Generic drugs: protest group was not quite what it seemed

By Margaret McCartney, general practitioner, Glasgow, and Financial Times columnist

margaretmccartney@doctors.org.uk

Last month the Times published a letter from doctors and patients’ groups warning against generic drugs and supporting branded prescribing. But who was really behind the protest? Margaret McCartney investigates

Generics are good for us. That’s the mantra that is taught to doctors again and again: they are cheaper for the NHS but just as effective for the patient. So it was surprising to find a letter in the Times recently, signed by several doctors, decrying generics and pleading for doctors’ choice to prescribe branded drugs to be paramount. The letter, titled "Patient wellbeing at risk from substituted generic medicines," was also signed by patients’ groups such as the Cure Parkinson’s Trust and the British Liver Trust and carried the names of the media doctor Patricia Macnair, Stephen Kownacki, chairman of the Primary Care Dermatology Society, and Jean Mossman, former chief executive of Cancer BACUP (www.timesonline.co.uk/tol/comment/letters/article7037957.ece).

The letter was a response to the Department of Health’s current consultation on prescribing, which proposes an automatic generic substitution scheme (BMJ 2010;340:c135, 8 Jan, doi:10.1136/bmj.c135). The consultation aims to find acceptable ways to reduce prescribing of branded drugs in the NHS, such as by allowing pharmacists to substitute generics in certain classes of drugs, such as statins, even when a brand has been prescribed. This, the consultation suggests, would save money without compromising the safety of patients or effectiveness of the treatment. However, there is evidence that certain branded drugs, such as treatments for epilepsy, should not be changed, and the consultation does recognise that prescribers may need to state that they do not want a switch to a generic. This seems reasonable, and we could exclude some groups of drugs altogether from a substitution scheme. So what’s the problem?

Generic drugs are a threat to many parts of the industry. The European Court of Justice has recently said that drug switching incentive schemes, whereby general practices are paid to switch patients from more expensive to less expensive drug equivalents, often generics, are, in its opinion, illegal. This opinion is subject to appeal and needs to be ratified by the UK High Court, but the Association of the British Pharmaceutical Industry, which brought the case, is clearly sensing a squeeze on the branded drugs market.

Far from being a spontaneous protest from a group of patients and healthcare professionals, however, the Times letter was coordinated by Burson-Marsteller, a public relations company (which advertises itself, interestingly, as "evidence-based communications") that was employed in this task by Norgine, a relatively small drug company. It seems that Burson-Marsteller searched the literature, particularly free journals funded by pharmaceutical advertising, for articles written in support of prescribing of branded drugs. These authors were then invited to sign a letter protesting against generic substitution. It is, however, notable that Peter Martin, the chief operating officer of Norgine, despite being the major influence behind the campaign, did not add his name to the list of signatories. That seems to be a lack of transparency. Why didn’t he add his name? "There was no conspiracy," he explains. "The frank truth, the honest truth, is that I thought that having a pharmaceutical company in there would sully the message somewhat. It shouldn’t, but I thought it could."

Norgine organised a paper to be written by a PhD writer from the PR company last year in response to the health department’s proposals on pharmaceutical pricing, and it was this document that was used initially to gather support. Mr Martin believes that his company would be under direct threat as a result of increased use of generics. He offers the hypothetical example of testing Movicol (a macrogol), one of Norgine’s products, for a new use, such as irritable bowel. "So we do a double blind trial, we register the trial, we do it by the book. And then, say our product works, we have a new indication on the licence. But we wouldn’t do it. We would have no incentive." If a cheaper generic equivalent could be had, the risk is that Norgine would not recoup its expenses in setting up the trial.

David Candy has done research with Norgine on constipation in children. As a consultant paediatrician he believes that branded drugs have a role in this area. "We worked very carefully with Norgine," he says, "to get things right for patients. For example, we used chocolate flavouring, and the paediatric Movicol doesn’t say ‘for constipation’ on the box, because children told us that they found it embarrassing, for example on sleepovers."

Certainly it is important that drugs are acceptable and palatable to patients, but this may also be seen as a failure of generic versions to compete properly. And while it is legitimate to be concerned that patients are happy with their drugs, it seems reasonable also to ask how much the drug industry is allowed to press for non-generics. The Cure Parkinson’s Trust, the Primary Care Dermatology Society, and the British Liver Trust, for example, have all received funding from various drug companies. Some of the doctors who signed the letter have also advised drug companies or received research funding from them.

If freedom to prescribe less cost effective drugs is of such importance to grassroots doctors and patients, why did an anti-generics campaign have to be coordinated by a drug company at all?

Cite this as: BMJ 2010;340:c1514