Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients (49 page)

BOOK: Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients
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In 2012 it was announced that GPs will be expected to work with drug companies to work out how to treat their patients. The ABPI has drawn up a guide to ‘joint working agreements’, with the support of the Department of Health,
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and the vision is clear: ‘Popular areas for joint working you may wish to consider include identification of undiagnosed patients, reviewing uncontrolled patients, improving patient adherence to medicines and treatment pathway redesign.’

To place this in context, it comes at a time when the structure of the NHS is being dismantled, and the job of planning health services is being given to local groups of family doctors, the vast majority of whom are very smart, but have little or no training and experience in commissioning services for whole populations (under plans opposed even by the Royal College of GPs). Whatever your views on the new NHS policy, one thing is clear: inviting drug companies in to design care pathways, at the very time when those are in flux, and suddenly being managed by people with limited commissioning experience, seems very dangerous.

And beyond that: inviting sales representatives in to go through your patient list, and pick out the patients they think should receive their company’s drugs, exceeds almost every problem we’ve documented so far around the dubious activities of drug reps; while reviewing patients’ progress with staff from a drug company raises huge concerns about consent and patient confidentiality. I don’t know if you would be happy for your GP to go through your medical history with the local salesperson from GSK, Merck, Pfizer, Roche, or any of the other companies that have come up over the past few hundred pages. I think you should at least be asked.

So that is the end of our story.

This mess has sat, hidden in plain sight, for lack of a clear explanation. It has persisted because it’s complex, and because the people we would normally trust to manage such technical problems have failed us. The government, the great and the good of medicine – the silverbacks of the Royal Colleges, the faculties and the learned societies – know everything that you have just read. They know full well, and they have decided, for their own reasons, that they are unconcerned. In some cases, like the regulators, they have actively conspired in the secrecy.

It’s hard to imagine a betrayal more elaborate, or more complete, across so many institutions and professions. This is a story of pay-offs, of course, but more than that, it’s a story of complacency, laziness, banal self-interest and people feeling impotent. You have been failed by the people at the very top of my profession, for decades now, on matters of life and death, and as with the banks, we’re suddenly discovering a terrifying reality. Nobody took responsibility, nobody was in control, but everybody knew something was wrong.

We only have one hope, though it is a small one: you.

Things you can do

If you are concerned by what you have read in this book, then here are some suggestions of things you can do.

There are detailed points on what needs to change at the end of each chapter, which I hope you’ll revisit. Here I have pulled out big-picture points, with something for everyone. Creating change is a complex process, especially when problems are diffuse and deeply embedded in the culture of powerful industries and professions: the people who need to be lobbied are doctors and patient groups, as much as politicians, and this is reflected below.

Everyone

The first thing you might do is write to your doctor, or briefly mention your concerns when you see them. To be clear: I don’t think it is helpful to waste valuable individual clinical time on political conflict with your doctor. However, if doctors know that their patients are concerned about these issues, they will be more inclined to take them seriously, and it is enough to do this in passing. Many are already very ethical on these issues anyway, and so they may find your concerns heartening. Here are some things you may wish to do:

You may wish to ask a question:

  • For example, you might want to know if your doctor accepts drug-company hospitality, or sponsored teaching.

You may wish to make your wishes clear:

  • For example, if you do not think it is acceptable for your doctor to go through your medical history with a sales representative from a drug company, you could ensure that they know that, just in case.

You may wish to make a request:

  • For example, you might suggest that they post a list of interactions with industry in their waiting room, as suggested earlier in this book.

There are also the usual outlets that anyone can pursue for general political activism, and for lobbying politicians. It would be good to raise what you regard as the key concerns with your MP, but there is no clear legislation in the pipeline (in fact, quite the opposite, as you’ve seen).

If you have time, there is a clear need for
organisers
. Currently there is no substantial public campaign group on the issues raised in this book. I will maintain a list of involved organisations on the Bad Pharma pages at badscience.net, but as of now, these groups are small, and focused on professions rather than patients or the public. You may wish to offer your support, financially or by cheering from the sidelines, even if you are not a healthcare professional.

Lastly, since changing laws is complex business, I would like to see work from
policy people
, wonks who know how government works, with suggestions of how some of the problems raised here could be fixed in legislation, or otherwise.

At this moment we should take a brief moment to mention quacks: alternative therapists who sell vitamins and homeopathy sugar pills, which perform no better than placebo in fair tests, and who use even cruder marketing tricks than the ones described in this book. These business people often like to pretend, with some swagger, that their trade somehow challenges the pharmaceutical industry. If they profit at all from the justified anger that people feel about the problems you have read about here, then it comes at the expense of genuinely constructive activity. Selling ineffective sugar pills is not a meaningful policy response the dangerous regulatory failure in the pharmaceutical industry.

Patients

Patients are at the centre of this story, and you are in a strong position. Firstly, I hope that you will be asked to participate in a trial at some stage in your disease: trials are the only way we have of finding out what works, they are generally safe, and they save lives. There are four simple questions you should ask about any trial you’re invited to participate in, and if you’re refused on any count, I would like to hear about it:

 
  1. Ask for a written guarantee that the trial has been publicly registered before patients are recruited, and ask where you can see it.
  2. Ask for a written guarantee that the main outcome of the trial will be published within a maximum of one year after completion.
  3. Ask for the name of the person who will be responsible for that.
  4. Ask whether, as a participant in the trial, you will be offered a copy of the report describing its results.

If you have an ongoing medical problem, there will be a patient group that covers it, run by people with patients’ interests at heart. There are problems with some of these groups, as described above, which you could address, but I would strongly encourage a different path: you can join them, and then encourage these groups to lobby the companies with which they have relationships.

For example, there is one important letter that every special-interest patient group should be sending to every drug company in the world, containing a simple query: ‘We are living with this disease: is there anything at all that you’re withholding? If so, tell us today.’ This letter serves two purposes. Thinking optimistically, it might prompt a declaration: someone might disclose trial data that they were previously withholding, and this will improve patient care. But if they don’t, and they have something they should be sharing, then you have still done something valuable: you have created anxiety; you have forced someone to attach their name to the responsibility of misleading you; and you have put a clear date-stamp on a company’s ongoing dishonesty. If a company denies withholding trial data on drugs for your disease today, in 2012, but is then caught out in 2014, and puts out a press release saying ‘Everything has changed now,’ you will know, for certain, that it was still willing to mislead and harm patients in 2012.

Patient groups

There is much more that patient groups can do, in their role as collective organisers, and I would strongly encourage these groups to meet, and consider what they can do to address the issues in this book, using the unique resources they have. At present, for example, it is nobody’s job to monitor missing trial results: so even though we have huge registries filled with details of ongoing studies, nobody is flagging up the trials which have completed, but failed to publish. We should remember that it was independent academics, investigating on a whim, who discovered that only one in five trials had met the reporting requirements of the FDA’s new law from 2007. The absence of proper, centralised compliance auditing for withheld trial results is a catastrophic failure in the information architecture of evidence-based medicine, but since it hasn’t been fixed, patient groups are in a very strong position to do the job.

They can act as observers for their own area, monitor the registers, look at the completion dates of trials, and then hunt for the publications. If researchers fail to produce results within a year, patient groups should first name them – since this carries a valuable public sting, which can change behaviour in future – then contact them, and ask for the data that will improve their members’ treatment. Patient groups are also in a strong position, with their extensive grass roots membership, to find out about trials which are being conducted, but which have not been placed on a trials register. If there are patient groups who are willing to address the problems in this book, I would be happy to work with them to help develop further interventions, as would many other doctors and academics.

Doctors

Medics, in my view, need to think and talk about these issues much more, share what they know, and act. This might mean a number of things, as discussed earlier in the book: individuals could avoid industry marketing; declare what they’ve had to their patients; decline sandwiches and free flights; and so on. They could also engage with the senior figures in their professional societies and Royal Colleges, to try and encourage them to step back from the current dangerous positions that most hold.

Medical schools

Medical schools can teach medical students about how to spot bad evidence from the pharmaceutical industry, and in particular, how its marketing techniques work. There is some evidence from the US that students taught about these techniques are better able to spot distortions in promotional material, and this deserves much more concerted work: the current generation of trainee doctors will go on to practise medicine independently for at least three decades, without any further formal teaching. If we do not future-proof them, they will be taught by industry, with the encouragement of the government and – reading the latest collaborative document – with the encouragement of every eminent medical body in the UK. If there is to be any hope of defending the medical profession against the technical distortions used as marketing techniques by industry, young doctors must be trained to identify them.

Ghostwriters

Commercial medical writers – and the International Committee of Medical Journal Editors – need to fix their ridiculous guidelines, because everybody knows that they still permit ghostwriting to happen. Commercial medical writers could organise an amnesty where they expose every paper they’ve covertly written, and every ghost author they’ve ever paid, on ethical grounds, for the protection of patients. They won’t, but they could.

Lawyers

In the US, individuals and the state are better able to take action against those who have harmed them, often reframing the issue in terms of financial fraud. Drug companies are not the only target here, and many have argued recently that ghostwritten articles also present an opportunity.
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If a patient is injured, when their doctor is relying on the content of an article that was covertly manipulated, then the commercial medical writers, the ‘ghost authors’, could be held liable. More than that, the ‘guest authors’ – the academics who allowed their names to be put onto these papers, despite minimal contribution, often in exchange for money – might also bear responsibility. If an academic paper is used by Medicare or Medicaid, in the US, to justify off-label use of a drug, but that paper subsequently turns out to be ghostwritten and distorted, then, again, the authors may be liable for this act of fraud, perpetrated on the government. There are also anti-kickback laws to consider, and a clear precedent that the First Amendment right to freedom of speech does not shield fraud. This could rapidly become an interesting avenue.

Journal editors

Journal editors are the current gatekeepers for medical evidence, and they have dropped the ball. All journals should declare their industry income, in full, and no journal should permit any trial to deceitfully switch its primary outcomes: this practice misleads doctors and harms patients. All journal articles reporting unregistered trials should state this fact clearly, and the ICMJE should publicly declare that they have failed to police this practice, so that others know to fix it properly.

The pharmaceutical industry

There is a great deal to cover here, and much has already been said in the book, but there is a special call I would like to make, to the many good people who work in industry. It’s possible for companies and professions to be structured such that good people participate in projects which overall do great harm, without necessarily ever knowing. I strongly encourage you to familiarise yourself with the activities of your company, and the real details of any legal cases brought against them, and criticisms made in the academic literature.

BOOK: Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients
3.85Mb size Format: txt, pdf, ePub
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