Making medicines safer for all of us

Adverse drug events are now the fourth leading cause of death in hospitals.

It’s a reasonable bet they are an even greater cause of death in non-hospital settings where there is no one to monitor things going wrong and no one to intervene to save a life. In mental health, for instance, drug-induced problems are the leading cause of death — and these deaths happen in community rather than hospital settings.

There is also another drug crisis — we are failing to discover new drugs. [Read more...]

Archive for Madness of North Wales

42 or Thereabouts

42 answer

In response to the recent BMJ editorial on serotonin and depression, there were seventeen letters of which three were published, along with my response.  These are copied below along with the best letter – by Barney Carroll – which wasn’t published.  Make your own mind up as to why.

Another piece of minor intrigue is that this editorial, originally entitled So Long and Thanks for all the Serotonin, a title BMJ felt uncomfortable with, registered well on Altmetric – an index that tracks how much Buzz an article is generating.  When I started looking at this, the article was rated at 43 on Altmetric and then moved down to 40 passing through 42 en route.  It will presumably pass back through 42 at some point as it gets displaced by Buzzier pieces.  Amusing given the Hitch-Hiker link.

serotonin and depression

Healy states the obvious

As a matter of clinical science, the notion of a simple serotonin deficiency in depression ended 45 years ago, when the proposed therapeutic utility of monoamine neurotransmitter precursors was disconfirmed.1 There has been little incisive progress since then, owing to major missteps in the intervening years – for starters, the foolish introduction of generic major depression in lieu of clinically differentiated types of depression as the focus of investigations;2 the displacement of disinterested clinical science by corporate experimercials;3 the corruption of journals and of educational forums by key opinion leaders who promoted corporate marketing narratives;4 and the capture of research funding agencies and regulatory agencies by commercial forces. The discomfort that David Healy’s editorial has caused in some quarters reflects a general embarrassment at the emptiness of current research in mood disorders. The yield has not been commensurate with the billions of dollars thrown at the problem – to the point where most corporations have exited the field out of a healthy self-interest. Little wonder, then, that those who have reason to be embarrassed are now throwing the book at Dr. Healy for stating the obvious.

REFERENCES
1. Carroll B.J. Monoamine precursors in the treatment of depression, in «Clinical Pharmacology and Therapeutics» 12, 743-76 (1971).
2. Carroll B.J. Bringing back melancholia, in «Bipolar Disorders» 14, 1-5 (2012).
3. Carroll B.J. Sertraline and the Cheshire cat in geriatric depression, in «American Journal of Psychiatry» 161, 1145-1146 (2004).
4. Carroll B.J., Rubin R.T. The high cost of non-disclosure, in «Clinical Psychiatry News» 34(10), 27 (2006).

Bernard Carroll

Serotonin and depression – Healy does a disservice to psychiatrists

Alexander E Langford,  South London and the Maudsley NHS Foundation Trust

David Healy does a great disservice to jobbing psychiatrists with this editorial. By portraying them as ‘co-opted into a myth’ about low levels of serotonin being the sole cause of depression he paints them as gullible, and by stating that the same theory is ‘an easy shorthand for communication with patients’ he paints us as lazy and reductionist in our appraisal of the complex and diverse causes of depression.

In reality, good psychiatrists are and always have been only too ready to admit that they are unsure how antidepressants work. Serotonin does play an important role – likely via factors like neurogenesis and gene expression downstream from synapses – but modern psychiatry is way ahead of where Healy seems to think it is. The picture is far more complex. The fact that ketamine has been shown to be useful in depression does not ‘cast doubt on the link between serotonin and depression’, it rather confirms that the neurobiological underpinnings are as multifaceted as we think.

In any case, whatever their mode of action, SSRIs do work. Even the most stringent of analyses (i.e. Kirsch) support this. There is no good evidence that SSRIs work any less well than TCAs for depression , and the SSRIs have not become so commonplace in clinical practice due to some form of pharma-doctor conspiracy, as Healy would suggest, but because the older TCAs have a far less admirable side-effect profile and were also lethal in overdose. The safety of our patients should always come first, and they are far less safe without treatment for their depression.

Healy D. Serotonin and depression. BMJ 2015;350:h1771. (21 April.)

Serotonin and depression: myth or legend?

Philip J Cowen, Professor of Psychopharmacology, University of Oxford,

David Healy’s observations on serotonin and depression make interesting , if familiar, reading [1]. However, I was struck by the remarkable claim that the focus on serotonin has led to the ‘eclipse of cortisol’ in mood disorder research. A quick search in Scopus with ‘cortisol’ and ‘depression’ revealed a rapidly increasing number of published articles from the late 1990s, continuing unabated to the present time. Only last year saw the completion in the UK of a large placebo-controlled study which examined the effects of inhibiting cortisol synthesis in patients with depression refractory to SSRIs[2]. David also manages to suggest that ketamine has been shown superior to SSRIs in melancholic depression whereas no such comparison has been carried out. He further implies that the work of Andrews and colleagues is based on the intellectually paralysing notion that low serotonin causes depression whereas in fact these authors argue exactly the opposite [3].

Should one confront myths by constructing different ones? As an avid BMJ reader I find myself increasingly confused by this question. For if scientific narratives are manifestations of competing power claims and vested interests perhaps there isn’t really a ‘fact of the matter’- the important thing is to be on the right side. I agree with David.

  1. Lacasse JR, Leo J. Serotonin and depression: A disconnect between the advertisements and the scientific literature. PLoS Med 2005; 2: e392 DOI: 10.1371/journal.pmed.0020392 (http://medicine.plosjournals.org).
  2. Watson S, Anderson IM, Apekey TA, et al. Antiglucocorticoid augmentation of antidepressants in depression: The ADD study. J Psychopharmacology 2014; 28 (suppl): A38.
  3. Andrews PW, Bharwani A, Lee K R, et al. Is serotonin an upper or a downer? The evolution of the serotonergic system and its role in depression and the antidepressant response. Neurosci Biobehavior Rev 2015; 51: 164-188.

Serotonin and depression – Personalized pharmacotherapy: An interim solution?

Adam M Chekroud. Yale University, USA

Prof. Healy offers an engaging historical perspective on the rise of serotonergic antidepressants that questions their efficacy and biological plausibility. However, this focus on low serotonin levels is a distraction that is basically irrelevant to whether serotonergic antidepressants are effective treatments for depression. It is important to note that response to serotonergic antidepressants appears to be heterogeneous rather than universally poor.  Unbiased trajectory-based analysis of over 2500 patients treated with SSRI antidepressants or placebo indicated that the majority of patients (over 75%) showed a superior response to patients treated with placebo.  However, nearly one quarter of patients treated with SSRIs showed a poorer response than patients treated with placebo. This suggests that in these patients, SSRI treatment actually interferes with their capacity to mount a placebo response, or perhaps even their capacity for resilience to depression [1]. This raises the critical issue of whether there are ways to identify those patients who would seem to be better off avoiding SSRIs and to divert these individuals to other treatments for their depression.

One factor reducing the effectiveness of antidepressants treatment is our inability to personalize pharmacotherapy, i.e., clinicians have no mechanism for predicting whether a particular patient will respond to a specific antidepressant. Instead, the process of matching patients and treatments requires a prolonged period of trial and error, delaying clinical improvement and increasing the risks and costs associated with treatment. Despite important progress in trying to identify depressed patients at high risk of treatment resistance [2], Psychiatry continues to lag behind other specialties like Cardiology and Oncology in which personalized treatment selection is far better established [3,4].

Developing more generally effective treatments and more rapidly effective treatments would be extremely important advances for public health.  However, in the absence of any such silver bullet, we advocate the development and implementation of innovative statistical methods to get the best available drug to each patient, as an interim solution. Personalized pharmacotherapy may still enable us to “save lives and restore function”. Giving up on these patients is not an option.

1          Gueorguieva R, Mallinckrodt C, Krystal JH. Trajectories of Depression Severity in Clinical Trials of Duloxetine: Insights Into Antidepressant and Placebo Responses. Arch. Gen. Psychiatry. 2011;68:1227–37. doi:10.1001/archgenpsychiatry.2011.132

2          Perlis RH. A clinical risk stratification tool for predicting treatment resistance in major depressive disorder. Biol Psychiatry 2013;74:7–14. doi:10.1016/j.biopsych.2012.12.007

3          Kumbhani DJ, Wells BJ, Lincoff AM, et al. Predictive models for short- and long-term adverse outcomes following discharge in a contemporary population with acute coronary syndromes. Am J Cardiovasc Dis 2013;3:39–52.http://www.ncbi.nlm.nih.gov/pubmed/23467552

4          Roobol MJ, Carlsson S V. Risk stratification in prostate cancer screening. Nat Rev Urol 2013;10:38–48. doi:10.1038/nrurol.2012.225

A pleasing look of truth

I wrote an almost identical editorial as this in 1991 (1). Covering the marketing of serotonin in 1997 (2), I cited Jerome Gaub’s 1767 opinion of Leibniz’ views on the relations of the mind to the body – it is a “fable whose novelty has recommended it, whose recommendation has spread it, whose spread has polished it, refined and adorned it with.. a pleasing look of truth” (3)

I use SSRIs.  Nevertheless I believe the SSRI era will soon stand as one of the most shameful in the history of medicine.  The shame does not stem from what pharmaceutical companies have done, which is just as might have been expected.  The shame will be seen to have arisen from the failure of doctors to know as much as they should have done about medicines they dish out so liberally.  A recent study showing how a dollop of neuroscience dressing can disguise otherwise meaningless material should be compulsory reading for doctors who are after all the true consumers of these drugs (4).

But perhaps an even greater shame will be seen to lie with the fact that this has been an era in which the bulk of publications on on-patent drugs in our best journals were ghostwritten, an era in which the journals refused to demand access to trial data as the price of publication – nowhere more clearly demonstrated than in the area of antidepressant studies on children.  It has been an era when industry has controlled journals, by spending money on some of them and by intimidating others into self-control.

  1. Healy D. The Marketing of 5HT.  British J of Psychiatry, 1991; 158, 737‑742.
  2. Healy D. The Antidepressant Era. Harvard University Press, Cambridge Ma 1997.
  3. Rather LJ. Mind and Body in 18th Century Medicine. Wellcome Historical Medical Library, London, P 17. 1965
  4. Weisberg DS, Keil FC, Goodstein J, Rawson E, Gray JR The Seductive Allure of Neuroscience Explanations. J Cogn Neurosci. 2008; 20, 470–477.

 

Meanwhile the patient information leaflets for pretty well all antidepressants and wannabe antidepressants like quetiapine as of today continue to promote versions of the Low Serotonin Hypothesis (thanks to Julie P for pointing this out).

Citalopram low serotonin

This should incense a lot of people.

Compulsory vaccination and the media – the Australian experience

no vaccinations

Editorial Note: This is another post on the vaccination and censorship theme. Elizabeth Hart’s comments, over the past few weeks in response to some of the posts here, on efforts to stifle debate have been balanced and eloquent.  Given the growing number of new journalism outlets, such as The Conversation, that portray themselves as tackling cutting edge issues fearlessly but in fact do no such thing it is a pleasure to help her get a message out that the editor of The Conversation has ignored.

Her interest in the issues began in an unusual way – after her dog died from a booster dose.  Checking into it she became aware that pet vaccination is big business and one that has does more for the health of Vets than Pets.  This is what radicalized her.

For the attention of:
Mr Andrew Jaspan
Executive Director and Editor
The Conversation

Mr Jaspan

I suggest there are serious problems of bias and censorship at The Conversation and I question whether you are fulfilling your charter.

The Conversation is very ‘pro-vaccination’, there is little in the way of critical analysis of vaccine products. For example The Conversation has helped promote HPV vaccination.  I suggest HPV vaccination is controversial, see for example my summary which discusses the questionable way HPV vaccination was initiated in Australia when Tony Abbott was Health Minister in 2006.

The Conversation should be mindful that it has conflicts of interest in that it receives funding from universities that receive funding from the pharmaceutical industry for vaccine research.  It seems to me that The Conversation is a marketing arm for the university and research sector.

Today comments were closed down on The Conversation article “Forget ‘no jab, no pay’ schemes, there are better ways to boost vaccination”.

Comments were also recently closed down on “Want to boost vaccination? Don’t punish parents, build their trust” and “’No jab, no pay’ policy has a serious ethical sting”.

I had posted detailed and referenced comments on these articles relevant to vaccine policy and practice, with some still awaiting a response. I had planned to post more comments, but I have now been thwarted in this regard, as ‘the conversation’ has been closed down.  Opportunities for serious discussion on vaccination policy and practice are limited in the current hostile climate, and The Conversation does not help by curtailing debate.

Mr Jaspan, Prime Minister Tony Abbott’s announcement that vaccination will be compulsory to obtain family tax benefits is a very serious matter.  We are on a slippery slope when governments mandate medical interventions such as vaccination.

There are serious problems with transparency and accountability for vaccination policy in Australia, and I have recently raised this matter with Prime Minister Abbott, see my letter dated 21 January 2015.  There is a serious problem of potential conflicts of interest and lack of disclosure by people influencing vaccination policy.

Tony Abbott, and Opposition Leader Bill Shorten, have reacted to the crude “No Jab, No Play” campaign by News Corp Australia media, e.g. The Sunday Telegraph.

It appears the vigilante pro-vaccination group SAVN (Stop the Australian (Anti) Vaccination Network) was also instrumental in this campaign.  It also appears The Conversation is a supporter of SAVN, as evidenced by its publishing articles by self-avowed SAVN members, e.g. Rachael Dunlop and Patrick Stokes.  It is notable that Patrick Stokes’ membership of SAVN is not included in the Disclosure Statement on his article “No, you’re not entitled to your opinion”.

I have tried to raise serious discussion about vaccination and individual vaccine products on The Conversation as my ‘activity’ illustrates, but I have often been impeded by followers of the SAVN who colonise comments threads on vaccination articles on The Conversation.

I was astonished today to discover that SAVN member Patrick Stokes has the ability to ‘hide’ (i.e. censor) comments on articles on vaccination on The Conversation, (see discussion between Patrick Stokes and Adam Bonner on “Forget ‘no jab, no pay’ schemes, there are better ways to boost vaccination”).  Patrick Stokes is hardly an impartial arbiter, on what basis have you given him this power?

I also suggest there are serious problems at The Conversation in regards to proper disclosure of authors’ potential conflicts of interest.  In this regard see my discussion with Professor C Raina MacIntyre on the “Want to boost vaccination? Don’t punish parents, build their trust” comments thread.

It is also ironic that experts on vaccination such as Professor MacIntyre and A/Professor Kristine Macartney do not appear to understand the difference between ‘vaccination’ and ‘immunisation’, and incorrectly use these words interchangeably, another point I raised on their articles.  If ‘experts’ are so careless with the basics, what else are they getting wrong?

Mr Jaspan, compulsory vaccination is at odds with the requirement for ‘valid consent’ before vaccination, see Section 2.1.3 of The Australian Immunisation Handbook.

I suggest there should be an investigation into the aggressive campaign to make vaccination compulsory in Australia, and the tactics used by News Corp Australia, SAVN, and The Conversation.

Yours sincerely

Elizabeth Hart

http://over-vaccination.net/

 

The Couric Incident: HPV Vaccine & Mass Bullying

Katie Couric

Editorial Note: This post is by John Stone at my invitation. I am broadly speaking pro-Vaccination and reluctant to stray into the Vaccination Wars but the issues about free debate in recent posts seem most acute in this domain.  Anyone who even thinks about questioning is vilified.

There are important public policy issues involved in MMR but less so with the HPV vaccine and the Flu Shot.  For many working in healthcare, the Flu Shot is worrying. While in Britain it is not compulsory, there is a lot of pressure even though the case for having it seems weak.  Elsewhere Flu Shots have been made compulsory. I’m sure many of us wonder what we would do if put on the spot like this.

Some of the strongest Vaccination advocates double up as Pro-Transparency campaigners.  A Furor Vaxicanus  just doesn’t seem to match up with transparency.  John Stone is a Vaccine Safety Advocate who to my mind has also been one of the most reasonable voices commenting on some of the posts on this site over the last year.  I don’t know John from a bar of soap (as we’d say in Dublin).

But I do know Rokuro Hama whose work John cites here.  Rokuro and the group behind MedWatcher Japan are the most extraordinary courageous scientists and lawyers and all round safety advocates there are.  Their MedCheck Bulletin is being made available in English for the first time this week and will be worth following – see MedCheck.

The point being raised by Rokuro goes to the heart of Evidence Based Medicine.  When “girls” complain of serious problems after Gardasil or Cervarix, what weight do we put on what they say? What weight do we put on what we know about the biology of the HPV vaccine?  What weight do we put on the fact that any effort to ask about this runs into media flak from SMC UK,  or SMC Australia, SMC Canada or SMC USA?      

Katie

In 2012 Katie Couric was the best paid media presenter in the United States, referred to as America’s Darling. Late in November 2013 it was announce that Couric was to give room in her ABC Television show Katie to the subject of vaccine injury from HPV vaccine. The result was an immediate furore.

Wiki recalls aspects of this historic episode:

In December 2013, Couric ran a segment on the HPV vaccine…which critics accused of being too sympathetic to the scientifically unsupported claims that this vaccine was dangerous…For example, Seth Mnookin accused her broadcast of employing false balance. In addition, Alexandra Sifferlin, of Time magazine, compared Couric to Jenny McCarthy, a well-known anti-vaccine celebrity…On December 10, 2013, a week after the original segment was aired, Couric posted an article on The Huffington Post responding to this criticism, in which she stated:

I felt it was a subject well worth exploring. Following the show, and in fact before it even aired, there was criticism that the program was too anti-vaccine and anti-science, and in retrospect, some of that criticism was valid. We simply spent too much time on the serious adverse events that have been reported in very rare cases following the vaccine. More emphasis should have been given to the safety and efficacy of the HPV vaccines.”

The show which was falling in the ratings was due to be taken off the air the following summer was suddenly terminated 19 December, but not before a follow-up program had been screened giving all its room to the vaccine advocates. This was obviously a huge professional humiliation for Couric, but it was not the whole of the story: on Couric’s website a gigantic battle raged between families of injured people supporting the show and an angry mob of “skeptics” – many of them Australians – who ridiculed them. There were probably more than twelve thousand posted comments in all: more than a thousand apparently came from the keyboard of ubiquitous vaccine program advocate Prof Dorit Reiss, an academic (but not qualified lawyer) from Hastings law school in San Francisco, which is in partnership with Kaiser Permanente who were hired by Merck to study the post-marketing effects of their HPV vaccine Gardasil. Kaiser Permanente are also partners with Centers for Disease Control. While Reiss was more well-mannered than most of the vaccine advocates she dismissed any attempt to discuss vaccine injury as anecdotal, and her tactics were copied and deployed more brutally others. Many people, of course, speculated on how she could post so often while carrying out her professional duties at Hastings.

The episode also closely echoed a campaign earlier in the year to have Jenny McCarthy – widely labelled “anti-vaccinationist”  – excluded from broadcasting, an episode which also involved Reiss and her colleagues at Voices for Vaccines. V4V also parades as not accepting pharma money but is in fact an off-shoot of Task Force for Global Health, which does accept pharma money, and is in partnership with the Centers for Disease Control. It is interesting to note that the chair of Task Force’s Board of Directors is leading Atlanta product liability lawyer Jane Fugate Thorpe.

The View from Japan

It should be evident, whatever the words of Couric after the event, that these are not stories about science asserting itself but of corporate leverage and internet bullying. The strategies and their effect say nothing about the quality of the science at all. They speak to the ethics of the proponents. It is particularly salutary to view these events against the background of a recent review of the evidence in the independent Japan Institute of Pharmacovigilance  bulletin Med Check – The Informed Prescriber (editor-in-chief Rokuro Hama). Hama is also a special advisor to the Cochrane Collaboration:

Harm of HPV 

Abstract: Incidence of serious adverse reactions to HPV vaccine is 3.2% per year according to our  recalculation using the latest data (3,200 cases per 100,000 person years). This is almost equivalent to the incidence rate of serious adverse events within 1.2 years after the first vaccination (annual rate of 2.8%) reported in the randomized controlled trials (RCT) of Cervarix. In Cervarix RCTs, the excess incidence of serious reactions, autoimmune diseases and death after 3.4 years comparing with those during 1.2-3.4 years was calculated as 4,000 patients, 630 patients and over 100 deaths per 100,000 person-years respectively. These might also occur in Japan. As to the epidemiological surveys from Europe and North America that Japanese Ministry of Health, Labour and Welfare (MHLW) based on as the evidence for safety of the vaccine have flaws in their methodologies. One study confuses prevalence with incidence, and the other two have serious bias derived from “healthy vaccinee effect”. While there is no evidence confirming that HPV vaccination decreases incidence of and mortality from cervical cancer yet, supposing that the vaccine could halve the cervical cancer mortality, the expected maximum benefit would be two deaths per 100,000 person-years at the most. Hence, the harm experienced is overwhelmingly greater than the benefit expected.

The DisUnited Kingdom

In the United Kingdom media reporting of the harms of HPV vaccines has died out since 2009. An article in the Sunday Express by Lucy Johnston, much sneered at by Ben Goldacre in the Guardian, reported much the same thing as Med Check :

The cervical cancer vaccine may be riskier and more deadly than the cancer it is designed to prevent, a leading expert who developed the drug has warned. She also claimed the jab would do nothing to reduce the rates of cervical cancer in the UK. Speaking exclusively to the Sunday Express, Dr Diane Harper, who was involved in the clinical trials of the controversial drug Cervarix, said the jab was being ‘overmarketed’ and parents should be properly warned about the potential side effects.

It looks as if the article was withdrawn after a complaint by Dr Harper because she had alluded to the aggressive marketing of Gardasil by Merck in the US when the main topic was GSK’s Cervarix and this was not clear in the otherwise sound report. Be that as it may this is still a vaccine where the benefits are six years later still entirely theoretical and speculative and there are apparently many injured young women.

They and their families should be allowed to speak to the world without harassment. The public pay for these very expensive vaccines twice, first through the public purse, then through the harms they inflict.

 

So Long and Thanks for all the Serotonin

Leunig cartoon

The BMJ article on The Marketing of Serotonin has stirred some interest. There are some  highly technical comments on the BMJ site but of course the key point behind the piece is the rather obvious fact that twenty-five years ago many people were saying it was all a myth. The extraordinary Michael Leunig nailed it twenty years ago in the sketch above. (Leunig is wonderful across the board and razor sharp on medicine and mental health).

So did the BMJ know what they were doing when they sent the article to SMC leading to the extraordinary new Switch on Anti-Depression (SAD) theory?

I thought they were making a mistake, but maybe not. The figures for impact from Altmetric show a lot of interest.

Serotonin-and-Depression

There are good grounds for a lot of people to be very angry.

The lawyers for several pharmaceutical companies for instance claim to be very angry and upset by recent posts mentioning that finding out about things such as the idea that lowered serotonin was a myth could provoke murderous fantasies in some people, most of whom would do nothing but simmer and seethe. They have been even more upset at the suggestion that while some of us can view all this as “academic” others might be radicalized and might storm the offices of pharmaceutical companies or journals.

See War on Civilization and Pharmaceutical Rape.

serotonin and depression

Our rulers are exquisitely aware of the potential for violence in those who are oppressed – those who are powered out. The violence inflicted on us – mostly by White Males – from Ferguson and Charleston to Baltimore  playing out across television screens for the last year offers just one example. They expect Us to be as violent back as they are to US, and they tend to take pre-emptive action. At the first FDA Prozac and suicide hearings, the Chairman Daniel Casey wore a bullet-proof vest.

Clearly there has been no endorsement here for violent action but as one correspondent (MMC) put it, we sent Marlboro Man packing and something similar is needed here.

serotonin and depression

Better Die on your Feet than Live on your Knees sounds violent but was in fact the rallying cry of the Non-Violent Resistance movement that began in Ireland in the 1870s with Michael Davitt and later extended to Mahatma Gandhi and Martin Luther King.

If you want to see what is involved, fill a RxISK report on your behalf or someone close to you and take it to your/their doctor.  There is a good chance you’ll find out just how violent the system is.

But keep knocking until you find a doctor who listens, let us know about them and we can build networks that can change medicine. It is only going to change from the Bottom Up.

Switch on Anti Depression Today

5794416589_bb14397d5f_z

Science Media Centre Roundup

Expert reaction to editorial on serotonin and depression as published in The BMJ (British Medical Journal)*

Dr Clare Stanford, Reader in Experimental Psychopharmacology, UCL, said:

“Prof David Healy’s article treads a path that is well-worn but out of date. He argues that selective serotonin re-uptake inhibitors (SSRI) antidepressants are used because of a pervasive myth that they boost serotonin levels, but this is something of a straw man. He makes the mistake of assuming that antidepressants reverse a functional abnormality in the brain that causes depression. Actually, the theory that low ‘levels’ of serotonin in the brain (whatever that means, functionally) causes depression died many years ago, in spite of the fact that a deficit in the synthesis of serotonin in the brain can trigger relapse of depression in some patients who are in remission: a fact which he also fails to mention.

“By contrast, the monoamine theory of ‘anti-depression’ is alive and kicking. There is plenty of evidence that SSRIs increase communication from neurones that release serotonin, as well as other monoamine transmitters, and that the ensuing downstream changes, such as creation of new neurons (neurogenesis) or modification of gene expression, can ameliorate depression.

“In short, SSRIs probably switch-on anti-depression, rather than switch-off depression (which could explain the rapid efficacy of ketamine).”

“I am sure that most clinicians and scientists will be dismayed that a flawed argument is used to underpin a suggestion that the use of older tricyclic antidepressants, which are so dangerous in overdose, is always preferable to the SSRIs.”

 So long and thanks for all the fish

The BMJ editorial that the Science Media Centre are referring to is Attached Here.  It was originally called So Long and Thanks for all the Serotonin.

The first thing about the Science Media Centre comment is its wild.  It completely misreads the editorial its commenting on – at no point does the editorial say I or any academic ever believed the serotonin hypothesis or changed our beliefs because it has now been debunked.

In an extraordinarily brief space Clare Stanford introduces a whole new concept Switching on Anti-Depression – that no one I know has ever heard of.  And also manages to say that there was never any evidence for the serotonin hypothesis but that the serotonin hypothesis is right anyway.

Its hard to believe Clare Stanford wrote something like this.

Which raises the question – who are the Science Media Centre?  There were several posts last June about the Science Media Centre and  Sense about Science – see Follow the Rhetoric. First Admit no Harm, Follow the Lawsuit,  Follow the Patient – cover aspects of what’s at stake.  This is an organization that under the umbrella of taking a responsible approach to science ends up denigrating a lot of work or researchers that raise concerns about anything that might harm a corporation’s products.

Following the successful establishment of a UK SMC, comparable groups have been set up in Australia, New Zealand and Canada.  See SMC Feasiblity Study for a document apparently stemming from a consultation exercise about what a Canadian SMC might look like.

Earlier this year a fuss blew up about coverage of HPV vaccines in the Toronto Star.  The Star backtracked from its article, persuaded in part it would seem by input from SMC Canada that the Sixty cases of injured girls they had were just “anecdotes”.

The BMJ and other journals and media outlets divert a large amount of their content via the British SMC these days.  They seem to think that this will increase coverage of their content – when the SMC is much more interested ordinarily to close down stories like this one rather than open them up.  “We get our experts – who are usually media trained – to tell your journalists why you don’t want to bother with this story”.

Why do BMJ do this?

Who are the US equivalent of SMC?

Everyone Has the Right to Challenge “Scientific Experts”

the war on science

Editorial Note:  This post is from John Horgan who writes for Scientific American.  The original is here.  There is one change – the image used.  JH’s posts are always worth reading.  In this he takes on a worrying trend to regard science as sacrosanct.  A recent front cover for National Geographic brought this home to me.  To question whether vaccines might cause autism it seems is pretty well to be a Flat Earther.  This has clear and worrying implications for me, for RxISK and for anyone who has ever been injured by a drug.

Years ago I was blathering to a science-writing class at Columbia Journalism School about the complexities of covering psychiatric drugs when a student, who as I recall had a medical degree, raised his hand. He said he didn’t understand what the big deal was; I should just report “the facts” that drug researchers reported in peer-reviewed journals.

I was so flabbergasted by his naivete that I just stared at him, trying to figure out how to respond politely. I had a similar reaction when I spotted the headline of a recent essay by journalist Chris Mooney: “This Is Why You Have No Business Challenging Scientific Experts.”

(Journalist Chris Mooney argues that the views of anti-vaccine activist Jenny McCarthy can be dismissed because she is not a “scientific expert,” but by this logic the views of journalists like Mooney should also be discounted).

Mooney is distressed, rightly so, that many people reject the scientific consensus on human-induced global-warming, the safety of vaccines, the viral cause of AIDS, the evolution of species. But Mooney’s proposed solution, which calls for non-scientists to yield to the opinion of “experts,” is far too drastic.

In support of his position, Mooney cites Are We All Scientific Experts Now?, a book by sociologist of science Harry Collins. Rejecting the hard-core postmodern view of science as just one of many modes of knowledge, Collins argues that scientific expertise is uniquely authoritative. Here’s how Mooney puts it:

“Collins carefully delineates between different types of claims to knowledge. And in the process, he rescues the idea that there’s something very special about being a member of an expert, scientific community, which cannot be duplicated by people like vaccine critic Jenny McCarthy… Read all the online stuff you want, Collins argues—or even read the professional scientific literature from the perspective of an outsider or amateur. You’ll absorb a lot of information, but you’ll still never have what he terms ‘interactional expertise,’ which is the sort of expertise developed by getting to know a community of scientists intimately, and getting a feeling for what they think. ‘If you get your information only from the journals, you can’t tell whether a paper is being taken seriously by the scientific community or not,’ says Collins. ‘You cannot get a good picture of what is going on in science from the literature,’ he continues. And of course, biased and ideological Internet commentaries on that literature are more dangerous still. That’s why we can’t listen to climate change skeptics or creationists. It’s why vaccine deniers don’t have a leg to stand on.”

Mooney is hardly the only person insisting “You Have No Business Challenging Scientific Experts.” Versions of this assertion constantly pop up in debates over hot-button scientific issues. Defenders of supposedly canonical views of global-warming, genetically modified foods and vaccines dismiss non-expert dissidents. Just last week, a friend and fellow journalist mocked meteorologists who doubt climate change–because they’re meteorologists, not climate scientists.

The irony is that the “No Business Challenging Scientific Experts” argument applies not only to activists like Jenny McCarthy but also to journalists like Mooney and me. After all, we journalists are “outsiders” and “amateurs,” especially compared to the scientists whose work we cover, so how dare we second-guess them?

I agree with Mooney and Collins on some fundamental issues. I’m not a Kuhn-style postmodernist, the kind who puts scare quotes around “truth” and “knowledge.” Science is a uniquely potent method for discovering how nature works, and it gets some things right, once and for all: the atomic theory of matter, the (basic) big bang theory, evolution by natural selection, DNA-based genetics.

Also, I give great weight to consensus and credentials, which provide a fast and dirty way to decide whether a claim should be taken seriously. One of the reasons I doubted that “cold fusion” had been achieved in the late 1980s was that scientists claiming to have observed room-temperature fusion tended to be at second-rate institutions; scientists at top-tier institutions could not replicate the results.

But the history of science suggests—and my own 32 years of experience reporting confirms—that even the most accomplished scientists at the most prestigious institutions often make claims that turn out to be erroneous or exaggerated.

Scientists succumb to groupthink, political pressures and other pitfalls. More than a half century ago, Freudian psychoanalysis was a dominant theory of and therapy for mental disorders. The new consensus is that mental illnesses are chemical disorders that need to be chemically treated.

This paradigm shift says more about the financial clout of the pharmaceutical industry–and its control over the conduct and publishing of clinical trials–than it does about the actual merits of antidepressants and other drugs. That’s why I was so stunned when that Columbia student said peer-reviewed “facts” could speak for themselves.

Here’s another example related to the work of Harry Collins, who inspired Mooney’s column. Collins’s respect for scientific expertise stems in part from his decade-long immersion in the field of gravitational-wave studies. Gravitational waves made headlines a year ago, when astrophysicists overseeing an experiment called Background Imaging of Cosmic Extragalactic Polarization 2 announced they had discovered the “first direct evidence” of inflation, a 35-year-old theory of cosmic creation. According to the group, gravitational waves triggered by inflation had distorted the big bang’s microwave afterglow in measurable ways.

No less an authority than Stephen Hawking declared that the BICEP2 results represented a “confirmation of inflation.” I nonetheless second-guessed Hawking and the BICEP2 experts, reiterating my long-standing doubts about inflation. Guess what? Hawking and the BICEP2 team turned out to be wrong.

I’m not bragging. Okay, maybe I am, a little. But my point is that I was doing what journalists are supposed to do: question claims even if–especially if—they come from authoritative sources. A journalist who doesn’t do that isn’t a journalist. He’s a public-relations flak, helping scientists peddle their products.

And it’s precisely because we journalists are “outsiders” that we can sometimes judge a field more objectively than insiders. Mooney surely agrees with me on this. There is an enormous contradiction buried within his “No Business Challenging Scientific Experts” argument. He obviously doesn’t want us to yield to every scientific consensus, only to those that he, Mooney, deems credible.

Google is reportedly working on algorithms for evaluating the credibility of websites based on their factual content. But there will never be a foolproof way to determine a priori whether a given scientific consensus is correct or not. You have to do the hard work of digging into it and weighing its pros and cons. And anybody can do that, including me, Mooney and even Jenny McCarthy.

By the way, I think McCarthy grossly overstates the dangers of vaccines–I’m glad my kids got vaccinated–but I, too, have concerns about some vaccines.

Editorial Note:

On the vaccine issue, here is a recent article of interest on Vaccine Assay Secrecy by Matthew Herder and ColleaguesHerder Vaccine assay secrecy.


http://blogs.scientificamerican.com/cross-check/2015/04/08/journalist-chris-mooney-is-wrong-again-about-experts/

Everybody Has the Right to Challenge “Scientific Experts” II

(This is a follow up post from John Horgan on the topic – the original is HERE.)

I recently knocked science journalist Chris Mooney for asserting that “You Have No Business Challenging Scientific Experts.” Non-experts have the right and even the duty, I retorted, to question scientific experts, who often get things wrong.

Far from reconsidering his stance, Mooney doubles down on it in a Washington Post column, “The science of why you really should listen to science and experts,” that defends not just scientific experts but experts in general. Mooney ends up not boosting experts’ credibility but undermining his own.

He cites a study that found that judges and other lawyers show less ideological bias—or “identity-protective cognition”–in their application of the law than law students and lay people. Titled “Ideology’ or ‘Situation Sense’? An Experimental Investigation of Motivated Reasoning and Professional Judgment,” the study was carried out by Yale law and psychology professor Dan Kahan and five other scholars.

To my mind, the study merely shows that lawyers and judges know the law better than law students and non-lawyers. That’s reassuring, but surely it does not mean we should always trust lawyers’ legal advice, especially since lawyers so often disagree on interpretations of the law. Consider the rancor of recent debates on health care, immigration, taxes, the environment and other issues in Washington, where more than one third of current Representatives and one half of Senators have law degrees, according to The National Law Journal.

Mooney nonetheless insists that the Kahan study “fits nicely alongside a growing trend toward robustly defending and reaffirming the importance of experts.” As an example of this trend, he cites the 2005 book Expert Political Judgment by political psychologist Philip Tetlock.

Mooney’s citation of Tetlock is bizarre, because Expert Political Judgment—far from a defense of experts—is a devastating critique of them. Tetlock reports on his long-term study of 284 professional pundits, including academics, government officials and journalists, who comment on politics and related issues in scholarly journals and conferences and via mass media. Over two decades, Tetlock recorded some 28,000 predictions by the experts related to wars, elections, economic collapses and other events.

In a terrific 2005 review, “Everybody’s An Expert,” New Yorker writer Louis Menand summarizes Tetlock’s conclusions as follows:

“people who make prediction their business—people who appear as experts on television, get quoted in newspaper articles, advise governments and businesses, and participate in punditry roundtables—are no better than the rest of us. When they’re wrong, they’re rarely held accountable, and they rarely admit it, either. They insist that they were just off on timing, or blindsided by an improbable event, or almost right, or wrong for the right reasons. They have the same repertoire of self-justifications that everyone has, and are no more inclined than anyone else to revise their beliefs about the way the world works, or ought to work, just because they made a mistake. No one is paying you for your gratuitous opinions about other people, but the experts are being paid, and Tetlock claims that the better known and more frequently quoted they are, the less reliable their guesses about the future are likely to be. The accuracy of an expert’s predictions actually has an inverse relationship to his or her self-confidence, renown, and, beyond a certain point, depth of knowledge. People who follow current events by reading the papers and newsmagazines regularly can guess what is likely to happen about as accurately as the specialists whom the papers quote.”

Menand’s review is loaded with gleeful one-liners, including this one: “Human beings who spend their lives studying the state of the world, in other words, are poorer forecasters than dart-throwing monkeys.” And yet this is no laughing matter. Consider how “experts” in the government, academia and media helped enable the catastrophic U.S. wars in Afghanistan and Iraq and the economic collapse of 2008. Example: New York Times columnist Thomas Friedman, who just before the U.S. invasion of Iraq expressed the hope that it would lead to “a more accountable, progressive and democratizing regime.”

How can Mooney possibly interpret Tetlock’s book as a defense of experts? Here’s how. He seizes on Tetlock’s finding that some experts were better forecasters than others. They tended to be not what Tetlock calls “hedgehogs,” who explain the world in terms of one big unified theory, but “foxes.” Foxes, Tetlock explains, “are skeptical of grand schemes,” and “diffident about their own forecasting prowess.”

In other words, the most credible experts are those who, implicitly, warn us to be wary of experts. Mooney is oblivious to this irony. “So experts really do exist,” he blithely concludes, “and they really are different from non-experts. Now, all we have to do is listen to them.”

I prefer Menand’s conclusion. He writes that “the best lesson of Tetlock’s book may be the one that he seems most reluctant to draw: Think for yourself.”

Addendum: Listen to me talk about the need to challenge experts on New Hampshire Public Radio: http://nhpr.org/post/4615-challenging-experts-creationism-europe-world-beyond-your-head.

 

From Corey Powell, old friend, distinguished science writer, former editor-in-chief of Discover, whom I quote dissing meteorologists above:

Just to be clear–my argument wasn’t that meteorologists lack the ability (or worse, the right) to challenge climate studies. My argument is that they suffer from a false sense of expertise that makes them think they can speak with authority without bothering to really understand the other field. It’s a lazy kind of arrogance. This often happens when scientists get taken with their own brilliance and think, hey, I know about genes, I’ll bet I really understand consciousness or solar energy or alien life or whatever. Of course almost everybody with a healthy ego does this to some extent, fantasizing that they are experts at something they know nothing about. But with the meteorologists (as a case study) there is a more specific type of confusion, and a more specific type of unearned claim to authority. I liked our quick Twitter exchange about the role of curiosity vs. gall. Both of them are about questioning everything, including expert testimony & peer-reviewed truths. I take a bit longer to reach full boil when I come across BS, but I get there eventually.

From Matthew C. Nisbet, Associate Professor of Communication Studies, Northeastern University:

In American political culture, liberal commentators and advocacy journalists tend to put scientists on a sacred pedestal and are often funded to do so and attract audiences by doing so.

Climate scientists especially are not only portrayed as innocent priests and powerful seers but also as vulnerable martyrs that must be protected and defended against any criticism, even when such criticism comes from social scientists or specialist journalists who are speaking from the perspective of their own expertise.

On complex, wicked problems like climate change, the only way we identify paths forward and opportunities for political cooperation is through healthy disagreement.  Criticism helps widen the menu of options that might be pursued and calls attention to faulty assumptions.

Another example of the need for informed criticism of experts, as I discussed in a recent co-authored paper, is the work of the journalist Gary Taubes who helped spur scientists to reconsider their assumptions about the linkages between diet, obesity, and other negative health outcomes.

From David Gorski, physician and blogger at “Science-Based Medicine”:

Gorski critiques my column in a post titled “On the ‘right’ to challenge a medical or scientific consensus.” Like Mooney–and like me!–Gorski has concerns about the propagation of pseudoscience, but his piece is one long exercise in begging the question. That is, he implicitly assumes what he is attempting to argue. He writes: “It’s… important to remember that there are scientific consensuses and then there are scientific consensuses. What I mean is that some consensuses are stronger than others, something Horgan seems to ignore or downplay.” The primary point of my piece is that there is often no way to know whether a consensus is legitimate or not; scientists often claim more certainty than is merited, and hence outsiders are justified in questioning scientists’ proclamations. Gorski’s own field, oncology, offers an excellent example of this problem. For decades, the consensus was that cancer should be combatted with frequent testing and aggressive treatment, but now that consensus is unraveling. “In the end,” Gorski concludes, what Horgan seems to be arguing is that we should take pseudo-expertise seriously.” Actually, I am arguing that the public should be wary not only of pseudoscientific charlatans peddling homeopathy and “energy healing” (Gorski’s examples) but also of genuine experts like Gorski.

 

See also my next post, Sociologist Steve Fuller: Scientists Aren’t More Rational Than the Rest of Us“; and my Bloggingheads.tv chat with anonymous blogger “Neuroskeptic,” an expert who displays admirable skepticism toward his own field.

 

Further Reading:

Advice to Young Science Writers: Think Like Chomsky.”

A Dig through Old Files Reminds Me Why I’m So Critical of Science.”

What Should We Teach When We Teach Science Communication?

Should the Humanities Embrace Scientism? My Postmodern Response to Pinker’s Patronizing Plea.”

 

Winging it: Antidepressants and Plane Crashes

Pilot

The crash last week of the Germanwings plane has shocked many.  In view of the apparent mental health record of the co-pilot Andreas Lubitz, questions have been asked about the screening policies of airlines.  The focus has generally been on the conditions pilots may have or the arguments they might be having with partners or other situational factors that might make them unstable.

Even when the issue of the medication a pilot may be taking is raised, as an article by Erica Goode in the New York Times makes clear it is in the context of policies that permit pilots to continue on drugs like antidepressants to ensure any underlying conditions are effectively treated.

Side-Effective 

Clearly if a drug is effective in clearing up an underlying condition, its use should make the pilot – or driver of a coach carrying 50 or more passengers – safer.  But fewer treatments in medicine are effective in this sense than people might think and even when effective they come with effects that need to be balanced against the likely effects of the underlying condition.

Doxycyline, for instance, a widely used medicine for acne and for malaria prophylaxis, can be very effective for acne.  But doxycycline can also make someone depressed, suicidal and homicidal, while acne doesn’t do this.

Other antibiotics like Levaquin and Cipro can cause a range of serious and enduring problems including psychosis but are ordinarily given for problems that are unlikely to compromise a pilot’s ability to fly and keep her passengers safe.

Antidepressant Effects

So what about depression?  The risks of suicide or homicide from mild to moderate depression or anxiety are almost nil.  Think of it this way – what we call depression today in nine cases out of ten was called anxiety 30 years ago before the development of the SSRIs and anxiety was not thought of as a significant risk factor for suicide or homicide.

Difficulties with a partner or at work can lead to precipitate action including suicide or homicide.  They can also lead to anxiety or depression but the anxiety or depression linked to these events don’t for the most part cause problems except in so far as sleeplessness on the one side or a sedative drug on the other might cause an accident.

Whatever the risks of suicide or homicide linked to such anxiety or depressive states might be, in clinical trials antidepressants close to double them – and not just in younger adults. They do so by causing psychosis, or by producing an agitation laced with suicidal or homicidal thoughts, or by producing an almost lobotomized state in which people will do things they would ordinarily never do, or by increasing blood alcohol levels if the person has had a drink.

GSK data suggest these drugs appear to make someone more likely rather than less likely to “act out” if they have just had a partner break up with them.  See Kraus – Clinical features of patients with treatment-emergent suicidal behavior following Paroxetine.

All of this has been relatively well known for decades.  We could have made things much safer by discussing the changes treatment can trigger openly much earlier and permitting patients and doctors to identify problems and find solutions – such as switching to a drug of a different class.  Doctors and patients have been left flying by the seat of their pants.

The Debate

There are likely to be a number of features to the current debate.

First an impression will be created that we know more about these drugs than we in fact do. 

We know almost nothing about what antidepressants actually do – we still don’t know what they do to serotonin.

Rather than being effective like an antibiotic, these drugs have effects – as alcohol does. Their primary effect is to emotionally numb. Patients on them walk a tightrope as to whether this emotional effect is going to be beneficial or disastrous.

We know even less about other drugs Lubitz might have been on such as mood-stabilizers.  These too can produce suicidality and homicidality but they have a different signature to that of antidepressants.  The trouble is that, unlike the case of the SSRIs, no doctor giving any patient a mood-stabilizer can tell them what to watch out for or what the timeframe of problems is likely to be.

Lubitz has been widely reported as having vision problems – see  Mail on Sunday. Antidepressants cause visual problems – see RxISK.  But there is little known about these problems.

Second there are a lot of powerful interests at stake.

Some of these will think nothing of playing the personality card in the case of Lubitz to create the impression this was all about his instability rather than an instability in him created by treatment.

Third these powerful interests employ the best public relations on the planet.

These companies will in a variety of ways play the card that anyone suggesting treatment may have been part of what went wrong are just conspiracy theorists.

Fourth efforts to manage the problem will be portrayed as effective. 

We will hear that the Federal Aviation Authority in the US only permits pilots to fly on a selected number of antidepressants when they have been stable on treatment for six months.  Sounds good.  But no mention of the problems that happen on withdrawal – which are as great as those that happen on starting.  See Antidepressant Withdrawal: A Prozac Story – on RxISK.  Prozac is one of the selected antidepressants.

Once treated with a drug, a pilot is never the same again.  Even if the underlying condition clears, he may not be able to stop.  The risks are not eliminated.  The only way to manage these risks is to have a close relationship between the pilot and her doctor in which the doctor is fully informed as to what the risks are – a doctor who acts like a pilot in the sense that she doesn’t take risks that will bring her down along with her pilot–patient.

Let them Burn

In lectures for several years  – see Professional Suicide, I have compared the roles of doctors and pilots saying that we are all safer flying than we are in the hands of our doctors because the pilot knows if the system isn’t safe and you die, she will also, whereas doctors can always and routinely do blame your condition or your circumstances.

This idea has now crashed into Andreas Lubitz and his doctors.  We are all wondering about Lubitz and what motivated him.  What about the doctors who may have unintentionally primed him?

At the moment it is difficult to see Lubitz as a victim but he may be.  His doctors may also be victims.  They may have joined a string of doctors who agonize over horrific events they are party to.

Treatment may not have precipitated what happened in this case but there are many people in the pharmaceutical industry who have known for a long time that something like this can happen on their medication and they have done nothing to put in place systems to manage these risks or to dismantle the system that gives rise to risks like this at a much greater rate than we should have to tolerate.

That corporations might do this is not a conspiracy theory. In the famous Ford Pinto case, a Ford executive made aware of risks that their car would lead to a regular number of drivers and passengers being incinerated each year – a problem that could have been inexpensively put right – famously wrote

“it’s cheaper to let them burn

The powers that be have been winging it for decades.

Antidepressants and the Tell-Tale Heart II

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Editorial Note:  This is Part 2 of The Tell-Tale Heart.  It fits into a sub-series about Pharmaceuticals: Rape and Consent.  It also maps straight on to Antidepressant Withdrawal: A Prozac Story and Saving Grace both of which are on RxISK.  Saving Grace picks up the Bipolar theme running through Tell Tale Heart.  

For the record, there is no question but that citalopram and escitalopram have significant effects on the heart, and astonishingly almost none of these are at present understood.  We talk about QT interval changes but even these are not understood.   There are EKG – ECG – cardiogram Apps but not one that can handle some the problems SSRIs cause.  Someone who could design one would help a lot of people.   

Withdrawing Again

After 6 months my GP suggested coming off the antidepressant again. I had learned a little about tapering by then and asked to be referred to Addaction. Maybe I was addicted.

Addiction was added to my file notes… another nail in my coffin, as addiction, I later discovered is often considered to be co-morbid with SMI – Serious Mental Illness.  My GP referred to it as “chemical dependency”…. but addiction was the only thing that appeared in my notes.

My GP wanted me off the antidepressants quicker than the 3 month taper I had researched through an online support group called CITA. However, she prescribed drops and tolerated my request to do it slowly.

Addaction were very helpful and supportive but knew nothing about citalopram. They researched withdrawal but found no advice. We were in the dark and followed the withdrawal charts I had downloaded from CITA.

I went through the tapering without too many problems until I got to the final few drops, then all hell broke loose.  I dispensed with the last few drops and braced myself.  This was a big mistake. I should have re-instated and stabilised instead of giving up on the taper. There was no advice available.

Withdrawal kicked in with physical as well as emotional symptoms.  Profuse sweating, jaw clenching, no saliva, leg jerks, brain zaps, blood sugar feeling like it cleared too quickly leaving me shaking and sweating. An awful confused dream processing with images whizzing through my head kept me awake and I had unbearable restless legs.

This will Help…

After a holiday in the sun, where I was unable to leave my hotel room, and was taking diarrhea remedies to deal with the blood sugar problems, I begged my cardiologist for help.  “Ah yes,” he said, “this is the fainting condition. A corticosteroid will sort that out…just one tiny pill….” I asked about withdrawal being the cause and was told that the antidepressant had cleared my system long ago and it was impossible that it’s impact could be felt due to it’s half life. Therefore this could not be withdrawal.

He placed me on the steroid… and admitted me for a pacemaker implantation.

On the corticosteroid my mood plummeted as it built up in my system. I became slightly puffy and moon faced and then seriously depressed.  This time it really was depression. I became convinced I was dying and couldn’t stop crying. I made memory boxes for my children and kept telling my husband about my wishes for a Dignitas type death.

My GP referred me for CBT as I wouldn’t take the antidepressant again. I got 9 sessions and was discharged in the same state.  It was a complete waste of time and it added to my misery.

 Pacemaker

After the pacemaker operation I was in shock, tearful and repulsed by the new lump in my chest. There was a long scar.  I felt disfigured and violated and couldn’t come to terms with it, although everyone kept telling me it was a marvelous device keeping me alive and I should be grateful. I didn’t feel grateful at all.

I recovered at home then went back for a check up. My pacemaker had automatically changed setting to a more aggressive form of pacing. The technicians pronounced this wrong and dangerous for me and re-set it, saying it shouldn’t have happened.

After being interfered with again, something couldn’t cope. On arrival home I couldn’t co-ordinate my limbs to walk and the stiff legs returned and Parkinson type jerks came on. I became tearful and afraid and we rang the pacing clinic. They pronounced my symptoms “impossible” but changed the setting back to the original more aggressive pacing, writing up that the new pacing didn’t appear to “suit me”.  The physical reaction was ignored and written up in my notes as anxiety.

The aggressive pacing was left in place for 5 years and a condition which should have been paced 2% of the time, was being paced over 80% of the time by the end of this period. I was becoming pacemaker dependent… but no one would listen to me as that “bipolar?” comment had found it’s way through to all concerned.

Faint Hearted

In the midst of all of this I was still trying to contest my diagnosis of a fainting disorder and asked for a referral to the autonomic nervous system clinic in Paddington to have the diagnosis challenged.  My GP agreed, as he didn’t think I should be on the steroid… probably because “bipolar?” was in my notes.

I remember being terrified in the tunnels of the London Underground travelling down to the appointment and having an anxiety attack on the station. Just 10 years previously I had lived in London and had traveled on the underground daily in my sales job as a confident young woman. What was happening to me? I was a nervous wreck, jumping at my own shadow.

I had two negative tilt table tests at the clinic and the professor suggested that my diagnosis was wrong. It was probably a cardiac problem.  His letter to my doctor was full of sarcasm regarding my account of my symptoms such as “paresthesiae, burning sensations” etc.  The emphasis, again, was on delusions concerning my mental health and this overshadowed everything else.

My GP agreed that I should come off the steroid. I did so and the depression and thoughts of death disappeared as the drug cleared from my system. But the delusions were now in my file along with health anxiety relating to drug use… another nail in the SMI coffin.

Falling Apart

My life outside medicine was in bits by then. My husband had lost his job and his shares had plummeted, his father had died and his mother was in a care home. We were trying to live on a pittance and an overdraft against our house. My son developed school phobia and I suddenly couldn’t cope anymore feeling I was to blame for my son’s problems….which I probably was as my behavior on the steroid must have frightened him, coupled with the heart admissions.

At some point, I became suicidal and made plans. Everything was my fault – I was a hopeless mother, I had failed and I was doing more harm than good being alive. My husband discovered the stash of razor blades and drugs and took me to the GP who prescribed the same antidepressant again. “It can’t hurt you this time” the GP patronised,” because you have a pacemaker”.  I reluctantly took it as I knew there was no choice.

After 6 months I came off it and again had withdrawal symptoms and roller coaster mood swings.  I think there was one more bout of suicidal ideation after this and I had been experiencing hypervigilance and paranoia when anxious. I asked for a referral to psychiatry. This suicidality, roller coaster mood swings, and paranoia was not normal for me and was becoming too frequent to be ignored.  My GP agreed.

After a few sessions, I was told that the psychiatrist and my doctor had already decided what was wrong with me, it was just a question of time.  Every letter following my psych appointments pulled out evidence to support a diagnosis of SMI….detailing “dramatic behavior”, the suicidal ideation, health anxiety etc.  All I remember was sitting there, feeling out of it and worrying that I was like my father. I was told they were considering two serious diagnoses… and I joined up the dots and panicked.

Fighting Back

I was having private psychotherapy at the same time, and that Achilles heel from my past, and my suggestibility had come up.  I was working through those issues and realizing where I had gone wrong – seeing patterns of behavior that I was misinterpreting as hereditary mental illness.

My sons and husband had decided by then that I was quite mad. They wanted me medicated and safe. According to them. the therapist was putting nonsense in my head and validating me, when he should be listening to my doctors. I resented them all bitterly and withdrew to an online mental health forum for support.

I found a group of MH patients online who were far more knowledgeable than me about withdrawal issues and who put me in touch with another doctor, who saw me without a referral.  I was afraid of seeing another psychiatrist and worried myself to distraction. But I needn’t have worried as he understood. He cut through the crap and saw what was happening.  This was a turning point for me, and I will be eternally grateful for someone in a position of “knowledge” intervening and helping me fight my corner.

My doctors were not so grateful and branded him “out for his own ends and using me as a tool in a fight against the pharmaceutical companies”.  I disagreed.

On my therapists advice I withdrew from psychiatry. He felt that I went backwards every time they suggested hereditary SMI as the cause of my issues and this was the cause of my problems.  That psychotherapist was right! I never went back… but the self doubt was hard to shift.

Feeling slightly more validated I sent off for my father’s notes and discovered that he was diagnosed with personality issues and reactive depression.  This made sense as he had been brought up by a step father who was a Polish Jew and had fought in the world war. This man had resented my father as a stepson and his upbringing had been very difficult as a result.  I began to unravel my beliefs about hereditary MI.

Listening Against Me

I complained to my GP about being placed on psych drugs and misunderstood withdrawal and obtained copies of my notes which were full of inaccuracies.  It was then that I discovered the “bipolar” comment which had been read by all who treated me. I began to realize that I had not been taken seriously for years.

I requested a re-diagnosis of my heart condition. This was translated as “health anxiety” again as my doctors maintained that I had received a full and comprehensive investigation previously.  The consultant used the opportunity to gather information… supplied by me…. and placed it on file under relevant psychiatric history / reactions.

Apparently, I was delusional (whilst on the steroid), the dream disturbances I had experienced in withdrawal were hallucinations and I had experienced paranoia.  I clearly had health anxiety regarding psychiatric drugs and my notes showed marked episodes of depression and relapses.  I had reacted to small doses of antidepressants and steroids which was indicative of bipolar disorder and there was evidence of mental illness in the family with my father and my son’s school phobia.

I tried to go back to work but was told that I may have a hereditary form of mental illness and my GP would only sign me off part time. “Do you think I’m too dangerous for a classroom?” I asked.

I withdrew again, afraid, misunderstood and with a huge amount of self doubt.  No one would back me up or believe in me.  I felt hurt, angry and abused by a system that would not admit it’s own shortcomings or be open minded about drug side effects and expected me to accept a serious mental health diagnosis because as my GP said, “so many professionals could not be wrong”.

All this, when I had been dismissed by psych services after just two sessions of counselling 10 years ago with no significant symptoms or need for help apparently!! This did not add up.

We Mark our Destinies with our Fears

Although my logical brain tells me that they cannot diagnose me with anything, I am terrified to go to the doctor now. Terrified to ask for help if I have heart symptoms for fear of them being diagnosed as health anxiety and terrified of what lies ahead with my heart condition which is still being treated as a fainting condition 6 years on despite no fainting during the intervening years and no drugs to prevent fainting either.

I have lost many friends, my dignity and my self-confidence. I have deep rooted fears surrounding hospitals.  I nearly lost my husband’s respect and my marriage when I became suicidal and I have had to battle to regain the trust of my children, who lost all respect for me too as I fell apart whilst in withdrawal or on steroids.  I worry about the effect on them.

I will never visit another psychiatrist  and I will never take another psych drug or steroid unless I become suicidal again, which I think is highly unlikely now that I am two years drug free and back to the relatively calm and stable person I originally was.

Worst of all though is the specter of that SMI diagnosis. It probably won’t happen now but it still frightens me to know that there is evidence on my file. What if I become unwell or confused in later life or the menopause throws up depressive symptoms… will they pluck it out of my file again?  I need to put it behind me… but that’s easier said than done.

They say that history within families repeats itself. Maybe this is true if you allow it to and buy into hereditary mental illness as a possibility like I did. It can become a self-fulfilling prophecy…. but that’s nothing to do with genetics really is it?

We mark out our own destinies sometimes with our fears…. and that’s where I went wrong.

Antidepressants and The Tell-Tale Heart

We have slightly detoured from the Persecution theme.  The detour came after a lawyer, a woman, representing a company that markets escitalopram said it wasn’t appropriate to compare the lack of consent in pharmacotherapy to rape.  This gave rise to a Consent-Rape mini series of posts which this two-part post continues.  Persecution will resume very soon.

This post feeds into a series of posts about antidepressant withdrawal on RxISK – see Antidepressant Withdrawal: a Prozac Story and the dangers of letting a strange medication into  your life – see Saving Grace.  

Perhaps linked to the Rape theme, in healthcare at least it seems to be mostly women who stand up to power, who want to reclaim the streets or in this case our clinics, and whose oratory echoes great men who have spoken out in other settings.  But no-one has made a movie of their march from Selma to Montgomery yet…  

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Like many of us I have an Achilles heel.  For me, that topic is familial mental health. This is due to my father who had a breakdown when I was a teenager. He behaved erratically, desperately for a few weeks, and then disappeared into the local mental health hospital, before re-emerging tearful and vulnerable.

This was frightening to witness, difficult to understand and – being a teenager – embarrassing.  Due to my parent’s subsequent divorce I became estranged from him for years and those memories of his mental health deteriorating, leading up to his business collapse, divorce and losing our home are traumatic ones.  They made me susceptible to suggestions of hereditary mental illness.  Usually reasonable, I am quite the reverse around this topic, and easily frightened by it.

Becoming Depressed?

Twelve years ago,  I was exhausted and tearful and had moved from a town where I had employment as a teacher to an idyllic rural location away from my family… the ripples of divorce and my father’s behavior yet again having caused problems for me in my thirties.

Once away from my home town and in the sticks, I no longer needed to work as the mortgage was paid off and I had no money worries.  My husband had a good job and commuted to the city. I had the children to ferry around and care for and a beautiful home, but family events preceding the move had got on top of me and the empty days provided too much time for reflection.  I went back to bed a lot during the day and became exhausted and tearful. “I think you may be depressed” said my kind and gentle husband, “let me take you to the GP”.

A diagnosis of mild anxiety/depression with no suicidal thoughts was confirmed and a course of antidepressants – escitalopram 10 mg  – followed during the six week wait for counselling.  The drug was new to the market.  It felt like little light bulbs were exploding behind my eyelids when I took it.  I couldn’t shut my eyes or sleep through it but I felt my fatigue lift.  How, I wondered, could one little white pill cut through the exhaustion and make me feel like this?  It was obviously exactly what I needed. This was depression for sure, what luck it had been spotted.

When I went back to the GP to tell her that I couldn’t close my eyes, she reduced the dose by half and added to my notes…”bipolar?”  She put me back up to 10 mg after a couple of weeks and this time there were no exploding light bulbs. I felt energised, happy and well. I could put up with the dry mouth, lack of orgasm, funny feelings in my brain like zaps and bloated stomach and tummy pains which developed – I put this down to IBS.

Six weeks later, counselling passed in just 2 sessions.  I told them I felt great and told them a little of the events leading up to moving house.  I was rewarded with a gentle smile and a letter to my GP which said there was nothing significant wrong.  I was discharged. On reflection, I think the counsellor was quite right… it was just life getting me down and I needed to recharge my batteries and deal with the crap rather than “medicate” it. But I could have done with some talk therapy to uncover the misinformation that my “Achilles heel” was causing.

I went back to my GP.  She felt I looked and sounded so much better that it would be a good idea to keep taking the drug as depression could be long lasting. Eight months’ worth of pills were prescribed.  I was happy to take them as they made me feel better.

Hints of Withdrawal

After eight months, I stopped, following GP advice – dropping a pill every other day over two weeks.  The exhaustion and tearfulness returned pretty quickly. I went back to the GP.  “Ah yes, the depression hasn’t gone yet,” she said. “I’ll re-prescribe your drug, but this time NICE suggest that in the case of a relapse you should stay on the drug for a year.  You may not need to though, so don’t worry.”

….and so the roundabout turned. Every time I tried to come off the drug, no tapering, as I knew nothing about this, I had what I now know are withdrawal effects… they got worse each time and I found I was emotionally labile, flying into rages, driving erratically and susceptible to the slightest stress.  I believed myself to be mentally ill and getting worse. I needed that drug to keep my children safe from my mood swings as I was a monster when I stopped.  I feared I was an unfit mother. I drew comparisons with my father.

My periods became unmanageable. I bled so profusely that I couldn’t leave the house.  My stomach blew up with painful IBS type symptoms and I collapsed one day, without warning, whilst on the loo, waking up on the tiled floor with a banged head.  It didn’t enter my head that any of this could be caused by the drug. I put up with it, passing off the collapse as an embarrassing incident probably linked to constipation.

Eventually, I saw a different GP who looked at my notes, scoffed and said, “what on earth are you on these for?”  By then I was sleeping more than I had been sleeping when first put on the drug, I had gained weight and although calm I was very lethargic and didn’t have much energy.  I was no longer energised. I accepted that I needed to come off the drug.  I had been on it for 5 years.

My world was turned upside down within weeks of the quick taper as per packet instructions.  I became that rage filled, over-reacting, crazy woman I had come to fear.  I mentioned the rages to my GP and a look of concern crossed her face… but it was too late.  I’d been off the drug for some weeks. I wasn’t going to go back on it. Enough was enough, and the doctor had told me I didn’t need it.

Under the Ribs lies a Tell-Tale Heart

Following an argument which made me anxious, I felt something lodge in my chest.  Some hours passed but the feeling wouldn’t go away. I rang an NHS out of hours advice line who told me they thought I’d had a heart attack. I thought this was ridiculous, I was too young (43) and had no indicators for heart disease.  After a lengthy chat and some scare tactics, I agreed to go to A&E when my husband got home.

In A&E I was placed on an ECG and kept in the cubicle for a very long time. Eventually I was told I had an arrhythmia and a slow heart beat.  I had a positive troponin test for heart attack and was kept in.  I remained in hospital for 2 weeks. I was terrified.

No one knew what was going on – the doctors gave me heart attack drugs which caused my blood pressure to plummet. They gave me zopiclone to make me sleep at night and gave me various diagnoses from heart attack to sick sinus syndrome. My anxiety went through the roof when I was told I would need a pacemaker as my heart was going too slowly and I was at risk of stroke.

I was sent for a scan of my arteries – no blockages – and then discharged back to my GP’s care.  She didn’t know what to do with me as there was no diagnosis and my pulse was very faint and arrhythmic.  When I mentioned the antidepressants role in all of this, she said “maybe….”  She placed me back on an antidepressant – citalopram 10mg this time which she said was half the strength. I can’t remember if it helped or not, I was in such a mess.

Two weeks later I was back in hospital again with the same problems. They took me off the citalopram – saying antidepressants were no good for the heart….you don’t say!! I was put on the stroke ward but they couldn’t cope with me there as the bell attached to my heart monitor, which indicated that my pulse had fallen below 30 went off all night and my blood pressure plummeted.

They tried felodipene to help the pumping action of my heart and my pulse increased to about 45 but my legs stiffened and I couldn’t walk . God knows which other heart drugs I was on – they were swapped around like smarties.  The stiff legs weren’t possible apparently – I was told I had to keep taking the drug for 3 months.

My mood by then was frankly on a rollercoaster and I threw an embarrassing tantrum unable to put up with not being able to walk. I called my husband and discharged myself despite nurses trying to persuade me I was in danger of stroke and should stay.  When I got home I panicked and realized that I had over reacted to stress and was an emotional wreck. I broke down, but refused to go back. I felt like no one could help me and no one understood.

My GP was furious with me and I was placed back on the antidepressant again. She took me off the felodipene though and suggested “I put it to one side….” This felt very wise.

When your Problem doesn’t fit their Boxes

I got referred to an electro-cardiologist who put me on a tilt table which is designed to induce faints in people with certain heart conditions. My heart stopped after 10 seconds of tilt and I lost continence. I woke up shaky and afraid.

I also had a cardiac stress MRI which consisted of a drug being administered that made my heart race. Afterwards, in a hotel room, I kept losing consciousness and was in a mess. The procedure had obviously been too much for my heart.

I felt at risk from the men in white coats who thought they knew everything, but didn’t think to listen to me.  They knew best… but clearly knew very little.

A fainting condition was diagnosed caused by an arrhythmia – neurally mediated syncope.

But I’m not fainting” I said.
“It’s your autonomic nervous system which is faulty causing low blood pressure and an irregular heart beat which causes you to collapse”.
But I’m not fainting and my blood pressure is normal”.
“Your blood pressure was really concerning in hospital and you felt faint during an exercise test” they said.
Yes, but they took me off the antidepressant and gave me loads of heart drugs which lowered my blood pressure …” I argued to no avail.

The condition was treated with 6 teaspoons of salt per day and 2 litres of water to increase blood pressure.  My blood pressure went through the roof to hypertensive levels.  This was not expected, as low blood pressure typified the condition.

I was also told that my veins were dilated and that this was causing “low blood volume”.  I was offered Prozac which I refused. I didn’t want any more drugs. Later on I was told that the same hospital were using Prozac in patients with congested arteries as it helped with vasodilation.  The exact opposite of the use proposed for me.

The consultant was puzzled by my blood pressure reaction as it didn’t fit the diagnosis of neurally mediated syncope, neither did the night time dips in heart rate.  Heart rates usually dip in fainting conditions when you stand up… not at night in bed.  But this was ignored and my protests that the diagnosis was wrong were ignored.

After 6 months my GP suggested coming off the antidepressant again…

to be continued

 

Pharmaceutical Rape

Editorial Note:  A riff by Laurie Oakley on the issue of Rape and Consent.  See Laurie’s recent post on RxISK – Over the Top. Tackling Medical Power and for pharmaceutical lawyers on the issue or Rape and Consent – see Dangerous Liaisons II.  It should be read in conjunction with Doctors Writing Scary Scripts: Saving Graceon RxISK

We are interested in any additions anyone – even The Chester Burn-Ettes can offer.

Crazy and it was - book by Laurie Oakley.

PHARMACEUTICAL RAPE

An act of plunder, violent seizure or abuse, despoliation, to rob of goods by force, to seize wrongfully or by force, steal.

PHARMACEUTICAL RAPE CULTURE

A concept that examines a culture in which harm from pharmaceutical products is pervasive and normalized due to societal attitudes about medicine and health care. It is a complex set of beliefs that encourages capitalistic, pharmaceutical domination of healthcare and supports everyday harms in medical and mental health care settings. It is a society where harm is only acknowledged as rare, yet is accepted as necessary, and inevitable. In a pharmaceutical rape culture, doctors and patients unknowingly trust what are oftentimes pseudo-scientific facts put forth by drug makers about drug safety. Both doctors and patients end up disbelieving the reality of the adverse events they see and instead believe alternate explanations for such events. A pharmaceutical rape culture condones harms caused by the industry-government-medical trade alliance because the culture produces, reproduces, and is completely saturated with “information” that supports that alliance.

BEHAVIORS ASSOCIATED WITH PHARMACEUTICAL RAPE 

  • Denial of widespread pharmaceutical rapeA tendency to remain oblivious in the face of evidence of harm.
  • Trivializing pharmaceutical rape: A response to harm by denying that real damage was done.
  • Medical/pharmaceutical objectification/commodification.: An attitude about patients that is limited to placing primary value on what goods or services can be employed for reimbursement or compensation. Reducing him/her to a commodity with value being limited to financial usefulness.
  • Victim blaming: It is your fault you were hurt because you did x, y, z. If you hadn’t done x, y, z, you would not have been harmed. You went to the doctor, you asked for medication, you consented to the treatment, you kept going back to the doctor, you didn’t do your homework, you should have known better, you should have listened to your body, I knew better and I didn’t do those things.
  • or, what you experienced was your own illness, it was your poor diet, your lifestyle, your lack of exercise, your use of alcohol or other drugs, your age, your family genetics, etc.
  • or you are at fault because you are a drug addict, (even though the addiction came about through or was aided by what is considered legitimate prescribing).
  • The refusal to acknowledge reports: only accepting controlled clinical trials and not case studies.

Pharmaceutical rape culture such as victim blaming (addiction) and trivialization of harm (adverse outcomes of mandatory vaccination) correlate with increased incidence of racism, homophobia, ageism, classism, religious intolerance, ableism and other forms of discrimination.

EVERYDAY EXAMPLES OF PHARMACEUTICAL RAPE CULTURE

A comment made at the water cooler by a co-worker stating that those who opt out of vaccination for any reason should forfeit all access to healthcare.

A doctor who responds to a patient’s report of injury after her compliance to a different doctor’s orders by saying, “If the medication made you feel so bad why didn’t you just stop taking it.”

Someone who tells an injured person, “But weren’t you the one who asked your doctor for the medication.”

News reports about the autopsy of an American comedian who committed suicide that declares no drugs or alcohol were found in his system while completely omitting mention of the pharmaceutical drugs that were in his system.

A patient who gains weight after being prescribed an anti-psychotic being called a “beached whale” for levity by medical staff while patient is under anesthesia on the operating table.

Articles in publications like Forbes magazine that examine how drug companies may alter after incidents of harm (to patients) and focus on how companies will bounce back for the sake of profits and attracting/retaining shareholders, as if this were the primary concern.

A disabled patient reporting side-effects while taking Ativan is then prescribed an anti-depressant for those symptoms instead of side-effects being reported to the FDA or drug manufacturers.

An ad for a freshly-patented drug for hot flashes (Brisdelle), that downplays known side-effects, including suicide, popping up in the browser of someone who does an internet search on hot flashes.

Pharmaceutical Rape Myths

  • The FDA protects the public;
  • Drug safety is assured through hard science;
  • Serious adverse events are extremely rare;
  • Development of drug dependence or addiction is unrelated to accepted prescribing protocols;
  • Adverse events are always recognized by doctors and a connection to the drug is normally made;

It is not enough for pharmaceutical companies to pay out large settlements in instances where victims can actually prove injuries were caused by pharmaceutical products. Since the problem lies in a culture that is eager to trust a medical system that sells products to fix their health issues while remaining largely passive and dependent as patients, the solution is to look at pharmaceutical injuries as a result of this authoritarian/passive relationship in healthcare and to solve it at the cultural level. We all play a part in allowing pharmaceutical rape culture to exist—so we can all do something to correct it.

ENDING OUR TOLERANCE for PHARMACEUTICAL RAPE:

Name the problems:

  • tainted science and denial of adverse effects.
  • re-examine and re-imagine science;
  • get serious about informed consent:
  • pharmaceutical.rape culture relies on our collective inclination to downplay what we see right before our eyes (adverse event) in favor of trusting doctors and science.
  • media literacy: ask the right questions about who creates media that profits from the pharmaceutical companies.
  • know your history: how has greed operated in the past ie. Slavery, genocide of indigenous populations, great depression, labor rights, economic crisis, etc.
  • tell your story: every issue has a personal narrative that helps form connections to the issue and bolster support for present and future victims.
  • hyper-masculinity can be compared to the public’s trust in scientific evidence and the moral superiority and authority of doctors (while remaining ignorant of corruption)

MISCELLANEA

  • rape culture is “we can’t do anything about it”
  • rapists going to rape
  • rape culture is skepticism and distrust of those who report harms instead of recognizing the harm potential of the
  • legal right to make own choices even for vaccines
  • industry-government-medical trade alliance – a powerful/male dominance
  • subsidiary doctors; insecure about their power attack those who threaten it – they get bitchy
  • pharma fascism is not to be underestimated
  • companies and their personnel are held in high social regard, so the reality of news of their behavior is unwelcome, denied, wished away, would cost, becomes ugly, threatens the “success story.”
  • Doctors are about as welcoming of a pharmaceutical rape victim as the police are of a rape victim
  • Unconcerned public enables the status quo
  • DSK – GSK

RAPE

Rape involves a bodily violation. Something is put into your body that causes harm, something that you didn’t consent to, something that if you had known about you might have made a different choice.

Pharmaceutical rape involves trusting and having that trust violated.

As with physical rape, the victims are everywhere, walking among us unrecognized. Many may not even know they are victims of rape.

Pharmaceutical rape involves suffering physical, emotional, mental, social, and spiritual damage at the hands of those holding power who deny any wrongdoing and remain free to do the same to others.

Those unconcerned with physical rape know on some level that it occurs and that it is wrong, perhaps because they have had good experiences of physical intimary. Those who are unconcerned with pharmaceutical rape go along with the status quo perhaps because they have had positive medical experiences and don’t yet recognize that they cannot walk by – what affects others will ultimately affect them. We need to reclaim the streets.