The pharmaceutical industry has been left to its own devices for too long and, as a consequence of this lax oversight, its influence has expanded and “a number of practices have developed, which act against the public interest.” This is amongst the stark conclusions drawn by the UK Government’s Health Select Committee’s investigation into the influence of the pharmaceutical industry. The report also claims that the current regulatory system is “at times frustrating, arguably with excessive attention to unimportant detail… [and] insufficiently effective,” and that companies are free to promote “the view that there is a pill for every ill”, with an “unhealthy reliance on, and over-use of, medicines” and “a strong and growing tendency to believe that life’s problems are best dealt with as medical conditions.”
The Health Select Committee launched an inquiry into the influence of the pharmaceutical industry last June [[21/06/04b]]. Although its 126-page report recognises that the Industry has “improved many people’s quality of life, reduced the need for surgical intervention and the length of time spent in hospital and saved many lives,” it says that the Industry has become dominated by “marketing forces” rather than science. The recent problems surrounding the COX-2 inhibitor class of pain-killing drugs [[22/02/05c]], and selective serotinon reuptake inhibitors for depression [[18/10/04b]], have served to highlight the problems, it says, adding that the UK regulator, the Medicines and Healthcare products Regulatory Agency, has failed to provide “the discipline and leadership that this powerful industry needs.”
It recommends an independent review of the body, as well as greater independence from both the government and Industry. It says that the MHRA should more closely monitor newly-approved drugs and recommends it is given the same authority to propose restrictions on drug use as it has when approving drugs.
In addition, it urges more transparency in the clinical trials process, and recommends that the MHRA work with the pharmaceutical industry and outside experts to design clinical trials that establish the real therapeutic value of new medicines using measures that are relevant to patients and public health. It heralds the arrival of the proposed clinical trials register [[07/01/05a]], but says this should be maintained by an independent body, with all information to be placed on the registry as a condition of the marketing licence.
With regard to marketing, the Committee says that “intensive marketing, which encourages the inappropriate prescribing of drugs” must be curbed. It also recommends that limits be set as to the quantity of material prescribers receive, particularly in the first six months after launch, as it believes that less experienced and non-specialist doctors are ill-equipped to cope effectively with the promotional material. “Stricter controls are needed in respect of drug company representatives’ promotion of their products to junior doctors and to nurses or pharmacists with new prescribing powers,” it says. In addition, the report calls for illegal marketing practices to be reported directly to the MHRA. Furthermore, it deems current procedures for investigating complaints about breaches of regulations as “too slow, poorly enforced and weakly sanctioned,’ and backs a major review of the investigation of complaints to ensure the process is far quicker and that effective sanctions are enforced. It also recommends a public inquiry whenever a product is withdrawn on health grounds, and calls for “a systematic review of so-called evergreening and other practices that impede the entry of generic drugs on to the market” to ensure a healthy generics market.
However, UK Industry body, the Association of the British Pharmaceutical Industry, slammed what it terms “a number of fundamental misconceptions” within the committee’s report. For example, the report claims that drug consumption is rising in the UK, but the ABPI asserts that the UK remains bottom of the European league in spending per head on medicines. Furthermore, it says that intensive marketing does not encourage inappropriate prescribing, as doctors receive only a handful of visits in a month, and the majority say they value the clinical and product information provided.
In addition, the ABPI asserts that artificially limiting the ability of doctors to receive information about medicines and restricting further their ability to prescribe medicines already licensed for use “would be a step backwards in the National Health Service’s bid to prevent disease and raise access to best quality treatment.”