We are the Ninety Nine Percent

Editorial Note:  This is a Coda to the four posts about Sense about Science and AllTrials – Follow the Rhetoric, First Admit no Harm, Follow the Lawsuit & Follow the Patient.

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 Woman2.

 

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. Its about good quality rather than degraded quality adverse event reports in the belief that good words come before good numbers.
2. Its 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. Its about intervening early in adverse events to reduce harms.
4. Its 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. Its about taking on the power imbalance between doctors and patients.
6. Its 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 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.

Its 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.

 

 


RxISK: Research and report prescription drug side effects on RxISK.org.

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You and your meds. Give the real story. Get the real story.

Pharmageddon

Pharmaceutical companies have hijacked healthcare in America, and the results are life-threatening.

 

Dr. David Healy documents a riveting and terrifying story that affects us all.

 

University of California Press (2012)

 

Available on Amazon.com

 

Comments

  1. Many, many doctors will be insulted when a patient appears with a Rxisk report. I know for a fact that my three doctors in a little village surgery from start to finish were capable of a bullying culture.

    I was an isolated case, if I had been in a Metropolitan area, then perhaps you could draw some sort of conclusion, but the world is too big and groups of adverse effects have occurred in your heat maps.

    I have always been a believer in that it all comes out in the end and who pays for Paroxetine, is, of, course, GlaxoSmithKline.

    It was in the press yesterday, for the first time, from the Daily Mail, that Glaxo have a Sex Tape sent to Andrew Witty regarding his colleague who might spend the rest of his life in prison. His colleague, who is part of the China investigation.

    GlaxoSmithKline are in so much trouble that you wonder how they can carry one…bribery allegations all over the world…serious fraud office in the UK…Paroxetine deforms babies and kills innocent children and teenagers and adults.

    The Press Statement from Sir Andrew Witty tells us that GlaxoSmithKline are no longer interested in old drugs. They plan to offload Seroxat within two years.

    Who would take on Seroxat, in the current climate of worldwide shame? It could be any one of a number of pharmaceutical companies, but, I would hesitate to gamble that GlaxoSmithKline would ever find a potential customer for this bag of worms…

    http://www.telegraph.co.uk/finance/newsbysector/pharmaceuticalsandchemicals/10863562/GlaxoSmithKline-invites-bidders-for-old-drugs.html

    Seroxat is not part of Andrew’s future…..

  2. “It’s about changing doctors into listeners ”
    I think doctors listen ok, it’s just that they are so sure of their authority and expertise that what they hear becomes more indications of an”illness” that needs to be medicated. And so on and so on.

  3. Anne-Marie says:

    Rxisk is the only place that addresses all side effects, the regulators and drug companies just ignore us. What is the point in a regulator if they ignore your concerns and don’t warn others. It seems to me you get more information on drug side effects from public forums. The regulators are out dated and lagging behind the rest of us.

  4. And, why are the regulators out-dated and lagging behind the rest of us?

    1. The Head Regulator is an ex GlaxoSmithKline creature
    2. The Regulators sent me a Call Centre type letter re Paroxetine
    3. Doctors rarely send in yellow cards because if the patient suffered then it was their fault, so they are not going to do that, are they?
    4. Whilst we are investigating the raw data, it might be an idea to investigate fading yellow cards, gathering dust

    What is the point of the MHRA?

    Even Ofcom, investigate one public complaint if the telly programme is not to one’s taste….

    Surely, the MHRA, should be behaving like The No.1 Ladies’ Detective Agency. Precious Ramotswe, Botswana’s only – and finest – female detective agency (Alexander McCall Smith) and not like the Enigma Variations…

    http://www.youtube.com/watch?v=_VSTjo0i_EE

    t

    • As a member of my local Patient Participation Group, I asked the doctors attending the recent meeting and the manager of the local Pharmacy what they were doing about yellow card reporting – the doctors hung their heads (all 3 of them) and the manager didn’t know about it.

  5. It’s a very sad state of affairs. From my experience, Most GP’s are clueless when it comes to SSRI withdrawal or dealing with side effects. I think- they don’t want to face that the drugs they prescribe can cause harm sometimes so they bury their head in the sand. Psychiatry is a different story, they know damn well the dangers of the drugs they endorse but they are too arrogant to admit that their treatments can often be very harmful for many people. Allopathic medicine is aligned with very powerful corporate interests- and Sense About Science et all- is just another tentacle off the branch of that tree which refuses to budge- unfortunately this leaves patients stranded..

  6. Fiachra says:

    The doctor told me about a month ago that I had higher cholesterol and that I might think about medication. I told him if I did this I might go on to get diabetes. I told him I had higher cholesterol before and when I lost weight, it reduced the cholesterol. I’ve lost most of my excess weight now.
    I was in the supermarket earlier today and I saw one of the British Newspaper Headlines saying that – Statins are completely safe (from a top UK heart specialist).
    I hope my diabetes risk is down.

  7. I think we live in an age where Doctors are too keen to prescribe drugs – it’s like they are addicted to doing so. Doctors need to be re-educated so they think more about how they can reduce the number of drugs a patient is on and also whether the drugs they are on could be damaging rather than improving. This doesn’t sound like rocket science to me :)

  8. “This is excellent and amazing…”

    http://www.independent.co.uk/news/business/analysis-and-features/glaxosmithkline-the-plot-thickens-9577641.html

    “I couldn’t be more happier…”

    http://www.badscience.net/2013/02/this-is-excellent-and-amazing-gsk-have-just-signed-up-to-alltrials-net/

    “Medicine is broken”

    https://www.youtube.com/watch?v=Kto5vuiS5rA*****

    We all want Clinical Trial Transparency, but, do we want someone who has never spoken about suicides and deaths and murder…do we?

    The elephant is still in the room.*****

  9. http://www.ibtimes.com/china-indicts-brit-american-glaxosmithkline-spying-case-1626688

    Two interesting phrases as this case jogs along:

    “Betrayed and used”

    “Ethics matter”

    Sounds like the ChinaWhys’ couple need a few of Glaxo’s pills to keep them going…

    Only GlaxoSmithKline could choose a law firm with a name like >RopesGray< and keep a straight face…

  10. Rebekah Beddoe says:

    DEAR LUISE: a story that exemplifies all that is wrong with psychiatry, not just in Denmark, but world-wide; not just in the past, but right now, still, today.

    Harrowing as it is, it is true to life right now, right around the world. We need hundreds, likely thousands of David Healys to remedy the problem, or at least that many in his profession adopt his mindset . . . already!

  11. Dear Phil

    http://news.sky.com/story/1314765/gsk-close-to-luring-rbss-hampton-as-chairman

    “he has said repeatedly that company chairmen should be expected to serve for between five and seven years.”

    In, clink….?

    Still, time to change your mind, Phil; jumping ship from RBS to GSK…a company, with… er… ethics…?

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