Bad Pharma? Better laws needed

Paul Gershlick

Matthew Arnold &amp, Baldwin LLP

Paul Gershlick of Matthew Arnold &amp, Baldwin LLP discusses topics from Ben Goldacre’s recent book, Bad Pharma, and what changes ought to be made in order to achieve true transparency in the pharmaceutical industry.

I have finished reading Ben Goldacre’s Bad Pharma book. I strongly recommend it. Whether you agree or disagree with some or all of his views, you cannot be in this sector without having an opinion and needing to know or be able to counter any of the issues that he raises. What he says will shape the debate in the coming months. And I hope that means stricter laws and regulations too.

There is one key paragraph in his book that should concern anyone who wants to see the pharma industry do good, albeit whilst making money at the same time:

“Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques which are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer. When trials throw up results that companies don’t like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug’s true effects. Regulators see most of the trial data, but only from early on in a drug’s life, and even then they don’t give this data to doctors or patients, or even to other parts of government. This distorted evidence is then communicated and applied in a distorted fashion. In their forty years of practice after leaving medical school, doctors hear about what works through ad hoc oral traditions, from sales reps, colleagues or journals. But those colleagues can be in the pay of drug companies - often undisclosed – and the journals are too. And so are the patient groups. And finally, academic papers, which everyone thinks of as objective, are often covertly planned and written by people who work directly for the companies, without disclosure. Sometimes whole academic journals are even owned outright by one drug company. Aside from all this, for several of the most important and enduring problems in medicine, we have no idea what the best treatment is, because it’s not in anyone’s financial interest to conduct any trials at all. These are ongoing problems, and although people have claimed to fix many of them, for the most part they have failed, so all these problems persist, but worse than ever, because now people can pretend that everything is fine after all.”

That is a summary of Goldacre’s key ideas from his book in one paragraph.

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"What he says will shape the debate in the coming months. And I hope that means stricter laws and regulations too."

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It’s time for the pharma industry to put patient before profit. Without exception. There should never be a situation allowed where pharma businesses can make money by being knowing or reckless as to whether (a) it costs healthcare purchasers (such as the National Health Service) money that would otherwise be used on better treatment (because there is always an opportunity cost) if they knew how ineffective the particular medicines were, or (b) worse still, their medicines were making people’s lives worse rather than better.

I appreciate that there are grey areas where you have to weigh up benefits against costs and risks. But there are also black and white occasions where pharma businesses may be aware of the damage that their drugs do and do not disclose this, because the rules allow them not to. If pharma suppliers are not going to voluntarily disclose information that will lead to less revenues, then they should be compelled to do so.

I am not going to focus here on all of the claims that Goldacre makes in his book.

What I wish to see is total transparency. But unlike the sort of “transparency” that applies to some patient information leaflets with meaningless details of general side effects that are always quoted - such as “may cause drowsiness, sickness, diarrhea, headaches, etc” – I mean true transparency, where there is lots of information presented in a meaningful and accessible way. Data and information should be used to cast light, not obfuscate.

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"It’s time for the pharma industry to put patient before profit. Without exception."

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As a lawyer who practises in both pharma and IT, I see great strides in convergence between those two areas. In particular, data and the way it is presented could be used in such a better way in this “information age”.

What sort of transparency do I wish to see the law require?

• Publication and disclosure of all clinical trial data, regardless of whether the results are helpful or not to the trial sponsor.

• Clear percentages of likely improvements and side-effect risks, available to all – i.e. to regulators such as the MHRA and NICE, to doctors, pharmacists and patients.

• Ensure the trials compare new drugs to other similar drugs, rather than placebos.

• Show data for each of the benefits and side effects separately (rather than something more bland such as a “10% reduction in symptoms”).

• Publish the extreme effects of the drugs and not average results that can mask the extremes.

• Publish drop-out rates of participants in trials and explanations for them dropping out.

• Disclose on an on-going basis any known side effects that may apply to particular groups of people, such as children, even if the marketing authorisation licence does not cover those people, as drugs may be prescribed to them in an unlicensed basis.

• Publish the names of all writers of articles on drugs, including any ghostwriters, and whether they have been or are being paid by any pharma suppliers.

• Enable data to be readily updated through clearer pharmacovigilance programs, so that doctors and indeed patients have easier ways of recording side effects. This data needs to be carefully managed to avoid fraud, mistake and to take account of people’s other conditions.

• Ensure that if trials are stopped because of adverse consequences, those results are also published with explanations.

• Forbid gagging clauses from anyone involved in clinical trials.

These measures should have the full force of the criminal law and be agreed and applied internationally, so that no one country suffers because they are encouraging more ethics than another.

Ben Goldacre has raised some important issues. But he does not attack people generally in the industry. He is very clear to point out: “I suspect most of the people who work in this industry are fundamentally good-hearted, and there is no medicine without medicines. Drug companies around the world have produced some of the most amazing innovations of the past fifty years, saving lives on an epic scale.”

It is that consequence which I want people to see more of – and not the terrible practices that the currently weak law allows to exist, to patients’ detriment.

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