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 January 2012

Burn in Hell

In my last post, Psychotic Doubt, we saw the most successful maneuver that has ever been devised for hiding dead bodies and silencing us when we are injured.

We saw a mechanism that acts like the authority of a psychoanalyst (when Freud was still in vogue), or an ecclesiastical authority (until recently), to silence dissent and cause someone who has been abused to doubt their sanity and blame themselves for something done to them.

This mechanism that allows companies, regulators, and academics to hide dead bodies by an appeal to evidence that in actual fact shows an increased risk of death on treatment is not just psychosis-inducing; it also has a Burn in Hell component to it.

This is how it happens.

Here is Ronald Krall being deposed in 2007. He is the head of Global Safety at GlaxoSmithkline.

Q.  Are you willing to tell the jury under oath that you are not aware of a single side effect that is caused by Paxil?

A:  I am prepared to say to the jury that I am not sufficiently familiar with all of the data for all of the adverse events to tell you that there is an adverse event that is caused by Paxil.[1]

Here is Ian Hudson being deposed in 2001, then head of Global Safety at GSK, later a member of the British regulatory apparatus, the MHRA:

Q.  Okay. So, your view is: It’s simply impossible for SmithKline Beecham to decide whether Paxil did or did not contribute to the homicidal or suicidal behavior of any one given individual; is that your testimony?

A.  We would certainly gather all the information, but on an individual case basis it would be impossible to decide whether paroxetine caused an event or not… It is impossible, on an individual case basis, from individual reports, to assign causality especially in a very complicated area such as this. That’s why, when we have issues, we review all the available data and make a determination, on the basis of all the available data, whether there is an issue or not.

Q.  Okay. Do you believe that it is possible that Paxil has caused any person, worldwide, to commit an act of homicide or suicide?

A:  I have seen no evidence to suggest that at all.[2]

Determining causality of problems

Hudson and Krall are demonstrating the standard company approach to determining causality. In this case GSK had lots of reports of suicide, aggression, birth defects, or dependence. In many cases the doctor, or patient, or a company employee notes that the problem happened soon after the drug was started, cleared up when the drug was stopped, and reappeared when the drug was restarted. As a result in many cases a GSK employee has said the drug has caused the problem. Both men know this, but for Hudson and Krall there is still no evidence that their drug causes a problem — even when the dependence on Paxil (Seroxat) is universally recognized.

Why not?

For Hudson and Krall and regulators like Bob Temple or Ian Hudson (who is now a member of the British regulatory apparatus), if a clinical trial hasn’t confirmed a statistically significant link between treatment and an adverse event, then the adverse event hasn’t been shown to be caused by the treatment. If there is even a small possibility the problem could have been caused by chance, then it has been caused by chance.

Refusal to do a study for reported side effects

While the company avoids doing a sufficiently large clinical trial to test out the link, there will never be any evidence that the drug causes a problem. The refusal to do a study while events pour into the company that meet all the standard criteria for causality is the real Burn in Hell moment. Thousands of reports can pour in, each making a compelling case that the drug has caused the problem, but a Hudson or Krall or Temple will feel comfortable saying under oath they have seen no scientific evidence that the drug causes a problem.

Unbelievable though it will seem, lawyers for pharmaceutical companies have recently advised that company coding staff, when faced with convincing evidence a drug has caused a problem (that is, when a problem appears after the drug is started and clears when it is stopped and reappears when it is restarted), should not code this as caused by the drug as they have been doing.


When patients report problems to the company and ask if there is any evidence the drug might be contributing, they are commonly referred back to the doctor who has prescribed the drug — who will be faced with the scientific literature, which will say there is no evidence that the drug has caused the problem.

Referred back to doctor

Here is an unknown woman in 2001 contacting GSK. She terminated her first pregnancy, after radiology showed the baby had a serious heart defect (truncus arteriosus) and would likely not survive.

The response from GSK is as follows:

‘We are attaching a copy of our current product information for Paxil… Please review the section on USE DURING PREGNANCY.Further questions about your treatment should be directed to the physician, pharmacist or healthcare provider who has the most complete information about your medical condition. Because patient care is individualized, we encourage patients to direct questions about their medical condition and treatment to their physician. We believe because you physician knows your medical history, he or she is best suited to answer your questions. Our Drug Information department is available to answer any questions your physician or pharmacist may have about our products.

She responds:

‘This response is in regards to an email I sent you preciously [sic].  I was asking to see if you have any, or were in the process of any clinical trials for women who are currently on Paxil and pregnant.  I wanted to find out any information on women who were on Paxil during pregnancy and if they were able to have healthy babies.  I am in no way insinuating your product did this to my child.  I love the product and don’t think that I could have gotten through my panic attacks without the wonderful help of this miracle drug.  I just want to get pregnant again soon.  I do not want to put my unborn child through anything that would hurt him/her.  Please, if you do not have information, where is this information held?  Does anyone do studies like this?  Please any information that you may give me would be great’.

Internal documents

In internal company documents, the birth defects this woman’s child had suffered were coded as almost certainly linked to Paxil but neither she nor her doctor were told this.

This seems eerily reminiscent of appeals by Catholic cardinals to Canon Law (an idiosyncratic take on legal significance) when asked to account for their handling of abuse cases in the Church.

[1] Deposition of R Krall, Head of Global Safety GlaxoSmithKline, 2007.

[2] Deposition of Ian Hudson in Tobin vs SmithKline Beecham, December 15th 2000, 30–33.

Psychotic Doubt

Toward the end of the 1990s, hiding the suicide risk on antidepressants by unearthing ghost suicides and suicidal acts from the early washout phase of trials looks like it might have seemed to company and FDA officials as problematic as Macbeth’s invitation to Banquo to make sure he came back to the feast later that evening. A new strategy came to the fore. Again one of the earliest versions of this had been pioneered by Lilly. (It would be interesting to nail down the very earliest version.)

This was a statistical significance strategy — or how many bullets does the barrel of a gun have to contain before you say it’s loaded? The first step in this strategy was to focus on placebo-controlled trials only. This greatly reduces the numbers of patients under consideration, which was crucial to the success of the strategy. Reducing the numbers of patients meant that even if there were more suicides on Prozac or Paxil, the figures could never be statistically significant.

Statistical significance

In the case of Prozac, the placebo-controlled trials had shown that there were five suicidal acts from 1398 patients on Prozac versus one (ghosted) suicidal act in 645 patients on placebo. These data show double the number of suicidal events on Prozac, but the data are not statistically significant. This is what was published in the BMJ where it was read by up to 100,000 people, most of whom had no links to the pharmaceutical industry, many of whom might have been hostile to industry. But when the company wrote that data from these trials do not show that fluoxetine is associated with an increased risk of suicidal acts, there was not a peep — no one said, “Wait a minute, there is clearly an increased risk – a 12-year-old schoolboy could tell you there is an increased risk.”

Table 1



Relative Risk

Number Acts/Number Patients




(95% C.I, 0.27, 19.7)

It seems likely regulators and company personnel took note. SmithKline soon afterwards took the same approach to Paxil, where the figures looked as follows.

Table 2



Relative Risk

Number Acts/Number Patients




(95% CI 0.4, 25.7)

There is no need to breach regulations by moving dead bodies or suicidal acts around when taking this approach. The old way involved moving one dead body in Lilly’s case, and four suicides or suicidal acts in SmithKline’s case. This way 10 suicidal acts vanish.

Omitting the ghost suicide from the Prozac figures and adding the two sets of figures together gives a 5.2 fold greater risk on Prozac/Paxil than on placebo. The 95% confidence interval is 0.66, to 40.3. This means that if you’re dead set against conceding there is a risk, you can argue there is a small chance that these results happened by chance; but you have to concede there is a roughly equal chance that Prozac and Paxil are up to 40 times more dangerous than placebo.

A failure to tackle the issues

A lot of people in companies or regulatory agencies must have put these figures together and added in the Zoloft figures also, which make the problem look even worse. The regulators likely justified not doing so on the basis that their bureaucratic brief was/is to consider each drug in isolation. Company reviewers are regularly moved from desk to desk and not encouraged to remember what they might have been doing last week or to put pieces of the jigsaw together. Doctors are busy.

This applies not just to selective serotonin reuptake inhibitors (SSRIs) and suicides but to heart attacks or other events on pain-killers, like Vioxx, and hypoglycemics, like Avandia. There is nobody in the system it seems with an incentive to get to grips with the issues.

The consequences are not just avoidable deaths from heart attacks, suicides, and drug-induced homicides, but more to the point a close to North Korean level mass psychosis. Both patients and doctors report suicides, heart attacks, or other problems, but are told there is no scientific evidence to back up what they are saying, when in fact the science and their personal testimonies match precisely. Their heart attacks or suicide attempts are backed up by the clinical trial data, which shows an increased risk from the drug they are on. But they are told by regulators such as Bob Temple of FDA that while their stories are harrowing, the agency has to go by the science and the science does not show a risk.

The evidence of our own eyes

Freud led us to disbelieve the obvious and go by what experts told us stories about abuse meant. In an entirely comparable manner, we are now being told we cannot believe the evidence of our own eyes — that our experience is anecdotal. In fact 80% of the time, possibly more, when doctors report on adverse events they turn out to be right — from heart attacks to suicides to changed hair on oral contraceptives. The changed hair on oral contraceptives probably means that when hairdressers talk about side effects of treatment they are also likely to be right, and it’s patients rather than doctors who typically make the links to strange side effects from suicide to wetting the bed on a new drug.

The question is how do we treat this psychosis?

This does not seem to be a time to desert science but rather to embrace it. But it is a time to recognize that words come before numbers.

Doubt is our product

It may also be a time for humanists and post-modernists to come into their own. They have spent decades trying to deconstruct science but never did the job as well as drug companies now do. Holding out for statistical significance until you concede that a drug might have caused something is the ultimate manifestation of the Doubt is our Product strategy pioneered by the tobacco companies. And Doubt is our Product is the perfect caricature of post-modernism.

The Bureaucrat that Didn’t Bark

man with finger on lips asking for silence

Prozac’s commercial success after its launch in 1987 spurred SmithKline Beecham, Pfizer, and others to bring Paxil (Seroxat, Deroxat, Aropax), Zoloft (Lustral), and other Selective serotonin reuptake inhibitors (SSRIs) to market.

En route there was the tricky problem of managing what was recognized within companies by the early 1980s but denied in public, namely, that these drugs could cause agitation up to an including suicidality. There was an even trickier problem – managing the data on suicidal events from the clinical trials done to bring these drugs to market.

Lilly blazed a trail with suicidal acts on Prozac (see Drug companies use studies the way a drunk uses a lamppost). The strategies included discounting some suicidal acts on the basis that these were not genuine, including under the heading of placebo events that happened after withdrawal from Prozac, but in particular taking events before the trial proper had started when people had their prior treatment discontinued and before they began the double blind phase of the study. These events were filed under the heading of placebo on the basis that the patients weren’t actually on active drug at the time.

SmithKline filed their submission on Paxil with the FDA in 1989 shortly before concerns about suicides on Prozac became public in 1990 – see Table 1.

Table 1

Original 1989 Paxil Figures




Suicidal Acts

% Suicides & Suicidal Acts




Washout/Run In















Once suicide on Prozac became an issue, these figures posed an even bigger problem than they did to begin with. But somewhere in 1990, the reviewer of the Paxil application, Martin Brecher, developed the impression that FDA had decided the issue of suicide on antidepressants was: “not .. a real issue, but rather as a public relations problem” (Brecher Doc). He invited SmithKline to submit another set of figures.

In the revised set of figures, under the heading of placebo there are two completed suicides and five more suicidal acts that had not been there before. The two suicides and two more suicidal acts came from the washout phase of studies — just as Lilly’s suicide had been.

Table 2

Revised 1990 Paxil Figures




Suicidal Acts

% Suicides & Suicidal Acts
















Was Brecher alone in his understanding of the issues as a public relations matter? When there were hearings on antidepressants and suicide in September 1991, the FDA could have brought the data on suicides and suicidal acts on both Paxil and Zoloft into the frame but didn’t. Why not?

Adding the original Prozac, Paxil, and Zoloft figures together as of 1991 would have shown an absolutely conclusive picture of suicide risk on this group of drugs. Cynics might say that it’s clear why FDA didn’t permit these extra data in: the hazard would have killed the SSRIs. But at the same time, FDA licensed Clozapine despite the lethal risk of agranulocytosis it posed, and a case can be made that this risk helped create a perception of greater efficacy for Clozapine and may have increased sales and profitability.

If a class-wide labeling had been applied to all antidepressants, no individual drug would have been disadvantaged, and the market would likely have developed in almost exactly the same way as it did. We know that senior FDA figures considered the option of a class-wide warning. This seems to put them into a position of being aware that the risks did not come from just one drug and seems to position them in a management of perceptions domain.

If a class-wide labeling had been applied to all antidepressants, no individual drug would have been disadvantaged, and the market would likely have developed in almost exactly the same way as it did.

We need to be told what happened. The senior figures at the FDA at the time and later were Russell Katz, Bob Temple, and Paul Leber. At the FDA hearings in September 1991 on antidepressants and suicide, FDA officials and others put forward the view that warnings might be the right thing for those vulnerable to the risks posed by SSRIs but the wrong thing for the many who would be deterred from seeking treatment by prominent warnings.

Jonathan Cole one of the authors of the original paper on Prozac and suicide risk fingered Bill Potter (then of the National Institute of Mental Health (NIMH) and shortly afterwards an employee of Lilly’s) as the person who put forward the argument that warnings might do more harm than good, but it seems clear that others put it forward also.

In the background are the conspiracy theories. But this doesn’t account for the failure of regulators in Britain, Germany, and elsewhere to pick up the problem. It also doesn’t account for the failure of medical or other academics to pick up the problem.

In the background are the conspiracy theories. People note that George H Bush had been on the board of Lilly, that other Lilly officers involved in shaping some of the public relations messages later had prominent political positions in Washington, or as state governors. But this doesn’t readily account for the failure of regulators in Britain, Germany, and elsewhere to pick up the problem.

Why didn’t the bureaucrats bark? As we shall see in later posts, bureaucrats from the regulatory apparatus seem to miss an astonishing amount of what is going on.

Bureaucrats from the regulatory apparatus for the most part seem to miss a lot of what is going on.

How was/is international co-ordination of positions on these risks achieved? In the midst of the pediatric antidepressants and suicide problems, Bob Temple of the FDA said there was no liaison between the FDA and other regulators, such as Britain’s drug regulator – the MHRA. Are we talking about no formal liaison, no minuted liaison, or absolutely no liaison?

It also doesn’t account for the failure of medical or other academics to pick up the problem. These weren’t completely hidden data. Lilly’s ghost suicide appears in the footnotes of a BMJ article. SmithKlines’ ghost suicides and suicidal acts can be tracked down from Martin Brecher’s Safety Review of Paxil, which is a public domain document.

Figure 1 shows what’s going on. This breached regulations. Many looking at it use words like Fraud. Ten years later the regulators told companies – quietly – they could not do this anymore. But by then other strategies had been working out to handling the public relations issues.

Figure 1: Ghost Suicides and Suicidal Acts


Drug Companies Use Studies the Way a Drunk Uses a Lamppost


Drug companies use studies the way a drunk uses a lamppost — for support rather than illumination.

This quote adapted from English romcom author Jilly Cooper (who adapted it from others before her) seems an appropriate preface for a series of company approaches to data handling that have concealed rather than revealed treatment-induced problems.

In another galaxy, far, far away, somewhere in 1986, staff at Eli Lilly compiled the data on suicides and suicidal acts from Prozac clinical trials for reports they had to submit to regulators in the US, Britain, Germany, and elsewhere. They compared events on Prozac to events on other treatments, including placebo, no drug, or older drugs. In trials conducted in the US, they listed 4 suicides on Prozac and 1 on placebo, along with 26 suicide attempts on Prozac versus 9 on other. Various reports of this type were compiled and submitted to the regulators over the following four years, and part of the data ultimately ended up in a BMJ article published in 1991, at the height of the Prozac-suicide controversy, during the week FDA held hearings on antidepressants and suicide.

The 1986 data are intriguing. A short account of each suicide and suicide attempt is laid out. In the case of Prozac, 7 are discounted as not genuine suicide attempts; none on placebo are discounted this way. Of the 9 attempts classified as placebo or other, 4 involved patients treated with fluoxetine who had relatively recently discontinued from it. Classifying these under the heading of placebo, even in 1986, looks unsupportable.

Of the 4 suicides on Prozac, 3 are listed as using it under compassionate-use protocols, and these patients had been on it or exposed to it over a 3-4 year period. At first sight this doesn’t make sense; why include 3 extra suicides in the Prozac column? These suicides don’t find their way into the later BMJ article, for instance, where the company might have expected reviewers to ask for them to be removed. The 3-4 year period is key; this allows the company to make the case to the regulator that when the duration of exposure to Prozac is taken into account, the rate of suicides and suicidal acts is no greater than on placebo.

Method for counting adverse events

As of 1986, the standard method mandated by regulators like FDA for counting adverse events was to count events in proportion to the number of people exposed to the drug rather than events in proportion to the duration of exposure.

Insisting that events be counted in terms of duration of exposure is a way to make travel in space shuttles safe. If crashes are counted by the number of trips the shuttle takes, then it is about as risky a mode of travel as you can find. If crashes are counted by the number of thousands of miles travelled, it becomes maybe even the safest form of travel. The key thing with the space shuttle is that the risk periods are entry to and exit from orbit. For many (but not all) drug side effects, the riskiest periods are also entry into treatment and exit from it.

The placebo suicide

The most interesting event is the placebo suicide. This happened during the lead-in phase of the trial, when a patient removed from his prior medication during the week before starting in the trial proper committed suicide. A placebo suicide remains in the analysis all the way through to the later BMJ article — still coded as happening during what is variously called the lead-in or wash-out phase of the trial. See Figure 1.

Figure 1

placebo suicide

At the time, the regulations for submitting data to FDA made it clear that this should not happen. It was inappropriate. A later reviewer of an article I wrote on the issue wondered if it was outright fraud. More than 12 years later, when they again called for data on the antidepressants and suicide, the regulators made it clear to companies that they should not do this.

But there has been no public acknowledgement that this was done. No detailing of who turned a blind eye to the issue. How do we account for the fact that a series of regulators across Europe and North America appear to have turned a blind eye at the same time? Why when the issue is in the public domain do the legal departments of major academic journals like BMJ or NEJM advise journals not to carry articles mentioning the issue?

When the range of ways the suicide data were handled by Eli Lilly in this case or other companies in other cases do come up, companies tend to portray themselves as not statistically sophisticated. The implication is that if things went wrong, they did so by accident. The response from regulators and others has often been that perhaps mistakes were made but this is now in the past. There is no need to take an adversarial approach with companies, we are told, we don’t expect this to happen again.

Don’t we?

The January 6th issue 2011 of the BMJ – the journal which carried the original article in which the Ghost suicide first appears – was devoted to the issue of academic and research fraud and the need for access to the data from trials. There was lots of mention of Andrew Wakefield and his MMR study but none of this or any other comparable distortions of the data by pharmaceutical companies.

We expect academics to do this again but not pharmaceutical companies?

As the BMJ issue could have shown, this is not something from a distant galaxy long long ago – almost identical strategies were adopted by Pfizer and SmithKline Beecham for Paxil and Zoloft in the 1990s, and then by Merck for Vioxx and GSK for Avandia in the 2000s.

These methods hid a crucial few deaths on each drug, but as we shall see in the next post, there are even better methods to hide many more deaths.

Welcome to Data Based Medicine

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.

Companies are sawing off the branch on which they are sitting. Doctors are failing to recognize the most treatable cause of death today.

These two crises may be linked in that detecting adverse events on drugs is still the best way to discover a new use for a drug, and new drugs. But there are fewer and fewer incentives for anyone to recognize adverse events. Companies are blocking efforts to detect problems and in so doing are sawing off the branch on which they are sitting. Doctors are neutering themselves by failing to recognize and treat what should be the most recognizable threat to life and moreover the most eminently treatable cause of death in the world today.

Part of the problem is cultural

A century ago Freud drew our attention to the many ways in which speech could be biased. Half a century ago clinical trials drew our attention to the biases that both doctors and patients bring to therapy. Just as Freud’s insights once made it difficult for anyone to accept things that were said at face value, so clinical trials and evidence-based medicine have created a culture that makes it increasingly difficult for doctors or patients to spot what is right in front of our own eyes. Ultimately Freud ended up being used to explain away or deny claims of abuse that we now know were happening, and in much the same way companies and doctors are now using trial data, or the lack of it, as a drunk uses a lamppost — for support rather than illumination. Just as a point came at which claims of abuse could no longer be denied, we may be nearing a point where treatment-induced problems will have to be recognized.

This blog aims at raising the profile of this interlocked set of problems and the need for Data Based Medicine.

It will do several things:

1. First — the key thing is to pave the way for, a website for doctors and patients to enter reports of treatment related problems. For reasons outlined below and in my latest book, Pharmageddon, having another talking head is not a way to solve problems. It’s time to do rather than talk or write, and is about doing. It will be the only site on the web where patients and patient-doctor teams on a global basis can enter the details of what happens on treatment and can discover both new things about treatments and also whether a particular treatment is actually producing a problem for this patient.

It’s time to do rather than talk or write, and is about doing.

2. Second — I will post a set of questions and mysteries for which I have no answers. These are not questions without answers, or mysteries that cannot be solved, but some will likely remain unanswered and unsolved. Some because they are quite old and the trail may be going cold. Others because they are enduring. But some because the answers are hidden behind barriers of attorney-client privilege – a barrier that few people are aware of. The best response to these questions and mysteries will be data or documents that provide answers to the questions or information that sheds light on the mysteries.

The best response to these questions and mysteries will be data.

The style in which these questions are raised will often be quite stilted and the posts will not come thick and fast. There is a reason for this. Several years ago I put in a Freedom of Information request to Eli Lilly. The 103rd document that came back read as follows:

103             “Healy long term strategy.
Thank you for the message outlining your strategy to counteract Dr David Healy’s claims re: Prozac and violence.
Send a letter to Healy designed to get him to stop discussing a study that he has never done. Have a third party expert in the audience at BAP to ask Healy questions when he presents.
Just last Thursday Healy was quoted in a Cincinnati paper saying Prozac causes violence and suicide…X has asked that we go back to legal and determine if we can sue Healy under UK law.” 

Anyone responding to this blog therefore needs to take care with their choice of words.

Anyone responding to this blog therefore needs to take care with their choice of words and ideally needs to stick with data, and documents. This is not a forum for prejudices or unsupported opinions; it’s for moving questions forward or solving mysteries.

(Note Post Hoc: Some colleagues have wondered if I am or was being sued by Lily. The answer is No. If you want to read more on this episode, see the Academic Stalking section on or download this article on Academic Stalking.)

Other documents show that at least one public relations agency linked to Lilly was tasked with developing a Healy management plan. Given that the marketing departments of each pharmaceutical company employ several PR agencies and I’ve given several marketing departments an incentive to manage me, this seems a reasonable way to explain for instance getting an email from a colleague in Japan who had just met psychiatrists from the US who on hearing he knew me advised him to have nothing to do with me as I was trouble and I would soon be in trouble. The interesting aspect of this was that the American psychiatrists he named had never met me, and had never engaged with me in any way.

A UK PR rep told me I was doing more for sales of Prozac than anyone else!

But the picture is complex. Many years ago a woman who claimed to be responsible for PR for Prozac in the UK introduced herself to me at a meeting saying she was really pleased to meet because I was doing more for sales of Prozac in the UK than anyone else.

This is not a simple picture with the good guys (the clinicians) on one side and the bad guys (industry) on the other. Most of the grief I’ve experienced has come from clinical colleagues, as the website, especially the academic stalking section, shows. The solid help I’ve had has mainly come from within industry.

A Japanese colleague was advised to have nothing to do with me by an American psychiatrist who had never met me.

The challenge in this world managed by public relations agencies and marketing departments for both scientists in industry and insurance companies and the rest of us is to find a way to turn this dynamic around and use efforts to hide problems as a way to make things safer. If there are just two boxers in the ring, it’s possible to try Muhammad Ali’s rope-a-dope strategy, but there are at least three in this case. The third party is organized medicine — doctors. The fact that medicines are available on prescription only has made doctors, rather than companies, the chief deniers that a drug might be causing problems. Insurance companies, regulators, and others are also parties to these events and their interests in the outcome shift around from time to time.

3. Third — this site will in due course have a category of posts for people who have been through the system, people who have had partners, parents, children, or friends injured by treatments and who have found themselves trapped in a Kafkaesque world when they have sought help from doctors, regulators, or others who seem to be there to help us.

Their stories will highlight the lunacy of the system but will also show how we can change everything.

Their stories are aimed at highlighting the lunacy of the current system but also showing how someone who is determined can change everything. These stories will likely migrate to when it is up and running.

4. Fourth —the site will have a myth-fable-fairy tale slot. Academic lectures or articles seem to make little difference, perhaps even increase sales of whatever drug is being discussed. But very often people trying to describe the issues turn to fairy-tales or myths to explain what’s going on. If the Emperor’s New Clothes turns up once, it does so hundreds of times. This suggests trying to pull together a collection of alternate ways to describe things. I’ll take a stab at posting one or two examples as starters over the next few weeks and then throw the slot open to others.

If the Emperor’s New Clothes turns up once, it does so hundreds of times.

5. Finally — the main theme of the early posts is missing data and how impossible it is today to practice Data Based Medicine. If the data on which we base our treatments is missing, what might data-based position papers on various treatments look like? I will post a draft position paper on the Antidepressants. The principle underpinning these position papers is a set of questions to which the answer will commonly be: We have no data. It would be excellent to have input from anyone who can provide comparable statements for other drug groups or who can see ways to improve on what has been done here for the antidepressants.

If the data on which we base our treatments is missing, what might data-based position papers on various treatments look like?

8 February 2012: Lancaster, UK

The Eclipse of Medical Care

Lancaster University Management School

Wednesday 8 February 2012, 16:00

Lecture Theatre 1, LUMS

23-30 January 2012: Toronto

Interviews, meetings, and pre-planning for the launch of my latest book, Pharmageddon.

Have had some enquiries about where I might be speaking. Stay tuned for my March schedule — am back in Toronto, and some other North American cities, and will post another blog with details as I get them.