Posts tagged ‘Health’

FDA May Require Testing of Electroconvulsive “Therapy” Devices

You may remember a couple of posts I made last year at this time about the importance of speaking up when the FDA opened itself up to comments on the issue of reclassifying the as yet untested ECT (shock treatment) machines from a class III to a class II. The situation was simple — in all the years the machines have been in use, the industry has never had to prove that they are either safe or effective. For decades people have been having their frontal lobes assaulted by electricity in varying amounts from just plain dangerous to thoroughly destructive on machines with no standard of testing to ensure that they’re working as designed, much less designed to address any established clinical use at all. This is not only frightening but a terrible insult to the rights and safety of the approximately 100,000 people who face ECT each year in the US (by choice or force) and only serves those profiting from the shock industry. In essence, the hundreds of thousands of people who have undergone this so-called treatment are the experiment — the living test.

Well, the good news is that it seems that the FDA’s protection of the shock industry may be coming to an end…

Peter Breggin, MD for the Huffington Post:

Friday afternoon, January 28, 2011: The FDA’s panel for electroconvulsive therapy (ECT) voted to place ECT machines in Category III for all but one indication. If the FDA accepts the panel’s recommendation, the agency will require testing for all uses except “catatonia” which was recommended for Category II, requiring less stringent testing.

A tiebreaker by the chair was needed to propose putting ECT machines into Category III for depression. Given acute trauma caused by the treatment and the evidence for long-term memory and cognitive problems, it reflects poorly on the panel that the vote was so close.

Indeed. Despite the polarized response to the matter from proponents and opponents of giving ECT a pass, each side claiming history has proven their point, the fact of the matter is that the FDA is supposed to be ensuring our expectation of some level of safety. If an industry is unwilling or unable (or in this case both) to prove its product safe and effective given the established (and frankly, lax) channels, then that product has no business being passed off as a reasonable course of action in our nation’s hospitals. This shouldn’t have come off as a vote on ECT’s supposed merits but on its decades-long exemption from the system — and that shouldn’t be a close vote at all.

It’s a little early to cry victory as it remains to be seen whether the FDA will follow the panel’s recommendation, what result that will actually have and how much the overlapping psychiatric and shock industries will play off of the catatonia exemption.

If the diagnosis of catatonia is given this loophole, we will see more and more people diagnosed with this disorder…It’s similar to what happened to children: massively increasing the diagnosis of bipolar disorder to justify giving them adult mood stabilizers and antipsychotic drugs.

Unfortunately, the FDA is already waffling about whether or not it will in fact require the usual testing for Category III devices. In response to questions at the hearing, the agency staff said it was not certain whether a Category III designation for ECT would require the same rigorous testing routinely carried out for safety and efficacy. No one on the panel seemed to think the treatment should be phased out until safety and efficacy were proven.

Psychiatric reform moves ahead a step at a time, falters, and hopefully moves ahead again. The classification of ECT into Category III for most conditions, which at this point is only a recommendation, is a step forward and a somewhat positive sign to those of us who have called for this for decades. We hope the FDA will uphold its obligation to the public to thoroughly test such a dangerous device for safety and efficacy.

Since the psychiatric and shock industries have essentially shaken off the burden of responsibility for the safety of the consumer (certainly at the industry level the term is more fitting than patient) and the FDA is apparently questioning its convictions about the protection of the public, the burden rests on the people. As neither of those entities are wholeheartedly committed to moving forward of their own accord to ensure the safety and the efficacy of products on the market and ECT cannot prove itself under any honest scrutiny, the burden then falls on the people to pressure them toward forward momentum and to keep the scrutiny honest…but then, has there ever been a time when that wasn’t the case?

January 31, 2011 at 11:01 am 6 comments

Doctor Gets Prison Sentence for Faked Studies

Dr. Scott Reuben has been sentenced to six months in federal prison for proving to be one of the most fraudulent players in an increasingly fraudulent pharmaceutical industry. While his behavior is nothing new one, arrests like this do not seem to come along often. I can only hope it’s a sign of things to come — but I won’t hold my breath. I’m left wondering if he was arrested for perpetrating fraud or for not being good enough to keep it hidden.

From The Day:

Dr. Scott S. Reuben, a prolific pain researcher at Bay State Medical Center in Springfield, Mass., who during a 12-year span is believed to have faked at least 21 studies, will also have to return more than $360,000 to drug firms, including Pfizer, that gave him money for research. Pfizer will receive more than $300,000 in the deal that Reuben reached with federal prosecutors as he pleaded guilty earlier this year to one count of healthcare fraud.

Other fines and penalties in the case will require Reuben to repay nearly half a million dollars to various parties.

His faked studies include among others, studies for the drugs Celebrex and Vioxx. The latter of course, was pulled from the market due to concerns about its safety. You may remember those “concerns” adding up to more than 25,000 deaths by the FDA’s estimate.

Purported studies published in well-regarded medical journals specializing in anesthesia have since been retracted…

Rueben’s studies had been seen as pioneering when they were published. His data had supported the use of two of Pfizer’s major products – Celebrex and Lyrica – in combination to treat certain types of post-operative pain.

Of course his studies were pioneering — they were made up. With some of his studies pulled and others remaining on the books, one has to wonder if any are legitimate or if some just haven’t proven to be frauds — yet. I would certainly not want to be on a drug that was shown to be safe by one of the most fraudulent drug researchers in pharmaceutical history. One also has to wonder how many other doctor have faked studies in the major medical journals — or are we supposed to think Reuben’s the only one?

Pfizer getting their money back doesn’t mean they’re blameless either. It seems likely that they were happy to keep paying him as long as he kept coming up with the right answers. Sadly, frauds in this arena seem to be overlooked all too often. I say sadly because millions of lives hang in the balance while their products are sold in staggering quantities based on the work of researchers who are often paid  more for supporting a company’s interests than carrying out research with anything resembling actual integrity. As Jim Edward for BNET put forth in an informative article on the topic,

Pfizer wasn’t looking for research that simply broadened doctors’ knowledge of how Cox-2 painkillers work. It was almost certainly using that research to bolster its “operate for cash” promotion, in which pharmaceutical sales reps persuaded surgeons to write “protocols” for using Pfizer’s Bextra and Celebrex as post-operative painkillers instead of opioid drugs. Such uses were not approved by the FDA.

With all of the money these doctors are getting paid to study the safety and efficacy of drugs that they’re simultaneously paid to promote on the lecture circuit (read: pharma sales pitches as continued education), is a conflict of interest even in question?

June 26, 2010 at 8:46 pm 1 comment

Free John (Psychiatric Prisoner)…Action Requested: via Beyond Meds

Sometimes blogs like this give us the opportunity to do much more than offer up snapshots from  our fairly ordinary lives or our opinions on the state of the world around us. Just as with every word we speak out in the real world, we have a multitude of opportunities to say something that matters. When someone’s words offer us a chance to become a part of the solution, those words become an action whether in speech, on paper or in the glow of our screens — and that is why I so often visit and repost from Gianna Kali’s Beyond Meds.

The following is lifted entirely from Beyond Meds. These are Gianna’s words not mine. I say that to give credit, not to separate myself from it as there is nothing in the post that I do not fully endorse. That’s why it’s here.

John Hunt is a trauma survivor with a diagnosis of ‘paranoid schizophrenia’. He has spent over four years locked up in Carraig Mor psychiatric treatment centre in Cork city, Ireland.

He has been over-medicated on an array of psychotropic medications with dangerous adverse effects. He has had tardive dyskinesia, akathasia and has developed incontinence. His physical/ mental/ emotional/ spiritual health has been severely neglected and has deteriorated since being in Carraig Mor.

He has had no access to a rehabilitation team or psychotherapist and no day release in two years. There are no plans to rehabilitate John and return him to the community where he belongs. He is merely maintained and contained. John and his family have no voice in relation to his future. We are afraid that John’s physical health is being damaged considerably. We cannot stand by and watch this happen any longer.

Sign the petition to free John Please take action here.

Facebook cause: The incarceration of John

The blog: The incarceration of John

Check back later for more links. Grainne is being swamped with calls from reporters today, but she will update me with more links when she is able. Please look a the other work Grainne has done for this blog as it’s extremely inspiring and will also shed more light on what is happening to John.

June 21, 2010 at 9:14 pm

Kings County and the Death of Esmin Green: Still Outraged

Some time around 6:30 am, two years ago today, Esmin Green was involuntarily admitted to Kings County’s psychiatric ER where she was ignored for 24 hours, the last of which she spent face down on the floor — writhing at first and ultimately dying in the presence of  the staff members whose job it was to care for her.

Think about that as you glance at the clock, going about your day today — how far 6:30 in the morning seems from your lunch, the end of the workday, prime time television. Think about where you’ve spent your day and how it compares to where Esmin was all that time just two years ago.

I’m still outrageed, still disgusted that we live in a society that allows that and — as long as it’s just those mentally ill over there — accepts it. We’ve created a line and carefully keep who and what lies on the other side out of our sight –as if there really is an us and a them. There isn’t. As long as we have a class of people who can be treated by force we have a public that cares little about what happens to them behind closed doors but there is no class and public. There’s just us and what we do to others, we’re doing to one of our own.

The only real rarity in this story is that it was caught on video. If it hadn’t been you would never have known about it. It would just be another death in another psych hospital — with no one to cry foul. KCHC has been operating like this for decades and even now, in their costly new building, under federal monitoring and with new accountability policies in place — the abuses continue.

I’m going to Brooklyn today — to King’s County. I’m going in remembrance of Esmin Green and in protest of an institution beyond reform. I’m going to stand aside others who won’t accept the state of the system and are standing up in the streets, demanding change — and when I glance at the time, I’ll know I’m where I need to be. Will you?

Previous Related Posts:

Esmin Green Demonstration and Vigil (2009)

Kings County Hosital to be Monitored by Federal Judge

Sexual Assault by Kings County Employee

Kings County: A Call to Action

June 18, 2010 at 10:46 am

iTherapy 2.0

Welcome to the future of reductionist psychiatry. You can now be diagnosed, labeled and treated without a doctor ever having to even look you in the eye or hear the stories that make you tick. Just click the boxes for your symptoms, fill out the questionnaire and the complexities of the human psyche can be unraveled as quickly as e-filing your taxes in the last hour of tax day. Never mind the subtle differences that define us or the experiences that got us here.

This is not some luddite rant about the technology takeover, though to some extent there is a worthwhile wariness in that discussion. I’m talking about the power of the DSM, which was never meant to be a stand-alone collection of boxes to check off in diagnosing, now essentially uploaded and online to be used in just that fashion.

From Australia’s The Age:

MENTALLY ill Australians are increasingly being diagnosed and treated online in virtual psychiatric clinics, without ever seeing a doctor.

Patients suffering from depression, anxiety and post-traumatic stress disorder are being assessed by computer and given ”e-prescriptions” for online counselling courses instead of medication or treatment sessions with a psychologist or psychiatrist…

With e-therapy, patients are clinically diagnosed after completing psychiatric reviews by answering online questions

“Assessed by computer”? It makes you wonder what we need all these psychiatrists for? Apparently all we really need are the DSM committee and a handful of tech guys to work out the interface and we’ll be well on our way to solving those pesky problems that keep cropping up and reminding us how hopelessly human we all are.

One positive point is that it presents a shift from medicine and toward some sort of counseling but I see that aspect of it as short lived. It seems likely to follow the trend of “real life” psychiatry and revert to drug based care, printing out its e-prescriptions for the latest in pharmaceuticals. Also, it makes you wonder — if these kinds of treatments are so effective, why do we need a computer to veer away from drugs? I can see computer based communication and the easy transfer of information as useful but only as a supplement to truly involved care from a living, breathing human – not a replacement. I question the quality of online counseling when compared to real counseling. Of course it’s limited to relatively minor difficulties like depression, anxiety and PTSD. They wouldn’t dare try to treat the as yet uncharted depths of serious mental illness — would they?

In Melbourne, David Austin, the co-director of the National eTherapy Centre’s Anxiety Online program, which is run from Swinburne University of Technology, said the service did not attempt to treat people with more serious conditions such as schizophrenia or bipolar disorder but there was scope for that in the future.

“Within five to 20 years we will have a proven e-therapy for most of the psychological conditions. Once you do that, you have 24-hours-a-day, seven-days-a-week low-cost access for everyone,” said Professor Austin.

Everyone. Oh good. At least they’re planning ahead. This is where the drugs are likely to come into play as most things perceived as serious mental illness are treated with drugs as a chemical problem in the brain not simply a coping, life handling or perception problem.

Patients log on anonymously to complete modules on cognitive behavioural therapy and breathing and relaxation techniques through videos, podcasts, online forums and interactive questionnaires.

Next month, courses will begin for people with eating disorders and gambling addiction.

I’m convinced computers can be of some benefit in a therapeutic setting whether it’s to impart information, the support found in many forums or supplemental counseling. The biggest problem, though isn’t in the counseling aspect of it but in the assessing. While the move to computer based diagnosis promises to extend mental health care to more people, we need to question the level of care and its potential to do more harm than good. We’re talking about diagnosing people online that we’ve never met. The internet has proven to be an unreliable way to get to know people. Something gets lost in translation between the keyboard at one end and the screen at the other. That’s why some people hide behind them, filtering and crafting their online persona and others with the best and most honest intentions just don’t come across as themselves. Many would argue that the computer isn’t even a good way to determine whether someone is dateable but somehow we think we can ascertain someone’s mental and emotional state and diagnose them which will have a huge and far reaching impact on the course of their lives.

We are all complex individuals to varying degrees. One can no more experience another’s state of mind through a computer’s screen than the fullness of a symphony through its crackling plastic speakers. I can’t imagine letting the care of someone’s mental well being hinge on that poor a translation.

June 13, 2010 at 1:07 pm

Is Health the New Sickness?

Do you plan tomorrow’s food today? Do you care more about the virtue of what you eat than the pleasure you receive from eating it? Do you feel an increased sense of self-esteem when you are eating healthy food?

You’d think answering yes to these questions would be a good thing, a sign that you’re on the right track but no — answering yes to these questions and more like them are signs that you suffer from the newest mental disorder to gain traction, orthorexia nervosa, which literally means “correct eating.” That’s right, there is now an eating disorder label for correct eating. It was inevitable. When obesity and consumption of toxic foods becomes the norm, eating correctly becomes a sickness.

While it’s not an official DSM diagnosis, it is a new label to throw into the ever growing lexicon of western pseudoscience. This one was created by a Dr. Steven Bratman in the nineties. I’m not downplaying the self destructive habits and behaviors some of us adopt but that doesn’t make them disorders, just things we shouldn’t be doing to ourselves and eating healthful foods isn’t one of them.

Whole Living had a fairly balanced take on the idea but still offered it far too much credence, saying, “Orthorexia is an eating disorder…” (emphasis mine). The article comes off as a disclaimer — as if they have to absolve themselves from contributing to a newly created disorder by promoting…health, of all things. It seems like we collectively have this sense that if a doctor somewhere calls something a disorder, we’re remiss in not warning people of its dangers without even questioning the legitimacy of the label.

That healthy eating can be pushed to extremes goes without saying. We all want to eat diets that are as natural as possible. But when that goal becomes a religion or an obsession, our efforts at finding health go very much awry: As sufferers of orthorexia can attest, fixation on dietary “righteousness” is the very opposite of healthy.

At the same time, we have to be cautious about throwing labels around, especially labels as inexact as this one. What does it mean to fixate on healthy eating?

That’s a good question considering some of the healthiest and happiest people in the word would suggest we accept no less. God help us when eating KFC’s Double Down becomes a sign of recovery.

Where does a passion for healthy food and fitness end, and psychological disturbance begin?

The answer exists, but I think it’s as hazy as the question itself. The key to eating healthily while avoiding rigidity lies in a reasonable mindset.

The article goes on to say that it’s not necessarily what you do but why you do it that may be where the problem lies and that seems very reasonable. There was a far more bizarre article in WRCB’s Eye on Health which took the trademarks of diligent and healthful eating and framed them as obsessive symptoms while repeatedly referring to orthorexia like a title behind a person’s name.

Jill Brown, Registered Dietitian says “It is a twist of an eating disorder that where a patient is so fixated on eating pure or eating clean.”

Peggy Moe, Orthorexic says “It kind of snowballed into everything that I ate had to be organic and pure and non processed…”

Jill Brown, Registered Dietitian says “It takes over and it interferes with relationships and they obsess about it. There’s a certain righteousness that goes along with it. Judgmental. They judge how others eat.”

I find it odd that Brown, in an article calling into question other people’s food choices, points a finger at “orthorexics” for judging how others eat.

Peggy Moe, Orthorexic says “I would always say, ‘You shouldn’t feed your kids any of this. You should eat organic…”

Peggy Moe, Orthorexic says “I had to drive forty minutes to the nearest grocery store that had all organic foods and I had to keep it on supply so whenever I was at someone else’s house I brought my own food.”

There’s definitely a problem here but the problem is — she’s right. Sure you can do almost anything to an unhealthy extent. For example, some would rather not eat at all than eat some of our toxic but accepted foods. Is that a choice we should  ever have to make? It shouldn’t be so hard to find organic, healthy foods on your local grocer’s shelves and they shouldn’t be priced out of the range of affordability to so many people but that’s the current situation. The major players in the food industry all stand to make a lot of money by keeping our standards low. We have antibiotics and hormones in our milk, pesticides on our produce, chemically modified fats and sweeteners that aren’t even technically food. Somehow if you acknowledge this refuse what they’re offering, you’re just not normal.

There’s a clear problem with measuring wellness by adherence to a social norm and while it’s not limited to food, this is another example of labeling the ones who won’t just go along. Currently, it’s normal to ignore all of the very unhealthy things we’ve accepted into our foods and order your family’s dinner from McDonalds at the Wal Mart cash register. Like everything it’s normal because a lot of people do it — but as Jiddu Krishnamurti said, “It is no measure of health to be well adjusted to a profoundly sick society.”

June 11, 2010 at 11:17 am 2 comments


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