Pharma in the dock The case for the prosecution goes: large pharmaceutical companies are raking in huge sums of money, peddling drugs and devices to the ‘consumer’ at extortionate costs. Worse still, the voluntary code of practice and current regulatory bodies do not appear to be sufficiently robust to prevent unsafe drugs from being marketed for public use. How many times have you heard this? Have you noticed how frequently and ferociously this battle is raging in the corridors of hospitals, government buildings and research laboratories? It appears that pharma is once again under attack from various institutions and groups, some of which are having a significant impact on public perception. The case for the defence goes: researching molecules for new life-saving treatments requires millions of pounds of investment. Given that only one or two molecules will make it to the shelf, the cost of that product requires profit to make up for all the unsuccessful research. Once it is licensed and available, marketing and advertising are needed to ‘brand’ the molecule for prescribers and influencers, as the time available to reap profits is limited by patent laws that eventually allow generic manufacturers to ‘copy’ the end product of significant investments. Furthermore, the pharma industry contributes not only to research and development, funding of disease treatments and healthcare infrastructure, but to the economy as a whole. To shoot the industry would be to shoot our economy and healthcare – for without pharma there would be no treatments. And without treatments there would ultimately be no hope. The clouds gather I used to find it easier to give prescribing advice. I suspect prescribing itself was easier in the past. Now there are more complexities. The number of influences on my view of clinical data will be altered by edicts from significant organisations and authorities. So whereas, say, ten years ago I would look at the evidence from a clinical trial, take note of what the company was saying and then look at cost-effectiveness, I now need to include the following in the equation: • NICE (opinion, recommendation, guidance, avoidance, outright ban) • MHRA (warnings, safety, doubt, further decisions, fear, worry, anxiety) • EMEA (rules and regulations, licencing, data, member states not agreeing) • FDA (licensing, as for EMEA but can affect decisions in UK) • SMC (yet to make a decision that conflicts with NICE) • NSF (service delivery, standards, priorities, support of non-drug approaches) It’s not surprising that Area Prescribing and Drugs and Therapeutics Committees all over the country are having considerable difficulty in assessing new medicines in a rational way. In fact, there has been significant concern that issues affecting postcode prescriptions are still creating a lottery for the availability of a variety of treatments, including cancer chemotherapies. Surviving the storm How do pharmaceutical companies deal with these issues? It is difficult to promote a drug when a public campaign or MHRA warning is recommending a negative view, causing public confidence in the product to wane. Sales reps and pharmacists are both caught up in this. Pharmaceutical companies are struggling in two ways: how does the head office come up with rapid responses to negative recommendations that would reduce the impact of sales materials and campaigns; and how can this strategy best be put across to the pharmacist? It’s not an easy task. I have just read a warning on your product, and you want to see me in order to counter the effect of the warning! The MHRA Created on April 1 2003, the Medicines and Healthcare products Regulatory Agency consisted of a merger of the MCA (Medicines Control Agency) and the MDA (Medical Devices Agency). In general, while medicines are perceived clearly, the nature of ‘devices’ is less well understood. They range from inhalers, needles and syringes to breast implants and tongue depressors. Since its inception, significant criticism has been levied against the MHRA. The MHRA has its own targets and quality standards for decision making. They are certainly trying to improve their communications: their annual report has emphasised the need to enhance the tone of the group’s reporting. Now I am seeing communications as never before, with the MHRA not only producing new bulletins, warnings and safety alerts on a regular basis but also trying to reach out to patients and pharmacists, asking them to give “help and assistance” and to be “proactive” in reporting side-effects, problems and issues surrounding medicines that are in the public interest. They have recently come under criticism for their dual role: protecting the public and preserving the interests of the pharmaceutical industry (which provides most of the funding for the MHRA). One can see how their independence would come under scrutiny. Which way the wind blows For once, the Matrix is unsure. What will happen from here on? Will the public interest be served? Perhaps more importantly, will this be the perception that is created? How will pharma prepare itself for an MHRA warning to tell parents and patients of the risk of liver failure that occurs in 1/50,000 users of a drug? Only one thing is certain. The climate will change . . . and so will you and I. Keep an eye on the weather.
|OMAR ALI is the Formulary Development Pharmacist for Surrey and Sussex Healthcare NHS Trust and is a PCT Formulary Adviser to 2 PCTs. He is a lecturer on the MSc on Pharmacy Practice at Portsmouth University and is also an adviser to three Drugs and Therapeutics Committees in the South of England. Omar is a National Speaker in the UK (cardiovascular, diabetes, mental health) and is an Executive Board Member for the National Obesity Forum. He can be reached directly on ‘firstname.lastname@example.org’|