may not want to take.”

“Doctors routinely (and legally) prescribe drugs “off label” — that is, for conditions not approved by the FDA–for any use they see fit. Most don’t tell their patients. The results of this practice are alarming.”

Klonopin (clonazepam), an anti-anxiety drug, is routinely prescribed off-label for restless leg syndrome and insomnia, for which there is insufficient evidence for its effectiveness — let alone the fact that it poses an addiction risk and a risk of birth defects when prescribed to pregnant women.

Trazodone, an antidepressant, is routinely prescribed off-label for insomnia, but a black box warning says it increases suicidal thinking in children, teens, and young adults.

Seroquel (quertiapine) and Abilify (aripiprozole), antipsychotics, are routinely prescribed off-label for dementia, but the FDA has issued black box warnings about their use by people with dementia, which ups their risk of death. By the way, it doesn’t actually treat dementia, it is only used to suppress a person’s agitation.

“One reason drug companies may want more freedom to market or advertise drugs for unapproved uses is to eliminate financial penalties for off-label promotions.” Johnson & Johnson was fined $2.2 billion in 2013 for illegally promoting the off-label use of the antipsychotic Risperdal (risperidone). GlaxoSmithKline was fined $3 billion in 2012 for promoting the off-label use of the antidepressant Paxil (paroxetine).

All the more reason to learn how to protect yourself, your family and friends, with full informed consent. Courts have determined that informed consent for people who receive prescriptions for psychotropic (mood-altering) drugs must include the doctor providing “information about…possible side effects and benefits, ways to treat side effects, and risks of other conditions…,” as well as, “information about alternative treatments.”

More About Marijuana and PTSD

Sunday, April 3rd, 2016

More About Marijuana and PTSD

 Recent news is full of articles about making marijuana legally available for those diagnosed with Post-Traumatic Stress Disorder (PTSD).

While marijuana’s popularity may be based on the perception that it is safer than other methods as a treatment for so-called PTSD, a new study just published March 23 in the journal Clinical Psychological Science finds that regular marijuana smokers experience more work, social and economic issues at midlife in comparison to the ones who use pot just occasionally or not at all.

Backing up for a moment, we should mention that PTSD is not a real medical illness. It has become blurred as a catch-all diagnosis for some 175 combinations of symptoms, becoming the label for identifying the impact of adverse events on ordinary people. This means that normal responses to catastrophic events have often been interpreted as mental disorders when they are not.

Indeed, people can experience mental trauma; unfortunately, the “treatments” being used — psychiatric drugs and marijuana — have their own issues.

People take drugs to get rid of unwanted situations or feelings. Marijuana masks the problem for a time; but when the high fades, the problem, unwanted condition or situation returns more intensely than before.

The University of California, Davis researchers in this newly published study tracked roughly 1,000 young people for decades and found that the ones who smoked cannabis four or more days in a week over many years suffer lower-paying, less-skilled jobs in comparison to those who didn’t smoke pot on a regular basis. Quoting from the study, “Persistent cannabis users experienced more financial difficulties, engaged in more antisocial  behavior in the workplace, and reported more relationship conflict.”

“Against the backdrop of increasing legalization of cannabis around the world, and decreasing social perception of risk associated with cannabis use … this study provides evidence that many persistent cannabis users experience downward socioeconomic mobility and a wide range of associated problems. Individuals with a longer history of cannabis dependence (or of regular cannabis use) were more likely to experience financial difficulties, including having troubles with debt and cash flow, … food insecurity, being on welfare, and having a lower consumer credit rating. Persistent cannabis dependence (and regular cannabis use) was also associated with antisocial behavior in the workplace and higher rates of intimate relationship conflict, including physical violence and controlling abuse.”

The study concludes with, “Our data indicate that persistent cannabis users constitute a burden on families, communities, and national social-welfare systems. Moreover, heavy cannabis use and dependence was not associated with fewer harmful economic and social problems than was alcohol dependence. Our study underscores the need for prevention and early treatment of individuals dependent on cannabis. In light of the decreasing public perceptions of risk associated with cannabis use, and the movement to legalize cannabis use, we hope that our findings can inform discussions about the potential implications of greater availability and use of cannabis.”

We urge everyone embarking on some course of treatment to do their due diligence and undertake full informed consent.

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!

H.R.271 Creating Options for Veterans Expedited Recovery Act

Friday, December 25th, 2015

Elf On A ShelfThis bill, H.R.271, introduced in the U.S. House by Rep. Gus Bilirakis [R-Florida] on 1/12/2015 and forwarded to the full Veterans’ Affairs Committee on 5/15/2015, would “establish a commission to examine the evidence-based therapy treatment model used by the Secretary of Veterans Affairs for treating mental illnesses of veterans and the potential benefits of incorporating complementary alternative treatments available in non-Department of Veterans Affairs medical facilities within the community.”

Effectively, this bill calls for an official government investigation into the drugging of veterans and into the treatment of veterans diagnosed with mental illness.

When we checked, it had 30 co-sponsors, although none yet from Missouri. Please contact your U.S. Congressional Representative and ask them to help pursue the passage of this bill.

The drugging of the military is off the charts, especially in the United States. From 2005 to 2011 the U.S. Department of Defense increased its prescriptions of psychiatric drugs by nearly seven times. These powerful mind-altering psychiatric drugs carry warnings of increased suicidal thoughts, anxiety, insomnia, and psychosis, especially with high dosages or when abruptly stopped.

In early 2013, the official website of the United States Department of Defense announced the startling statistic that the number of military suicides in 2012 had far exceeded the total of those killed in battle – an average of nearly one a day. A month later came an even more sobering statistic from the U.S. Department of Veterans Affairs: veteran suicide was running at 22 a day — about 8000 a year.

The situation became so dire that the U.S. Secretary of Defense called suicide in the military an “epidemic.”

According to the CCHR documentary The Hidden Enemy: Inside Psychiatry’s Covert Agenda, all evidence points in one direction: the soaring rates of psychiatric drug prescribing since 2003. Known medication side effects of these drugs such as increased aggression and suicidal thinking are reflected in similar uptrends in the rates of military domestic violence, child abuse and sex crimes, as well as self-harm.

The Hidden Enemy reveals the entire situation in stark relief, while urging that soldiers and vets become educated on the true dangers of psychiatry and psychiatric drugs. The answer lies in their right to full and honest informed consent—as well as exercising their right to refuse treatment. Our service members need to know there are safe and effective non-psychiatric solutions to the horrors of combat stress, and that these solutions will not subject them to dangerous and toxic treatments that will only send their health spiraling downward.

For more information:

Download and read the CCHR reportA Review of How Prescribed Psychiatric Medications Could Be Driving Members of the Armed Forces and Vets to Acts of Violence and Suicide.

Watch the CCHR documentary onlineThe Hidden Enemy: Inside Psychiatry’s Covert Agenda.

If you are in the military, a veteran, a member of a military or veteran support group, or family or associate of a member of the military or a veteran, you quality for a free Hidden Enemy DVD. Fill out this form to receive a free DVD.

Not An Antidepressant

Thursday, October 22nd, 2015

Not An Antidepressant

I’m reminded of a song by 10CC — “I’m not in love; So don’t forget it; It’s just a silly phase I’m going through…”

I saw an ad on TV recently for Lyrica (generic pregabalin), a drug commonly prescribed for seizures and nerve pain. What struck me as most interesting was the small print that said, “Lyrica is not an antidepressant.”

Why would they need to explicitly call out that Lyrica is not an antidepressant? Could it be because antidepressants and other psychotropic drugs are finally being widely recognized for their addictive nature and disastrous side effects? (For which CCHR has no small part in making public.)

They did not, however, go on to say that Lyrica is in fact a psychotropic drug, albeit not an antidepressant. It is also prescribed off label in the U.S. as an anti-anxiety drug; it was promoted for other uses which had not been approved by medical regulators up until 2009. For this practice, with three other drugs, Pfizer was fined a record amount of $2.3 billion by the Department of Justice.

It has many of the same adverse reactions as other psychotropic drugs, such as dizziness, drowsiness, weight gain, euphoria, confusion, irritability, depression, agitation, hallucinations, withdrawal symptoms, and (drum roll) suicidal thoughts or behavior.

It messes with the release of neurotransmitters in the brain. They don’t really know how it works; when pressed, they may say that, “the mechanism of action of pregabalin has not been fully elucidated.”

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

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.