These words are from David Foster Wallace. I don’t know if he was speaking about the depression he had or the akathisia that antidepressants can cause. Maybe he didn’t know and this contributed to his suicide.
This post needs to be read in conjunction with What to do about Sex on RxISK. This post is about structural aspects to the problems not just of sexual dysfunction and suicidality caused by drugs but all other adverse events also. The RxISK post is about the specific things people can do about a specific sexual dysfunction or adverse event such as suicide.
Here’s the easy bit.
Its impossible to argue with the proposals after the last post by Heather, Tim and others to try to raise awareness about akathisia. The word is confusing and it’s difficult not to think as Sally does that its obscurity, almost meaninglessness, has been a godsend to industry
Something like Drug Induced Emotional Turmoil (DIE.T) might have got the message over more effectively twenty years ago but MISSD and others have produced such good material on akathisia already that its not clear that going back is an option.
The tee-shirt ideas are great. I’ve been in touch with Bill James who has produced all of the really striking images we have had on RxISK. It takes a while for images to come to Bill – and this time will likely take longer as the outlines of a song is what has turned up first. There is no reason to wait around till more comes from Bill – quite the contrary the fact something else is happening should encourage more diverse effort. As the message on RxISK and below puts it don’t be put off by experts – even expert artists.
There is no point looking to a regulator to solve problems with any adverse effect on a drug. Their brief is to supervise the wording of drug labels and adverts by drug companies primarily before a drug comes on the market. It is not to ensure that patients or doctors are properly warned before they take a drug.
Being bureaucrats their job is to make sure they have a good reason for doing nothing. This means for instance that there needs to be a hint from an RCT that a drug does something they can point to if politicians ask questions. If a politician asks about akathisia, the regulator can say – ah but if we warn about that we will deter people from seeking treatment and lives will be lost.
This is why they are so vulnerable on the issue of SSRIs for children. There is no benefit they can point to – not even for fluoxetine (Prozac).
Why did RxISK submit a petition to FDA, EMA and MHRA about PSSD? You have to be seen to cover all the bases but there is no expectation that things will change.
Government will never do anything companies don’t want. Even if you were to go on hunger-strike outside Congress or Parliament, it would count for nothing.
In the case of AIDS activists their protests got somewhere with Government and Regulators – primarily because they were asking for politicians to ease the regulations on companies. ACT-UP wanted things made easy for Pharma. This resulted in them getting early access to thalidomide and a host of other drugs that may have killed as many people as the virus did.
Bodies like NICE and others who write guidelines base their recommendations on ghost written articles. They have no access to the data. They invariably recommend the latest high cost drug over superior lower cost but off-patent drugs because if they don’t pharma will threaten to pull out of a small country like Britain – and there are presumably other threats in the US.
The guideline makers are unwilling to share a platform with anyone who might raise the issue of access to data or what they do about ghost-written articles.
The SSRIs and children story is supremely inconvenient for NICE and other Guideline bodies but they don’t have to share a platform with anyone or answer questions from a journalist on the issues so don’t hold your breath.
Through till 1991, journals carried case reports of adverse events – Evident Based Medicine. These reports contributed more to the progress of medicine than Evidence Based Medicine has done. But following the publication of the Beasley et al 1991 meta-analysis of Prozac trials in BMJ (which showed an increased suicide risks that BMJ reviewers and editor missed) – the which are you going to believe the anecdotes or the data article – journals like BMJ are now scared to publish case reports or anything about adverse events. Besides which reprints of RCT and meta-analyses are so much more lucrative.
It takes a brave journal to provide a forum for adverse events – see Villains and Heroes.
These are largely marketing companies these days. The research, clinical trials, medical writing, public relations (SAS and SMC) and increasingly pharmaco-vigilance has all been outsourced. There is no-one at home who will understand the question being asked.
Some of the major breakthroughs though have come from people within pharma sending documents to people in the media or others. Or taking the high risk route of filing a legal action against their own company. They may get lucky and get money from it but there are more likely to just lose a job. In general, people working in pharma have done vastly more than politicians, bureaucrats or clinicians to bring problems to light.
For every Schindler though, there are thousands of ordinary folk who by doing a good job (keeping to the rules and following orders) are at least as ethical as anyone injured by their drugs from thalidomide to Zyklon B and on.
There are a large number of people who read these blogs and comment and are desperate to find a way forward who have been injured by treatments or lost loved ones to treatment.
There is also a large number of people, perhaps an even larger number who have been injured by treatment and in particular who have lost loved ones to treatment who have become advocates for more treatment – who will front up programs to pick up schizophrenia or depression or osteoporosis or cancer at the earliest possible stage. If only we’d picked things up in time, everything would have been okay.
This is the side Prince Harry or Camilla Parker-Bowles or Ivanka Trump are always going to end up on – they will all want to spread the good news of salvation through baptism and treatment.
This is where Americans have an advantage. They can take a lawsuit – although its incredibly difficult to do so. Europeans can’t. Winning a lawsuit can make a difference – 20 years later. Tim Tobin won his case against GSK in 2001. The benefits of that win are still making a difference. But for the most part companies have become adept at shutting down any publicity that might stem from a legal loss. Pretty well no doctors have heard that GSK lost the Tobin case or cases against them for dependence on paroxetine or birth defects on paroxetine or even the Dolin case.
NGOs from the ACLU to Medecin sans Frontieres (MSF) to Open Society and others are committed to your rights. This is great but in practice they are committed to your rights to treatment so drug companies actually rather like them.
The coin hasn’t dropped for any of NGOs that access to medicines should mean full access to all the information that transforms a chemical into a medicine. When it comes to harms, NGOs at the moment are part of the problem not part of the solution.
ACT-UP put activism on the map. Its fizzled out. Its not clear that AIDS type activism can play a useful part in terms of raising the profile of adverse events. It hasn’t so far.
RxISK put a much older form of Irish activism on the map – the Reverse Boycott. We called this an AbbVie – Lets Do the AbbVie Again – which may be why it didn’t catch on. Basically this involves getting people to stop writing to companies or regulators asking them to be reasonable and bombarding them instead with reports of adverse events on drugs. Only 1% of the serious adverse events on drugs are reported.
The ideal form of this would involve getting your doctor to submit a report also – this was the idea behind RxISK reporting. The courts cannot ignore reports that have people’s names on them and is very unlikely to be able to ignore reports from both you and your doctor.
Companies dismiss your reports with the phrase – The plural of Anecdote is not Data. Maybe we need a catchy slogan – Corroborates are Compelling. Corroborates are Conclusive. Please suggest
But people seem scared to do this. This is an important discovery – people are scared silly. Their doctors are even more scared. We are facing a Structural Violence that almost no-one is talking about.
The people who are failing everyone the most are doctors and their professional associations. If the American President of their Psychiatric Association or Medical Association were to make it clear they thought some drug caused a problem, the pharmaceutical companies and regulators would have to act. They’d be trumped.
Why would the President do this? At the time of the 1962 regulations, FDA and other regulators were viewed as small beer – regulating advertisements. The real people regulating medicine and keeping their patients safe were doctors. Who for the most part had a good track record in putting conditions like tardive dyskinesia (1959) or dependence or drugs (1961) on the suicide that antidepressants can cause (1959) on the map.
For those with the time to let the dish go cold, the revenge will be that this ignoring of adverse events is going to put doctors out of business. Just as salt that loses its flavour is useless, there is no point spending money on high cost prescribers if they can’t deliver anything that lower cost prescribers would and perhaps even less than robots soon will.
You can’t depend on it. The Spectre of Dissent post fell foul of Facebook. It was removed. If a post threatening to raise the profile of adverse events, even an effort to save children from suicide, ever looks like it might get anywhere, the chances are Facebook or other outlets will find some way to block it. Facebook has 23 community standards – they’re worth a look at. It will always be possible using one of them to limit the spread of unwelcome information.
RxISK has an Akathisia page. In 2016 when it was put up it featured near the top of Google searches. MISSD have produced a great video on akathisia but it has begun to slip down the rankings also. We are being replaced by articles and sites like WebMD and related that focus only on the visible motor restlessness this condition involves. Rather than outright block something – which feels like a Facebook own goal – this is a more subtle way to control the conversation.
There is a thing called the ZPD – Zone of Proximal Development – that mothers know about. Its means knowing what A to encourage your child to do next to help him get to B and C and then D rather than trying to force him to get straight to D (the way his sister did).
We sometimes think that being reasonable – arranging meetings to talk to the regulators, or those other people we need to keep onside – is taking the A step, after which B and C and then D will follow. They won’t follow. The regulators, and professionals may smile nicely but landing on A makes you an enemy of the people. You will never be let get to B or C, never mind D. We will hang on to the carriages being used to transport you to Auschwitz even when the Army are asking for them to try and shore up the Eastern front against the Russians.
This has led RxISK to Taper MD. It may take 10 years for Taper to begin to make a difference but the trick is to go with the flow. If everyone wants to hear drugs work, and no-one wants to hear they might cause problems, then this is what we talk about.
Let’s get you maximal efficacy – this it turns out means 5 or ideally less than 5 drugs at any one time. Clinicians and patients working together are going to have to perm from among the thousands of possible drugs a winning combination. What the patient wants will be key to this. This is what’s going to get people to D.
Meanwhile, for those trying to get a son rather than a daughter somewhere, you need a bunch of Anne-Maries – See What to do about Sex. People with motivation can move mountains if they don’t sit around waiting for experts or other authority figures to do it for them.