As some of you may know I’ve managed to get myself embroiled (at a local level and from a patient perspective) in some of the health service reforms which are now happening.

Partly as a result of this I’m reading Ben Goldacre’s latest book Bad Pharma: How drug companies mislead doctors and harm patients.

Even if only 25% of what Goldacre alleges in the first quarter of the book is true (and that seems conservatively low) there is a scary, systematic and unethical ethos pervading the whole of the pharmaceutical industry which emanates from both the drug companies and the regulators.

At the end of the first chapter [p.99], where Goldacre has discussed the problem of missing drug trial data, he issues this challenge:

If you have any ideas about how we can fix this [the missing drug trial data], and how we can force access to trial data — politically or technically — please write them up, post them online, and tell me where to find them.

What follows is my small response to Goldacre’s challenge.

— o O o —
As patients there is not a lot we can do to address these issues; they’re just too big for the man on the Chapham omnibus to be able to make, individually, a difference. Given that the drug industry, the academics, the medical professional bodies and the regulators have singularly failed to adequately address the issues, the major thrust of the resolution probably now has to come in the form of primary legislation across all territories — something for which sadly few politicians are likely to have the stomach and no government the priority. However that doesn’t mean we patients can (or should) do nothing. This is what I think we can do, at least in the UK.

1. Through our doctor’s Patient Participation Groups (PPG), and through our local LINk/Healthwatch/Health & Wellbeing Boards, we should be putting pressure on the medical world and specifically the local Clinical Commissioning Groups (CCGs, replacements for the PCTs) to force GPs to act ethically and without bias.

   One way to do this would be for GPs to be given guidance on what patients expect of them. This is likely to be way beyond the minimum acceptable standards required by legislation and regulation. And indeed I’m involved at my local level in drafting just that. I can’t say more about it at present as the work is still in draft form, uncompleted by the authors, unapproved by the sponsoring group and of course not yet delivered to its expected recipients. (That it is being done is in the public domain as it is referenced in publicly accessible meeting minutes.) However we are committed to it being published, and publicly accessible, when completed. With luck this will be before the end of the year, so I hope to return to it in a later column.

   But such guidance could contain clauses like (all my wording will need tightening):

   • Clinicians are expected to behave in unbiased and ethical ways. They must declare annually and publicly on their practice’s website all benefits received (services, goods, money) worth over [[name some modest value like £50]] received from any pharmaceutical company or healthcare provider (public or private). They should demand the same transparency from those who they themselves consult or to whom they refer patients.
   • All clinical trials/research in which a clinician is involved must be publicly registered and defined prior to starting and be referenced by the practice’s website. All clinical trial data (including anonymised patient-level data) and results must be published within 12 months of study completion. Again clinicians should demand the same transparency from those who they themselves consult or to whom they refer patients.

2. All members (medical and lay) of CCGs, Health & Wellbeing Boards, etc. must also make declarations as in 1 above.
3. Is it possible to find an MP who is willing to put down an Early Day Motion (or Motions) in Parliament demanding legislation to:
   • require all clinical trial data and documents (including anonymised patient-level data) be made publicly accessible, without hindrance, within 12 months of the completion of the study, and within 3 months to the appropriate regulatory bodies.
   • make all clinical trial data, whoever performs the studies, funds or sponsors them, subject to Freedom of Information requests at no charge, and with no exceptions, worldwide and retrospectively.
   • make gagging and other “interference” contracts illegal?

   We should then be encouraging our MPs to support the motion.

4. There doesn’t appear to be an e-petition to the government. What about it? The partition should require that the actions outlined in 3. above be passed into primary legislation during the lifetime of the present parliament. I guess this would need someone more skilled than I am at drafting to write the petition effectively and without allowing wriggle room.

   According to the government’s own rules 100,000 signatures on an e-petition should trigger a parliamentary debate. That ought to be achievable if everyone buying Goldacre’s book signs and gets another couple of signatures. Create a Facebook page and it could attract even more signatures.

No that isn’t actually a lot in terms of fixing a worldwide, pervasive problem with Big Pharma. But we have to start somewhere and it is probably as much as we patients can realistically do initially, at least initially. Items 1 and 2 should start a trickle up of activity. Hopefully 3 and 4 will start a hammer down.

Thoughts from anyone?