Ruminations

Blog dedicated primarily to randomly selected news items; comments reflecting personal perceptions

Wednesday, February 12, 2020

Mental Health and Prescription Drug 'Tranquilizers'

"[In their first year on the market in the 1960s benzodiazepine, described by their pharmaceutical producer as safe and effective as an alternative to barbiturates] the first report in the medical literature describing their addictive nature was published."
"There is a serious lack of physicians [in Canada] who are willing to do tapers and no accessible community-based resources where people can get help [with their addiction to 'benzos'."
"By the way, benzos are also sold on the street and widely used by heroin addicts and alcoholics."
Janet Currie, Canadian researcher, educator, doctoral candidate, University of British Columbia School of Nursing
"Dad was put on a low dose of a benzodiazepine a few years ago for anxiety following an extremely severe autoimmune reaction to food. He took the medication as prescribed. We weren’t aware that he was developing a physical dependence on the drug until last April when my mom was diagnosed with terminal cancer and the dose of the medication increased.  It became apparent that he was experiencing a paradoxical reaction to the medication, meaning the benzos did the opposite of what they’re supposed to do. These reactions are rare but are not unheard of."
"The worst symptom for dad was akathisia. Akathisia is an absolutely god awful condition where the person feels an incredible, irresistible restlessness, and an inability to sit still. It was so severe he was suicidal."
"For the last six months he’s been in horrible, unbearable discomfort from this drug, made worse when trying to remove it because of the physical dependence. We took him to several hospitals in North America where he experienced multiple cases of misdiagnosis, and the addition of more medications to cover the response he was experiencing from the benzodiazepines. He nearly died several times."
"In early January my dad, my husband, my daughter, and I flew to Russia. To make matters worse he was diagnosed with a fever and pneumonia in both lungs upon arrival. He was put into an induced coma for eight days and had the most horrific withdrawal I’ve ever read or heard about. He almost died from what the medical system did to him in the West. The doctors here aren’t influenced by the pharmaceutical companies, don’t believe in treating symptoms caused by medications, by adding in more medications and have the guts to medically detox someone from benzodiazepines."
"So, finally Dad is on the mend. His sense of humour is back. He’s smiling again for the first time in months, but he has a long way to go to recover fully. He spent four weeks in the ICU, he has neurological damage from the benzodiazepines, which is hopefully temporary."
"He’s still taking anti-seizure medication, and he can’t type or walk steadily yet. Still, this is a vast and rapid improvement. Last week he couldn’t sit up without help. The week before that he couldn’t lift an arm or speak."
Mikhaila Peterson, February 7, 2020 
Prof. Jordan Peterson in March 2018.   Craig Robertson/Postmedia

Benzodiazepines belong to the prescription sedative class of drugs. Although benzodiazepines have a calming effect, they are highly addictive, and a person who abuses them faces a host of symptoms. Some of the physical, psychological, and behavioral symptoms of benzodiazepine abuse include:
  • Weakness
  • Blurred vision
  • Drowsiness
  • Poor judgment or thinking
  • Doctor shopping
  • Asking friends, family, colleagues, and/or classmates for their benzodiazepine pills
  • Wanting to cut back on the volume of abuse but not being able to do so
  • Mood changes
  • Risk-taking behaviors, such as driving after abusing benzodiazepines
  • Combining benzodiazepines with alcohol or other drugs
Due to the natural process of building a tolerance, over time, a person will require a higher volume of benzodiazepines to reach the familiar high. When the abuse stops or the familiar dose is significantly cut down, withdrawal symptoms will emerge. Benzodiiazepine withdrawal can be particularly dangerous and even life-threatening. Undergoing medical detox under the direct care of a doctor is generally advised.
American Addiction Centers

In 1966, a woman by the name of Joan Gadsby who was a municipal official in British Columbia lost her young son to brain cancer. Her grief and subsequent depression theatened to consume her, until she was prescribed the "tranquilizer" drug benzodiazepine. She soon became addicted to the drug and its various side effects made her extremely ill. She brought a lawsuit against her prescribing doctor, but the case was lost even while the prosecution used all her retirement savings. She decided not to leave the situation at that point, but instead became an expert on drug over- and mis-use.

She wrote a definitive book on the subject, "Addiction by Prescription", and is generally acknowledged as the expert she became, so much so that she was given an honourary doctorate in view of the expertise she had attained and her focus on educating both the medical community and the lay public on the over-prescription of medications that have the very real potential to make people far more ill than they were before they were prescribed medication.

Pharmaceutical companies are not that interested in public health; they are focused on the sale of their patent-protected drugs, and in persuading the medical community of the efficacy of those drugs. When benzodiazepine was introduced to the modern pharmacopoeia, the medical community was assured it was non-addictive, a familiar old ploy seen more recently with opioid-alikes like fentanyl. It has been on the market for 60 years, under the names Ativan, Serax, Klonopin, Xanas, and most famous of all Vallium, among others.

They were originally marketed as a safer alternative to barbiturates, but that screen was soon enough shunted aside when its true nature as an addictive drug was revealed. Its use now, however, is pervasive. And instances of things going dreadfully wrong with its use, brought into public focus by the recently-revealed plight of Professor Jordan Peterson, Psychologist of note at University of Toronto, and public speaker of international renown, are not generally very well known.

An estimated 15 percent of adults may currently be prescribed the drug, roughly 65 percent of whom are women and the vast majority of those using the drugs as prescribed are likely to become hugely dependent on them, experiencing difficulties attempting to withdraw from their use. According to Canadian and international studies, 20 to 50 percent of all women over age 60 may be prescribed benzos or sleeping pills; long-term use of which increases with advancing age.

Moreover, a strong link has been established between elderly women taking these drugs, "of which 90 percent are benzodiapezines" and the issue of falling, which becomes swiftly catastrophic to the earlier mortality of these women as they age. A 2000 report stated that "one in three status Aboriginal women over 40 in Western Canada were prescribed benzodiazepines". This is a drug that is not meant for long-term use. When prescribed they should be taken for a course of mere weeks, and in carefully calibrated dosages.

Dr. Peterson suffered a situation where a "prescribing cascade" took place when withdrawal symptoms fail to be associated with benzos, resulting in more drugs being prescribed, and the outcome becomes even more deleterious than the condition of the patient when benzos were first prescribed. Prescribing doctors should be prepared to monitor their patients prescribed this drug, and to help them taper off the drug, meaning the process of gradually weaning a patient off a drug by incrementally lowered dosage, a process which can take months or years.

It's extremely difficult to sue pharmaceutical companies and doctors for malpractise. Pharmaceuticals have very deep financial resources and even deeper motivation in comparison to anything private citizens can muster, for legal costs. In the United Kingdom a class-action lawsuit through Britain's Legal Aid Funding Plan was undertaken, involving 14,000 patients and 1,800 lawyers. The group lawsuit failed for the simple reason that insufficient funds were available to pursue the already-year-long commitment for legal aid services to continue.
Benzodiazepines are a type of medication known as tranquilizers. Familiar names include Valium and Xanax. They are some of the most commonly prescribed medications in the United States. When people without prescriptions obtain and take these drugs for their sedating effects, use turns into abuse.
Doctors may prescribe a benzodiazepine for the following legitimate medical conditions:
  • Anxiety
  • Insomnia
  • Alcohol withdrawal
  • Seizure control
  • Muscle relaxation
  • Inducing amnesia for uncomfortable procedures
  • Given before an anesthetic (such as before surgery)
Benzodiazepines act on the central nervous system, produce sedation and muscle relaxation, and lower anxiety levels.
Although more than 2,000 different benzodiazepines have been produced, only about 15 are currently FDA-approved in the United States. They are usually classified by how long their effects last.
WebMD

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Tuesday, May 14, 2019

DNA And Prescriptive Drugs for Depression

"Psychiatric medicines make people feel horrible if you choose the wrong one."
"And they feel great if you choose the right one."
Dr. Jeremy Bruce, general practitioner, Cincinnati

"The differences [between haphazard drug prescriptions and prescriptions after genetic testing] are very small, and there's no reason to think you couldn't have done better by just following standard protocols, which are free."
"Metabolism is only a part of drug response, and even it is more determined by nongenetic factors."
"I'm not saying that drug metabolism doesn't matter. It's a question of degrees, it's a question of how much of somebody's response is determined by metabolism."
Dr. Bruce Cohen, director, Program for Neuropsychiatric Research, McLean Hospital, Massachusetts

"Over and over and over again studies show that patients who have 'particular' genetic defects have more toxicity, for example, than patients who don't [which could cause adverse reactions to a drug]."
Dr. Mary V. Relling, chair, pharmaceutical sciences department, St.Jude Children's Research Hospital

"I would say to the critics, 'Do you have any other suggestions right now when you have a person in your office and things don't seem to be working'?"
"I think that it [genetic testing in aiding antidepressant prescriptions] has a place at the present time."
"Maybe something else will come along that's better, but this is an important start."
Dr. Anthony Rothschild, professor of psychiatry, University of Massachusetts Medical School


Dr. Bruce, practising in Cincinnati, had any number of experiences where a patient would present with depression and he would prescribe an antidepressant, and refer the patient to a psychiatrist. The psychiatrist, observing that the first medication failed to help the patient, tried another, and then another and another yet, each time hoping that one of the drugs would end up working and the patient's depressed state would begin to lift.

Dr. Bruce treated his patients for depression in a time-honoured way, practised by all physicians in response to a patient's need for a mood-lifting therapy. He would initiate the patient on one antidepressant, switching to another until finally one of the drugs was proven to be of help. While he may have had the patience to follow through on the routine, some of the patients got fed up when nothing helped and would leave his practise in search of another doctor.

"They would usually be very angry", commented Dr. Bruce. Three years ago it occurred to him to approach the vexing problem in a different direction. When a patient who failed to respond well once one or two different antidepresssants were prescribed, he began making use of a company claiming it used an individual's genetics and matched the patient with the antidepressants based on their DNA results, most likely to lead to a successful outcome.
Getty Images

The result was less than sterling, but it did hold out hope for some patients; the test's recommendations were of benefit to some patients, while not all. He has taken to offering the test to any of his patients presenting with depression, instead of prescribing the first antidepressant. The ensuing genetic report outlined the medications on a list of drugs unlikely to work with that genetic profile, and a list of patient-specific medications based on their DNA analysis.

The process, new to the profession, is called pharmacogenetics in the treatment of depression -- but not all health professionals believe in its efficacy. While Dr. Bruce feels the procedure has demonstrated some good results, there is a host of others who claim an absence of solid evidence indicating that pharmacogenetics works in reflection of the complexities of mental health treatment, is less than convincing.

The relation between genes and the manner in which a drug can affect the body have been validated by some laboratory tests, yet studies focusing on whether the use of that information will lead to improved results for patients remain inconclusive. Studies thus far have failed to demonstrate that genetic testing in the selection of antidepressants leads to better outcomes for patients. The holdup? Genetic testing comes with a price tag from $100 to over $2000.

Dr. Cohen points out that the genetics tests focus on variations in genetic metabolism and how that affects the manner in which a person's body will process a drug where faster metabolism may lead to lower drug levels in the body, and slower metabolism can cause higher levels of drugs. Nothing is ever as simple as it seems; age, diet and other substances in the body have a major influence on drug processing, as well.

Reviews of published research provide prescribing guidelines which advise how to use genetic information already available, rather than calling for genetic tests to be ordered. And it is that already available genetic information that the Clinical Pharmacogenetics Implementation Consortium uses to rank the strength of various gene-drug pairings. Dr. Relling who co-founded the Consortium feels that genes dominate other factors such as age and diet.

Studies show a strong relationship between a gene and a drug which should be sufficiently useful to support prescribing guidelines, according to Dr. Relling, while Dr. Cohen feels that simply observing a relationship on the genetic level leaves out other important indexes, that studies are needed to prove patients actually experience improved outcomes with treatment guided by genetics.

In November, the U.S. Food and Drug Administration released a statement with the warning to patients and doctors that caution is required on genetic testing that has not been approved by the FDA, inclusive of those meant to guide the prescribing of antidepressants. And Dr. Rothschild feels such testing should be considered one tool in the depression-treating toolbox, most particularly where patients failed to respond to medication.
Your doctor may use cytochrome P450 (CYP450) tests to help determine how your body processes (metabolizes) a drug. The human body uses cytochrome P450 enzymes to process medications. Because of inherited (genetic) traits that cause variations in these enzymes, medications may affect each person differently.
Drug-gene testing — also called pharmacogenomics or pharmacogenetics — is the study of how genes affect your body's response to medication. Tests look for changes or variations in these genes that determine whether a medication could be an effective treatment for you or whether you could have side effects from a specific medication.
The cytochrome P450 enzyme includes the CYP2D6 enzyme, which processes many antidepressants and antipsychotic medications. By checking your DNA for certain gene variations, CYP450 tests can offer clues about how your body may respond to a particular antidepressant. CYP450 tests can also identify variations in other enzymes, such as the CYP2C19 enzyme.
Mayo Clinic

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Tuesday, October 31, 2017

What Side Effects?

"We contend that the [U.S.] Food and Drug Administration [FDA] -- in regulating direct-to-consumer advertisements to list side effects that range from the serious, such as stroke and thoughts of suicide, to those less serious, such as dry mouth and headache -- have diluted consumers' judgements of the overall severity of the drugs' side effects."
Researchers, new DTC study

"For professional advertisers, the idea that long disclosures will work is ridiculous."
"Good advertising has short, simple messages that people can understand and act on. These long messages we've seen in DTC [direct-to-consumer] is a broken regulation that needs to be fixed quickly."
John Kamp, head, Coalition for Healthcare Communication

"All drugs, whether prescription or over-the-counter, can have side effects. Side effects can range from headaches and upset stomach to those more serious such as liver or kidney injury, heart problems, or even death. Some side effects can be predicted in some people based on what occurred during the drug’s testing, but some rare events occur unexpectedly when many more people take the drug after it is approved."
U.S. Food & Drug Administration
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Well-intentioned it may have been for the U.S. FDA to require the pharmaceutical industry to list all the potential side-effects that might be encountered as a by-product of a particular drug's use, but it seems that unintentionally their inclusion in television advertising might have a lulling effect in the minds of viewers. Too much detail, too much content may lead the potential consumer to the belief that divulging all in this manner provides some kind of assurance that there is nothing to be concerned about.

In other countries such as Canada, DTC advertising is not permissible by law, although the law is rarely enforced through Health Canada. Still, if prescription products are advertised they are done so in a manner that fails to link the drugs with the cause of their use, as a means of getting around the prohibition. DTC advertising in Canada is a muted affair, barely noticeable, in comparison to the loud and garish prominence of DTC pharmaceutical advertising commonly seen in the United States.

The FDA doubtless felt it was aiding the consuming public in requiring pharmaceutical companies to list all possible side-effects of drugs. Their purpose was to alert consumers to all and any potential risks in drug use. Unfortunately, it seems people have no wish to be alerted. Research has indicated that people have a tendency to pay little attention to the most serious side effects and instead they focus on the purported benefits of the drug, a newly-published study points out.

Researchers must have felt incredulous at their own results; instead of creating a cautionary atmosphere with the revelations of possible side-effects in drug use, the drugs have become a more marketable commodity, with increased sales resulting from the situation, according to researchers whose study was published in Nature Human Behaviour. Six experiments were operated by the researchers with over 3,000 participants in the United States.

The purpose of the study was to test whether the provision of this information highlighting major and minor side effects reached its purpose to increase awareness; instead it was found to reduce overall perception of the severity of side effects. The United States represents one of two countries permitting this type of prescription drugs promotion [along with New Zealand]. Critics point out that all too often advertisements promote new, higher-priced medicines, encouraging consumers to seek unecessary prescriptions.

The American Medical Association unsuccessfully campaigned to ban direct-to-consumer advertising two years ago. Three years ago the FDA launched a study of its own in hopes of determining whether the long list of potential risks could lower consumer understanding, minimize important risk data, and cause some people to potentially skip medicines, fearing side effects. The pharmaceutical industry had its own concerns over advertising requirements feeling consumers could react unfavourably to drugs listing side effects.

They now doubtless feel relief that the new research posits that some consumers may tune out these warnings in large part. Whatever the Food and Drug Inspection Agency determined from its own study has not been released to the public, however.
"If FDA is keen that all side effects are listed, especially if certain ones impact a subsample of the population, then one route is to categorize the seriousness of these side effects by increasing the attention people afford to those side effects, such as 'heart attack and stroke' versus side effects such as 'headache and nausea'."
"We show that simply highlighting and providing larger red font to the more serious side effects, while keeping to normal black font to the less severe side effects, helps mitigate the problem."
Niro Sivanathan, lead author, associate professor of organizational behavior, London Business School

Required listing of drug side effects may be backfiring on FDA  -- The Boston Globe



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Wednesday, January 11, 2017

Free Enterprise: Free of Scruples

"I'm quite disappointed and amazed that even in my neighbourhood they actually have billboards on the street advertising weight-loss injections."
"This is to me totally unscrupulous."
Dr. David Lau, endocrinologist, University of Calgary

"Obesity is the greatest silent killer in Canada."
"Our goal is to not mislead the public; our goal is to be cutting-edge leaders in combating obesity."
Dr. Tony Bruno, medical director, Slimwell

"It sounded like I'm just going to get this injection and all this weight is going to fall off me."
"It sounded like you didn't have to do anything else."
"[Then the "alarming" detail; weight-loss participants with Slimwell are permitted only 500 calories a day]."
Stephanie Moston, nutritionist, Calgaryslimwell_injections
Fancy that, even a nutritionist, someone who specialized in nutrition studies at an academic institution and presumably knows a thing or two about the role that overeating and questionable nutritional dietary choices play in people's never-ending hate-love affair with food and gaining weight, viewing herself as having gained a few too many extra pounds, visualized herself losing it all efficiently and without effort by signing up to be a Slimwell client. Then backed out at the prospect of eating a mere subsistence diet of 500 calories a day while on the program.

It goes without emphasizing too strongly that one can only subsist on 500 calories intake on a daily basis and then, obviously for a strictly limited amount of time. And such a starvation diet in and of itself would, of course, guarantee substantial weight loss, rather swiftly. Think about it: if the average daily recommended calorie intake for good health for a male is 2,500 and for a woman 2,000 calories, that 500 calories a day doesn't even fulfill the barest minimum nutritional requirements for healthy people.

But Calgary-based Slimwell knows human nature, always looking for the easy way to solve a problem. And so their public relations emphasize that they have cornered the market on easy weight loss through a  hormone to be injected to curb hunger while preserving muscle tissue, as all that unsightly fat just seeps away as waste. Their prescription hormone medicine , human chorionic gonadotroin (HCG) is, in fact, a medically debunked failure for weight loss.

The U.S. Food and Drug Administration, along with American obesity doctors warn against its use. The hormone shots, injecting clients with what is essentially a pregnancy hormone, is useless. Anyone wanting to lose weight the Slimwell way need only confine their dietary uptake to 500 calories daily and then watch themselves become skeletal and their goal would be accomplished. Slimwell is now under investigation by Health Canada.

A Google Street View of the Slimwell clinic in Calgary. Google Street View / Screengrab

The company has clinics in Calgary and in Markham, Ontario, and to make access to their marvellous remedy for ungainly, unsightly, unhealthy weight gain convenient, takes mail-orders for their misleading prescription drug derived from the urine of pregnant women. HCG is, in fact, approved as a fertility treatment, a product whose monograph states that it should not be used in weight loss treatment. And, as such, the use of HCG for a medically non-approved purpose is illegal.

This is an industry, and it is not only Slimwell that preys on people wanting to lose weight, but many other weight loss clinics as well. "Bluntly, the data says it's useless and the policies say don't [use it] -- at least [they do] in the United States", commented Ottawa-based obesity expert, Dr. Yoni Freedhoff, alluding to the fact that Health Canada, while taking action against purveyors of the diet, has not yet issued a blanket statement denying the use of HCG for obesity.

The medical director of Slimwell contends that his company offers a new, advanced version of the diet, through the addition of medical supports and diets designed to target individual needs, and which evidence collected by his company supports their contention that what results is cutting fat but not muscle, reducing the "perception" of hunger. Many clients, he emphasized, post testimonials on the company's website, lauding the diet.

A meta-analysis dated 2995 of research came to the conclusion that HCG "does not bring about weight-loss or fat-redistribution, nor does it reduce hunger or induce a feeling of well-being". The American Society of Bariatric Physicians came to the same conclusion in 2009. The Ontario College of Physicians and Surgeons brought in a regulation that doctors should not prescribe HCG for weight loss, back in 1987. But, it's back in fashion.

Slimwell's website features a protocol of daily injections of HCG along with vitamins B6 and B12 for periods of between 23 to 40 days Costs of the programs go up to $825. All a prospective client requires is a note from a doctor informing that they need to lose weight, to enable them to apply to be taken on as clients. And these weight loss clinics that advertise in all media venues are doing very well indeed, thank you.

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