We Are the Ninety-Nine Percent

Editorial Note: This is a Coda to the four posts on davidhealy.org about Sense about Science and AllTrials – Follow the Rhetoric, First Admit no Harm, Follow the Lawsuit and Follow the Patient. It’s running here because it attempts to lay out some of the principles behind RxISK.

The last post ended on this note:

Over 18 months ago, RxISK attempted to open up a debate on the ambiguities and conflicts at its heart. Doing what it does, could it operate as a business in the marketplace or should it be a Foundation or an Occupy your Doctors’ Office movement?

It seems clear that although legally obliged to access any adverse event data they are aware of, pharmaceutical companies seem unlikely to endorse RxISK in the way they have endorsed AllTrials. They seem to be pushing us toward finding something more co-operative – perhaps something that is not out there yet – perhaps something that David Graeber or Thomas Piketty might have views on.

Over the next few weeks on RxISK, we will be featuring a series of just published articles based on RxISK data – one on what is now a Ninety-Nine+ case series of SSRI induced Alcoholism. A second on what is an over one hundred and twenty case series of persisting sexual dysfunction following SSRIs, isotretinoin or finasteride. The third will be on a novel ethical dilemma linked to reports of QT-interval changes.

There are several hundred cases embodied in these articles covering most antidepressants and a number of other drugs. Companies who are interested in the safety of their drugs, or companies simply keeping to the letter of the pharmacovigilance law should be contacting us to enquire further whether their drug was involved , as might also the companies gearing up to market S-3 antagonists for alcoholism. How do we deal with this? Who pays for the work involved in establishing which version of paroxetine was involved?

Could RxISK be captured?

Quite possibly. Industry can capture almost anything – they may have captured AllTrials. They are making great efforts to capture, defang or otherwise manage patient adverse event reporting systems. GSK’s ability to hide clinical trial data pales compared to the subtlety of their approach to and lengths to which they appear to go to block or otherwise hide adverse event reporting – See American Woman, American Woman 2.

Some pre-capture RxISK principles

• Doctors and patients make medicines. Industry make chemicals. A medicine is a combination of a chemical and information about how to use that poison to bring good out of a bad situation. Doctors, nurses, pharmacists and patients make the information that transforms a chemical into a medicine.

• Doctors and patients are the only bulwark against the degradation of medicines caused by branding and marketing. Regulators and academics or other experts aren’t.

• Medicine involves following the patient. It’s the inconvenient patient, with the inconvenient problem that points the way forward.

• The marriage of patient and doctor is often cast as a marriage of scientific and personal expertise with lip-service paid to the equality of both forms of expertise. But in fact faced with an inconvenient fact, a doctor’s expertise almost by definition risks getting in the way – this is the time for doctors to work with patients as genuine equals. This is where doctors find out that a motivated patient, even one with no academic credentials, is far more likely to turn up an answer than a bored researcher. This is where each finds out if the marriage is enduring. As part of a dowry, the patient who finds the answer to a problem will often happily let the doctor take the credit.

• Embracing adverse events can restore the fun to medicine. It calls on doctors, pharmacists, nurses or others to be generalists rather than partialists. None of our drugs act on one system – there is more serotonin in the gut than the brain and more cholesterol in the brain than in the blood. To work out what is going wrong and put it right you have to draw on everything you have ever learned rather than just stick to the tramtrack of standard practice.

• This is about making the market work properly. We ultimately are where the value lies.

The RxISK report

The main tool to move things forward is the RxISK report. When some anomalous event happens on the street, its axiomatic that the police get as many eye-witnesses as they can. In clinical practice this means you don’t want to leave reporting to hurried and disengaged doctors and you definitely don’t want to leave it to pharmaceutical companies for whom collecting details on a case is all about collecting excuses to rule out an effect of their drug.

It makes much more sense if a doctor or pharmacist or nurse comes to an agreed account with the person affected who has usually spent time with the problem and is motivated to nail down what is going on.

1. It’s about good quality rather than degraded quality adverse event reports in the belief that good words come before good numbers.
2. It’s about us being willing to make a judgement call that this event is likely to be linked to a drug in a way regulators will never do.
3. It’s about intervening early in adverse events to reduce harms.
4. It’s about adding local knowledge to the mix – getting people in Swindon and London (or Hamilton and Toronto; or Lyon and Bordeaux, or Verona and Milan, or Chicago and Milwaukee) to account for why something is happening in one place and not another rather than thinking someone with no local knowledge is going to sort it out
5. It’s about taking on the power imbalance between doctors and patients.
6. It’s about changing doctors into listeners – this can be done by getting patients to quality mark doctors based on those who agree to engage in the process versus those who don’t. We can force the deaf to hear us. We are after all the Ninety-Nine Percent.
7. The RxISK report has led to the idea of a RxISK clinic and report as an even more potent way to equalize the power imbalance.

It’s about medicine as it needs to be if its going to survive. Leaving reporting to doctors alone has not worked – at present only 1% of adverse events are reported. The question is whether doctors have what it takes to save themselves by insisting on the evidence of their own eyes and reporting adverse events. Saving themselves will do more to save their patients than anything else could.